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For Standard Length IBR36d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

When using Southern Implants' Standard Length IBR36D Implants with angulation of 36° a minimum of 4 implants must be used and splinted

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR36d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Extra Length IBR36d Implants can be placed bicortically in cases of reduced bone density. Extra Length IBR36d Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Extra Length IBR36d Implants are indicated for surgical installation in the pterygoid region only, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

For Extra Length IBR24d Implant Range:

Southern Implants' External Hex Implants are intended for surgical placement in the upper jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

Southern Implants' Extra Length IBR24d Implant Range when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

The angled Co-Axis External Hex Implants are intended to be used with straight multiple-unit abutments (Compact Conical abutments) only with no additional angulation allowable on the restoration.

External Hex implants are fully-threaded, tapered, root-form dental implants with an external hexagonal abutment interface, and are threaded internally for attachment of mating multiple-unit abutments, cover screws, or healing abutments. The External Hex implants have a Co-Axis design with the prosthetic platform angled at 36° and 24° (inclined) from orthogonal to the long axis of the implant.

Additionally, the External Hex implants are provided in two configurations, regular surface and MSC surface implants. The regular surface implants are fully roughened excluding a machined collar at the coronal aspect of the implant. The MSC surface implants have an extended length of machined area at the coronal aspect of the implant, with the remaining implant length being roughened.

The implants subject to this submission are the External Hex IBR36d and IBR24d implant range. The reduced platform MSC-IBR24d implants are only provided as Co-Axis implants, in both the regular surface and MSC surface configuration. The reduced platform IBR36d implants are only provided as Co-Axis implants, in regular surface configuration. The IBR36d implants are available in two body configurations depending on the implant length.

The IBR36d implants of overall lengths 8.5 mm to 18 mm have a major body diameter of 4.20 mm tapering to 2.60 mm. The IBR36d implants of overall lengths 20 mm to 24 mm have a major body diameter of 4.20 mm tapering to 2.00 mm. Both the IBR24d and MSC-IBR24d implants of overall lengths 20 mm have a major body diameter 4.07 mm tapering to 2.60 mm. All of the subject device implants utilize the same prosthetic connection, previously cleared in K163634.

All External Hex implants are manufactured from unalloyed titanium (cold-worked, grade 4, UTS ≥ 900 MPa). The MSC-IBR24d implants have a smooth machined surface of length 3 mm extending parallel from the implant prosthetic platform for all implant lengths. The remainder of the implant is grit-blasted with aluminum oxide particles to provide a surface roughness of 1-2 um. The subject device implant material and surface are identical to those of the implants cleared in K163634.

The IBR36d and IBR24d External Hex implants are provided with a dedicated pre-mounted fixture mount of 36° and 24 respectively, similar to that provided with the other Co-Axis External Hex implants cleared in K163634.

All of the subject device implants utilize the same prosthetic connection, previously cleared in K163634 for the External Hex IBR24d and MSC-IBR24d implants. The External Hex implants are used in conjunction with the same abutments cleared for use with the External Hex IBR24d implants (implants cleared in K163634). These abutments are cleared in K053478, K070841, K093562, and K163634. The components that are compatible with the External Hex implants include Cover Screw, Healing Abutment, and Compact Conical Abutments. The Compact Conical Abutments are compatible with Temporary Titanium Abutment Cylinders, Gold Abutment Cylinders, and Passive Abutments.

The subject device Co-Axis implants are indicated for use with straight multiple-unit abutments with a 0° allowable restoration angle, only. This includes restricting straight abutments, that can be restored on a multi-unit abutment, that have an allowable restoration angle of up to 20° associated with them, so that they may only have a restoration angle of 0°. Thus, all the possible compatible abutments will have a 0° allowable restoration angle.

All External Hex implants are provided sterile to the end-user in a single-unit package, and are for single-patient, single-use only.

The provided text describes the 510(k) summary for the "External Hex Implant System" and references performance data to support its substantial equivalence to legally marketed predicate devices. However, it does not contain explicit "acceptance criteria" for the device, nor a study design with specific performance metrics against those criteria in the way typically seen for AI/ML device evaluations.

Instead, the document focuses on demonstrating substantial equivalence based on non-clinical performance data (mechanical testing and biocompatibility) and clinical literature review. The clinical literature review is used to show that similar devices with comparable characteristics (e.g., angulation, length) have proven safe and effective.

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance with specific metrics like sensitivity, specificity, or AUC, as these are not defined or reported in the provided text. The "performance" discussed relates to the device's mechanical strength and the success rates of similar implants documented in clinical literature, not an AI algorithm's diagnostic performance.

However, I can extract the relevant information regarding the studies referenced to support the device's safety and effectiveness, interpreting "acceptance criteria" as the demonstration of substantial equivalence through various assessments:

Interpretation of "Acceptance Criteria" for this device:

For this device, "acceptance criteria" are not quantitative performance metrics in the traditional sense for diagnostic AI. Instead, they are met by demonstrating the device's substantial equivalence to legally marketed predicate devices through:

• Biocompatibility: Conformance to ISO 10993-1.
• Mechanical Performance: Conformance to ISO 14801 (static and dynamic compression-bending fatigue test), with results showing sufficient strength for intended use.
• Sterilization: Conformance to ISO 11137-1, ISO 11137-2, and USP 39-NF 34 for bacterial endotoxin.
• Dimensional Analysis: Verification of critical dimensions.
• Clinical Safety and Performance (via Literature Review): Demonstrated favorable survival rates and clinical indices for comparable implants under similar conditions and specifications (length, angulation, loading protocols). This implicitly acts as an "acceptance criterion" for clinical effectiveness by showing established safety and effectiveness of similar devices.
• MR Safety: Conformance to FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (ASTM F2503, ASTM F2013, ASTM F2182, ASTM F2119).

