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

The OSSEOTITE NT Certain Implants are internally connected, tapered implants designed to mimic the shape and form of a natural tooth.

Let's break down the provided text to extract the requested information.

Analysis of the Provided Text:

The document is a 510(k) Premarket Notification for OSSEOTITE NT™ CERTAIN™ Implants. The core purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing the new device's technological characteristics, indications for use, and performance to those of the predicate. It does not generally involve an extensive independent clinical study with predefined acceptance criteria and a detailed statistical analysis of performance metrics like accuracy, sensitivity, or specificity in the same way a PMA (Premarket Approval) submission would.

Instead, the "study" demonstrating the device meets acceptance criteria in a 510(k) is often a comparative analysis against the predicate device to show that it is as safe and effective.

Here's how to interpret the information and answer your questions given the context of a 510(k):

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

Explanation: In a 510(k), "acceptance criteria" are implicitly met by demonstrating substantial equivalence. The "reported device performance" is the manufacturer's assertion and justification that these criteria are met through comparison to predicate devices, rather than through independent clinical performance metrics.

Regarding the "Study that proves the device meets the acceptance criteria":

For a 510(k), the "study" is primarily the comparison to predicate devices. The document explicitly states: "The OSSEOTITE NT Certain Implants are substantially equivalent to the legally marketed OSSEOTITE NT Implants and 3i Innovative Implants and Cover Screws." This substantial equivalence is the proof for a 510(k). The basis for this determination is the comparative analysis of indications for use and technological characteristics against the identified predicate devices (K014235, K972444, K935544, K980549, K983347, K022009).

Now, let's address the specific numbered points based on the provided text, and acknowledge when the information is not present in this type of submission.

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

• Sample Size for Test Set: Not applicable/Not provided. A 510(k) for a dental implant primarily relies on engineering specifications, material science, and comparison to predicate devices, not typically a "test set" in the context of clinical performance data collection. No patient data or clinical study data is presented.
• Data Provenance: Not applicable/Not provided.

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)

• Number of Experts: Not applicable/Not provided. This type of information is generally associated with clinical trials or diagnostic device performance studies, which are not detailed here. The "ground truth" for a 510(k) for a new version of an implant is typically established by engineering standards, biocompatibility testing (which is assumed to have been done, but not detailed here), and the prior approval status of the predicate devices.

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

• Adjudication Method: Not applicable/Not provided. This refers to methods for resolving discrepancies in expert opinion for diagnostic assessments, which is not relevant to this 510(k) submission as no such "test set" requiring expert adjudication is described for clinical performance.

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

• MRMC Study: No. This is a dental implant, not an imaging device or AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or described.
• Effect Size of AI: Not applicable.

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

• Standalone Performance Study: No. This device is a passive dental implant, not an algorithm or AI system.

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

• Type of Ground Truth: For a dental implant 510(k), the "ground truth" for demonstrating substantial equivalence is generally established by:
  • Engineering specifications and material properties: Ensuring the device meets accepted standards for strength, biocompatibility, and durability.
  • Successful historical use of predicate devices: The fact that the predicate devices are legally marketed and have a history of safe and effective use provides the "ground truth" for the new device's design principles and intended use.
  • (Implied) Biocompatibility testing: Not explicitly detailed here, but standard for implants.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not provided. No "training set" in the context of machine learning or complex diagnostic algorithms is relevant to this submission.

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

• How Ground Truth for Training Set was Established: Not applicable/Not provided. As there is no training set described, this question is not relevant.

Summary of 510(k) Context:

It's crucial to understand that a 510(k) premarket notification, especially for a device like a dental implant that is similar to existing ones, focuses on demonstrating substantial equivalence to predicate devices. It typically does not involve new, extensive clinical trials with statistical endpoints, large test sets, expert adjudication, or AI performance metrics. The "proof" in this context is the detailed comparison of the new device's design, materials, manufacturing, and intended use against those of already-approved predicate devices to show that it is just as safe and effective. The provided document aligns perfectly with this 510(k) paradigm.

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