Search Results

The OSSTEM Abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

TS Abutment System is made of titanium alloy. TS Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. TS Abutment System is similar to other commercially available products based on the intended use, technology used, material composition employed and performance characteristics.

The provided document is a 510(k) summary for the Osstem Implant Co., Ltd. TS Abutment System. It describes the device and claims substantial equivalence to previously cleared predicate devices. The document does not describe a study that uses acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, nor does it involve expert reviews or clinical trials for such metrics.

Instead, the submission focuses on demonstrating substantial equivalence through comparisons of technical characteristics and performance testing (bench testing, biocompatibility, sterilization validation, etc.) against existing predicate devices and established standards.

Therefore, most of the requested information regarding acceptance criteria for device performance (accuracy, sensitivity), sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment would not be applicable to this type of regulatory submission. This submission does not pertain to an AI/ML powered device, but rather a physical dental implant component.

However, I can extract information related to the technical comparisons that demonstrate substantial equivalence.

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

The document does not present explicit acceptance criteria in terms of numerical performance metrics (e.g., specific thresholds for accuracy, sensitivity). Instead, the acceptance is based on demonstrating that the subject device's characteristics and performance are "substantially equivalent" to predicate devices, often by adhering to established standards or by justifying that any differences do not raise new questions of safety or effectiveness. The reported "performance" for most components is implicitly that they function equivalently to their predicates and meet relevant mechanical and biological standards.

Here's a summary of the non-clinical performance and "acceptance criteria" through comparative analysis:

• Same design, function, connection, and platform as predicate.
• Adherence to ISO 14801 standard (maintaining 11mm distance between embedding plane and hemispherical loading member).
• Differences (e.g., added lengths or diameters) not creating a new worst-case scenario. | Rigid Abutment: No additional fatigue testing conducted, as the proposed device has the same design, function, connection, platform, and moment arm as the reference/predicate, and added lengths are within acceptable ranges or previously cleared for similar components.
  Transfer Abutment: No additional fatigue testing conducted for similar reasons, justifying that changes in connection features were evaluated and not a new worst case, and that the device has the same moment arm.
  Angled Abutment: No additional fatigue testing conducted, as differences in feature (guide for connecting with implant body) do not change the fundamental design or platform and the proposed device's fatigue is considered equal to or greater than the predicate.
  FreeForm ST Abutment: No additional fatigue testing conducted, as added dimensions are within the range of the reference device and it maintains the same moment arm.
  Temporary Abutment: No additional performance test needed as it's for temporary use, and the proposed gingiva height has primary predicate clearance.
  Multi Abutment: No additional fatigue testing conducted, as added dimensions (gingival height) are covered by primary predicates and it maintains the same moment arm.
  Ti Cylinder Screw: No fatigue testing considered necessary as it's a component using with cylinder, and material biocompatibility is established.
  Convertible Abutment: No additional performance tests as difference is sterilization process. Its mechanical performance is expected to be equivalent to predicate. |
  | Biocompatibility | The device materials must have acceptable biocompatibility, typically demonstrated by using materials already cleared in predicate devices or by following ISO 10993-1. | The TS Abutment System uses the same materials (e.g., Ti-6Al-4V (ASTM F136), Titanium Gr.3 (ASTM F67), Titanium Gr.4 (ASTM F67)), manufacturer, manufacturing process, and surface treatment as primary predicate and reference devices. Therefore, no additional biocompatibility testing was conducted. |
  | Sterilization Validation | The sterilization process must be validated to ensure sterility, or justified if changes from predicates do not create a new worst-case scenario. For sterile devices, shelf-life must be validated. | For those components provided sterile, the validation of the gamma irradiation process was previously conducted for the predicate device. Changes in dimensions for the subject device do not create a new worst-case scenario for sterilization, thus no additional validation was required. Shelf-life for sterile components (e.g., Transfer Abutment, Angled Abutment, Multi Abutment, Convertible Abutment, Port Abutment, Stud Abutment, Healing Abutment) is established as 8 years. For non-sterile devices made of titanium, no specific shelf-life is considered for the material itself due to its known stability. |
  | Pyrogen Test | Absence of pyrogens to meet established standards (e.g., ISO 10993-11:2006 and USP). | Bacterial Endotoxin Test Report on implants was referenced from K161604, indicating previous compliance. |
  | MR Compatibility | Evaluation of magnetically induced displacement force and torque based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods et al., 2019), addressing parameters for magnetically induced displacement force and torque for all compatible implant bodies, abutments, and fixation screws and material composition. |

