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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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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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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.

This submission includes threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12º from orthogonal to the implant). The Straight and Co-Axis implants are each provided in two diameters, 4.0 mm (actual major diameter 4.07 mm tapering to 2.6 mm), and 4.7 mm (actual major diameter 4.70 mm tapering to 3.13 mm), in one prosthetic diameter (3.575 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.

This submission also includes: a Cover Screw (one design/size); Healing Abutments in three diameters (3.7, 4.5, and 5.5 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); Cosmetic Abutments in straight (0°), 12°, and 24° angled engaging designs for single-unit restorations; Passive Abutments with a plastic burn-out component, in one size and two designs (engaging); Compact Conical Abutments in straight (0°), 20°, and 30° angled designs for multi-unit restorations; and abutment screws.

All Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar. The remainder of the implant (the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K163634. The Cover Screw and all abutments (except Compact Conical) are manufactured from unalloyed titanium conforming to ASTM F67. The Compact Conical Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136, or gold-platinum 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 K163634 and K163060.

This 510(k) summary is for a dental implant system (Provata Implant System), not a software-driven AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML device, its performance study details, or ground truth establishment.

Specifically:

• No Acceptance Criteria Table: The document describes the device's design, materials, and comparison to predicate devices, but does not present a table of acceptance criteria and performance metrics typically associated with AI/ML device validation (e.g., sensitivity, specificity, AUC).
• No AI/ML Performance Study: The "Performance Data" section states, "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility... engineering analysis; dimensional analysis; sterilization validation... bacterial endotoxin... sterile barrier shelf life... and static and dynamic compression-bending according to ISO 14801. No clinical data were included in this submission." This explicitly indicates no clinical or reader study was performed for this device as it is physical hardware.
• No Ground Truth Establishment: Since no clinical data or AI/ML model performance is being evaluated, there is no mention of ground truth, expert opinions, or adjudication methods.

Therefore, I cannot provide a response with the requested information based on the provided text.

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Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• replacing single and multiple missing teeth in the mandible and maxilla,
• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,
• . immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors

The Deep Conical (DC Implant) has a deep conical connection system. The implants are available in Cylindrical, Tapered, Deep Conical 12º Co-Axis Cylindrical, and Deep Conical 12º Co-Axis Tapered configurations with various lengths and diameters. The implants have a moderately roughened surface, are non-roughened around the coronal region, and have an external thread and microthreads at the coronal end. The Co-Axis Implants are compatible only with straight abutments. The submission also includes various abutments (Cover Screw, Healing Abutments, Overdenture Abutments, Temporary Cylinders, Cosmetic Abutments, Gold Cylinders, Compact Conical Abutments, Passive Abutments, Titanium Abutments, Angled abutments) designed for use with the Deep Conical Implants.

The provided text is a 510(k) Summary for a medical device (Deep Conical (DC) Implants and Accessories) and does not describe an AI/ML powered device. Therefore, it does not include acceptance criteria, performance studies, or details regarding AI model development such as training/test set sizes, ground truth establishment, or expert involvement.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical testing.

Here's an overview of the non-clinical testing performed, but please note that this is not a performance study for an AI/ML device:

Non-clinical Testing and Performance Testing (for a dental implant device, not AI/ML):

• Fatigue testing: In accordance with ISO 14801, to prove sufficient strength. Reported as substantially equivalent to predicate devices.
• Comparative surface area, pullout strength and bone to implant contact analyses: For implants less than 7mm in length. Reported as substantially equivalent to predicate devices.
• Placement torque testing: To show sufficient strength to withstand placement torque. Reported as substantially equivalent to predicate devices.
• Sterilization method validation: Gamma radiation (for sterile devices) validated per ISO 11137; moist heat (for end-user sterilized devices) validated per ISO 17665-1 and ISO 17665-2.
• Packaging validation: In accordance with ISO 11607, with accelerated aging per ASTM-F-1980 to substantiate 5 years shelf life.
• Biocompatibility: The device is manufactured from the same material using the same method as the applicant's predicates, has the same intended use, and patient contact type and duration. It is reported as biocompatible in accordance with ISO 10993-1.

Absence of AI/ML Specific Information:

The document explicitly states: "No clinical studies were conducted." This further confirms the lack of any study that would typically be associated with evaluating the performance of an AI/ML device.

Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document as it pertains to a different type of medical device (dental implants) and its regulatory pathway (510(k) for substantial equivalence).

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