(346 days)
The Dental Low-speed Handpieces and Accessories are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.
Halley spray is intended to be used during routine maintenance in order to lubricate Dental Handpieces (including high and low speed) and Dental Air Motors after cleaning and prior to sterilization.
The low-speed dental handpieces are hand-held instruments driven by air motor or electric motor and relevant gear mechanism, capable of high speed, which is integrated into the head of the handpiece and has a chucking device coaxial with a rotating spindle. The Halley Series includes several models of contra-angle handpieces, straight handpieces, and air motors.
The handpieces are intended to be used by well-trained professionals in the field of general dentistry. They are reusable and some have a fiber-optic light system. They are supplied with drive power, water spray, and light through the electric or air motors connected to the tube and dental units.
The low-speed handpieces are divided into 4 types: contra-andle handpieces and straight handbieces. with or without fiber-optic. The contra-angle handpieces with fiber optic have 2 models and those without fiber optic have 3 models. The straight handpieces with fiber optic have 1 model and those without fiber optic have 2 models.
The handpieces are mainly made of stainless steel and must be reprocessed by the user before first use and after each use.
The Halley spray is a special formulated lubricating general handpieces and air-motors. The application ensures well performance and durability for high/low-speed handpieces and air motor.
This document is a 510(k) Premarket Notification for a dental device, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets those criteria, specifically concerning AI/ML performance, do not apply.
The document describes the non-clinical testing performed to establish substantial equivalence for the Dental Low-speed Handpieces and Accessories. These tests are based on applicable technical standards and FDA guidance documents for medical devices.
Here's an overview of the non-clinical testing summarised in the submission:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a direct table of acceptance criteria versus reported device performance in a quantitative manner as would be expected for an AI/ML device. Instead, it lists the standards considered and states that the device was found to be "in compliance with the applicable international and internal standards" through bench testing. This implies that the acceptance criteria are defined within these standards, and the device met them.
Applicable Standards Considered:
- ISO 14457: Dentistry — Handpieces and motors (Version 2017)
- ISO 1797: Dentistry -- Shanks for rotary and oscillating instruments (Version 2017)
- ISO 5349-1: Mechanical vibration — Measurement and evaluation of human exposure to hand-transmitted vibration — Part 1: General requirements (Version 2001)
- ISO 9168: Dentistry — Hose connectors for air driven dental handpieces (Version 2009)
- IEC 62366: Medical devices — Application of usability engineering to medical devices (Version 2007)
- ISO 10993-1: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Version 2018)
- ISO 10993-5: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (Version 2009)
- ISO 10993-10: Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization (Version 2010)
- ISO 17664: Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (Version 2017)
- ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (Version 2006)
Reported Device Performance:
The conclusion states that based on bench testing (against the above standards), the device is substantially equivalent to the predicate devices. Specific quantitative performance metrics are not detailed in this summary.
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 provided in a way that applies to AI/ML device testing. For traditional medical device testing like this, the "test set" refers to the physical units of the device being tested according to the standards. The sample size for these engineering tests (e.g., number of handpieces tested for vibration, durability, or sterilization effectiveness) is not specified in this summary. Data provenance related to patient or image data is not applicable.
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 question is not applicable. "Ground truth" in the context of this device would refer to the objective, measurable parameters defined by the engineering standards (e.g., rotation speed, material strength, sterilization efficacy). These are established by validated laboratory methods, not by expert consensus in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of medical device submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI/ML evaluations to resolve discordant expert opinions on ground truth, which is not relevant here.
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 device is a dental handpiece, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is derived from compliance with international and internal engineering and biological safety standards (e.g., ISO 14457 for handpiece performance, ISO 10993 for biocompatibility, ISO 17665 for sterilization). The device's physical and functional characteristics are objectively measured and compared against the defined limits or requirements of these standards.
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. As there is no training set, the concept of establishing ground truth for it is not relevant.
In summary, the provided document details a 510(k) submission for a non-AI/ML dental device. The "acceptance criteria" are the requirements of the various listed international and FDA-recognized standards, and the device's performance was proven by "bench testing" to be in compliance with these standards and substantially equivalent to predicate devices.
§ 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.