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The Premium Plus Prophy Air Motor is intended to be used with a disposable prophy angle and polishing paste by a trained dental clinician to perform dental prophylaxis.

Premium Plus Prophy Air Motor is a dental low speed prophy air motor with pneumatic rotor, scroll bearing, stainless steel inner parts and anodized aluminum body surface. With the impulse of air current supplied. it can drive a disposable prophy angle with polishing paste to polish teeth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Premium Plus Prophy Air Motor. Based on the document, this is a Class I medical device (dental handpiece and accessories). For Class I devices, the level of regulatory scrutiny and required evidence of "performance" to establish substantial equivalence is generally much lower than for Class II or Class III devices, especially those involving AI/ML.

The provided document describes a 510(k) premarket notification, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove efficacy or performance in the same way an AI/ML device would be scrutinized. Therefore, the "acceptance criteria" here relate to meeting basic safety and performance standards for a simple mechanical device and demonstrating similarity to an existing device. The "study" refers to the engineering and biocompatibility tests conducted.

Most of the specific information requested in your prompt (e.g., sample size for test set regarding AI algorithms, number of experts for ground truth, MRMC studies, standalone AI performance) is not applicable or not present in this type of submission for a simple mechanical dental device. This FDA submission is not for an AI/ML device.

Here's the closest breakdown based on the provided text:

Acceptance Criteria and Device Performance for Premium Plus Prophy Air Motor (K170261)

The Premium Plus Prophy Air Motor is a Class I mechanical dental device. The "acceptance criteria" in this context are defined by compliance with recognized international standards for dental handpieces and by demonstrating substantial equivalence to a predicate device. The "performance" refers to the device meeting the specifications outlined in these standards and its functional characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test (e.g., "Performance Test," "Biocompatibility Test," "Validation Testings"). These typically involve testing a representative sample of devices, but specific numbers are not provided in this summary. For Class I mechanical devices, the number of units tested is generally small as standardized tests are conducted on representative samples to ensure manufacturing quality and design integrity.
• Data Provenance: The device manufacturer, Premium Plus International Limited, is located in Hong Kong, China. The testing itself is conducted to international standards (ISO) and FDA guidance, but the exact location of the testing laboratories (e.g., in Hong Kong, or a third-party lab elsewhere) is not specified. The tests are prospective in the sense that they are performed on the device being submitted for marketing.

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

This concept is not applicable here. "Ground truth" established by experts is relevant for diagnostic or AI/ML devices where there is an interpretation or classification task. For a mechanical dental handpiece, the "ground truth" is determined by objective physical measurements and adherence to engineering standards.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, often for AI/ML devices or diagnostic tests. Here, the "tests" are compliance with engineering standards and validation protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly AI/ML-driven ones, to assess how AI assistance impacts human reader performance. This device is a simple mechanical prophy air motor, not a diagnostic tool or an AI/ML product.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study in the context of an "algorithm" was not done. This device does not contain an algorithm or AI component. Its performance is measured directly through mechanical, airflow, and material safety tests.

7. The Type of Ground Truth Used

As this is a mechanical device, the "ground truth" is established by:

• Compliance with objective engineering standards (e.g., ISO 14457, ISO 9168).
• Results from biocompatibility assays (e.g., cytotoxicity, irritation, sensitization tests per ISO 10993 standards) where "ground truth" is defined by the test's positive/negative control and specific criteria for material response.
• Results from reprocessing validation tests (e.g., protein/hemoglobin analysis, sterilization cycles) designed to demonstrate effective cleaning and sterilization.
• Direct physical and operational measurements (e.g., dimensions, weight, air pressure, operating speed, power output) compared against specifications and the predicate device.

8. The Sample Size for the Training Set

This concept is not applicable. This device is a mechanical product, not an AI/ML algorithm. There is no "training set" for an algorithm.

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

This concept is not applicable as there is no training set.

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