Summary of Information from the Provided Text:

1. Table of "Acceptance Criteria" (interpreted as equivalence demonstration points) and "Reported Device Performance":

| Area of "Acceptance Criteria" (Demonstration of Equivalence) | Reported Device Performance / Evidence |
| Biocompatibility | Evaluated according to ISO 10993-1 (referenced from K163634). |
| Mechanical Performance (Static & Dynamic Compression-Bending) | Testing to ISO 14801 was performed on representative worst-case constructs for angulation and abutment/screw materials. Twelve (12) samples for each subject device group were subjected to fatigue testing. The fatigue limit was determined to be where a total of three (3) samples endured 5 x 10^6 cycles with no failures. Results confirmed that the strength of the subject device is sufficient for its intended use. |
| Sterilization & Shelf Life | Sterilization according to ISO 11137-1, ISO 11137-2. Bacterial endotoxin according to USP 39-NF 34. Sterile barrier shelf life (referenced from K222457). |
| Dimensional Analysis | Performed. (No specific values reported in this section, but implied to meet design specifications). |
| Clinical Safety & Performance (Standard Length IBR36d) | Retrospective analysis of real-world clinical data (literature review). The literature review demonstrated that implants with lengths of 7-18mm and angulation range of 20-50° as part of a splinted approach showed similar success rates to standard implants. Survival rates and clinical indices were favorable in both maxillary and mandibular applications, with immediate and delayed loading protocols. The subject device (8.5-18mm lengths, 36° angle) falls within this "window of successful implants." |
| Clinical Safety & Performance (Extra Length IBR36d) | Retrospective analysis of real-world clinical data (literature review). The literature review supported the use of long implants (10-25mm) placed at angles of 15-90° in the pterygoid region, showing similar success rates to standard implants. The subject device (20-24mm lengths, 36° angle) falls within this "window of successful implants." |
| MR (Magnetic Resonance) Safety | MR safety testing (ASTM F2503, F2013, F2182, F2119) was performed on previously cleared devices (referenced from K222457). The subject devices are considered equally MR Safe as the predicate devices because they are not worst-case components in terms of material, size, or shape. |

2. Sample Size and Data Provenance for Test Set (Clinical Literature Review):

• Standard Length IBR36d: A retrospective analysis of real-world clinical data was conducted by reviewing 14 clinical literature articles.

  • Sample Size (Patients/Implants, per article):
    • Article 1: Not specified, but follow-up up to 17 years.
    • Article 2: Not specified (100% survival rate), follow-up 3 years (42 months).
    • Article 3: Not specified (98.7% survival rate), follow-up 3 years.
    • Article 4: Not specified (96.1% and 95.7% survival rates), follow-up 5 years.
    • Article 5: "High level of implant failures (10%), however; the same number of tilted implants and straight implants failed." Follow-up 1 year.
    • Article 6: Not specified (96.6% survival rate), follow-up 5 years.
    • Article 7: Not specified (94.5% survival rate), follow-up 7 years.
    • Article 8: Not specified (94.8% survival rate), follow-up 10 years.
    • Article 9: Not specified (98.1% for tilted implants), follow-up 3 years.
    • Article 10: Not specified (93.9% cumulative survival rate), follow-up 5-13 years.
    • Article 11: Not specified (93% survival rate), follow-up 18 years.
    • Article 12: Not specified (100% survival rate for tilted implants), follow-up 13 months.
    • Article 13: Not specified, follow-up 3 years (42 months).
    • Article 14: Not specified (100% survival rate), follow-up 3 years (42 months).
    • Note: Specific sample sizes (number of patients or implants) for each referenced article are generally not provided in the summary, which is common for literature reviews used in 510(k) submissions to support equivalence.
  • Data Provenance: Retrospective analysis of real-world clinical data (published literature). The country of origin of the data is not specified for individual studies but can be inferred from the journal names and author affiliations in the references (e.g., Clinical Oral Implants Research, Odontology, Journal of Oral Implantology, Clin Implant Dent Rel Res, European Journal of Oral Implantology, The Journal of the American Dental Association, Dentistry Journal).

• Extra Length IBR36d: A retrospective analysis of real-world clinical data was conducted by reviewing 5 clinical literature articles.

  • Sample Size (Patients/Implants, per article):
    • Article 1: "Many authors have reported success rates of pterygoid implants ranging from 90% to 100% after follow-up period ranging from 1 to 12 years."
    • Article 2: "Thirteen articles were included, reporting a total of 1053 pterygoid implants in 676 patients."
    • Article 3: "121/125 of the implants were considered successful" after 2 years.
    • Article 4: "A total of 634 patients received 1,893 pterygoid implants."
    • Article 5: Not specified (93.9% survival rate), follow-up 3 years.
  • Data Provenance: Retrospective analysis of real-world clinical data (published literature). The country of origin of the data is not specified for individual studies but can be inferred from the journal names and author affiliations in the references (e.g., International Journal of Contemporary Dental and Medical Reviews, Journal of Oral Implantology, Dent Adv Res, Journal of Craniomaxillofacial Surgery, International Journal of Oral Maxillofacial Implants).

3. Number of Experts and Qualifications for Ground Truth: No direct "ground truth" establishment by experts for specific cases in the context of an AI algorithm is mentioned in this document. The clinical studies cited in the literature review represent real-world clinical outcomes and expert clinical practice by the authors of those papers. Their original reports would have involved clinical expertise to determine success/failure, bone loss, etc.

4. Adjudication Method: Not applicable. This document relies on published clinical literature, not an internal test set requiring adjudication for ground truth. The adjudication method, if any, would have been part of each individual study in the literature review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This document does not pertain to an AI algorithm or human-in-the-loop performance. It describes a physical dental implant device.

