(104 days)
The Xtrallux Alpha, Super Plus, Turbo Pro, and Extreme RX are intended to treat Androgenetic Alopecia (AGA) and promote hair growth in males who have Norwood-Hamilton Classifications of hair loss and, females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
The Xtrallux devices are non-invasive, low level laser therapy (LLT) devices containing red, visible light diode lasers operating at 650 nm wavelength. The maximum power output of each diode is 5 mW. The diodes are configured within a cap, enclosed between the outer shell and inner liner. They deliver non-thermal energy to hair follicles via photostimulation of the scalp and are intended to stimulate hair growth. Xtrallux has developed four models: Xtrallux Alpha, Xtrallux Super Plus, Xtrallux Turbo Pro, Xtrallux Extreme RX.
This FDA 510(k) summary (K222364) for the Xtrallux devices does not include a clinical study with acceptance criteria and reported device performance in the way typically expected for an AI/ML medical device.
The document indicates that the Xtrallux devices are Low-Level Laser Therapy (LLLT) devices intended to treat Androgenetic Alopecia (AGA) and promote hair growth. The FDA clearance is based on the devices being substantially equivalent to predicate devices (CapillusX & CapillusX+ and HairMax Laser).
Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those specific acceptance criteria, as this type of study was not conducted or presented in this 510(k) summary.
Instead, the summary focuses on non-clinical testing to demonstrate safety and substantial equivalence to existing devices.
Here's a breakdown of the requested information based on the provided document:
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A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. The 510(k) relies on substantial equivalence to predicate devices, not on a standalone performance study against specific acceptance criteria for efficacy. The non-clinical tests performed were for safety (biocompatibility, electromagnetic compatibility, electrical safety, usability, and laser safety) to ensure the device is as safe as legally marketed predicate devices.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. There was no clinical "test set" in the context of an AI/ML medical device performance study described. The non-clinical tests are on the device itself, not on data from patients.
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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. There was no clinical "test set" requiring expert ground truth in this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was described.
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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
- No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in interpreting medical images or data. The Xtrallux devices are therapeutic LLLT devices, not diagnostic AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The Xtrallux devices are hardware-based therapeutic devices, not AI algorithms.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. There was no clinical performance study requiring ground truth in this submission. The "ground truth" for the non-clinical tests would be the established safety standards and regulatory requirements.
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The sample size for the training set
- Not applicable. No AI model was trained for this device.
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How the ground truth for the training set was established
- Not applicable. No AI model was trained for this device.
In summary, the provided document describes a 510(k) submission for Low-Level Laser Therapy devices based on substantial equivalence to predicate devices, primarily demonstrating safety through non-clinical testing rather than clinical efficacy studies with specific performance metrics and 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.