(279 days)
K5 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.
A Dental Unit and Chair K5 is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K5 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate device.
The provided text describes a medical device, the K5, which is a dental operative unit and accessories, including a dental chair. It is a 510(k) submission to the FDA. However, the document does not contain acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.
The document focuses on demonstrating substantial equivalence to a predicate device (K3, K183347) based on indications for use, technological characteristics, and compliance with various safety and performance standards.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the document. The document discusses compliance with safety standards and functional equivalence to a predicate device, but it does not specify quantitative acceptance criteria for features like diagnostic accuracy, sensitivity, or specificity, nor does it provide a table of reported device performance against such criteria. The device is a dental operative unit, not an AI/diagnostic software, so these types of performance metrics are not applicable in this context.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of AI/diagnostic software. The document describes non-clinical testing for areas like biocompatibility, cleaning validation, electrical safety, electromagnetic compatibility, and software verification/validation. These tests do not involve a "test set" of clinical data for performance evaluation in the way an AI algorithm would.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The device is a dental operative unit, and its evaluation focuses on safety, functionality, and compliance with engineering standards, not on diagnostic performance or interpretation by experts to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. As there is no "test set" of clinical data for diagnostic performance requiring expert interpretation, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, particularly AI-powered ones, to assess how human readers' performance changes with AI assistance. The K5 is a dental operative unit, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm or AI was not done. The K5 is a physical dental unit with electronics and software for controlling its functions, not an AI algorithm intended for standalone performance evaluation in a diagnostic capacity.
7. The Type of Ground Truth Used
This information is not applicable in the context of diagnostic accuracy. The "ground truth" for the K5 device's evaluation is primarily based on:
- Compliance with recognized standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).
- Functional performance (e.g., chair movement, fluid delivery, suction) as designed and tested against specifications.
8. The Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" in the context of machine learning or AI algorithms because the K5 is a dental operative unit, not an AI-driven diagnostic or analytical tool.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.