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510(k) Data Aggregation
(540 days)
The Stainless Turbine is intended for the following applications: Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment). The coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces.
The Stainless Turbine handpieces are air driven dental handpieces for use by a trained professional in the field of general dentistry. The handpieces are air-powered, high-speed dental handpieces capable of reaching rotational speeds of 325,000 to 450,000 revolutions per minute. Handpiece models include fiber optic, LED, and non-optic lighting. The handpiece models are available to connect directly to NAKANISHI INC. manufactured couplings. Available handpiece models include the S-Max M Series, Pana-Max Plus Series, Pana-Max Plus2 Series, and the S-Max pico Series. The Stainless Turbine couplings are connection devices used to attach the dental unit to the Stainless Turbine handpieces. Available coupling models include the Glass Fiber Rod Series, LED Series, and No Light Irradiation Series.
The provided text describes a 510(k) premarket notification for a dental handpiece and its accessories, referred to as the "Stainless Turbine." The submission aims to demonstrate that this new device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as separate targets but are implied through the comparison with predicate devices and claims of conformance to ISO standards. The performance characteristics of the proposed Stainless Turbine and the predicate/reference devices are presented in Tables 1 and 2 of the document.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Reference) | Reported Device Performance (Stainless Turbine) |
|---|---|---|
| Rotation Speed | Primary Predicate: 250,000 - 400,000 min-1 | |
| Secondary Predicate: 380,000 – 450,000 min-1 | 325,000 - 450,000 min-1 | |
| Torque | Primary Predicate: Information Not Available | |
| Secondary Predicate: $\geq$ 0.09 N·cm | ||
| Reference (Mach-Sigma): Standard: 8.0 g·cm, Mini: 7.5 g·cm, Torque: 13 g·cm (Note: g·cm needs conversion to N·cm for direct comparison with Secondary Predicate; 1 g·cm = 0.000980665 N·cm. So, 8.0 g·cm = 0.0078 N·cm, 7.5 g·cm = 0.0074 N·cm, 13 g·cm = 0.0127 N·cm) | $\geq$ 0.05 N·cm or $\geq$ 5.0 g·cm (Presented in both units, with a note in g·cm in Table 2) | |
| Noise-Level | Primary Predicate: Information Not Available | |
| Secondary Predicate: $\leq$ 80 dBA | ||
| Reference (Mach-Sigma): 75 dBA max. at 2 kg/cm² air | $\leq$ 80 dBA | |
| Supply Air Pressure | Primary Predicate: Information Not Available | |
| Secondary Predicate: 0.22 - 0.30 MPa | ||
| Reference (Mach-Sigma): 1.8 - 2.0 kg/cm² (0.176 - 0.196 MPa) | 0.18 - 0.30 MPa (1.8 - 3.0 kg/cm²) | |
| Supply Water Pressure | Primary Predicate: Information Not Available | |
| Secondary Predicate: 0.05 - 0.20 MPa | ||
| Reference (Mach-Sigma): $\leq$ 2.0 kg/cm² ($\leq$ 0.196 MPa) | 0.08 - 0.20 MPa (0.8 - 2.0 kg/cm²) | |
| Bur Conformity | Predicate/Reference devices are intended for use with friction grip bur conforming to ISO 1797-1 standard. | Intended for use with a friction grip bur that conforms to ISO 1797-1 standard. |
| Connection Types | Predicate/Reference: Various ISO 9168 compliant connections. | Direct Connection to 4-hole types. (ISO 9168); Connection via swivel adapter to 5-, 4-, 3-, and 2-hole types. (ISO 9168) |
| Special Features | Secondary Predicate: Clean Head System and Anti-Retraction Value. | |
| Reference (K980162): Anti-Retraction Valve. | ||
| Reference (K991701): Clean Head System and Anti-Retraction Valve. | Clean Head System and Anti-Retraction Value |
2. Sample size used for the test set and the data provenance
The document states: "Tests were performed on the handpieces including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent to FDA cleared devices." However, it does not provide any specific sample sizes for the test set or details about the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing appears to be functional and engineering-based (bench testing) rather than involving human experts for ground truth establishment.
4. Adjudication method for the test set
This information is not provided in the document, as the testing described is primarily technical and quantitative, not involving clinical 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
This information is not applicable to this device. The Stainless Turbine is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this device, as it is a mechanical dental tool and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the technical performance characteristics (rotation speed, torque, noise level, pressure), the "ground truth" or reference for comparison appears to be the specifications and performance of legally marketed predicate and reference devices, as well as conformance to international standards (e.g., ISO 1797-1, ISO 9168, ISO 14457:2012). For sterilization, the ground truth is conformance to ISO 17665-1:2006. For biocompatibility, it's ISO 10993-1:2018 and FDA guidance. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for verification of this type of device.
8. The sample size for the training set
This information is not applicable to this device, as it is a mechanical device and not an algorithm or AI system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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