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 applicable. This submission relies on comparisons to predicate devices and existing standards, not a new test set for performance evaluation in the clinical sense (e.g., diagnostic accuracy).
• Data Provenance: The document references previously cleared 510(k) submissions (e.g., K182091, K161689, K221684, K163634, K161604, K120847) from Osstem Implant Co., Ltd. and one from Southern Implants (Pty) Ltd. The specific country of origin for the data from these predicate clearances is not detailed in this summary, but the manufacturer of the subject device is based in the Republic of Korea. The data is retrospective, as it refers to performance data and justifications from prior clearances.

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. No "ground truth" as typically understood in AI/ML diagnostic performance studies was established or used for this device's submission. The evaluation is based on engineering principles, materials science, and conformity to recognized standards.

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

Not applicable. No adjudication method for a test set 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-powered device.

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

Not applicable. This is not an AI-powered device.

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

Not applicable. No "ground truth" of this nature was used. The ground truth, in a regulatory sense for this type of device, is conformity to established material specifications, manufacturing processes, and recognized performance standards (like ISO 14801 for fatigue testing).

8. The sample size for the training set

Not applicable. This is not an AI-powered device.

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

Not applicable. This is not an AI-powered device.

Ask a specific question about this device

The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Implant System is intended to be used in the molar region.

Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.

The Osstem Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The Ultra-Wide implants are intended to be used only to replace molar teeth and angled abutments are not to be used with the Ultra-Wide implants.

Osstem Implant System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study:

The document is a 510(k) summary for the Osstem Implant System, seeking substantial equivalence to predicate devices. As such, it focuses on demonstrating that the new device modifications (primarily additional dimensions and a non-hex connection for some implants) are as safe and effective as the previously cleared predicate devices. Therefore, the "acceptance criteria" discussed are primarily about meeting existing performance standards (like ISO 14801 for fatigue testing) and demonstrating consistency with the predicate devices in terms of materials, manufacturing, indications for use, etc.

Since this is a substantial equivalence submission for a dental implant system involving physical product variations rather than a novel AI/software device, many of the typical AI-specific criteria (like MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set size/ground truth establishment) are generally not applicable or explicitly stated in the context of this traditional medical device submission.

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

For the specific modifications in the proposed device, the primary acceptance criterion for mechanical performance is successful fatigue testing according to ISO 14801:2016 for the worst-case scenario. Other performance criteria are met by leveraging tests performed on predicate devices, demonstrating equivalence in materials, manufacturing, and design principles.

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

• Fatigue Testing (ISO 14801:2016): The document mentions "worst-case implant-abutment combination" was chosen. ISO 14801 typically specifies minimum sample sizes (e.g., 5 or 10 samples per test condition for static or dynamic testing). The exact number of samples tested for the new Non-Hex implants is not explicitly stated in this summary, nor is the provenance of the test data (e.g., conducted in-house, by a certified lab). However, such tests are generally conducted prospectively on newly manufactured devices or representative samples.
• Other tests (Sterilization, Shelf-Life, Biocompatibility, Bacterial Endotoxin): These were leveraged from predicate devices (K121585, K121995, K161604). The sample sizes and provenance for those original predicate device studies are not detailed in this submission.

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 for this type of device submission. This is a mechanical and material performance evaluation, not a diagnostic or interpretative device requiring clinical expert ground truth for a test set. Design requirements and performance standards (like ISO 14801) define the "ground truth" to be met.

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

• Not applicable for this type of device submission. Adjudication methods are typically used in clinical or image-based studies to resolve discrepancies among experts.

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 implant system, not a diagnostic or AI-assisted device.

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

• Not applicable. This is a hardware medical device; there is no algorithm or AI component for standalone performance.