6. Standalone (Algorithm Only) Performance Study: No. This document describes a physical dental implant device, not an algorithm.

7. Type of Ground Truth Used (for Clinical Performance): The "ground truth" for the clinical performance claims is derived from real-world clinical outcomes data reported in the referenced scientific literature. This includes:
* Implant survival rates
* Marginal bone loss (MBL)
* Clinical indices (e.g., pain, prosthetic mobility, bleeding, discomfort)
* Success rates of implants under various loading protocols (immediate/delayed) and angulations.

8. Sample Size for the Training Set: Not applicable. This document describes a physical dental implant system, not a machine learning model that requires a training set. The "training" for the device's design would be engineering principles, material science, and clinical experience/literature.

9. How the Ground Truth for the Training Set was Established: Not applicable, as it's not an AI/ML device.

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For the implants:

The Single Platform SP1 Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Single Platform SP1 Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.

The Single Platform SP1 implants in lengths 20, 22 and 24 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.

For the conventional abutment and screws:

The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous maxilla and/or maxilla and/or mandible to provide support for crowns, bridges or overdentures.

For the Titanium Abutment Bases and Passive Abutments:

The TIB and Passive Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB and Passive abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

For the Temporary Titanium Cylinders:

The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

This submission includes fully threaded root-form dental implants with an internal cone and hexagon interface and mating abutments. The implants are provided in three diameters: Ø3.5, Ø4.0 and Ø5.0 mm. The implants are provided in a straight (0° angled) configuration only, with a 3.0 mm extended machined coronal section. The implants are provided in one prosthetic diameter (2.95 mm implants are provided in overall leneths of 8, 10, 11.5, 13, 16, 18 and 20 mm. The Ø4.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, 18, 20, 22 and 24 mm. The Ø5.0 mm implants are provided in overall lengths of 8, 10, 11.5, 13, 16, and 18 mm.

This submission also includes: a Cover Screw, Healing Abutments in four diameters and multiple gingival heights, Titanium Cylinder Abutments for temporary restorations, Passive Abutments with a plastic burn-out component, Equator Overdenture Abutments in multiple gingival heights, Compact Conical Abutments in straight (0) and angled (17° and 30°) designs, TIB Abutment Bases, and abutment screws.

The Passive Abutments may be restored using either traditional cast-on workflows or digital CAD/CAM workflows using milled zirconia restorations (similar use to the TIB Abutment Bases).

Using the traditional cast-on workflow, the Passive Abutments function as UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment, limited to a straight (0°) restoration when utilizing precious metal cast-on restorations.

Using digital CAD/CAM workflows, the TIB Abutment Bases and Passive Abutments function as two-piece abutment designs, consisting of standard premanufactured titanium alloy abutments for supporting the second half (or top-half) of the abutment, a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB Abutment Bases and Passive Abutments then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Bases and Passive Abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx Zirconia), which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration and a maximum allowable angulation of 20° for the mesostructured component.

All Single Platform SP1 implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (extended machined surface of 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K222457 and K163060. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K222457 and K163060.

The provided text describes a 510(k) premarket notification for the "Single Platform SP1 Implant System." This document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a clinical study or a standalone algorithm performance test.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical performance with statistical measures, expert reading, and ground truth establishment is not present in the provided document. The 510(k) pathway for medical devices typically relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring new clinical efficacy studies unless there are significant technological differences or new intended uses that raise new safety or effectiveness questions.

The "Performance Data" section explicitly states: "No clinical data were included in this submission."

However, I can extract information related to the non-clinical performance data provided to support substantial equivalence and the device's characteristics compared to predicates.

Here's a breakdown of what is available:

1. Table of Acceptance Criteria and Reported Device Performance:
The document does not define specific "acceptance criteria" for clinical performance (e.g., sensitivity, specificity, accuracy) or report device performance against such metrics. Instead, it demonstrates through non-clinical testing that the device's mechanical, material, and functional properties are substantially equivalent to marketed predicate devices.

Here's a table summarizing the non-clinical performance data and findings:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of clinical efficacy; the "test set" here refers to the non-clinical testing of the physical device. For example, "dynamic compression-bending testing was performed on worst-case subject device constructs." The exact number of constructs tested is not specified but would be dictated by the ISO standard.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data directly, but the manufacturer is Southern Implants (Pty) Ltd from Irene, Gauteng, SOUTH AFRICA. The data is retrospective in the sense that it supports a submission for a new device, often using internal lab data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not applicable as no clinical study with human readers or ground truth established by experts for diagnostic performance was conducted or reported.

4. Adjudication Method for the Test Set:

• Not applicable, as there was no human reader interpretation or clinical assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical data were included in this submission." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.

6. Standalone (Algorithm-Only) Performance:

• Not applicable. This is a physical dental implant system, not an AI algorithm. The only "software" mentioned is for design (CAD/CAM workflow), and its validation is to ensure it prevents designs outside of allowable limitations.

7. Type of Ground Truth Used:

• For the non-clinical performance data, the "ground truth" is established by adherence to recognized international standards (ISO, ASTM, USP) and internal engineering specifications. For instance, the "ground truth" for fatigue performance is the passing criteria defined by ISO 14801.

8. Sample Size for the Training Set:

• Not applicable. This product does not involve machine learning or AI models that require a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as there is no training set for an AI/ML model.

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The Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The ASC Solution Abutments and SI-BASE Abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.0 External-Hex implants, Ø3.3 PROVATA implants and Ø3.5/Ø4.0 Deep Conical implants are intended for use with a straight mesostructure component.

