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The dental chair is used so that the patient at the dentist office may sit on it while the dentist is performing diagnosis, treatment, and/or operation. The dental unit consists of patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. 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.

Ajax Dental Unit AJ1X is a dental operative unit attached to a chair. It consists of a patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. The AJ1X unit is specially designed to meet the needs of dental professionals. The concept of hygienic treatment is emphasized in the unit design. Components are designed in the way which dentist can easily maintain and clean. Concept of the unit is to optimize the work for dental practice, as well as provide a very clean and healthy treatment environment for both dentists and patients.

The provided FDA 510(k) document for the AJAX dental unit (K132245) is a premarket notification for a Class I medical device (Dental Unit with Chair). For such a device, the focus of the submission is primarily on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical performance studies with acceptance criteria in the way a Class II or Class III device might require for diagnostic accuracy or efficacy.

Therefore, the structure of the acceptance criteria and study information will be adapted to reflect what is typically found in a 510(k) for a dental unit. The document focuses on non-clinical testing to ensure safety and performance according to relevant standards, and comparison of technological characteristics to predicates.

Here's an interpretation of the provided information in the requested format:

Acceptance Criteria and Device Performance for AJAX dental unit (K132245)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of clinical patient data or samples for performance evaluation. The "test set" here refers to the device itself being subjected to a series of engineering and safety tests.
• Data Provenance: The tests were performed on "the device" (Ajax Dental Unit AJ1X). The specific test reports indicate dates such as 04/13/2012, 04/30/2012, 04/18/2012, etc. This is retrospective testing performed on manufactured units to demonstrate compliance with standards. The origin of the device is Guangzhou, China (manufacturer: Guangzhou Ajax Medical Equipment).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not explicitly provided in the 510(k) document. For standard compliance testing, "ground truth" is typically defined by the test protocols within the ISO and IEC standards themselves, and the assessment is performed by certified testing laboratories and their engineers/technicians, who are experts in conducting these specific tests and interpreting their results according to the standards. The nature of these tests (e.g., electrical safety, mechanical robustness) means "expert consensus" from medical practitioners is not directly involved in setting the "ground truth" for the technical compliance.

4. Adjudication Method for the Test Set

• Not applicable in the context of technical standard compliance testing. The outcome of each test (e.g., "complied," "fulfilled," "pass") is determined by whether the device's performance meets the quantitative and qualitative requirements specified by the respective IEC and ISO standards. There is no mention of a multi-reviewer adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (e.g., imaging AI) where the impact on human reader performance is being assessed. The AJAX dental unit is a Class I general dental operative unit, not a diagnostic device, and therefore this type of study is not relevant or required for its 510(k) clearance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• No, a standalone (algorithm-only) performance study was not done. This device does not feature an algorithm or AI component that would require such a study. Its function is mechanical and electrical support for dental procedures.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" is primarily defined by the established international and national engineering, electrical safety, and mechanical performance standards (e.g., IEC 60601-1, ISO 7494-1, etc.). The device's compliance or non-compliance against these predefined technical specifications constitutes the "truth" for these evaluations. There is no pathology, expert consensus (in the medical sense), or outcomes data used to establish ground truth for this type of device submission.

8. The Sample Size for the Training Set

• Not applicable. The AJAX dental unit is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for it.

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