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3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

The proposed OSSEOTITE® implants are identical to the predicate implants currently on the market, K983347, K980549, K935544.

The provided 510(k) summary for the OSSEOTITE® Dental Implants does not describe an AI/ML powered device, therefore, many of the requested details about acceptance criteria, study methods, and ground truth are not applicable. This document is a summary for a traditional medical device (dental implants) and focuses on substantial equivalence to predicate devices rather than performance metrics typically associated with AI.

However, I can extract the relevant information presented in the document pertaining to the closest equivalent of "acceptance criteria" and the study that supports it.

Acceptance Criteria and Reported Device Performance

Detailed Study Information (where applicable and extractable)

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

   • Sample size: Not explicitly stated. The document refers to a "meta-analysis of clinical data" and "a second analysis" but does not provide the number of patients or implants included in these analyses.
   • Data provenance: Not explicitly stated. It is inferred that the data is clinical, but the country of origin, whether retrospective or prospective, is not mentioned.

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

   • Not applicable/Not provided. The "ground truth" here is implied to be clinical outcomes (implant survival), which would be derived from patient data, not expert consensus on an image or diagnostic output.

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or diagnostic assessments. This study relies on clinical outcomes data.

4. 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/ML device, and no MRMC study was performed or is relevant to this submission.

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

   • Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

   • Clinical outcomes data (specifically, long-term cumulative survival of dental implants).

7. The sample size for the training set:

   • Not applicable/Not provided. Dental implants do not typically have "training sets" in the context of AI/ML. The "meta-analysis of clinical data" would represent the overall dataset analyzed for the study.

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

   • Not applicable. The "ground truth" (clinical survival) would have been established through follow-up observations of patients who received the implants in clinical studies. The details of how this was measured (e.g., specific criteria for survival, follow-up period) are not provided in this summary.

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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 and to restore a patient's chewing function.

With use of OSSEOTITE® implants, the time between surgical implant placement and evaluation for prosthetic loading may be reduced from previously recommended four months (mandible) and six months (maxillary) to, two months for either mandibular or maxillary sites, when such evaluation confirms appropriate conditions for prosthetic attachment and masticatory loading.

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The provided document is a 510(k) summary for the OSSEOTITE® Dental Implant System, detailing its substantial equivalence to previously marketed devices and a performance claim for reduced healing time. It describes the scientific basis for this claim but does not provide specific details about a formal study with acceptance criteria and statistical analysis as would typically be found in a clinical trial report.

Therefore, many of the requested sections below cannot be fully answered or will be marked as "Not Applicable" or "Not Provided" based on the information available in this 510(k) summary.

Acceptance Criteria and Device Performance for OSSEOTITE® Dental Implant System

The acceptance criteria for the OSSEOTITE® Dental Implant System, as presented in this 510(k) summary, revolve around demonstrating a reduced healing time for prosthetic loading compared to historical recommendations. The document focuses on achieving "adequate healing" within two months, regardless of the implant site.

Study Details (Based on the provided K983347 510(k) Summary):

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

   • Sample Size: Not explicitly stated. The document refers to "numerous academic and clinical researchers," "ongoing evaluations," "animal studies," and "clinical trials." No specific numbers for human subjects or animal models are provided.
   • Data Provenance: Not explicitly stated. The document mentions "numerous academic and clinical researchers" which implies varied sources, but no specific countries or locations are given.
   • Retrospective or Prospective: "Ongoing clinical studies" and "interim results from various ongoing evaluations" suggest a prospective nature, but details are lacking.

2. 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):

   • Number of Experts: Not provided. The evaluation of "adequate healing" and "clinical evaluation" would typically involve dental professionals, but no details on their number or qualifications are mentioned in this summary.
   • Qualifications of Experts: Not provided.

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

   • Adjudication Method: Not provided. The document refers to "clinical evaluation" and "radiographic examination" to confirm healing, but there is no description of an adjudication process for conflicting clinical assessments or interpretations.

4. 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:

   • MRMC Study: Not applicable. This document pertains to a dental implant device and its healing properties, not an AI-assisted diagnostic or interpretation tool.
   • Effect Size of AI assistance: Not applicable.

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

   • Standalone Performance: Not applicable. This document is about a physical medical device (dental implant), not an algorithm or software.

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

   • Type of Ground Truth: The ground truth for successful integration and healing appears to be based on clinical evaluation (assessment by dental professionals) and radiographic examination (absence of radiolucency suggestive of bone-implant interface issues). The mention of "resistance to countertorque extraction" from animal studies suggests a mechanical measure as well, likely correlating with bone-implant integration.

7. The sample size for the training set:

   • Sample Size for Training Set: Not applicable in the context of this 510(k) summary. The document describes clinical experience and ongoing studies with the OSSEOTITE® implant, which would contribute to understanding its performance, but it doesn't refer to a "training set" in the machine learning sense. The development of the OSSEOTITE® surface itself was likely informed by extensive research and prior observations, but specific "training set" data for a statistical model is not mentioned.

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

   • Ground Truth for Training Set: Not applicable, as no "training set" is described in the context of this device's submission. The understanding of the device's performance evolved from "market introduction," "numerous academic and clinical researchers," "ongoing evaluations," and "animal studies."

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