The intended use for the engaging ASC Solution Abutments and SI-BASE Abutments used with the Ø3.4 and Ø4.0 External-Hex implants. PROVATA implants and 03.5 and 04.3 TRI-NEX implants is limited to replacement of maxillary and mandibular lateral and central incisors.

The ASC Solution Abutments and SI-BASE Abutments for Compact Conical Abutments are intended for use on straight Compact Conical Abutments with a straight mesostructure component.

This submission includes two major components which make up the ASC Solution and SI-BASE Abutments - The ASC Solution and SI-BASE Abutment Base and the mesostructure restoration. Twopiece and three-piece abutments models are included. Two-piece abutments consist of the ti-base abutment and mesostructure. Three-piece abutments consist of the ti-base abutment, mesostructure, and compatible compact conical abutments.

The ASC Solution and SI-BASE Abutments are standard premanufactured titanium alloy abutments for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The ASC Solution and SI-BASE Abutments then serve as the interface between the endosseous implant and the zirconia restoration. The abutments are designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The ASC Solution and SI-BASE Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The abutments are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by Titanium nitride coating (ASC Solution Abutments) or yellow anodizing (SI-BASE Abutments). The TiN coating and anodization processes are the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Intra-oral scanner: 3Shape E3 Desktop Scanner
• Abutment design software: 3Shape Abutment Designer Software (K151455)
• Milling machine: Roland DWX51D Milling Unit

The provided text describes the Angulated Screw Channel (ASC) Solution Abutments and SI-BASE Abutments for dental implants. The document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner with defined thresholds. Instead, it demonstrates compliance through comparison to predicate devices and adherence to relevant standards and guidance documents. The "reported device performance" is largely qualitative and comparative, focusing on demonstrating equivalence rather than meeting specific numerical performance targets.

However, based on the "PERFORMANCE DATA" section and "Table of Substantial Equivalence", we can infer the following:

2. Sample sizes used for the test set and the data provenance

• Sample Sizes for Test Set:
  • Biocompatibility: Not explicitly stated as a number of devices. The statement mentions "materials are identical in formulation, processing, component interactions, and storage conditions to the predicate device" and "biocompatibility testing per the FDA Guidance Document for Use of Standard ISO 10993-1... and ISO 10993-5 'Biological Evaluation of Medical Devices - Part 5: Tests for In-Vitro Cytotoxicity' was performed." This implies biological samples were used for in-vitro cytotoxicity, but the number is not specified.
  • Mechanical Performance (Fatigue): "Dynamic testing was performed on worst-case subject device constructs." The exact number is not provided, but typically, mechanical fatigue testing involves a statistically significant number of samples per "worst-case construct" to establish fatigue limits.
  • Software Validation: Not explicitly stated as a numerical sample size. It involved verification and validation for the "abutment design library" and screenshots under user verification testing, indicating a functional test rather than a numerical sample size.
  • MR Safety: Not explicitly stated for the subject device. It refers to testing performed on "previously cleared devices, K222457, PROVATA Implant System."
• Data Provenance: Not explicitly stated for any of the tests. Given it's a 510(k) summary, the testing was likely conducted by or on behalf of Southern Implants (Pty) Ltd, which is located in "Irene, Gauteng, 0062 South Africa." The studies appear to be non-clinical (bench testing) and retrospective in the sense that they rely on comparisons to previously cleared devices and established standards, rather than new prospective human clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies described are primarily non-clinical bench testing, software validation, and biocompatibility assessments, which typically do not involve establishing "ground truth" through expert consensus in the way a diagnostic AI device would. Instead, performance is measured against engineering specifications, standards (like ISO 14801), and equivalence to predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable to the types of non-clinical, hardware-focused studies described. Adjudication methods are typically used in clinical studies or studies evaluating subjective interpretations (e.g., image reading) to establish a consensus ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study and no mention of AI assistance. This device is a component for dental implants (abutments), not a diagnostic AI system or an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical medical component (dental abutment) and related software for design. While software validation was performed, it's for design limitations and functionality, not for an "algorithm only" performance in a diagnostic or interpretive sense. The "standalone" concept typically applies to AI algorithms that provide a diagnosis or interpretation without human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as it applies to diagnostic or prognostic data is not directly applicable to these non-clinical studies. Instead, the "truth" or reference for the tests described is:

• Biocompatibility: Established biological safety standards (ISO 10993-1, ISO 10993-5) and comparison to predicate device materials.
• Mechanical Performance: International standard ISO 14801 for dynamic fatigue testing of dental implants and abutments. This involves objective physical measurements.
• Software Validation: Functional specifications of the software and demonstration that defined design limitations are enforced.
• MR Safety: FDA guidance document recommendations and physical testing methods to determine MR compatibility.

8. The sample size for the training set

This information is not applicable. This device is not an AI diagnostic or predictive algorithm that requires a training set in the conventional sense. The "design workflow" involves CAD/CAM software but this refers to a process for custom fabrication, not machine learning model training.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

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The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.

The intended use for the TiB narrow abutments used with the Ø3.0 mm External hex and Ø3.0 mm Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular lateral and central incisors.

The Narrow TIB Abutment bases are standard premanufactured titanium allov abutments for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The DC Ø3.0mm Narrow TiB abutments are only to be placed straight in the patient. Occlusal loading forces are only to be applied through the central longitudinal axis of the implant body.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The subject Narrow TIB Abutments are compatible with the Southern Implants' Deep Conical and External Hex implants and screws. The subject TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K193084. The mesostructured restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Intra-oral scanner ●
• . Lab scanner: 3Shape E3 Desktop Scanner (3Shape A/S)
• Abutment design software: 3Shape Abutment Designer Software (K151455) ●
• Milling machine: Roland DXW51D ●

This is a summary of the provided text regarding the TIB Abutments.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for the subject device. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of the subject device (TIB Abutments) with primary and reference predicate devices. The implicit acceptance criterion is that the subject device's performance, as demonstrated by the listed tests and comparisons, is equivalent to the predicate devices.