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

• For mechanical performance (like fatigue testing), the "ground truth" is defined by international standards (ISO 14801:2016) and applicable FDA guidance documents. These standards specify test methods, failure criteria, and acceptable performance limits for dental implants.
• For material and biological compatibility, the "ground truth" is established by adherence to ISO 10993 standards for biocompatibility, ISO 11137 for sterilization, and ASTM F1980 for shelf-life. These are laboratory-based, objective performance measures.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices.

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

• Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Blue Sky Bio Multi One Implant System is intended for surgical placement in the bone of the upper or lower jaw to provide support for prosthetic devices to restore chewing function. Implants may be used with single-stage or two-stage procedures. They can be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Multi One Implants are indicated for multiunit restorations in splinted applications. Blue Sky Bio Multi One Implant System with a 45° angulation 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.

Blue Sky Bio Long Implant System is intended for surgical placement in the bone of the upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. Implants may be used with single-stage or two-stage procedures, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Blue Sky Bio Long implants can be placed bicortically in cases of reduced bone density. Blue Sky Bio Long implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants. Blue Sky Bio Long Implant System with a 45° angulation 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.

Blue Sky Bio 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.

Blue Sky Bio BIO|MAX MULTI ONE Implants include a one-piece implant/abutment construct provided with body diameters of 3.0 mm to 4.3 mm. in multiple lengths from 10 mm to 20 mm. They are provided with a head angulation of 17°, 30°, or 45°. Multi One Implants with body diameters of 3.5 mm and 4.3 mm, in lengths ranging from 10 mm to 20 mm with a 45° angulation are indicated for the pterygoid region only. Implant body diameters of 3.0 mm and 3.25 mm are only intended for the alveolar ridge and not intended for placement in the pterygoid region.

Blue Sky Bio BIO|LONG implants and BIO|MAX MULTI ONE LONG implants include implant lengths designed for placement into the posterior maxillary region. including the pterygoid plate. The implants have one of three connections, an internal hexagon interface (3.5 mm platform), a tapered internal hexagon interface (NP platform) or a Multi One one-piece design. The implants are provided with a body diameter of 3.7 mm to 5.0 mm in implantable lengths ranging from 20 mm to 25 mm. BIO|MAX MULTI ONE LONG implants are provided with a head angulation of 17°, 30°, or 45°. Blue Sky Bio BIO/LONG implants and BIQIMAX MULTI ONE LONG implants are intended to be used with the TILT procedure in the maxilla as shown in the clinical literature. Implants with 45° angulation are indicated for the pterygoid region only. BIOJINTERNAL HEX LONG implants (3.5 mm Platform) are for use with abutments of up to 30° only.

Details of specific implant diameters and lengths are outlined in the table below. Abutment screws compatible with the BIOJLONG Implants were cleared in K060957. K102034 and K190491.

Blue Sky Bio 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. Subject device PEEK abutments are provided with two implant/abutment connections, BIO|INTERNAL HEX (3.5 mm Platform) and BIO|MAX (NP).

The subject device implants are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Previously cleared abutments and abutment screws are made of material conforming to ASTM F136. Temporary PEEK abutments are made from TECAPEEK conforming to ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.

The Blue Sky Bio Implant System (K212785) is a dental implant system. The document does not explicitly state acceptance criteria or a formal study that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis. Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and a review of existing clinical literature.

Here's a breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria with corresponding reported device performance in terms of clinical outcomes (e.g., success rates, marginal bone loss) derived from a dedicated study of the subject device. Instead, it relies on:

• Non-clinical performance test data demonstrating compliance with ISO standards and FDA guidance for dental implants.
• Clinical literature review to support the safety and effectiveness of similar implant dimensions and placement techniques, concluding that the subject device's dimensions and indications do not raise new questions of safety and effectiveness.

Here's a summary of the non-clinical performance and the basis of equivalence:

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

• Non-clinical tests: The document does not specify sample sizes for the non-clinical tests. For leveraged data (packaging, sterilization, material biocompatibility), the sample sizes would refer to those used for the predicate devices, which are not detailed here. For fatigue, the ISO standard typically specifies a minimum number of samples (e.g., 11 per group for staircase method).
• Clinical Literature Review (not a "test set" in the traditional sense): This is a review of retrospective and prospective studies already published in scientific literature. The data provenance is global, as scientific literature authors are not limited by country. The "test set" here refers to the patient cohorts described in the reviewed articles, which would vary significantly. For example, one article mentions "1053 pterygoid implants in 676 patients" (Article 7).

