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510(k) Data Aggregation
(136 days)
Theralase Inc.
The Theralase TLC-2000 Therapeutic Medical Laser System is in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
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I am sorry, but the provided text is a 510(k) summary from the FDA for a medical device. It does not contain the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications that you requested. The document primarily focuses on the substantial equivalence determination for regulatory purposes.
Therefore, I cannot fulfill your request to create the table and answer the specific questions about the device's acceptance criteria and the study that proves it meets them.
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(150 days)
THERALASE INC.
The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.
The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.
Acceptance Criteria and Device Performance for Theralase™ TLC-1000 Therapeutic Medical Laser System
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Efficacy (Pain Relief) | Statistically significant difference in pain reduction (VAO scores) between active laser and sham laser groups. | p-value |
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