Here's a table comparing the subject device's characteristics to the primary predicate, which serves as the basis for demonstrating equivalence:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily relies on non-clinical performance data for mechanical fatigue testing (ISO 14801).

• Sample size: The specific sample size for the dynamic fatigue testing is not provided in the summary. It states "Dynamic testing was performed on worst-case subject device constructs." This typically implies multiple samples were tested to statistical confidence.
• Data provenance: The document does not explicitly state the country of origin of the data for the performance tests, nor whether it was retrospective or prospective. Given that this is a 510(k) submission for a South African company, it is likely the testing was conducted at a certified lab, possibly in South Africa or internationally, to ISO standards. The type of testing (mechanical fatigue) is inherently prospective in its execution (i.e., new tests are run on new devices).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a physical dental implant component, not a diagnostic AI system or image analysis tool. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy or clinical interpretation is not applicable here. The "ground truth" for this device's performance is established by engineering tests and material science standards, such as ISO 14801 for mechanical fatigue.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a diagnostic device involving human interpretation that would require an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical dental implant component, not a diagnostic or AI-assisted device. No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or software-only device in the context of a diagnostic or interpretive tool. The "digital dentistry workflow" involves software (3Shape Abutment Designer Software) but it's for design and manufacturing, not standalone diagnostic performance. Software validation was referenced from K193084.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the TIB Abutments is based on:

• Compliance with material specifications (e.g., Titanium Grade 5 Alloy (ASTM F136), Zirconia - Sage Maxx NexxZr).
• Performance against international engineering standards (e.g., ISO 14801 for dynamic fatigue testing).
• Biocompatibility established through material equivalence to a predicate device with established biocompatibility.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set mentioned for an AI/machine learning model.

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The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved. The intended use for the Ø3.30 Provata implants is limited to replacement of maxillary and mandibular lateral and central incisors. The 12° angled Co-Axis Provata Implants are intended to only be used with straight abutments.

The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. The TIB abutments consist of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: Scan files from desktop scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The Conventional Abutments and Prosthetic Screws are premanufactured prosthetic components directly connected to endosseous dental implants and intended for use in fully edentulous or partially edentulous maxilla and/or mandible to provide support for crowns, bridges or overdentures.

The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

The Southern Implants Temporary Titanium Abutments are prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

This submission includes fully threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two diameters: Ø3.30 and Ø4.07 mm. The Ø3.30 implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12° from orthogonal to the long axis of the implant). Both the Straight and Co-Axis versions are available in fully roughened and 3 mm machined coronal section configurations. The Ø3.30 Straight and Co-Axis implants are each provided in in one prosthetic diameter (2.90 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.

The Ø4.07 implants subject to this submission are provided in length 6.4mm and as Straight (0°) implants only. The Ø4.07 implants are provided with a 3.575 mm prosthetic diameter and are available in fully roughened and 2 mm machined coronal section configurations.

This submission also includes: a Cover Screw (one design/size); Healing Abutments in two diameters (3.5 and 4.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Passive Abutments with a plastic burn-out component, in one size and two designs (engaging and non-engaging); PEEK Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Compact Conical Abutments in straight (0°) and 20°, angled design for multi-unit restorations: Narrow TIB Abutment Bases (engaging): and abutment screws.

Passive Abutments are UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment, limited to a straight (0°) restoration.

The Narrow and Compact Conical TIB Abutment bases are two-piece abutment designs, consisting standard premanufactured titanium alloy abutments for supporting a hybrid/crown dental restoration and mesostructure (SageMaxx Zirconia) bonded with cement (Ivoclar Vivadent Multilink Hybrid cement). The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the Zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient. The mesostructured restoration is a CAD/CAM designed prosthesis milled out of Zirconia (SageMaxx Zirconia), which is designed to fit the abutment base in order to restore chewing function for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case-by-case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration and a maximum allowable angulation of 20° for the mesostructured component.

All Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar (0.6mm or extended machined surface of 2 or 3 mm). The remainder of the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K163634 and K180465. The Cover Screw and Healing Abutments are manufactured from unalloyed titanium conforming to ASTM F67. The remaining Abutments are manufactured from titanium alloy conforming to ASTM F136. The PEEK Abutments are manufactured from medical grade white Polyetheretherketone. The abutment screws are manufactured from titanium alloy conforming to ASTM F136. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K163634, K180465, K193084 and K191250.

The provided text is a 510(k) summary for the Provata Implant System, which describes various dental implants and abutments. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria beyond the general statement of "demonstrated fatigue performance of the subject device that exceeds its indication" based on ISO 14801 testing.

Therefore, most of the requested information cannot be extracted from the given text.

However, I can extract information related to performance testing and mention the lack of specific acceptance criteria and performance reports.

1. A table of acceptance criteria and the reported device performance
   This information is not explicitly provided in the document. The document states that "Dynamic testing was performed on worst-case subject device constructs. The results from the testing demonstrated fatigue performance of the subject device that exceeds its indication." However, no specific acceptance criteria or quantitative performance results are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size for Test Set: Not specified. The document only mentions "worst-case subject device constructs" were used for dynamic compression-bending testing.
   • Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
   Not applicable. The reported testing is non-clinical (mechanical fatigue testing), not related to clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable. This is not a clinical study involving adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
   No, a multi-reader multi-case comparative effectiveness study was not done. This submission is for dental implants and abutments, and the non-clinical performance data focuses on mechanical and biological characteristics, not AI-assisted human reading.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   Not applicable. The performance data is based on non-clinical mechanical testing and material equivalence.

