(39 days)
The System B HeatSource, Model 1005, is intended to be used in dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus and for tissue cauterization and coagulation.
The device is a battery-operated dental instrument heater which is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip and the Cauterizing Tip, to test tooth response to thermal stimulus and for tissue cauterization and coagulation, respectively. The battery is fully rechargeable through the use of the plug-in charge adapter. The temperature is regulated by a feedback control system which automatically maintains a preset temperature for consistent results. The handpiece and cord assembly are completely removable. Both the handpiece and cord assembly and the dental instruments used with the device are autoclavable.
It seems there might be a misunderstanding or a lack of relevant information in the provided text. The documents describe a "System B HeatSource" dental instrument heater and its intended uses, as well as a claim of substantial equivalence to an existing device.
However, the provided text does not contain any information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, or any of the specific details requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details).
The text is a 510(k) summary and an Indications for Use statement, which primarily focus on:
- Device Name and Submitter Information: Identifying the product and the company.
- Device Description: What the device is and how it works (a battery-operated dental instrument heater for thermal stimulus testing and tissue cauterization).
- Intended Use: The clinical applications of the device.
- Substantial Equivalence Claim: Stating that it is similar to another legally marketed device (Analytic Technology Corporation, Touch N' Heat).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.
To answer your request, I would need a different type of document, such as:
- Performance testing reports: Detailing specific tests, their methodologies, acceptance criteria, and results.
- Clinical trial summaries: If applicable, describing patient populations, outcome measures, and statistical analyses.
- Verification and Validation (V&V) documentation: Outlining the V&V activities conducted for the device.
§ 872.1720 Pulp tester.
(a)
Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.