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

This is not applicable as there was no dedicated clinical "test set" with a pre-established ground truth. The submission relies on scientific literature published by various researchers and clinicians, implicitly accepted by the regulatory body as supporting evidence.

4. Adjudication Method for the Test Set

Not applicable, as there was no dedicated clinical "test set" requiring 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 device is a dental implant system, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device (dental implant).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the safety and effectiveness claims related to clinical use (e.g., implant success rates, complications, bone loss), the "ground truth" is derived from the clinical outcomes data reported in the published scientific literature that was reviewed. This literature typically involves various forms of clinical follow-up, radiographic assessment, and professional judgment by the treating clinicians/researchers in those studies.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable.

Ask a specific question about this device

The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8mm, max 30°
• · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• Southern Compact Conical Abutments, 4.8mm
  • · MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• Keystone Multi Unit Abutment, 4.8mm, 0°
• · Neodent GM Mini Conical Abutment, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5mm, max 30°
• · Paltop Multi Unit Abutment, 5.0mm, max 17°

The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B.

This document is a 510(k) summary for a dental device, the Osteon Precision Milled Suprastructure. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, rather than presenting a study that proves the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's why and what information can be extracted:

• This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against a set of novel acceptance criteria through a clinical trial.
• Focus on Substantial Equivalence: The document compares features like indications for use, materials, design, and manufacturing processes to existing devices.
• Non-Clinical Testing Mentioned: The document refers to non-clinical tests performed, but these are primarily for demonstrating compatibility, material safety, and sterility, not performance against specific clinical efficacy or accuracy metrics.

Information that can be extracted or inferred:

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

This document does not present explicit "acceptance criteria" in the traditional sense of performance metrics for an AI/algorithm-driven device. Instead, it demonstrates similarity to predicate devices based on design specifications and material properties. The "performance" is implicitly deemed acceptable if it's shown to be substantially equivalent to the established predicate devices.

(Note: "Similar" indicates that the values or characteristics fall within or are comparable to those of the predicate/reference devices, with stated differences not impacting safety/efficacy from the manufacturer's perspective.)

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

• Test Set Sample Size: Not applicable. This submission relies on "non-clinical tests" (dimensional analysis, biocompatibility, sterilization validation) and comparison to existing predicate marketing clearances. It does not describe a "test set" in the context of an AI/ML algorithm evaluation with human interpretation or image analysis. The "test" consists of demonstrating manufacturing conformance and material properties for the physical device.
• Data Provenance: The device is manufactured by Implant Solutions PTY LTD (trading as Osteon Medical) in Mulgrave, Victoria, 3170 Australia. The non-clinical tests (e.g., biocompatibility and sterilization validation) would have been performed there or at certified labs. These are bench tests, not clinical data sets.

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

• Not applicable. There's no "ground truth" to establish in the context of an AI/ML algorithm or diagnostic accuracy study. The assessment is based on physical device characteristics and established standards.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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 device (suprastructure), not an AI algorithm.

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

• Not applicable. This is a physical dental device (suprastructure), not an AI algorithm.

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

• Not applicable. The "ground truth" for this medical device submission is compliance with engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, all demonstrated through non-clinical bench testing.

8. The sample size for the training set:

• Not applicable. This is a physical dental device. While it is manufactured using CAD/CAM technology, it does not involve an AI/ML model that requires a training set of data.

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

• Not applicable. See point 8.

Ask a specific question about this device

The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs. DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136). The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants. The subject device abutments components mate exclusively with the subject implants of the same line.

This is a 510(k) summary for the DSP Implant System, a dental implant device. It establishes substantial equivalence to various predicate devices rather than providing performance data against specific acceptance criteria for the new device. Therefore, it does not present a typical study design with acceptance criteria and results in the way a clinical trial or device performance study would.

However, based on the provided text, we can infer the approach taken by the manufacturer to demonstrate substantial equivalence, which serves as their "proof" that the device meets regulatory requirements.

