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Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The Luvis Chair (LC700C) includes a chair used by dentists to provide seating for patients during dental procedures. It is designed to position the patient during treatment. The chair consists of a seat, backrest, and armrests that can be adjusted to accommodate the patient's position. Additionally, it may feature a headrest to offer additional support. Dental unit chairs come equipped with various tools and attachments, including dental lights, suction devices, and air- water syringes. The chair's controls are usually located within reach of the dentist, allowing for quick adjustments during the procedure. The Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories.

This document is a 510(k) Premarket Notification for a dental chair (Luvis Chair LC700C). However, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the manner requested.

Instead, it asserts substantial equivalence to a predicate device based on similar intended use, principles of operation, and technological characteristics. It lists various standards the device complies with for safety, performance, and biocompatibility.

Therefore, I cannot populate the table and answer the questions as requested because the specific information about acceptance criteria and detailed study results (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) are not present in this 510(k) summary.

The document indicates that "the conducted tests, as well as all verification and validation activities, demonstrate that the design specifications and technological characteristics of the Luvis Chair (LC700C) meet applicable requirements and standards." It also states, "The subject device had been subjected to the applicable safety and performance testing before release to ensure the device meets all its specifications." However, it does not provide the specific acceptance criteria (e.g., "device must perform with X% accuracy for Y function") or the detailed results of these tests for comparison or to be presented in a table format.

Summary of what is present:

• Device Name: Luvis Chair (LC700C)
• Intended Use: To supply power to and serve as a base for dental devices and accessories. It includes a dental chair for use in a dental clinic environment by trained dental professionals.
• Predicate Device: Osstem Implant Co., Ltd. K3 (K183347)
• Reference Device: MeqaGen Implant Co., Ltd. N2 (K211556)
• Testing Conducted (Non-Clinical Test Summary):
  • Thermal, electrical, mechanical safety & Electromagnetic Compatibility (compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60)
  • Software Validations (basic documentation level, moderate level of concern, designed and developed according to a software development process, verified, and validated)
  • Biocompatibility (in vitro cytotoxicity test, oral mucosa irritation test, skin sensitization test; in accordance with ISO 10993-1 and ISO 7405)
  • Performance Test (in accordance with IEC 80601-2-60, ISO 7494-1, ISO 7494-2)
  • Cleaning and Sterilization Validation (in accordance with FDA guidance for reprocessing, ISO 17665-1, ISO TS 17665-2, ISO 16954, ISO 19458)
• Conclusion: The device meets applicable requirements and standards, and the differences from predicate devices do not raise new questions of safety and effectiveness.

Missing Information (and why it's missing from this document):

The request for a detailed table of acceptance criteria vs. reported performance, sample sizes for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are typical for AI/ML-enabled devices or those requiring specific performance metrics (e.g., diagnostic accuracy). This document is for a dental chair, which is a Class I medical device. For such devices, "acceptance criteria" are usually defined by compliance with recognized electrical safety, mechanical safety, biocompatibility, and performance standards (like the ISO and IEC standards listed). The "study" proving it meets these is often a series of engineering tests and validations against those standards, rather than clinical trials or AI performance evaluations with detailed ground truth analysis as would be done for a diagnostic or image analysis device.

Therefore, the requested information (points 1-9) in the format of specific performance metrics is not applicable or not provided in this regulatory submission for a dental chair.

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