(90 days)
The LCT 101 low level laser accessory is a non-heating infrared lamp powered by the MBM 1010 console, as per 21 CFR 890.550. It emits energy in the infrared spectrum, with an auxiliary visible red guide light. It is indicated for adjunctive use in the temporary relief of the hand and wrist pain associated with carpal tunnel syndrome.
NMA 100 Laser Accessory primarily consists of a hand held laser cluster accessory powered by the NMA 1052 Console. The hand held laser cluster contains the laser diodes and assembly, circuit board, electronics and labels. The hand piece is controlled from the console. The console automatically times the 33-second cycles of treatment.
The NMA 100 Laser Accessory is an 830 nm infrared laser indicated for adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome. The NMA 100 Laser utilizes three semiconductor laser diodes each emitting approximately 30 milliwatts (maximum 35 mW) continuous wave light at 830 nm. It utilizes 830 nm gallium-aluminum-arsenide laser diodes. The console automatically turns itself off after three joules of energy has been delivered.
The LCT 101 low level laser accessory is a non-heating infrared lamp powered by the MBM 1010 console, as per 21 CFR 890.550. It emits energy in the infrared spectrum, with an auxiliary visible red guide light.
The provided text describes a medical device, the NMA 1052 Console with NMA 100 Laser Accessory (also referred to as MBM 1010 Console System and LCT 101 Laser in later sections), and its 510(k) submission to the FDA. However, the text does not contain information about acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The document is primarily a summary of the device's specifications, its classification, predicate device, and the FDA's 510(k) clearance letter. It focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The response below will indicate where information is Not Found (NF).
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NF | NF |
Study Information
- Sample size used for the test set and the data provenance: NF
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NF
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: NF
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: NF (This device is a laser accessory for pain management, not an AI imaging analysis tool, so an MRMC study is not applicable in the traditional sense.)
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: NF (This device is a physical therapy device; "standalone performance" in the context of an algorithm is not applicable.)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): NF
- The sample size for the training set: NF
- How the ground truth for the training set was established: NF
Additional Device Information from the Text:
- Device Name: NMA 1052 Console with NMA 100 Laser Accessory (also MBM 1010 Console System and LCT 101 Laser)
- Classification: Class II, Lamp, non-heating, for adjunctive use in pain therapy (21 CFR 890.5500)
- Predicate Device: MedX LCS Laser Series - K021985
- Intended Use: Adjunctive use in the temporary management of hand and wrist pain associated with carpal tunnel syndrome.
- Technical Specifications:
- Hand-held laser cluster accessory powered by the NMA 1052 Console.
- Emits 830 nm infrared laser light.
- Utilizes three semiconductor laser diodes, each emitting approximately 30 milliwatts (max 35 mW) continuous wave.
- Uses 830 nm gallium-aluminum-arsenide laser diodes.
- Console automatically times 33-second treatment cycles.
- Console automatically turns off after three joules of energy have been delivered.
- Regulatory Compliance:
- Meets requirements of UL2606 standards in United Sates.
- Health Canada - Medical Therapeutic Device approved.
- UL Entela field evaluated and labeled (file FE-32134-1).
- Underwriters Laboratories of Canada field evaluated (file FE:32505-2).
§ 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.