Search Results

The Capillus272 Pro, Capillus82 OfficePro, Capillus202 are intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V ; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.

The Capillus272 Pro and Capillus272 OfficePro both consist of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter (capillus272 Pro) and clinical office use (Capillus272 OfficePro). The Capillus82 and Capillus202 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are 82 and 202 respectively. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery are fully compliant to recognized, international standards. The OfficePro is directly powered by the DC charger, which is fully compliant to recognized, international standards.

The provided text is a 510(k) summary for medical devices (Capillus272 Pro, Capillus272 OfficePro, Capillus82, and Capillus202) intended for hair growth promotion. It does not contain a detailed report of a study with specific acceptance criteria and performance data in the format typically used for diagnostic or AI-based devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and the general understanding of Low-Level Laser/Light Therapy (LLLT) efficacy.

However, I can extract the relevant information from the document to construct an answer based on the intent of your questions, even if some points are addressed by referencing prior submissions or common knowledge about LLLT.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria related to efficacy (e.g., specific percentage increase in hair count) for this specific submission. Instead, it relies on the established efficacy of LLLT for androgenic alopecia and compliance with safety standards.

2. Sample size used for the test set and the data provenance

The document does not describe a new clinical study with a "test set" for this specific 510(k) submission. The submission relies on the established efficacy of LLLT devices in general and predicate devices. Therefore, there is no information on a specific sample size or data provenance (country, retrospective/prospective) for a new test set in this document. The efficacy claims are derived from prior studies of predicate and reference devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no new clinical study with a "test set" is detailed in this submission, there is no mention of experts forming a ground truth for such a set. The overall acceptance of LLLT as a viable modality is based on broader scientific consensus and regulatory approvals.

4. Adjudication method for the test set

Not applicable, for the same reasons as #3.

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. This device is a low-level laser therapy device for hair growth, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the device's intended effect (hair growth promotion) is based on:

• Clinical trial results of predicate and reference devices: The document refers to efficacy rates (e.g., 34-41% increase compared to placebo for iGrow, significant increase for HairMax LaserBand) from studies supporting the clearance of those devices.
• Scientific and Medical Consensus: The statement "the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenic alopecia" implies a broader acceptance based on accumulated evidence.
• Absence of reported adverse events: "There have been no reported safety issues with any LLLT device to date."

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "training" in this context would be the cumulative clinical evidence for LLLT technology.

9. How the ground truth for the training set was established

Not applicable. For the reasons stated in #8.

Ask a specific question about this device

The Capillus202 is indicated to promote hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications of I-II, and with Fitzpatrick Skin Phototypes I-IV.

The Capillus202 consists of 202 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. Just as for the previous version, the helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. This is achieved by a safety interlock. At the beginning and of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Nickel Metal Hydride battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.

The Capillus202 device is indicated to promote hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications of I-II, and with Fitzpatrick Skin Phototypes I-IV.

The study presented is a Special 510(k) Summary, which focuses on demonstrating substantial equivalence to a previously cleared device (Capillus272 Pro, K143199) rather than a full de novo clinical trial. The Capillus202 is essentially a modified version of the Capillus272 Pro with fewer laser diodes. Therefore, the "study" demonstrating performance relies heavily on the established performance of the predicate device and the assessment that the change (fewer diodes) does not negatively impact safety and efficacy.

Here's the breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a device modification, the "acceptance criteria" are primarily related to maintaining the safety and equivalence characteristics of the predicate device. The performance is assessed comparatively.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of a traditional clinical "test set" for this submission. The document doesn't describe a new clinical study with a test set for the Capillus202 itself. Instead, it leverages the established performance of the predicate device (Capillus272 Pro) and reference devices. The "performance data" refers to technical verification and validation activities (e.g., laser output, safety interlock) rather than clinical efficacy data on a "test set" of patients for the Capillus202.
• Data Provenance: The efficacy claims for Low-Level Laser Therapy (LLLT) in general and for the Capillus272 Pro specifically would have been derived from separate studies (not detailed in this document). The current submission relies on the technological equivalence and safety verification of the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable as there was no new clinical "test set" with ground truth established by experts for the Capillus202 in this submission. The "ground truth" for efficacy of LLLT for hair growth in the predicate device would have been established through clinical trials, typically involving dermatologists or hair restoration specialists.
• The document does mention "Feedback from hair restoration specialists and consumers indicate that a lower-cost alternative is desired," suggesting experts were consulted on market need and acceptance of potentially slower efficacy.

4. Adjudication Method for the Test Set

• Not applicable, as a new clinical test set requiring adjudication was not part of this Special 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done. This type of study is typically for diagnostic imaging devices where different readers interpret cases. The Capillus202 is a therapeutic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This concept is not applicable. The Capillus202 is a physical medical device, not an algorithm. Its performance is its direct therapeutic effect, which is measured in terms of hair growth, not reader performance.

7. Type of Ground Truth Used

• For the Capillus202 submission itself, the "ground truth" is primarily based on technical specifications, safety standards compliance, and the established clinical efficacy of the predicate device (Capillus272 Pro) and other cleared LLLT devices.
• The original ground truth for LLLT efficacy for the predicate device (Capillus272 Pro) would have been established through clinical outcomes data (e.g., hair count, hair density measurements, photographic assessment) in studies.

8. Sample Size for the Training Set

• Not applicable. There is no mention of a "training set" in the context of an AI/ML algorithm or a new clinical trial for the Capillus202. The device is a hardware modification.

9. How the Ground Truth for the Training Set Was Established

• Not applicable for the reasons stated above.

Ask a specific question about this device