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The Implant-One™ System is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

Endosseous implants are self-tapping and threaded, and offered having root-form or wide thread forms. Root-form implant diameters range from 3.25mm to 5.5mm having lengths from 8mm to 14mm. Wide thread implant diameters are available in 4.1 and 4.5mm (8mm to 14mm lengths), 5.5mm (8mm to 12mm lengths) and 6.5mm (8mm to 10mm lengths). Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre- packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. The Implant-One™ dental implants and cover screws are provided sterile. Not all abutments can be used for single-unit restorations. The conical, angled conical, ball, locator and glueless abutments are intended only for multi-unit loaded restorations. The ball, locator and glueless abutments are to be used in fully removable dentures. The conical and angled conical abutments are to be used in screw retained dentures and with the titanium sleeve for screw retention. The final design parameters for the custom blank abutment are as follows: maximum total height, 12.5mm; minimum/maximum gingival height, 0.5mm/6mm; minimum post height, 4mm; maximum angulation, 30°; minimum wall thickness, 0.78 (at 1.5mm above the proximal end); minimum diameter, 3.75 mm for the 300 Series, 4.25 mm for the 300 Series and 4.75 mm for the 500 Series.

The provided text is a 510(k) summary for the Implant-One™ System, a dental implant device. It demonstrates the device's substantial equivalence to existing legally marketed predicate devices through non-clinical performance data.

However, the document does not describe a study involving an algorithm, AI assistance, human readers, or any form of "acceptance criteria" related to diagnostic performance or accuracy as one would expect for an AI/ML medical device.

Instead, the "acceptance criteria" and "study" described in this document pertain to engineering and biocompatibility performance of a physical medical device (dental implants and abutments), not a software or AI-driven system.

Therefore, for each of the requested points, the answer is that the information is not applicable (N/A) in the context of this document, as it describes a physical dental implant system and not an AI/ML device that would have such performance criteria.

Here's how to address each point based on the provided text:

Acceptance Criteria and Device Performance (Based on Device Type - Dental Implants)

Since this is for a physical dental implant system, the "acceptance criteria" are related to mechanical integrity, biocompatibility, sterilization, and packaging/shelf-life, rather than diagnostic accuracy. The "device performance" indicates that the device met these criteria by demonstrating substantial equivalence to predicates.

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

Regarding AI/ML Device Specifics (Not Applicable to this Document):

The following points are typically relevant for AI/ML device submissions, and the provided document for a physical dental implant system explicitly states "No clinical data was used in support of this submission." Therefore, these points are not applicable.

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

• N/A. The submission is for a physical medical device (dental implant). No test set of clinical data was used. The document explicitly states: "No clinical data was used in support of 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)

• N/A. No clinical test set or ground truth established by experts was used.

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

• N/A. No clinical test set requiring adjudication 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

• N/A. This is a physical device, not an AI/ML system, so an MRMC study is not relevant and was not performed.

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

• N/A. This is a physical device, not an AI/ML system.

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

• N/A. No clinical ground truth was established or used, as no clinical data was involved in this submission.

8. The sample size for the training set

• N/A. This is a physical device, not an AI/ML system requiring a training set.

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

• N/A. This is a physical device, not an AI/ML system.

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