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An Endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function. This submission provides information and animal/clinical data to support a clinical performance claim of "Enhanced Performance in Poor Quality Bone".

Screw type implant with a "Defined Surface Structure".

The provided text describes a 510(k) submission for the "Osseotite" Dental Implant System, focusing on a claim of "Enhanced Performance in Poor Bone" due to a "Defined Surface Structure." It does not present acceptance criteria in the typical sense of quantitative targets for performance metrics from a formal validation study. Instead, it relies on demonstrating that the "Osseotite" surface performs at least as well as, and in some cases better than, other "non-Osseotite" surfaced implants, particularly in areas with poor quality bone.

Here's an attempt to extract and interpret the information based on your request, understanding that the structure of a 510(k) summary is different from a clinical trial report.

Acceptance Criteria and Reported Device Performance

The document doesn't define explicit numerical acceptance criteria for a new, unproven device's safety and efficacy because it's a 510(k) submission seeking substantial equivalence to a predicate device. The primary "acceptance criterion" for marketing approval through 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, which the "Osseotite" implants had already achieved in terms of design and materials in an earlier K submission (K935544).

This particular submission (K980549) is to support a marketing claim of "Enhanced Performance in Poor Bone" based on new data, not to re-establish fundamental safety and efficacy. Therefore, the "acceptance criteria" here implicitly relate to the sufficiency of evidence to support this performance claim rather than a predefined set of performance thresholds for device approval.

However, we can infer performance indicators and reported findings:

Study Details to Support "Enhanced Performance" Claim

The document describes several types of studies and data used to support the "Enhanced Performance" claim:

1. Sample size for the test set and data provenance:

   • Animal studies: Unspecified number of animals. Likely from research institutions where the studies were "published." Provenance not specified, but typically animal studies are prospective.
   • Clinical trials: Two ongoing prospective clinical trials. The sample size for the clinical trials is not explicitly stated in this summary, but they track "Osseotite" vs "non-Osseotite" (machined surface) implants. The "8.8% greater" outcome is reported for "similar implants at 24 months" in areas of poor quality bone. The specific countries of origin for these clinical trials are not mentioned.

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

   • The document mentions "Numerous academic and clinical researchers are involved with a variety of studies." It does not specify the exact number of experts involved in establishing ground truth for individual animal or clinical study outcomes.
   • Expert qualifications are inferred from the context of "academic and clinical researchers" but are not explicitly detailed (e.g., years of experience, specific certifications).

3. Adjudication method for the test set:

   • Not specified. This level of detail is typically found in full study protocols or publications, not a 510(k) summary.

4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

   • No, an MRMC comparative effectiveness study in the typical sense (e.g., human readers interpreting images with and without AI assistance) was not done. The "Osseotite" is a physical dental implant, and the studies assess its direct performance (e.g., osseointegration, stability, survival rates) rather than observational interpretations.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • This is not applicable as the device is a physical dental implant, not an AI algorithm. The studies assess the implant's standalone biological and mechanical performance in vivo.

6. Type of ground truth used:

   • Animal studies: Likely direct measurement of biological response (e.g., histology for bone-to-surface contact, mechanical testing for countertorque extraction).
   • Clinical trials: Clinical outcomes directly observed and measured (e.g., implant survival, success/failure based on established dental implant criteria, which might include absence of mobility, absence of pain/infection, etc.). These outcomes serve as the ground truth.

7. Sample size for the training set:

   • Not applicable in the typical sense of a machine learning model's training set. The "training" for this physical device would be the iterative design, manufacturing, and preclinical testing phases, which are not specifically quantified as a "training set" here.

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

   • Not applicable as described above. The ground truth for evaluating the device's performance (as described in points 1 and 6) is based on direct biological and clinical measurements and observations.

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