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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.

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

The OSSTEM Implant System - Abutment is intended for use as an aid in prosthetic restoration. It consists of Abutments, components and Abutment Screws.

This document is a 510(k) Premarket Notification of the OSSTEM Implant System - Abutment, indicating it is a dental device and not an AI/ML medical device. Therefore, the information requested in the prompt, which pertains to the acceptance criteria and study proving an AI/ML device meets those criteria, cannot be fully provided from this document.

The document discusses the substantial equivalence of the OSSTEM Implant System - Abutment to predicate devices. This typically involves demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through material comparisons, design comparisons, and performance testing for mechanical properties and biocompatibility, rather than clinical studies or performance against defined efficacy metrics tied to patient outcomes.

However, I can extract information related to the device and the type of testing performed that is relevant to its acceptance for market.

Here's a breakdown based on the provided text, addressing the points of your prompt where applicable, and highlighting what's not present due to the nature of the device:

Device Description: The OSSTEM Implant System - Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. It consists of Abutments, components, and Abutment Screws.

Acceptance Criteria and Device Performance (General):
For this type of device, "acceptance criteria" revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices. This means proving the new device is as safe and effective as the predicate. The performance is assessed through:

• Material composition: Comparing the materials used (e.g., Titanium Alloy, Zirconia, PEEK, PC, POM).
• Design and dimensions: Comparing the shapes, diameters, and lengths.
• Intended use: Confirming the device serves the same purpose.
• Technological characteristics: Ensuring the fundamental mechanism of action is similar.
• Nonclinical testing: Biocompatibility, sterilization validation, and mechanical properties.

Table of Acceptance Criteria and Reported Device Performance (as inferred from a 510(k) for a non-AI/ML device):

Here's how the remaining points of your prompt are addressed:

1. Sample sized used for the test set and the data provenance:

   • Test set sample size: Not applicable in the context of an AI/ML algorithm's test set. The "testing" here refers to nonclinical lab tests and comparison to predicates.
   • Data provenance: Not directly applicable. The "data" are internal company reports demonstrating compliance with standards or comparisons to their own previously cleared devices. The manufacturer is OSSTEM Implant Co., Ltd. and their correspondent is HIOSSEN Inc., based in Republic of Korea and Pennsylvania, USA, respectively. The data are typically generated in a prospective manner for regulatory submission (i.e., tests are performed specifically for the submission).

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

   • Not applicable as this is a physical medical device, not an AI/ML algorithm requiring ground truth from experts for image interpretation or diagnosis.

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

   • Not applicable. This concept pertains to consolidating expert opinions for ground truth in AI/ML performance studies.

4. 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 MRMC study was done, as this is not an AI/ML device. The document explicitly states: "No clinical studies are submitted." (page 12)

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

   • Not applicable, as this is not an AI/ML device.

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

   • Not applicable. For this device, "ground truth" is embodied by established engineering specifications, material properties, and performance benchmarks for dental implants, which are verified through nonclinical laboratory testing against international standards (e.g., ISO, ASTM) and comparison to predicate device characteristics.

7. The sample size for the training set:

   • Not applicable. There is no concept of a "training set" for this type of conventional physical device.

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

   • Not applicable. (See #7).

Summary of Acceptance:

The device's acceptance (clearance) by the FDA is based on demonstrating substantial equivalence to existing predicate devices (listed in section 3 and 6) in terms of:

• Indications for Use: Identical.
• Technological Characteristics: Very similar, with minor differences in design/dimensions that do not raise new safety/effectiveness concerns.
• Materials: Identical.
• Performance (Nonclinical): Biocompatibility is leveraged from predicate devices; sterilization validated according to relevant ISO standards.

The document explicitly states: "No clinical studies are submitted." This reinforces that the acceptance was based on nonclinical testing and comparison to predicates, as is common for many Class II medical devices in the 510(k) pathway.

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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, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Fixture 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.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the OSSTEM Implant System, indicating that the device has been deemed substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and contact information, but it does not detail any specific performance acceptance criteria or a study report.

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