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The intended use of the Satelec Implant Center 2 is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

The Satelec Implant Center 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools and accessories for use by qualified dental practitioners.

This document is a 510(k) summary for a dental operative unit called the "Implant Center 2." It primarily focuses on demonstrating substantial equivalence to a previously cleared device, not on presenting a study with specific acceptance criteria and performance data in the way a clinical study for a diagnostic AI device would.

Therefore, the sections of your request related to acceptance criteria, specific performance metrics (like sensitivity, specificity), ground truth, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies for AI interpretation are not applicable to this document. This filing is for a physical medical device (dental operative unit), not a digital health or AI-driven diagnostic tool.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

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

• Not Applicable. This document does not describe specific numerical acceptance criteria or performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or diagnostic function. Its acceptance criteria fundamentally revolve around demonstrating "substantial equivalence" to a predicate device. The performance is assessed against the predicate's known safety and effectiveness for its intended use, rather than quantifiable performance metrics.

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

• Not Applicable. No test set or data provenance is mentioned as this is not a study assessing AI performance or a diagnostic outcome. The "test" for this device is the comparison to the predicate device and assessment of manufacturing controls and safety features.

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)

• Not Applicable. No ground truth establishment for a diagnostic test set is mentioned.

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

• Not Applicable. No test set requiring expert adjudication is mentioned.

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

• Not Applicable. No MRMC study was done, as this is not an AI-assisted diagnostic or interpretation device.

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

• Not Applicable. This device is a physical dental operative unit, not an algorithm.

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

• Not Applicable. No ground truth for a diagnostic purpose is used. The "ground truth" for this filing is the safety and effectiveness of the predicate device as established by its prior clearance. The new device is intended to be as safe and effective as the predicate.

8. The sample size for the training set

• Not Applicable. No training set is mentioned for an AI model.

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

• Not Applicable. No training set ground truth to establish.

Summary regarding the device and its "study" for acceptance:

This document describes a 510(k) submission for a medical device (a dental operative unit) where the primary "study" and "acceptance criteria" revolve around demonstrating substantial equivalence to a previously cleared predicate device.

• Acceptance Criteria (Implied by 510(k) Process): The device (Implant Center 2) must demonstrate that it is as safe and effective as the predicate device (Implant Center, K072030) for its intended use and does not raise new questions of safety or effectiveness. This is achieved by comparing device descriptions, technical specifications, performances, and intended uses.
• Study/Evidence: The "study" isn't a clinical trial in the traditional sense, but a detailed comparison provided in the "Substantial Equivalence" section.
  • Device Comparison: The Implant Center 2 and the predicate device are both "dental operative units that supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners."
  • Conclusion: The document states, "Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the Implant Center 2."

In essence, the "study" is a technical and functional comparison to show that the new device is essentially the same, with only minor differences that do not impact fundamental safety or effectiveness, as its predicate.

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