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The Park Dental Research Corporation's LEW O-ball implant system is a self-tapping titanium threaded screw indicated for long-term intra-bony applications. Additionally, the LEW Mini O-ball Implant may be used for inter-radicular transitional applications.

These devices will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial edentulism, and employing minimally invasive surgical intervention.

The 2.0mm , 2.5 mm, and 3.0 mm diameter are intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches.

The LEW Mini O-ball implant (MD)) is available with a 1.5 mm gingival collar in three diameters: 2.0mm, and 3.0mm. The LEW Mini O-ball implant (MDI) is also available without a gingival collar in two diameters; 2.0mm and 2.5mm. The implant is made of Titanium alloy (Ti6A4V ELI per ASTM F 136-02), The thread surface is ablated with 50 micron aluminum oxide to remove shiny machined surface. The LEW Mini O-ball implant (MDI) is available in thread lengths ranging from 10mm to 18mm allowing for maximum bone engagement. The system consists of the major component, a root-form, screw type, self-tapping implant, and accessories designed to facilitate placing and using the implant. The accessories contact tissues for less than 1 hour and therefore are exempt from 510(k) requirements are described generally but are of course subject to general controls and are covered by the Quality System documents.

The provided document describes a 510(k) premarket notification for a dental implant, and therefore, the "acceptance criteria" discussed are primarily related to establishing substantial equivalence to existing legally marketed predicate devices, rather than performance criteria as might be seen for a novel device or AI/ML product. The "study" referenced is primarily fatigue testing conducted according to ISO 14801.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for LEW Mini O-Ball Implant

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices, particularly regarding its physical characteristics, materials, and mechanical performance (fatigue strength).

1. Table of Acceptance Criteria and the Reported Device Performance

Given this is a 510(k) for a dental implant, the "acceptance criteria" are more about demonstrating comparability to predicate devices. The primary performance metric reported is related to fatigue strength.

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or AI/ML evaluations. For the fatigue testing, the number of implants tested to ISO 14801 is not specified. ISO standards typically define the number of samples required for such tests.
• Data Provenance: The fatigue testing data appears to be laboratory-based mechanical testing, not human patient data. As such, there's no country of origin or retrospective/prospective distinction in the typical sense.

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

• This information is not applicable to this type of submission. Ground truth, in the context of expert consensus, is typically relevant for diagnostic performance studies (e.g., in radiology or pathology for AI/ML devices), not for mechanical testing of a dental implant. The "ground truth" for fatigue testing is the physical measurement of load and cycles to failure according to the ISO standard.

4. Adjudication method for the test set

• This information is not applicable as it pertains to expert disagreement resolution in diagnostic studies. For mechanical testing, the "adjudication" is based on objective measurements against the ISO standard.

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 information is not applicable. This submission is for a physical medical device (dental implant), not an AI/ML diagnostic or assistive device that would involve human readers.

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

• This information is not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

• The "ground truth" for the performance evaluation (fatigue testing) is based on physical measurements and adherence to an international standard (ISO 14801) for dental implant fatigue. For the substantial equivalence argument, the "ground truth" implicitly refers to the characteristics and performance of the legally marketed predicate devices.

8. The sample size for the training set

• This information is not applicable. There is no "training set" in the context of this 510(k) submission for a dental implant.

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

• This information is not applicable. No training set exists for this device submission.

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