8. The sample size for the training set
   Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established
   Not applicable. This is not an AI/machine learning device.

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Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ZAGA zygomatic implants are partially threaded root-form dental implants with an external hexagonal abutment interface angled 55° at the head of the implant, and are threaded internally for attachment of mating abutments. The ZAGA zygomatic implants are provided in two designs: the ZAGA Round zygomatic implant (previously named the ZAGA Regular), coronally and apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging of 30 mm and the ZAGA Flat zygomatic implant (previously named the ZAGA Advanced), apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging from 30 mm, with a flat cut into the buccal-facing side of the implant body. Only the length 30, 32.5, 57.5 and 60 mm ZAGA Round zygomatic implants and length 55, 57.5 and 60 mm ZAGA Flat zygomatic implants are a subject of this submission. All ZAGA zygomatic implants are manufactured from unalloyed titanium conforming to ASTM F67. The apically threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K192651. The subject device implants are manufactured in the same facilities using the same manufacturing processes as used for the Southern Implants predicate device previously cleared in K192651.

The provided text is a 510(k) Summary for the Southern Implants ZAGA Zygomatic System, a dental implant device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive independent clinical study data to meet specific numerical acceptance criteria for device performance.

Therefore, the document does not contain a table of acceptance criteria and reported device performance in the typical sense of directly measurable performance metrics (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is demonstrated through a comparison of technological characteristics, materials, and intended use with a predicate device, supplemented by non-clinical and limited clinical data to support similarities or address differences.

However, based on the information provided, here's a breakdown of the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, this document does not present acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, or specificity) that a diagnostic AI device would typically have. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device, specifically:

• Identical Indications for Use: The subject device must have the same indications for use as the predicate.
• Similar Technological Characteristics: The subject device must have comparable design principles, materials, and other characteristics to the predicate.
• Safety and Effectiveness: Demonstrated through non-clinical data (biocompatibility, sterilization, MR safety, mechanical testing) and limited clinical data, showing that any differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

This is not a traditional test set/training set scenario for an AI device. The submission relies on non-clinical testing and existing clinical literature.

• Non-clinical Data:
  • Mechanical Testing (ISO 14801): Referenced from K192651. The sample sizes are not explicitly stated in this document but are implied to be sufficient for the prior clearance. It's a lab-based, engineering test.
  • Biocompatibility, Sterilization Validation, Shelf Life, Bacterial Endotoxin, MR Safety: These are typically in-vitro or bench tests with specific sample sizes per standard, but the exact numbers are not detailed here. Much of this is "referenced from K192651," meaning the data was established for the predicate device.
• Clinical Data:
  • Clinical Case Report: 1 patient for the 60mm length zygomatic implant. The country of origin and whether it's retrospective or prospective are not specified, but case reports are typically retrospective observations.
  • Parel et al. (2001): 59 zygomatic implants (lengths 25-60mm). This is a published article; details on provenance (country, retrospective/prospective) are not provided in this summary but are usually available in the full publication.
  • Fernández-Ruiz et al. (2021): 40 zygomatic cases (lengths 35-60mm). This is reported as a "prospective randomized clinical study." Details on country of origin are not included here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable to this type of 510(k) submission. This is not an AI diagnostic device where expert ground truth for interpretation is established. The "ground truth" for the device's function is its mechanical integrity, biocompatibility, and clinical performance as an implant, supported by engineering standards and clinical observations/studies.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" requiring interpretation or classification by experts, no adjudication method (like 2+1, 3+1) was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies comparing human readers with or without AI assistance are not relevant here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. It is a physical medical device (dental implant).

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is established through:

• Engineering Standards: Bench testing against established international standards like ISO 14801 for mechanical properties.
• Regulatory Standards: Compliance with biocompatibility, sterilization, and MR safety guidelines.
• Clinical Outcomes/Acceptance: Historical clinical use data (from published literature and case reports) demonstrating successful rehabilitation and patient satisfaction with similar zygomatic implants, particularly at the extended lengths.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that uses a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable.

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The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA Cleared sterilizer for one of the following cycles:

• · Pre-vacuum Steam At 132ºC for 4 minutes with a 20 minutes dry time.
• · Pre-vacuum Steam At 135°C for 3 minutes with a 20 minutes dry time.

The trays are not intended for sterilization of non-porous loads.

The trays are recommended not to be stacked during sterilization.

The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams).

Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.

The device 'instrument trays' is a reusable rigid sterilization container or organizing tray intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit which contains and protects the interior Components during sterilization. Each tray consists of three components: a base tray, a lid and an internal individualized insert tray. All three the components are perforated for steam sterilization. The internal insert tray and base has the ability to hold individualized pieces and accessories which include dental tools, drills and ratchets /wrenches.

The lid, base and insert are made of Radel R-5000. This material is a polymer resin.

The instruments to be sterilized in the proposed tray are all non-porous devices and include dental surgical drills and tools.

The rigid multi-piece tray holds dental device apparatus and accessories before, during and after the sterilization process. The tray set has a locking lid to contain the products. The trays are designed to fit any standard autoclave, which allows it to be effective for sterilization and be able to withstand the environment of repeated steam sterilization and be able to withstand the environment of repeated steam sterilization cycles in normal operating room. Since the trays are perforated, an FDA cleared sterilization wrap mush be used for sterilization purposes to maintain the sterility of the contents

The provided text describes the acceptance criteria and the results of a study for the "Southern Implants Instrument Trays" device.

Here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

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The TIB Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

This submission includes two major components which make up the TIB Abutment Base and the mesostructure restoration.

