(262 days)
The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
The TerraQuant MQ2000 is a non-invasive pain therapy system, which utilizes heating lamps consisting of laser, infrared, and visible red light emitting diodes (LED). It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution into one complete, compact system.
The TerraQuant MQ2000 system consists of a desktop control unit, a hand-held emitter from which the laser and other radiances are released, and a 110 V power adaptor. The laser and light therapy releases radiation with wavelengths that fall within the range as defined in 21 CFR 890.5500 for an infrared lamp.
The provided text is a 510(k) Summary for the TerraQuant MQ2000 Laser Therapy Device, seeking substantial equivalence to a predicate device. It describes the device's intended use and technological characteristics but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, and ground truth based on the provided text.
The document indicates that the basis of approval was a "Predicate Device (PD)", implying substantial equivalence was established by comparing its technological characteristics and intended use to an already legally marketed device, not through new clinical trials or performance studies with specific acceptance criteria that would generate the kind of data requested.
Summary based on the provided text:
- Acceptance Criteria and Reported Device Performance: Not provided in the document. The clearance is based on substantial equivalence to a predicate device, not on specific performance metrics or acceptance criteria from a study.
- Sample size for the test set and data provenance: Not applicable. No test set or performance study data is described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No ground truth was established for a test set described in this document.
- Adjudication method for the test set: Not applicable. No test set is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document does not describe any MRMC study.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser therapy system, not an algorithm.
- The type of ground truth used: Not applicable. No ground truth data is mentioned for this 510(k) submission.
- The sample size for the training set: Not applicable. No training set is mentioned as this is a physical device, not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.