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

Osstem Abutment System is compatible with the following implant systems.
Osstem Implant Co., Ltd. TS SA Fixture Internal Hex 3.2, 3.5, 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63, 4.65, 4.8, 4.9, 5.05, 5.08, 5.1, 5.25, 5.92, 5.95, 6, 6.2, 6.8, 7.1
Osstem Implant Co., Ltd. US SA Fixture External Hex 3.6, 4.2, 5.1, 5.2
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.

The provided text is a 510(k) Summary for the Osstem Abutment System, which aims to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information related to an AI/ML-driven medical device, nor does it conduct a study measuring medical device performance against specific acceptance criteria in the manner one would see for an AI/ML model for diagnostic or prognostic purposes.

The document discusses non-clinical performance testing to support substantial equivalence, primarily focusing on materials, design, and mechanical properties (fatigue testing). It explicitly states:

• "Non-clinical testing data are submitted to demonstrate substantial equivalence." (Page 10)
• "No clinical studies are submitted." (Page 11)

Therefore, I cannot fulfill the request as it asks for information typically found in submissions for AI/ML-driven diagnostic devices, such as:

• A table of acceptance criteria and reported device performance (in terms of clinical metrics like sensitivity, specificity, AUC)
• Sample sizes for test sets, data provenance
• Number of experts and their qualifications for ground truth
• Adjudication methods
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth
• Training set sample size and ground truth establishment

The document presents a comparison to predicate devices, stating that new dimensions or minor design changes are not considered "worst-case" for fatigue given existing predicate device testing, thus negating the need for additional testing in some instances. It relies on the substantial equivalence principle, which means the device is as safe and effective as a legally marketed device.

In summary, the provided text does not contain the specific information required to answer your detailed questions about acceptance criteria, study design, and performance metrics for an AI/ML device.

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Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.
The document then lists various components of the system including Transfer Abutment, Angled Abutment, Link Abutment for Cerec, Temporary Abutment, Multi Angled Abutment, Multi NP-Cast Cylinder, Multi Combination Cylinder, Convertible Angled Cylinder, Stud Abutment, O-ring, O-ring Retainer Cap, Port Abutment, Port Angled Abutment, Port Angled Abutment Head, Port Male, Port Extended Male, Port Male Cap, Port Male Kit, Abutment Screw, Cylinder Screw, Esthetic-low Temporary Cylinder, and Temporary Cap (Narrow Ridge), along with their descriptions, materials, and dimensions.

The provided document is a 510(k) premarket notification for the Osstem Abutment System. It outlines how the device is considered substantially equivalent to already marketed predicate devices, rather than providing a performance study against specific acceptance criteria for a new AI/software device.

Therefore, many of the requested details, such as those related to AI/algorithm performance (e.g., test set sample size, expert ground truth establishment, MRMC studies, standalone performance), are not applicable to this type of submission. The document focuses on material properties, design, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not present explicit acceptance criteria in the typical sense of performance metrics for an AI/software device (e.g., accuracy, sensitivity, specificity). Instead, substantial equivalence is claimed based on similarities in:

• Intended Use
• Technology (design principles)
• Material Composition
• Performance Characteristics (mechanical properties, biocompatibility, sterilization)

The performance is "reported" by demonstrating that the device is equivalent to known predicate devices through non-clinical testing (biocompatibility, sterilization validation, mechanical properties, specifically fatigue testing and retention testing). The document states: "Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence."

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

This information is not applicable and not provided. The submission relies on non-clinical (laboratory) testing for mechanical properties and biocompatibility, as well as comparison to predicate devices, not on a clinical test set with patient data.

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 clinical test set or human expert review of "truth" data for diagnostic performance is described.

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

Not applicable.

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/software device that assists human readers.

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

Not applicable.

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

For mechanical testing, the "ground truth" would be established by the physical and mechanical properties of the materials and designs as measured in laboratory tests, and compared against established industry standards (ISO 14801) and FDA guidance for dental abutments. For biocompatibility, it's adherence to ISO 10993 standards. No clinical ground truth from patients is established or used for this 510(k) submission.

8. The sample size for the training set

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

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

Not applicable.

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