(104 days)
The Nakanishi iProphy mobile is a cordless prophylaxis handpiece for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth.
The iProphy mobile is a cordless prophylaxis system consisting of an electric motor driven handpiece and an AC powered battery charger (stand). The handpiece utilizes commercially available disposable, single use Disposable Prophy angles (DPA). The handpiece features on-board user controls for power, on/off, and speed with indicators for battery charging, battery life, and speed selection. The iProphy mobile is to be used with disposable handpiece sleeves.
The provided text describes the iProphy mobile, a cordless prophylaxis system, and its FDA 510(k) summary. However, it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Dentsply Midwest RDH Freedom Cordless System) based on:
- Intended use: Both are cordless prophylaxis handpieces for cleaning and polishing teeth.
- Principles of operation: Both use disposable prophylaxis angles.
- Functional design: Both are handpieces with user controls.
- Established medical use.
Instead of specific quantitative acceptance criteria and a study demonstrating their achievement, it mentions general compliance with standards and internal specifications.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Compliance with ISO 10993-1: Biological evaluation of medical devices | Documentation provided demonstrating compliance. |
| Compliance with FDA Guidance: "Use on International Standard ISO 10993..." | Documentation provided demonstrating compliance. |
| Compliance with FDA requirements for Software Contained in Medical Devices (Guidance for Premarket Submissions) | Documentation provided demonstrating compliance, including verification/validation plus traceability to software requirements and risk hazards. |
| Compliance with IEC 60601-1 (Electrical safety) | Testing confirmed compliance. |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | Testing confirmed compliance. |
| Compliance with ISO 11498: Dental low-voltage electrical motors | Documentation provided demonstrating compliance. |
| Implicit Criteria (Functional Specifications) | Reported Performance |
| Power on/off functionality | Achieved via user controls on handpiece. |
| Activation of rotation | Achieved via user controls on handpiece. |
| Setting rotation speed | Achieved via user controls on handpiece. |
| Observing speed setting | Achieved via indicators on handpiece. |
| Observing battery charging status | Achieved via indicators on handpiece. |
| Observing battery status | Achieved via indicators on handpiece. |
| Auto power-off function (after approx. 10 mins non-operation) | Device features this function. |
| Last memory function (recalls most recent settings) | Device features this function. |
| Compatibility with commercially available disposable prophylaxis angles (DPA) | Device can utilize any commercially available compatible DPA. |
Missing Information for Acceptance Criteria: The document does not provide specific quantitative acceptance criteria such as speed ranges, battery life, torque, or safety thresholds (e.g., maximum temperature rise, noise levels, vibration). It generally states compliance with standards.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "Tests were performed which demonstrated that the device is substantially equivalent to the predicate device. Tests included verification/validation testing to internal functional specifications, including software." This refers to internal product development testing rather than a clinical study with a specific patient sample size.
- Data Provenance: Not specified. The testing seems to be internal to the manufacturer (Nakanishi, Inc. in Japan) for engineering verification and validation.
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. This device is a dental handpiece, not an AI/diagnostic software that requires expert ground truth for a test set. The validation is based on engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This device is a dental handpiece, and its validation involves engineering and safety testing, not expert adjudication of diagnostic outcomes.
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 is a physical dental device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical dental device, not an algorithm. The device itself is "standalone" in that it performs its function when operated, but this is a different context than AI software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: For a physical device like this, "ground truth" refers to compliance with established engineering standards (e.g., IEC 60601-1, ISO 11498) and the device's ability to meet its functional specifications (e.g., maintain set speed, indicate battery life). There isn't an "expert consensus" or "pathology" type of ground truth for a mechanical and electrical device's performance in this context.
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
§ 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.