(127 days)
This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.
This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.
This 510(k) submission is for a dental handpiece, a general-purpose tool. As such, the submission does not contain the kind of detailed performance study data you'd typically find for an AI/ML powered device, which would require specific acceptance criteria related to accuracy, sensitivity, specificity, etc.
The document focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a clinical study. The "acceptance criteria" here implicitly refer to meeting the general safety and effectiveness standards a dental handpiece is expected to meet, and demonstrating that its performance is comparable to the predicate.
Given this, I cannot fill out all sections of your request as they pertain to AI/ML device testing. However, I can extract the relevant information from the provided text as it relates to this type of device submission.
No Specific Acceptance Criteria or Performance Study for AI/ML Device
This 510(k) submission is for a dental handpiece, which is a mechanical device, not an AI/ML-powered device. Therefore, the submission does not contain acceptance criteria related to accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML systems.
The submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device (PENG LIM High Speed Air Turbine Handpiece, K062947) by showing that it has the same intended use and similar technological characteristics. The "study" here is essentially the comparison to the predicate device and verification that the device is safe and effective for its intended use, consistent with general controls for Class I devices.
However, based on the provided text, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
Note: Specific, quantifiable acceptance criteria and performance metrics (e.g., accuracy, sensitivity) are not applicable for this type of mechanical device submission in the context of an AI/ML evaluation. The acceptance criteria are implicitly related to the safety and effectiveness of a dental handpiece and its substantial equivalence to a predicate.
| Acceptance Criteria (Implied for a Dental Handpiece) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Intended Use: Prepare dental cavities for restorations, such as tooth body treatment, tooth drilling, and tooth grinding of stomatology. | Met: Device's stated "Indications for Use" are identical to the predicate device, indicating it performs these functions. |
| Technological Characteristics: Air-powered, hand-held device. | Met: Device is described as an "air-powered hand-held device," matching the predicate. |
| Safety: Meets general controls for Class I devices, including good manufacturing practices. | Met: The FDA's letter states the device falls under general controls and allows marketing, implying safety requirements are met for a Class I device. |
| Effectiveness: Capable of performing the stated dental operations. | Met: Substantial equivalence determination implies the device is as effective as the predicate for its intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable in the context of an AI/ML clinical test set.
- For a traditional mechanical device like this, performance is typically confirmed through engineering tests, comparison to standards, and demonstration of equivalence to a predicate, rather than a clinical "test set" in the AI/ML sense. Data provenance for such a device would relate to manufacturing controls and material specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is not an AI/ML device requiring expert-established ground truth. Expert review would be part of the FDA's regulatory process for evaluating the submission's claims and data, but not for establishing a "ground truth" for the device's performance in the AI/ML sense.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is for AI/ML devices to assess their impact on human reader performance. It is not relevant for a mechanical dental handpiece.
6. Standalone (Algorithm Only) Performance Study
- No. This device is a mechanical tool and does not have an algorithm to be evaluated in a standalone performance study.
7. Type of Ground Truth Used
- Not Applicable in the AI/ML sense. For this device, "ground truth" is established by adherence to engineering specifications, recognized standards, and the demonstrated functional utility of the device for its intended purpose, as evidenced by its substantial equivalence to a predicate.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.