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K3 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.

K3, Dental Unit and Chair, is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with ISO 7494-1, ISO 7494-2 and ISO 6875. The 3way 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 K3 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 devices.

This FDA 510(k) summary describes the K3 dental unit, which is a dental operative unit and accessories, including a dental chair. The submission aims to establish substantial equivalence to a predicate device, the Sirona C8 (K983242).

Here's the breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet for a particular clinical task. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications, safety standards, and intended use. The "reported device performance" is largely framed within compliance with various international standards and the comparison table.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details:

This document is a 510(k) summary for a Class I medical device (Dental Operative Unit and Accessories). For such devices, clinical studies and elaborate performance evaluations focusing on diagnostic accuracy (like those for AI/ML devices) are typically not required. The primary mechanism for clearance is demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing and comparison of technical specifications and intended use.

Therefore, many of the requested details about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample sizes for test sets, ground truth establishment, MRMC studies) are not applicable to this submission.

Here are the answers based on the provided text, indicating "Not Applicable" where appropriate for this type of device submission:

1. A table of acceptance criteria and the reported device performance: See the table above based on inferred criteria and the comparison tables in the document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size for Test Set: Not applicable. The document describes non-clinical engineering and safety compliance testing (e.g., electrical safety, EMC, biocompatibility, sterilization, cleaning validation) rather than testing on a "test set" of patient data as would be used for an AI/ML diagnostic device. These tests are performed on either components or the assembled device.
   • Data Provenance: Not applicable. The tests are laboratory-based and standard compliance tests. The manufacturer is Osstem Implant Co. Ltd. from Seoul, Republic of Korea.

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):

   • Number of Experts: Not applicable. Ground truth as typically defined for diagnostic performance is not relevant here. Compliance with standards and technical specifications is verified by testing facilities and potentially by internal engineering teams.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Adjudication method: Not applicable.

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:

   • MRMC Study: No. This is a physical dental unit, not an AI/ML diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Standalone Performance: No. This is not an algorithm; it's a dental chair and associated components.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Type of Ground Truth: Not applicable. The "ground truth" here is compliance with established international standards (e.g., IEC, ISO, EN) for safety, electrical characteristics, biocompatibility, cleaning, and sterilization.

8. The sample size for the training set:

   • Sample Size for Training Set: Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

9. How the ground truth for the training set was established:

   • Ground Truth for Training Set: Not applicable.

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