The TIB Abutment base is a standard premanufactured titanium alloy abutment for supporting a dental restoration and mesostructure. The dental laboratory is to fabricate the mesostructure restoration by CAD/CAM technique out of zirconia. The TIB abutment base then serves as the interface between the endosseous implant and the zirconia restoration. The TIB Abutment Base is designed to support the restoration on an endosseous implant in order to restore chewing function for the patient.

The mesostructured restoration is a CAD/CAM designed prosthesis milled out of zirconia, which is designed to fit the abutment base in order to restore chewing for the patient. Each restoration is custom designed using 3Shape Abutment Designer Software in order to meet the requirements of each patient on a case by case basis. Limitations have been put in place in 3Shape Abutment Designer in order to prevent malfunctioning of the restoration.

The TIB Abutments are compatible with the Southern Implants' Deep Conical, External Hex, Provata and Tri-Nex implants and screws. The TIB abutment bases are manufactured from Titanium alloy conforming to ASTM F136 and are color coded by gold anodizing. The anodization process is the same as used for previously cleared anodized titanium alloy devices in K163634. The Mesostructure restoration is to be manufactured from Zirconia - Sage Max NexxZr which has been previously cleared for use in K 130991.

The digital workflow includes the following products (not subject devices to this submission):

• Ceramic material: Sage Max NexxZr Zirconia Restorative material (K130991)
• Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
• Desktop scanner: 3Shape E3 Desktop Scanner is 510(k) exempt under regulation . 872.3661)
• Abutment design software: 3Shape Abutment Designer Software (K151455)
• Milling machine: Roland DWX51D Milling Machine

The provided text describes the TIB Abutment System and its performance data to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a study with specific performance metrics.

Therefore, I cannot populate the table or answer questions 2 through 7 directly from the provided text as the document does not present acceptance criteria in a quantitative format, nor does it detail a standalone study with performance metrics for the TIB Abutment System against such criteria. Instead, it relies on comparative equivalence with already cleared devices and various non-clinical tests.

However, I can extract information related to the performance data and ground truth establishment that were conducted as part of the substantial equivalence demonstration.

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" for the TIB Abutment System in a format that would fit a table like the one requested. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons. The performance data listed are primarily compliance tests against recognized standards rather than specific device performance metrics against predefined thresholds.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests mentioned. It only lists the types of tests performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. The document refers to non-clinical tests and compliance with standards, not expert-adjudicated ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The document refers to non-clinical tests and compliance with standards, not expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a dental abutment system, not an AI-assisted diagnostic device, and no MRMC study or AI-related effectiveness is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document describes non-clinical testing of the device components and workflow, which can be considered a form of standalone evaluation for the device itself. The types of standalone tests performed include:

• Biocompatibility testing per ISO 10993-1 and ISO 10993-5.
• Validated sterilization instructions per ISO 17665-2.
• Software validation testing per FDA Guidance.
• Scanning and milling validation.
• Static and dynamic compression-bending to ISO 14801.
• Mechanical ISO 14801 Fatigue Testing for implant platforms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context is established by adherence to recognized international standards and FDA guidance documents for medical device testing. For example:

• Biocompatibility: ISO 10993-1 and ISO 10993-5 standards.
• Sterilization: ISO 17665-2.
• Software Validation: FDA Guidance Document for Off-The-Shelf Software Use in Medical Devices.
• Mechanical Testing: ISO 14801.

8. The sample size for the training set:

Not applicable. This document describes a medical device (dental abutment system) and its non-clinical testing for substantial equivalence, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for a machine learning model mentioned.

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Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

This submission includes partially threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon abutment interface angled 55° at the head of the implants are provided in two designs: the ZAGA Regular zygomatic implant, coronally and apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging of 35 mm and 55 mm; and the ZAGA Advanced zygomatic implant, apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging from 30 mm to 52.5 mm, with a flat cut into the buccalfacing side of the implant body.

This submission includes designs of the ZAGA screw-retained abutments in four gingival heights (1.5, 2.5, 3.5, and 4.5 mm) for use with the ZAGA zygomatic implants. The subject device abutments are for support of screwretained overdenture prosthetic restorations.

All subject device implants are manufactured from unalloyed titanium conforming to ASTM F67. The apically threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K173343. The subject device ZAGA screw-retained abutments are manufactured titanium conforming to ASTM F67, and have the same anodized surface treatment as the healing abutments cleared in K163634. All of the subject device components are manufactured in the same facilities using the same manufacturing processes as used for the Southern Implants previously cleared in K173343 and K163634.

The provided text is a 510(k) Summary for the Southern Implants ZAGA Zygomatic System (K192651). This document assesses the substantial equivalence of a new medical device to existing, legally marketed predicate devices. It does not describe acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving such a device meets acceptance criteria.

The document specifically states under "PERFORMANCE DATA": "No clinical data were included in this submission." This indicates that the evaluation was based on non-clinical data, primarily engineering analysis and comparison to predicate devices, rather than a human-in-the-loop or standalone algorithm study.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets these criteria, as the input document does not contain this type of data for an AI/algorithm-based device.

The "Performance Data" section in the document focuses on:

• Biocompatibility (referenced from K173343 and K163634)
• Engineering analysis
• Dimensional analysis
• Sterilization validation (according to ISO 11137-1, ISO 11137-2)
• Bacterial endotoxin (according to USP 39-NF34)
• Sterile barrier shelf life (referenced from K173343)
• Static and dynamic compression-bending (according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants)

These are standard non-clinical tests for dental implants to demonstrate mechanical performance and safety, not for evaluating an AI algorithm's performance.

