(63 days)
The TriLumina Therapeutic Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
The TriLumina Therapeutic Laser is an innovative, safe, easy to use, hand-held, battery operated, non-invasive, athermal low energy infrared laser device. The TriLumina Therapeutic Laser contains three gallium-aluminum-arsenide continuous wave diodes operating in the near infrared at a wavelength of 830 nanometers and a visible red light emitting diode is used as a quide beam. The device has a power output of 30 milliwatts for each GaAlAs diode with a noncollimating beam of dimensions of approximately 1 by 3 millimeters at the lens. The Laser has an "On / Off" switch to control the power to the device and two pressure switches that when pressed energize the laser diodes. A timer automatically times the 30 second activation cycle and the delivery of 3 Joules of energy.
The provided text is a 510(k) premarket notification summary for the TriLumina Therapeutic Laser System. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technical characteristics and intended use.
However, the document does not contain information about a study proving the device meets specific acceptance criteria related to its performance in temporarily relieving hand and wrist pain associated with Carpal Tunnel Syndrome. Instead, it relies on the substantial equivalence principle, comparing its technical specifications and intended use to already cleared devices.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies. These types of studies would typically be conducted to prove clinical efficacy, which is often not required for 510(k) submissions that demonstrate substantial equivalence to previously cleared devices.
The document essentially states:
- Intended Use: Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
- Mechanism: Non-heating infrared lamp (low energy therapeutic laser) using gallium-aluminum-arsenide continuous wave diodes at 830 nm.
- Basis for Clearance: Substantial equivalence to predicate devices (MicroLight 830 Laser System, Acculaser Pro Low Level Laser System, MedX LCS System) that are also low-level therapeutic lasers.
Without a clinical study described in the provided text, I cannot generate the detailed acceptance criteria and study information you requested.
§ 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.