(268 days)
- To treat temporomandibular joint (TMJ) disfunction and associated pain
- To relieve symptoms associated with muscle spasm
- To relax muscles and establish a physiologic occlusion
- To take occlusal registrations
- To take denture impressions
- To increase local blood circulation
- To maintain or increase mandibular range of motic
The DOLOTENS DENTAL TM2 is an ultra low frequency muscle stimulator, sending an electrical impulse to the muscles via the nerves in order to provide a minor level of muscle contraction. This gentle contraction of the muscles provides a pumping action for the blood increasing circulation in the muscles. Muscle spasm is relieved because fresh nutrients are brought into the muscles and waste products are pumped out.
The provided text describes a medical device, the DOLOTENS DENTAL™ 2, and its 510(k) summary for FDA clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, or the methodologies for establishing ground truth, sample sizes, or expert qualifications that would typically be found in a study proving the device meets acceptance criteria.
The document is a regulatory submission for premarket notification (510(k)), which primarily establishes substantial equivalence to a predicate device. This type of submission generally focuses on comparing the new device's technological characteristics and indications for use to an already cleared device, demonstrating that it's as safe and effective, rather than presenting new clinical study data with acceptance criteria.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria based on the provided text. The following points explain why:
- No Acceptance Criteria or Performance Data: The document lists "Indications for Use" but does not define quantitative or qualitative acceptance criteria for these indications (e.g., "reduce TMJ pain by X% in Y% of patients"). It also does not present any performance data (e.g., sensitivity, specificity, accuracy, or clinical improvement rates) from a study that would demonstrate meeting such criteria.
- No Study Details: There is no mention of a particular study (clinical trial, standalone study, MRMC study, etc.) conducted to evaluate the DOLOTENS DENTAL™ 2's performance against defined acceptance criteria.
- Focus on Substantial Equivalence: The primary objective of the 510(k) summary is to state that the DOLOTENS DENTAL™ 2 is "substantially equivalent to the MODEL J-5 MVO-MONITOR (K031998)." This typically involves demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as the predicate device. It does not necessarily require new clinical performance studies with acceptance criteria if a well-established technological basis and predicate device exist.
Conclusion:
Based on the provided text, it's not possible to describe the acceptance criteria or a study proving the device meets acceptance criteria because this information is not present in the 510(k) summary document. The document's purpose is to seek FDA clearance for market entry based on substantial equivalence, not to present detailed performance study results against predefined acceptance criteria.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).