Search Results

JINDELL High Speed Air Turbine Handpiece, models: SW, SP, SU, ETU, MU are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Dental Air-Powered Handpiece

This submission is for a dental handpiece, which is a mechanical device. The acceptance criteria and supporting study for such a device would typically focus on engineering performance, safety, and functional equivalence rather than clinical performance metrics common for AI/ML devices. Therefore, a direct mapping to all the requested categories for AI/ML performance studies is not applicable.

Based on the provided information, the acceptance criteria and supporting study are primarily focused on substantial equivalence to a legally marketed predicate device.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. For mechanical devices like dental handpieces, the "test set" would typically refer to engineering tests (e.g., durability, performance under load, sterilization cycle validation), not clinical data or human-annotated data sets. The summary indicates a comparison of "formulations and intended uses," suggesting a technical and functional comparison rather than a study with a specific data set.

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 and not provided. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI/ML devices. For a dental handpiece, "ground truth" would relate to objective engineering specifications and performance measurements, not expert interpretations of data.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts in diagnostic studies, which is not relevant 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

This information is not applicable and not provided. An MRMC study is relevant for AI-assisted diagnostic tools. The JINDELL High Speed Air Turbine Handpiece is a mechanical dental instrument and does not involve AI or human readers for diagnostic purposes.

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

This information is not applicable and not provided. This is a mechanical device, not an algorithm.

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

As noted in point 3, the concept of "ground truth" as typically applied to diagnostic studies is not applicable here. The "ground truth" for a mechanical device like a dental handpiece would be its adherence to established engineering standards, material specifications, and functional performance benchmarks (e.g., rotational speed, concentricity, torque, durability under simulated use conditions). This specific type of "ground truth" (e.g., specific engineering standard compliance) is not detailed in the provided summary. The basis for substantial equivalence is primarily a comparison to the predicate device's established characteristics.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a mechanical device like this.

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

This information is not applicable and not provided. There is no "training set" or corresponding "ground truth" for this type of device.

Summary of Acceptance and Study:

The primary "study" for the JINDELL High Speed Air Turbine Handpiece models (SW, SP, SU, ETU, MU) was a comparison for substantial equivalence to a predicate device (Dental Air-Powered Handpiece, models: TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202, K052822).

The acceptance criteria were that the device shares the same intended use and has substantially equivalent technological characteristics and performance that do not raise new questions of safety or effectiveness compared to the predicate device.

The "evidence" or "performance data" provided for this substantial equivalence claim is described as "comparisons of formulations and intended uses of the JINDELL High Speed Air Turbine Handpiece and its claimed predicate." This implies a technical assessment and documentation demonstrating that the new device is functionally, materially, and operationally similar to the legally marketed predicate. Specific quantitative performance metrics (e.g., speed, durability) and their comparison values are not included in this 510(k) summary but would have been part of the full submission reviewed by the FDA.

Ask a specific question about this device