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Southern Implants MAX implant is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This submission includes threaded root-form dental implants with an external hex and internal tri-lobe interface and mating abutments. The implants are provided in diameters of 6, 7, 8 and 9mm and lengths of 6, 7, 9 and 11mm. Specifically:

• MAX Implants with External Hex Connection
  • Ø6 mm at lengths of 6, 7, 9, 11 mm
  • Ø7 mm at lengths of 7, 9, 11 mm
  • Ø8 mm at lengths of 7, 9, 11 mm
  • Ø9 mm at lengths of 7, 9, 11 mm
• TRIMAX Implants with Tri-lobe Connection
  • Ø7 mm at lengths of 7, 9, 11 mm
  • Ø8 mm at lengths of 7, 9, 11 mm
  • Ø9 mm at lengths of 7, 9, 11 mm
• PROMAX Implants with Internal Hex Connection
  • Ø6 mm at lengths of 7, 9, 11 mm
  • Ø7 mm at lengths of 7, 9, 11 mm
  • Ø8 mm at lengths of 7, 9, 11 mm
  • Ø9 mm at lengths of 7, 9, 11 mm

This submission also includes: Coverscrews in two diameters and implant connection interfaces: Healing Abutments in two implant connection interfaces (tri-lobe and internal hex) with lengths between 3 and 6mm and diameters between 6 and 7.8mm; Titanium Cylinder abutments for temporary restorations in two implant connection interfaces (tri-lobe and internal hex) in engaging and non-engaging configurations; Cosmetic Abutments for permanent restorations in two engaging implant connection interfaces (tri-lobe and internal hex); Gold Cylinder Abutments for permanent restorations in three implant connection interfaces (external hex, tri-lobe and internal hex) in engaging and non-engaging configurations; Passive Abutments for permanent restorations in two implant connection interfaces (trilobe and internal hex) in engaging and non-engaging configurations; Compact Conical abutments in an internal hex connection for multi-unit restorations; and abutment screws. The Gold Cylinder Abutments and Passive Abutments are UCLA castable abutments which interface with a plastic, burn-out sleeve used to fabricate a prosthesis that is bonded directly to the top of the abutment.

All MAX implants are manufactured from unalloyed titanium conforming to ASTM F67. The implant surface is grit blasted with varying lengths of unroughened coronal portions. The Cover Screw, Healing Abutment, Titanium Cylinder Abutment, Cosmetic Abutment and Passive Abutment are manufactured from unalloyed titanium conforming to ASTM F67. The Gold Cylinder Abutment is manufactured from a gold alloy. The Compact Conical Abutments manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136, or goldplatinum alloy. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K071161, K163634, K070905 and K180465.

This document is a 510(k) summary for the Southern Implants MAX Implant System. It primarily asserts substantial equivalence to existing predicate devices, rather than presenting a standalone study with defined acceptance criteria and performance results directly from that study. Therefore, the requested information, particularly around acceptance criteria and performance specifically measured against those criteria in a dedicated study, is not explicitly detailed in the provided text for the subject device itself.

However, based on the information provided, we can infer the basis for equivalence and the performance data that was referenced or relied upon.

Here's an attempt to answer your questions based on the provided text, highlighting where the information is inferred or not explicitly stated for the "subject device" as a new, independently tested device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the Southern Implants MAX Implant System focuses on demonstrating substantial equivalence to existing predicate devices rather than meeting specific performance acceptance criteria for a novel device. Therefore, a table of new acceptance criteria and new device performance specifically for the Southern Implants MAX Implant System is not explicitly provided in the document as it would be for a de novo device.

Instead, the performance data presented is comparative, aiming to show that the subject device performs similarly to or better than predicate devices across various attributes. The acceptance criterion is implicitly "demonstrate substantial equivalence" based on similar materials, design principles, and mechanical performance.

The document states:

• "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K071161 and K180465); engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO TS 17665-2; bacterial endotoxin according to USP 39-NF34; sterile barrier shelf life (referenced from K071161)."
• "Pull out tests and surface area analysis comparing the worst-case subject device to the predicate device were performed."
• "In support of substantial equivalence in terms of mechanical performance, engineering analysis and dimensional analysis was performed and demonstrated fatigue performance of the subject device to be substantially equivalent to that of the predicate device K071161and reference devices K163634 and K180465."
• "Pullout tests and surface area analysis demonstrated that the subject device is substantially equivalent to the reference device K163634."

Implicit Acceptance Criteria and Reported Performance (based on substantial equivalence):

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the document for any of the non-clinical tests (engineering analysis, dimensional analysis, pull-out tests, surface area analysis). These tests typically involve a relevant number of devices or materials to be statistically significant or representative of the design space.
• Data Provenance: The document explicitly states "No clinical data were included in this submission." All data are non-clinical (biocompatibility, engineering analysis, dimensional analysis, sterilization, bacterial endotoxin, shelf life, pull-out, surface area analysis), likely performed in-house by the manufacturer or by contracted testing laboratories. The country of origin for the data generation is not specified, but the manufacturer is Southern Implants (Pty) Ltd, located in Irene, Gauteng, South Africa. The data would be considered prospective for the specific tests performed for this submission, even if some reference older data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This question is not applicable to the provided document. The submission is for a medical device (dental implant system) where substantial equivalence is demonstrated through non-clinical (bench) testing, not through diagnostic image interpretation requiring expert ground truth establishment.

4. Adjudication method for the test set

• This question is not applicable. There is no human interpretation or adjudication involved in the type of non-clinical tests described for this device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable. This is not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• This question is not applicable in the typical sense for a diagnostic device. For the non-clinical performance data, the "ground truth" would be established by validated test methods and engineering principles (e.g., standard physical/mechanical property measurements, biological assay results, comparison to known material properties, adherence to ISO standards for sterilization).

8. The sample size for the training set

• This question is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

• This question is not applicable. This is not a machine learning or AI device that requires a training set.

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