Here's an interpretation of the requested information based on the 510(k) summary:

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

Since this is a 510(k) submission focusing on substantial equivalence, there isn't a table of discrete acceptance criteria and reported device performance in terms of clinical outcomes or specific quantitative measures as one might find in a standalone performance study. Instead, the "acceptance criteria" are implied by the characteristics of the legally marketed predicate devices, and the "reported device performance" is the demonstration that the subject device shares these characteristics or has equivalent performance as validated through non-clinical testing.

The acceptance is based on demonstrating that the DSP Implant System is substantially equivalent to the predicate devices in terms of:

• Intended Use: The indications for use statement of the subject device is equivalent to the primary predicate device K101207, and within the scope of reference devices.
• Technological Characteristics: The subject device's design features, materials (CPTi Gr4, CoCr, POM, Ti6Al4V-ELI), sterilization methods (irradiation), and surface treatments (grit-blasted and acid-etched, machined collar) are compared to the predicate and reference devices. Minor differences are justified as not raising new questions of safety or effectiveness.
• Performance: Non-clinical testing demonstrates that the device performs comparably to the predicate devices in relevant areas for dental implants.

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

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 applicable for a typical clinical or performance study as presented in this 510(k). The "testing" referred to is non-clinical bench testing (sterilization, biocompatibility, pyrogenicity, material analysis). These tests typically use a representative sample size specified by the relevant standard (e.g., a certain number of devices for sterility testing). The document does not specify these individual sample sizes.
• Data Provenance: The data is non-clinical (bench testing) and generated by the manufacturer to support device characteristics. The 510(k) is submitted by a Brazilian manufacturer (D.S.P. Industrial Eireli) and prepared by a Brazilian regulatory affairs specialist (PR Servicos Regulatorios Administrarivos Ltda). The location of the actual testing labs is not specified. The studies are not clinical, so concepts like "retrospective" or "prospective" do not apply.

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. This is a non-clinical submission. Ground truth, in the sense of expert opinion on clinical data, is not established. The "ground truth" for the non-clinical tests is established by the specifications of the referenced international and national standards (ISO, ASTM, USP, AAMI/ANSI).

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

• Not applicable. Adjudication methods are typically for evaluation of conflicting expert opinions or clinical outcomes, which is not the nature of this non-clinical 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

• No. This is a submission for a dental implant system (hardware), not an AI/software device. An MRMC study is not relevant.

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

• No. This is a physical medical device. Not an algorithm.

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

• For the non-clinical performance data, the "ground truth" is defined by the requirements and test methodologies of the referenced industry standards (e.g., ISO 11137 for sterilization, ISO 10993-5 for biocompatibility, AAMI/ANSI ST72 and USP for pyrogenicity, SEM/EDS for material analysis). The demonstration is that the device conforms to these standards and shares equivalent characteristics with legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device 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 this type of device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

AR N SLA Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR_N SLA Type Implant System is for two stage surgical procedures. It is intended for delayed load.

The AR_N SLA Type Implant System is a dental implant system made of CP Ti Gr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading affer a conventional healing period. The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with SLA(Sandblasted with Large-grit and Acid-etching). The AR N SLA Type Implant System is offered in the following sizes. Subject implant bodies are to be used only with all abutments cleared in the primary predicate submission, and the cover screw and abutment screw to be used are the same as cleared in the primary predicate.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a dental implant system (AR_N SLA Type Implant System). It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing (sterilization validation, surface characteristics, fatigue, biocompatibility, pyrogenicity, LAL bacterial endotoxin, and shelf life).

The text does not describe any study involving AI, human readers, or the establishment of ground truth by expert consensus, pathology, or outcomes data. Therefore, I cannot extract details regarding:

1. Acceptance criteria for AI performance or reported device performance related to AI.
2. Sample sizes for test sets in an AI context or data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication methods for test sets.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect sizes.
6. Standalone (algorithm only) performance.
7. Type of ground truth used in an AI study.
8. Sample size for training sets.
9. How ground truth for the training set was established.

The document is purely about the physical and material characteristics, manufacturing processes, and safety testing of a dental implant for FDA clearance, not about any AI-powered device or diagnostic tool.

Ask a specific question about this device