(282 days)
For Model J6-126, J6-136:
The Dental Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L:
The Dental Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.
The Dental Handpiece is mainly composed of a machine head, handle, transmission shaft, and cartridge, and is designed to be attached to the drive via standard coupling which complies with ISO 3964 and hose connector which complies with ISO 9168. The head clamp accepts an instrument complying with ISO 1797-1. The handpieces are intended to be powered by air-powered or electric-powered, and they are also intended to provide optic series. They are intended to be provided non-sterile, so they must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization).
The provided document is a 510(k) Premarket Notification for a Dental Handpiece. This type of submission is focused on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy through clinical studies or setting and meeting specific acceptance criteria for performance as would be done for a novel device or a device requiring a PMA.
Therefore, the document does not contain the information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of diagnostic or actionable performance (e.g., accuracy, sensitivity, specificity for a diagnostic AI). The "acceptance criteria" discussed in this document refer to adherence to established safety and performance standards for dental handpieces, and "study" refers to non-clinical tests verifying compliance with these standards.
Here's why the requested information isn't available in this document:
- Device Type: A "Dental Handpiece" is a physical tool used for mechanical dental procedures (cutting, grinding, polishing). It's not a diagnostic device, an AI algorithm for image analysis, or a device that generates a patient-specific "result" that would require performance metrics like sensitivity or specificity.
- Regulatory Pathway (510(k)): The 510(k) pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, technological characteristics, and intended use, and running non-clinical tests to show adherence to relevant performance and safety standards. It generally does not require large-scale clinical trials or MRMC studies that would describe the kind of acceptance criteria you've outlined.
- No Clinical Testing: The document explicitly states: "Clinical testing was not included in the submission." This immediately tells us that there will be no data on human reader improvement with AI assistance, standalone algorithm performance, or ground truth established from clinical outcomes.
- "Ground Truth" irrelevant: For a dental handpiece, the concept of "ground truth" (e.g., for a diagnosis) is not applicable. Its "performance" is measured by its physical characteristics, safety, and ability to perform its mechanical function according to engineering standards.
- No AI component: There is no mention of an AI component in this device.
Based on the available document, I cannot fulfill your request as it pertains to a diagnostic/AI device. The document describes a traditional medical device (dental handpiece) and its regulatory clearance via a 510(k) pathway, which focuses on substantial equivalence and compliance with engineering and safety standards, not clinical performance metrics relevant to AI or diagnostic accuracy.
However, I can extract information related to the standards and non-clinical tests that were performed to demonstrate the device's adherence to established safety and performance requirements, which are the "acceptance criteria" in this context.
Summary of Acceptance Criteria and Device (Non-Clinical) Performance:
| Feature/Criterion | Acceptance Criteria (Standards Adhered To) | Reported Device Performance (Compliance) |
|---|---|---|
| Electrical Safety | IEC 60601-1, IEC 80601-2-60, IEC 62417 | Complies with requirements |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2, IEC/TR 60061-4-2 | Complies with requirements |
| Reprocessing (Sterilization) | FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", ISO 17665-1 (Validation of effectiveness and max. reprocessing cycles) | Meets requirements |
| General Dental Handpiece Performance & Safety | FDA Guidance: "Dental Handpieces - Premarket Notification [510(k)] Submissions", ISO 14457 | Complies with requirements |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 | Complies with requirements |
| Fiberoptics Light Intensity (if applicable) | ISO 14457 (≥7000 lx) | Meets standard's requirements |
| Bur Extraction Force | ISO 14457 (specific N values for models, e.g., ≥22N, ≥45N) | Complies with requirements |
| Maximum Air Pressure | ISO 14457 (specific kPa for models, e.g., 300kPa) | Complies with requirements |
| Maximum Water Pressure | ISO 14457 (specific kPa for models, e.g., 200kPa) | Complies with requirements |
| Rotation Speed | ISO 14457 (specific rpm ranges, e.g., 300,000-340,000rpm or max. 40,000 rpm motor compatible) | Complies with requirements |
| Gear Ratio Speed (if applicable to model) | ISO 14457 (confirming max. rotation speed) | Complies with requirements |
| Shank Type Design & Bur Extraction Force (Shank) | ISO 1797-1, ISO 14457 | Complies with requirements |
Here's why the other points of your request cannot be answered from this document:
- Sample size used for the test set and data provenance: Not applicable in the context of diagnostic/AI performance. The "tests" are engineering and safety verification tests on physical units of the device. The provenance of the device under test would be "Guangdong JINME Medical Technology Co., Ltd., China."
- Number of experts used to establish the ground truth... and qualifications: Not applicable. There is no diagnostic "ground truth" to establish for a dental handpiece.
- Adjudication method: Not applicable.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Explicitly stated "Clinical testing was not included in the submission." Therefore, no MRMC study, no human reader improvement data.
- Standalone (i.e., algorithm only without human-in-the-loop) performance: Not applicable, as there is no algorithm component.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as there is no AI or machine learning component that requires a training set.
- How the ground truth for the training set was established: Not applicable, as there is no training set.
§ 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.