(44 days)
The Clini-Lase System is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperture for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Clini-Lase System may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Clini-Lase System consists of a clinical and portable control base unit, and seperate attachment infrared heat lamp probes. The control base unit houses the electronics, LCD display and system controls and is powered by 12 Volts DC suplied by an AC-DC Power Adapter. The attachment probes produce infrared radiation to provide topical heating. Various single and cluster probes are available for the base units. The probes are conected by a readily replacable independent cable assembly.
The provided text is a 510(k) Premarket Notification for the Clini-Lase System, and it does not include detailed performance data from a clinical study to establish acceptance criteria or device performance in the way typically expected for an AI/ML device.
Instead, this document is a summary demonstrating substantial equivalence to legally marketed predicate devices, which is a common regulatory pathway for medical devices that are not novel. The key takeaway is that the Clini-Lase System is an infrared lamp, and its regulatory clearance is based on its similarity to existing infrared lamps, not on new clinical performance studies establishing specific efficacy outcomes with acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available in this document because a formal clinical study to prove new performance claims was not conducted or required for this type of submission.
Here's an analysis based on the information provided, addressing what can be answered and noting what cannot:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Not provided. The document states: "The differences in the specifications of the Clini-Lase System and the predicate devices do not result in different performance or raise new questions of safety or efficacy." This indicates that the device's performance is assumed to be similar to legally marketed predicate devices, and no new performance claims with specific acceptance criteria are being established or reported.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. No clinical performance study with a test set was conducted or reported in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. No test set or ground truth establishment by experts is described, as no new performance study was reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set involved in a clinical study for new performance claims is described.
5. 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
- Not applicable/Not provided. This is an infrared lamp, not an AI/ML diagnostic or assistive device. No MRMC study or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is an infrared lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No new ground truth was established for the purpose of this 510(k) submission, as it relies on substantial equivalence to existing devices.
8. The sample size for the training set
- Not applicable/Not provided. This is an infrared lamp, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. Not an AI/ML device.
Summary of what is known from the provided document:
- Device: Clini-Lase System (infrared lamp)
- Intended Use: To emit energy in the infrared spectrum to provide topical heating for the temporary relief of minor muscle and joint pain/stiffness, minor joint pain associated with arthritis, temporary increase in local circulation, relaxation of muscles, and to help muscle spasms, minor sprains/strains, and minor muscular back pain.
- Basis of Approval: Predicate Device (substantial equivalence).
- Predicate Devices: MedX LCT100 & MedX LCS Portable Laser, Thor DDII IR Lamp Systems, Vectra Genisis Laser System, Laser Sys*Stim 540 Model ME 540, Palomar LuxIR Handpiece.
- Performance Data: The submission explicitly states, "The differences in the specifications of the Clini-Lase System and the predicate devices do not result in different performance or raise new questions of safety or efficacy." This is the core "performance data" relied upon for substantial equivalence, implying performance is equivalent to the predicates.
- Non-clinical Data: Potential hazards identified and mitigated by design and labeling.
- Conclusion: The device is substantially equivalent to legally-marketed predicate devices.
In essence, this document is a regulatory submission for substantial equivalence based on the device's physical characteristics and intended use being similar to already cleared devices, rather than a report on a clinical study establishing new performance metrics against specific acceptance criteria.
§ 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.