(343 days)
The LumaProbe is intended to provide light to the body.
LumaProbe (Red-631) is generally indicated for the treatment of superficial, benign vascular, and pigmented lesions.
LumaProbe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris.
LumaProbe (IR-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The LumaProbe is a device that utilizes Light Emitting Diodes to provide LED light to the body. The LumaProbe Red, IR and Blue are a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Red is 631 +/- 4nm, IR is 830 +/- nm and Blue is 415 +/- 5nm. The LumaProbe unit contains the power supplies and the control unit; it has the capabilities to power and sequence up to 2 attachable probes depending on the product model, that deliver the light to the skin as they are moved over the skin surface. The STOP button directly on the probes allows the user to immediately remove all power to the probes.
The provided text is a 510(k) Summary for the LumaProbe device. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it aims to demonstrate substantial equivalence to predicate devices already on the market.
Therefore, many of the requested categories cannot be filled as they pertain to clinical or performance studies that are not detailed in this submission.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or report specific performance metrics from a study. It focuses on the LumaProbe's features being "virtually identical" to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or study data is described. The submission relies on "comparison of technological differences" and "overall performance characteristics" without detailing a specific study to generate this data.
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)
- Cannot be provided. No ground truth establishment is described as there is no specific test set or clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication method 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
- Cannot be provided. This device is a light therapy device, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a physical light therapy device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth is established as no specific performance study is detailed.
8. The sample size for the training set
- Cannot be provided. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Cannot be provided. No ground truth for a training set is relevant or mentioned.
Summary of the K073600 Submission for LumaProbe:
The K073600 submission for the LumaProbe device is a 510(k) Premarket Notification which asserts substantial equivalence to previously cleared predicate devices. It does not present novel performance data from de novo clinical studies with specific acceptance criteria that the device proves to meet. Instead, the core argument is that the LumaProbe is technologically similar to existing devices with established safety and effectiveness.
The relevant section stating this is:
"Comparison of Technological Differences: The intended use and technological characteristics of the LumaProbe system are virtually identical to the intended use and technological characteristics of the listed equivalent devices. Any differences between the LumaProbe and the equivalent devices have no significant influence on safety or effectiveness of the LumaProbe product."
"Conclusions: Based upon an analysis of the overall performance characteristics for the LumaProbe, Clareblend, Inc. believes that no significant differences exist between this system and the predicate systems quoted, therefore, the LumaProbe Light Therapy device does not impose any new safety or effectiveness concerns."
This means the "acceptance criteria" here are implicitly meeting the performance and safety profiles of the predicate devices based on a technological comparison, rather than direct, quantitative testing against specific numbers.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.