(251 days)
The Dental Unit is intended to supply power to and serve as a base for dental devices, and accessories. It is intended for use in the dental clinic /office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
The Dental Unit(model: Mare) is a dental treatment unit tested in accordance with IEC 80601-2-60. This product is used in dentistry only and may only be used by trained medical personnel and trained professional in the field of general dentistry. Dental Unit (model: Mare) consists of dental chair, arm dentist unit, assistant's unit, dental light, cuspidor, water unit, and multi-function foot control. It mainly relies on electricity, compressed air, water to achieve all functions. Various ancillary dental devices can be connected to the Dental Unit (model: Mare) which are attached by means of industry standard ISO connections. The ancillary dental devices include pneumatic handpieces, 3-way syringe, strong suction and weak suction vacuum instruments. The ancillary dental devices include 3-way syringe, strong suction and weak suction vacuum instruments are 510k clarence in the K142206. Based on Safety does not manufacture pneumatic handpieces, the pneumatic handpieces shall be purchased by the enduser. The recommended pneumatic handpieces are 510(k) clearance K170229 and K170236, which are held by GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. None of the Dental Unit (model: Mare), parts or accessories are provided sterile.
This document is a 510(k) premarket notification for a dental unit, indicating it's primarily a regulatory submission for device clearance. It does not contain the detailed acceptance criteria and study results typically found in reports specifically designed to demonstrate device performance against such criteria for AI/ML devices.
The document discusses the substantial equivalence of the "Dental Unit: model Mare" to a predicate device (K142206). The "acceptance criteria" here refers to the compliance with recognized consensus standards for medical devices and the demonstration of safety and effectiveness through non-clinical testing.
Here's an attempt to extract the requested information based on the provided text, with the understanding that it's a regulatory submission and not a performance study report:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for a medical device in a 510(k) submission are typically compliance with recognized standards. The "reported device performance" is the statement that the device meets these standards.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| Safety and Essential Performance: | |
| IEC 60601-1 (Edition 3.2 2020-08) | Complied |
| IEC 80601-2-60 (Edition 2.0 2019-06) | Complied |
| Electromagnetic Compatibility (EMC): | |
| IEC 60601-1-2 (Edition 4.0 2014-02) | Complied |
| Performance (Dental Units & Chairs): | |
| ISO 7494-1 (Third edition 2018-06) | Complied |
| ISO 7494-2 (Second edition 2015-04-01) | Complied |
| ISO 9168 (Third edition 2009-07-15) | Complied |
| ISO 9680:2021 (Operating Lights) | Complied |
| Waterline Biofilm Treatment: | |
| ISO 16954:2015 | Complied |
| Software Verification & Validation: | |
| IEC 62304 (Edition 1.1 2015-06) | Complied |
| Biocompatibility: | |
| ISO 10993-5 (Third edition 2009-06-01) | Complied |
| ISO 10993-10 (Third Edition 2010-08-01) | Complied |
| ISO 10993-23 (First edition 2021-01) | Complied |
| Sterilization & Reprocessing: | |
| ISO 17665-1 (First edition 2006-08-15) | Complied |
| AAMI TIR 12:2020 | Complied |
| AAMI TIR 30:2011/(R)2016 | Complied |
| ANSI/AAMI ST79 :2017 & 2020 Amendments | Complied |
| Shipping Performance: | |
| ASTM D4169-22 | Complied |
| Specific Performance Differentiators: | |
| Patient Chair Loading Capacity (150kg) | Met (per ISO 7494-1:2018) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical testing against standards for a physical medical device (dental unit), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of a "test set" in the context of data used for algorithm evaluation (as implied by the question) is not applicable here. The testing involves physical testing of the device itself to conform to engineering and safety standards. No information on data provenance (country, retrospective/prospective) is provided as it's not relevant for this type of submission.
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)
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set. The "ground truth" is established by the specifications of the recognized consensus standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device requiring adjudication of a test set.
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. This document explicitly states in Section 8: "There was no clinical testing performed." This is for a dental unit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical dental unit, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this device, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international and national consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 7494-1 for dental unit general requirements). Compliance with these standards is the ground truth for performance.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML model.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.