(209 days)
Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.
The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.
The provided document is a 510(k) premarket notification for a dental air motor. The core of this document is a comparison of the subject devices (Air Motor FX204 M4 and Air Motor M205) against predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device against acceptance criteria in the typical sense of AI/ML performance.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for AI/ML devices are not applicable in this context. The document focuses on performance testing to demonstrate safety and effectiveness for a mechanical device.
However, I can extract the information relevant to how the device's technical specifications and performance were evaluated against established standards and predicate devices.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds in a table format for each specific performance metric in the way you might see for an AI algorithm (e.g., AUC > 0.90). Instead, the acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to legally marketed predicate devices by showing that the subject devices perform similarly and meet relevant safety and performance standards.
The closest we have to "reported device performance" and "acceptance criteria" are the comparison tables (Table 1 for FX204 M4 and Table 2 for M205) and the "Judgement" column, which indicates if the subject device is "Same," "Similar," or "Different" to the predicate. For "Different" or "Similar" aspects, further testing or justification is provided to demonstrate that the difference does not raise new questions of safety or effectiveness.
Below are tables summarizing the key performance and safety aspects evaluated and how the subject device's performance compared to the predicates, along with the implicit "acceptance criteria" through this comparison.
For Air Motor, FX204 M4 (model without spray) - (Based on "DEVICE AND PREDICATE COMPARISON TABLE-1")
| Characteristic / Performance Aspect | Acceptance Criteria (Implicit from Predicate Comparison & Standards) | Reported Device Performance (Subject Device: Air Motor, FX204 M4) | Judgment (vs. Predicate/Reference) |
|---|---|---|---|
| Indications for Use | Same as predicate devices for general dental applications. | Driving handpiece for tooth restoration, prophylaxis, root canal preparation. | Same |
| Device Description/Technology | Pneumatically driven air motor for dental handpieces. | Converts compressed air into rotary motion for dental instruments. | Same |
| Supply air pressure | Within acceptable range for dental applications (compared to predicates). | 0.20 – 0.25 MPa | Different (lower pressure than primary predicate, but considered sufficient) |
| Optic lighting | Similar to some predicate devices or not raising new safety/effectiveness concerns. | No | Same with Reference Device (Air-Powered Handpieces) |
| Speed range | Similar upper speed range to predicate devices. | 19,800 - 24,200 min⁻¹ (0.25 MPa) | Similar |
| Max. air consumption | Similar to predicate devices, not raising safety/effectiveness concerns. | 50 (ml/min) based on predicate. | > 50 (ml/min) |
| Water pressure | Similar range to predicate/reference. | 1 – 2.5 (bar) | Similar range |
| Chip air pressure | Similar range to predicate/reference. | 1.5 – 2.5 (bar) | Similar range |
| Performance Testing | Conformity to ISO 14457 (dental handpieces) and other relevant standards (sterilization, cleaning). | Passed ISO 14457:2017; AAMI/ANSI/ISO 17665-1:2006 (Sterilization); FDA Guidance for Cleaning. Also check valve effect verification. | Similar (All devices passed ISO 14457, relevant testing to predicates) |
| Biocompatibility | Conformity to ISO 7405 and AAMI/ANSI/ISO 10993-1. | Conformity to ISO 7405:2018; AAMI/ANSI/ISO 10993-1:2018. | Similar |
| Clinical Testing | Not required for this type of device based on its nature and predicate comparison. | NO | Same (as predicates) |
| Air/water port | Spray equipped. | Spray | Same with Reference Device (Air-Powered Handpieces) |
| Dimensions | Similar to predicate devices, not raising new safety/effectiveness concerns. | 78.3 x φ20 mm | Similar |
| Patient-contacting portions | Indirect contact (waterlines) defined, conformity to biocompatibility standards. | Direct contact: No; Indirect contact: Waterlines | Similar with Reference Device (Air-Powered Handpieces) |
| Composition of the waterlines | Materials compatible with biocompatibility standards. | Fluor rubber, Stainless steel, Aluminum based alloy | Different (but conformity to ISO 10993-1 supports substantial equivalence) |
| Handpiece Connection | ISO 3964 standard connection. | ISO 3964 | Same with Reference Device (Air-Powered Handpieces) |
| Hose Connection | ISO 9168 standard connection. | ISO 9168 | Same with Reference Device (Air-Powered Handpieces) |
| Lubricant | Predetermined lubricant (PANA SPRAY Plus). | PANA SPRAY Plus (K163483) | Similar with Reference Device (Air-Powered Handpieces) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Statistical calculation of sample size" under performance testing, but does not provide specific numbers for units tested for each type of test. The nature of these tests (e.g., drop test, reprocessing resistance, water leakage, vibration, sterilization validation) typically involves testing a representative sample of devices, but the exact number isn't quantified in the provided text.
- Data Provenance: Not explicitly stated, however, the applicant is "NAKANISHI INC." based in "700 Shimohinata Kanuma Tochigi, 322-8666, Japan". It's highly probable the testing was conducted in Japan or through certified testing facilities used by the manufacturer. The data would be prospective in the sense that these tests are performed on the manufactured devices to ensure they meet specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This concept typically applies to clinical studies or studies involving human interpretation (e.g., radiology expert review for AI algorithms). This submission is for a mechanical dental device.
- The "ground truth" here is compliance with engineering standards (e.g., ISO 14457 for dental handpieces), safety standards (e.g., ISO 10993 for biocompatibility), and the performance characteristics of the predicate devices.
- No "experts" in the sense of clinical reviewers establishing ground truth for individual cases are mentioned. Instead, the evaluations are based on technical testing by qualified personnel in accredited laboratories.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often in AI/ML performance evaluation where ground truth is based on expert consensus.
- This is not applicable here as the evaluation is based on objective measurements against engineering standards and comparison with predicate device specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is a submission for a mechanical dental motor, not an AI/ML diagnostic or assistive device that would involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device does not involve a software algorithm in the context of an AI/ML device requiring this type of performance evaluation.
7. Type of Ground Truth Used
- The "ground truth" for this submission is primarily technical specifications/performance derived from engineering standards (e.g., ISO 14457, ISO 10993) and comparison to the known and established safety and effectiveness of legally marketed predicate devices.
- For example, passing ISO 14457 test methods indicates the device performs as expected for a dental handpiece. Biocompatibility is "ground-truthed" by adherence to ISO 10993.
8. Sample Size for the Training Set
- Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device.
§ 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.