(90 days)
The #8C Renegade Dental Handpiece is intended for use in general dentistry by licensed professionals for removing carious material, reducing hard tooth surfaces, cavity preparations, restorations, restorations and polishing teeth.
The #8C Renegade is a high speed air turbine handpiece with a push-button autochuck. The handpiece is powered by compressed air (26-35 psi) which activates an air turbine causing rotation of the chuck holding a burr (not supplied with the handpiece) at 380,000-530,000 rpm. The handpiece handle and head are constructed of chrome plated brass. The handpiece features a four (4) hole connector for air and water input and return. The head and burr are cooled by a water/air mist. The handpiece is supplied non-sterile and must be cleaned, lubricated and sterilized prior to each patient use.
Here's a breakdown of the acceptance criteria and the study information for the #8C Renegade Dental Handpiece based on the provided document:
This document is a 510(k) premarket notification for a dental handpiece, arguing for "substantial equivalence" to a predicate device rather than introducing a novel AI device. Therefore, the questions related to AI performance, ground truth, and human reader improvement are not directly applicable in this context. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device through non-clinical testing.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implicitly derived from the characteristics and performance of the predicate device, as the goal is to demonstrate "substantial equivalence." The reported device performance is compared to the predicate device's characteristics.
Implicit Acceptance Criteria & Reported Device Performance
| Characteristic/Criterion | Predicate Device (Thunder Tiger Dental Air-Powered Handpiece) | Proposed Device (#8C Renegade Dental Handpiece) | Acceptance Status (Implicit) |
|---|---|---|---|
| Indications for Use | Removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and polishing teeth. | Removing carious material, reducing hard tooth surfaces, cavity preparation, finishing tooth preparations, restorations, and polishing teeth. | Met: Identical intended uses. |
| Device Design: Operational Mode | 4-holes | 4-holes | Met: Matches predicate. |
| Device Design: Fiber Optics | No | No | Met: Matches predicate. |
| Device Design: Dimensions | Head: Φ12mm X 12mm to Φ12mm X 12.4mm | ||
| Length: not provided | Head: Φ12.5mm X 13.3mm | ||
| Length: 123.1mm | Met: Slight differences in head dimensions, but considered minor and do not raise new safety/effectiveness issues (as per conclusion). | ||
| Device Design: Type of chuck | Push-button autochuck | Push-button autochuck | Met: Identical. |
| Device Design: Type of connector | ISO-B, Midwest coupler | ISO-B, Midwest coupler | Met: Identical. |
| Device Design: Materials | Surface: Chrome plated | Waterline: 440C stainless steel | |
| Surface: chrome plated brass | Met: Similar, and biocompatibility testing noted. | ||
| Specifications: Burr Extraction Force | 35 N | 26 N | Met: Within acceptable range for function, difference considered minor. |
| Specifications: Burr Size | 1.59-1.60 diameter, 19-25mm and 16-21mm length | 1.6 diameter, 19mm length | Met: Compatible with common burr sizes. |
| Specifications: Water flow rate | >50mL/min | 120mL/min | Met: Exceeds predicate's minimum. |
| Specifications: Air pressure | 1.0-3.0bar | 2.0bar | Met: Within predicate's operational range. |
| Specifications: Speed (rpm) | ≥ 300,000 | 380,000-530,000 | Met: Exceeds predicate's minimum. |
| Specifications: Lubricant | Lubricant is required | Lubricant is required | Met: Identical. |
| Sterility | Provided non-sterile, must be sterilized prior to each patient use | Provided non-sterile, must be cleaned and sterilized prior to each patient use | Met: Both require sterilization before use. Differences are minor (proposed device adds "cleaned"). |
| Biocompatibility | (Implicitly safe and effective) | Finished, sterilized device meets ISO 10993-1 biocompatibility requirements. | Met: Demonstrated compliance with recognized standard. |
Summary of Acceptance: The device is accepted as "substantially equivalent" because its characteristics, indications for use, and performance, as demonstrated through bench testing, are comparable to or exceed the predicate device, and any differences do not raise new safety or effectiveness issues.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "Bench testing," which typically involves testing a limited number of manufactured units to verify specifications and performance. Details like the exact number of handpieces tested for each parameter (e.g., burr extraction force, water flow rate, speed) are not provided in this summary.
- Data Provenance: The testing was "Bench testing" performed by the manufacturer (Handpiece Club, LLC) to support their 510(k) submission. There is no information regarding the country of origin of the data beyond it being generated for this regulatory submission. It is by nature "prospective" in the sense that the testing was conducted on manufactured samples of the new device for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable to this submission. The "ground truth" here is establishing that the device's technical specifications and performance are comparable to the previously cleared predicate device. This is determined through engineering/bench testing against predefined technical standards and comparison, not through expert clinical interpretation of results. No information about experts for establishing ground truth is provided or relevant here.
4. Adjudication method for the test set
- This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or agreement on a diagnosis or outcome. Since this is a bench testing summary for a dental handpiece, such adjudication is not performed. The data is objective measurement and comparison.
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
- No, an MRMC comparative effectiveness study was not done. This is a 510(k) submission for a conventional medical device (dental handpiece), not an AI-powered diagnostic or assistive tool. Clinical testing was explicitly not conducted, as stated in Section 8: "No clinical testing was conducted to support this submission." Therefore, questions about human readers, AI assistance, and effect size are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This device is a mechanical dental handpiece, not an algorithm or AI system. This question is not applicable.
7. The type of ground truth used
- The "ground truth" in this context is the technical specifications and performance characteristics of the predicate device (Thunder Tiger Dental Air-Powered Handpiece) and relevant industry standards (e.g., ISO 10993-1 for biocompatibility). The new device's performance is measured and compared against these established benchmarks to demonstrate substantial equivalence. It does not involve expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth for a training set to be established.
§ 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.