(45 days)
The Dental Unit with Chair 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 applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168.
All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light.
The provided text is for a 510(k) summary for a "Dental Unit with Chair" (K080438). This type of device is a Class I product, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device based on common design principles, adherence to recognized standards, and safety considerations. It does not involve a study proving performance against specific acceptance criteria in the way a medical imaging AI or diagnostic device would.
Therefore, many of the requested categories (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. The "acceptance criteria" here are compliance with recognized standards and demonstration of substantial equivalence.
Here's a breakdown based on the available information:
Acceptance Criteria and Device Performance for K080438 (Dental Unit with Chair)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Compliance |
|---|---|---|
| Effectiveness | Compliance with ISO 7494-1 (Dental equipment — Dental unit), ISO 7494-2 (Dental equipment — Dental patient chairs), ISO 6875 (Dental equipment — Patient's chair), and ISO 9168 (Dental equipment — hose connectors) | Device complies with all listed ISO standards. |
| Safety (Biological) | Compliance with ISO 10993 (Biological evaluation of medical devices) for biocompatibility of skin-contact materials. | Device's skin-contact component material meets biocompatibility requirements. |
| Safety (Electrical) | Compliance with IEC 60601-1 (Medical electrical equipment - General requirements for safety) and IEC 60601-1-2 (Electromagnetic compatibility). | Device complies with both IEC 60601-1 and IEC 60601-1-2. |
| Safety (Software) | Compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices. | Software validation is in compliance with FDA guidance. |
| Substantial Equivalence | Same classification, indications, intended use, similar product design, technical, biological, and safety specifications as the predicate device (K032543 C8+DENTAL OPERATIVE UNIT). | The applicant device is substantially equivalent to the predicate device, excluding a video system feature not present in the applicant device. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a hardware device submission focused on compliance with recognized standards and substantial equivalence, not performance against clinical test data. No specific "test set" in the context of clinical or algorithmic performance data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2. Ground truth in the context of clinical data is not relevant here. Compliance with standards is assessed through engineering tests and documentation.
4. Adjudication method for the test set:
- Not Applicable. See point 2.
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 unit and chair, not an AI or diagnostic tool that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used:
- Engineering Standards and Predicate Device Characteristics: The "ground truth" for this submission is based on the requirements of recognized international and national standards (ISO, IEC, FDA guidance) and the specifications/performance of a previously cleared predicate device.
8. The sample size for the training set:
- Not Applicable. See point 2.
9. How the ground truth for the training set was established:
- Not Applicable. See point 2.
Summary Explanation:
This 510(k) submission (K080438) for a "Dental Unit with Chair" is a Class I medical device. For such devices, particularly those that are not complex diagnostic tools or AI-driven, the regulatory pathway primarily involves demonstrating substantial equivalence to an existing legally marketed predicate device. This demonstration is achieved by showing that the new device has the same intended use, similar design principles, and, crucially, complies with relevant recognized national and international consensus standards for safety and effectiveness (e.g., ISO, IEC).
The "study that proves the device meets the acceptance criteria" in this context refers to the manufacturer's internal testing and documentation verifying that the device (and its components, including software where applicable) meets the specifications outlined in the standards (e.g., electrical safety, biocompatibility, mechanical properties) and aligns with the design and features of the predicate device. There is no clinical trial, performance study with patient data, or AI algorithm validation involved.
§ 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.