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RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).

RDT3 is a reciprocating vertical vibrating handpiece attachment and is capable of providing the SAF with an impact movement of approximately 0.4 mm and up to 5,000 rpm drive speed required for conducting endodontic treatment. Low torque (max 9.5 ar cm) rotation motion is integrated in order to ease insertion of the file into the root canal. The file is attached to the RDT3 head via friction grip.

The provided document describes a 510(k) premarket notification for the REDENT NOVA's RDT3 Handpiece Head. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. However, it does not include information about a clinical study involving human or even simulated patients, nor does it involve AI, expert consensus for ground truth, or statistical measures like sensitivity, specificity, or AUC typically associated with device performance in diagnostic or prognostic applications.

The acceptance criteria and "study" described are engineering and material performance tests.

Here is the information based on the provided text, recognizing the limitations of its scope regarding "acceptance criteria" in a clinical sense:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test with pass/fail values. Instead, it states that tests were carried out in accordance with ISO 7785-2 and an in-house test, and for all of them, the device "functioned as intended" and "results observed were as expected." This implies that the RDT3 met the implied performance standards of the ISO standard and the internal test.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for the performance tests (e.g., how many handpieces were tested for chuck friction grip or corrosion). The tests are described as in vitro engineering and material tests, not tests on clinical data. No information on data provenance (country of origin, retrospective/prospective) is provided, as it's not applicable to these types of tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for these engineering tests would be derived from the objective measurements and standards set forth in ISO 7785-2, not from expert consensus or clinical evaluation.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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. This device is a dental handpiece head, a mechanical device. The submission does not involve AI or human readers, and therefore no MRMC study was conducted.

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

Not applicable. This device is a mechanical handpiece head, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on the standards and methodologies outlined in ISO 7785-2 and presumably a documented internal specification for the in-house Sodium Hypochlorite Exposure test.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI or machine learning model, so there is no training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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