(151 days)
The Acculaser Pro Low Level Laser Therapy Device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
The Acculaser Pro LLLT has a hand-held treatment probe, is non-thermal, and emits infrared energy at 830nm.
This 510(k) premarket notification for the Acculaser Pro Low Level Laser Therapy Device does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document is a submission for regulatory clearance based on substantial equivalence to a predicate device, not a performance study report. It states that the Acculaser Pro LLLT device has substantially equivalent technological characteristics and indications for use as the MicroLight 830™ Laser System (K010175).
Therefore, I cannot provide the specific details you requested, such as:
- A table of acceptance criteria and the reported device performance: This document does not define specific performance metrics or acceptance criteria for the Acculaser Pro, nor does it report its performance against any such criteria. It relies on the predicate device's established performance.
- Sample size used for the test set and data provenance: No new clinical or performance studies are described for the Acculaser Pro.
- Number of experts used to establish ground truth and qualifications: Not applicable as no new study is presented.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone algorithm performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (no algorithmic training is mentioned).
- How the ground truth for the training set was established: Not applicable.
Summary of available information relevant to "performance" (by inference):
The "performance" of the Acculaser Pro is implicitly considered equivalent to its predicate device, the MicroLight 830™ Laser System, which was cleared based on its indication for "adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome." The clearance of the Acculaser Pro is based on its technological characteristics (non-thermal, emits infrared energy at 830nm) and intended use being substantially equivalent to the predicate. Any performance data would have been submitted and reviewed for the predicate device, K010175.
§ 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.