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The device is an air-powered dental handpiece for use in general dentistry.

The CROMAX Turbine Handpiece is an air-driven high-speed dental handpiece. It has an airdriven turbine with appropriate power and speed for use with dental carbide burrs and diamond cutting instruments. Construction is stainless steel for corrosion resistance. It has water spray for cooling of the cutting burr. One model has push-button chucking mechanism to grip cutting instrument with ISO standard shanks. The CROMAX Turbine Handpiece may be sterilized by the steam autoclave method. The bearing are sealed. Technically supported and adopted key components of rotor and ball bearing from § •››Air, Switzerland. Foshion produced CROMAX turbine handpiece and powered by Bien -- ir.

The CROMAX Turbine Handpiece, an air-powered dental handpiece, received 510(k) clearance based on its substantial equivalence to predicate devices, namely the T1 Line Dental Handpieces (K972436) and the Rapidd Highspeed Dental Handpiece (K003518). As a Class I device, the regulatory pathway relies on demonstrating substantial equivalence rather than extensive clinical studies with specific acceptance criteria and performance metrics typically associated with higher-risk devices or novel technologies.

Therefore, the provided document does not contain the detailed information requested for acceptance criteria and a study proving the device meets them, such as a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or details on standalone or MRMC studies.

Instead, the submission focuses on demonstrating that the CROMAX Turbine Handpiece is as safe and effective as existing legally marketed devices. The key elements for establishing substantial equivalence are described as follows:

1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document as it is a 510(k) submission for a Class I device based on substantial equivalence. Performance data in the context of specific quantitative acceptance criteria is not a requirement for this type of submission. The 'performance' is implicitly deemed acceptable if it is substantially equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable/not provided. The 510(k) submission for this Class I device does not involve a specific clinical "test set" in the context of performance studies with sample sizes. Substantial equivalence is demonstrated through comparison of technical characteristics and compliance with recognized standards.

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):
This information is not applicable/not provided. The concept of "ground truth established by experts" for a test set is typically relevant for diagnostic or image analysis devices undergoing performance validation, not for a dental handpiece demonstrating substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. Adjudication methods are used in clinical trials or performance studies involving interpretation, which is not the basis of this 510(k) submission.

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/not provided. This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not provided. The device is a mechanical tool and does not involve any algorithms or standalone performance testing in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not provided. The regulatory process for this device did not involve defining a "ground truth" as would be done for diagnostic accuracy studies.

8. The sample size for the training set:
This information is not applicable/not provided. There is no "training set" for this type of mechanical device submission.

9. How the ground truth for the training set was established:
This information is not applicable/not provided. No training set or associated ground truth was established for this device.

Summary of Substantial Equivalence and Safety/Effectiveness Demonstration:

The safety and effectiveness of the CROMAX Turbine Handpiece are established through its substantial equivalence to already legally marketed predicate devices. The document highlights the following points to support this claim:

• Construction and Materials: "The handpiece is constructed of the same specifications as the predicate device to ensure biocompatibility." It is made of stainless steel for corrosion resistance.
• Operating Mechanism: It is an air-driven high-speed dental handpiece with an air-driven turbine, similar to the predicate devices.
• Functionality: It provides appropriate power and speed for use with dental carbide burrs and diamond cutting instruments, and includes water spray for cooling.
• Sterilization: It can be sterilized by the steam autoclave method, a common method for dental instruments.
• Key Components: It uses "technically supported and adopted key components of rotor and ball bearing from Bien-Air, Switzerland."
• Standards Compliance: "The handpiece conforms to applicable ISO standards." This is a crucial element for demonstrating safety and performance in line with internationally recognized benchmarks.

In essence, the "study" demonstrating the device meets the "acceptance criteria" here is the 510(k) review process itself, where the FDA determined that the CROMAX Turbine Handpiece has the same intended use and fundamentally similar technological characteristics to the predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" are implicitly met by successfully demonstrating substantial equivalence through comparison to the predicate devices and adherence to relevant standards.

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