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The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction, They are intended for immediate function on single and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock Endosseous Dental Implant System with Blossom is a screw-type implant system with a cutting design that incorpoarates at least one cutting surface on each thread. It ranges in diameter from 3.4 to 6mm. The 3.4, 4, and 6mm have a straight body design and there is also a 4mm with a conic body design. The internal connection is a six-spline taperlock design. Abutments include straight, flat top (a wedge shape), o-ball, and 15° & 25° angled (4mm and 6mm only). Prosthetic interface varies with the width of the implant. The 3.4mm has a narrow interface, the 4mms have a standard interface and the 6mm has a wide interface. The angled abutments do not come in narrow interface because of the small diameter of the narrow interface implant.

This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the "Intra-Lock Dental Implant System with Blossom." It describes a dental implant system and presents information to demonstrate its substantial equivalence to previously marketed predicate devices.

Based on the provided text, the device itself is a dental implant, not an AI/ML powered device, therefore no information regarding AI/ML powered device acceptance criteria, study design or performance is available.

The relevant "Testing" section states: "Fatigue testing according to ISO 14801 was done with both angled abutments in order to demonstrate the design changes did not change the fatigue properties. The fatigue properties of the new design are similar to those of the predicate device."

Therefore, the only acceptance criteria and study data provided relate to the physical properties of the dental implant, specifically its fatigue properties.

Here's the breakdown of the information that can be extracted, and where AI/ML related information is explicitly not present:

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

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified for the fatigue testing. (e.g., how many implants were tested, how many cycles).
• Data Provenance: The standard used for testing is ISO 14801, an international standard. No information regarding country of origin of the data or whether it was retrospective or prospective is given.

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

• This question is not applicable as the "ground truth" for a mechanical fatigue test is determined by the physical failure of the device, not expert opinion.

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

• This question is not applicable as there is no human adjudication involved in a mechanical fatigue test.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable as the device is a physical dental implant, not an AI/ML powered device that would involve human readers or AI assistance.

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

• This question is not applicable as the device is a physical dental implant, not an AI/ML algorithm.

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

• The ground truth for the fatigue test is the physical failure or successful endurance of the dental implant under specific cyclic loading conditions, as defined by the ISO 14801 standard. This is a mechanical performance ground truth.

8. The sample size for the training set

• This question is not applicable as there is no mention of an AI/ML model and therefore no "training set."

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

• This question is not applicable as there is no mention of an AI/ML model and therefore no "training set" ground truth.

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