Search Results

CST61 High Speed Turbine Handpiece is indicated for use intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth

CST61 high speed turbine handpiece is an air-powered, hand-held device for use as an operative dental unit accessory at 250KPa with rotation speed of 250,000 RPM in order to perform cutting, shaping, grinding, and polishing functions.

This document is a 510(k) summary for a dental handpiece, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific metrics (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not available in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are not novel.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not provide a table of quantitative acceptance criteria or performance metrics. Instead, it claims substantial equivalence to a predicate device based on technological characteristics.

   Acceptance Criteria	Reported Device Performance
   Not specified (equivalence to predicate device)	"CST61 high speed turbine handpiece is an air-powered, hand-held device for use as an operative dental unit accessory at 250KPa with rotation speed of 250,000 RPM in order to perform cutting, shaping, grinding, and polishing functions." (Implied performance is equivalent to the predicate for these functions).

2. Sample size used for the test set and the data provenance:

   Not applicable. This device is not analyzed using a "test set" in the context of an AI/ML study. Substantial equivalence is typically demonstrated through bench testing, performance testing, and comparison of specifications with a predicate device. The document does not mention any clinical trials or data sets for evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Not applicable. Ground truth establishment with experts is not part of the 510(k) pathway for a non-AI/ML device like a dental handpiece.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   Not applicable. Adjudication methods are relevant for interpretation tasks where expert consensus is needed to establish ground truth, which is not the case for this device.

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 not an AI-assisted device, and therefore, no MRMC study or AI improvement effect size is relevant or reported.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   Not applicable. This is a physical dental instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   Not applicable. The concept of "ground truth" as used in AI/ML validation does not apply to this device. The safety and effectiveness are established by demonstrating it functions as intended and is substantially equivalent to a predicate device based on its design, materials, and performance specifications.

8. The sample size for the training set:

   Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established:

   Not applicable. Since there is no training set, there is no ground truth for it.

Summary of the Study (as described in the 510(k) for this non-AI device):

The "study" or evaluation performed for the CST61 high-speed turbine handpiece is not a traditional clinical trial or AI performance study. Instead, it's a demonstration of substantial equivalence to a previously legally marketed device (K022535). This involves:

• Comparison of Technological Characteristics: The submission includes a tabulated comparison of the new device's features, specifications, and intended use against the predicate device.
• Performance Claims: The device is stated to operate at 250KPa with a rotation speed of 250,000 RPM for cutting, shaping, grinding, and polishing functions. The implication is that these characteristics are comparable to the predicate device to ensure similar safety and effectiveness.
• Intended Use: The intended use of the CST61 high-speed turbine handpiece is explicitly defined: "intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth." This is compared to the predicate device's intended use.

The FDA's review concludes that the device is "substantially equivalent" for the stated indications for use, allowing it to be marketed under the general controls provisions of the Act.

Ask a specific question about this device