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Infinity Pro, Logic, Quality, Sprint are in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, electricity, and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.

The Olsen dental units consist of a patient chair, foot control, dentist element, water unit and a dental operating light. The Olsen dental units also include coupling for various handpieces and accessories that can be added to the Olsen Dental System such as pneumatic handpieces, handpieces with generator, optical fiber handpieces, pneumatic scalers, air/water syringes, SE (saliva ejectors) and handpieces for vacuum.

None of the Olsen dental units, parts or accessories are provided sterile.

Infinity Pro, Logic, Quality and Sprint Dental Systems serves as a base that includes components to deliver air, water, electricity, and vacuum to dental handpieces instruments.

The provided text is a 510(k) summary for the Olsen Indústria e Comércio S.A. Infinity Pro, Logic, Quality, Sprint dental units. It details the device's characteristics, indications for use, and a comparison to a predicate device.

However, it does NOT contain information on acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or any quantitative performance measure for a diagnosis or treatment outcome).

Instead, the document focuses on non-clinical performance data to demonstrate substantial equivalence to a predicate device. This data includes:

1. Biocompatibility testing: Confirms that patient-contact materials are safe.
2. Electrical safety and electromagnetic compatibility (EMC) testing: Ensures the device meets electrical safety and interference standards.
3. Software Verification and Validation Testing: Assesses the software's functionality and safety for its moderate level of concern.
4. Reprocessing Validation: Confirms the effectiveness of sterilization and disinfection methods for reusable components.

The "Conclusions" section reiterates that the subject device has the "same method of development, design and assembly, same composition, technical specifications, technological and operational principles, same intended use, and has the same performance and safety tests." It explicitly states that "The non-clinical data support the safety of the device and the hardware and software verification, and validation demonstrate that the Olsen Dental System... should perform as intended in the specified use conditions and performs comparably to the predicate device that is currently marketed for the same intended use."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth, expert adjudication, or MRMC studies, as these types of performance studies were explicitly stated as not conducted ("No Animal Studies were conducted." "No Clinical Studies were conducted.").

The device is a dental operative unit, which is an equipment system for dental procedures, not an AI or diagnostic device that would typically have performance metrics like accuracy, sensitivity, or specificity. Its "performance" is assessed through adherence to safety standards, material compatibility, and functional validation of its mechanical and electrical components, and software.

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