Search Results

Promote hair growth in females diagnosed with androgenetic alopedia presenting with Ludwig-Savin Classifications I-II and Fitzpatrick Skin Phototypes I-IV.

The Capillus272 OfficePro is exactly the same as the Capillus272 Pro in every way except the following:

• 1. The Capillus272 OfficePro is the same hat, but mounted on a stand. The same electrical design has been applied (i.e. adapter steps down to ~12V DC; but no battery as it is not intended to be portable).
     The Capillus272 Pro consists of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable battery and adapter. The Capillus272 OfficePro is intended for in-office use and is not intended to be portable. The same hat is mounted on a stand and the adapter is connected directly to the cap through wiring threaded through the stand.
     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 end 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 (Capillus272 Pro only) assembled into a proprietary pack. Both the battery pack and charger are fully compliant to recognized, international standards.

This document is a 510(k) premarket notification for the Capillus272 OfficePro. It asserts substantial equivalence to existing devices and does not contain a detailed study demonstrating that the device meets specific acceptance criteria based on clinical performance.

The document states:

• "Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criterion were met by the device. See Section 12 for standards met and test reports." (Page 4)
• It also states, "The performance data included (Section 12) demonstrates that the Capillus272 Pro has the same or similar laser wavelength, output power, output beam, energy type, laser field, treatment area, and energy delivered (J/cm2) as the declared predicates." (Page 4)
• "Just as for all predicates (K143199) and reference devices (K140931, K141567, K132646), there are no reported adverse events for this technology." (Page 4)

Section 12, which would contain the details of the performance testing, standards met, and test reports, is not provided in the given text.

Therefore, I cannot provide the requested information regarding specific acceptance criteria and detailed study results from this document. The document points to an external section (Section 12) for this information, which is missing from the provided text.

Based on the provided text, the device's acceptance is based on demonstrating substantial equivalence to predicate devices, primarily in terms of technological characteristics and safety profile, rather than a new standalone clinical efficacy trial. The claims of "acceptance criteria were met" refer to design specifications and compliance with standards, not performance in a clinical trial to prove efficacy against a specific metric.

Here's what can be inferred, but the requested table and many other details cannot be populated from the provided text:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Not explicitly stated as clinical efficacy metrics in this document. The document implies compliance with "design specifications" and "standards" as acceptance criteria for engineering performance and safety.
   • Reported Device Performance:
     • The device operates as designed.
     • The device has the "same or similar" laser wavelength, output power, output beam, energy type, laser field, treatment area, and energy delivered as predicate devices.
     • No reported adverse events for this technology (referring to the technology class and predicates).
     • Intended to promote hair growth in females with Ludwig-Savin Classifications I-II and Fitzpatrick Skin Phototypes I-IV.

2. Sample size used for the test set and the data provenance: Not mentioned. The testing described appears to be engineering/design verification, not a clinical trial with a test set of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this document does not describe a clinical study with an expert-adjudicated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is not an AI/imaging device and no MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a low-level laser therapy device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical efficacy study for this device, as one is not described in the provided text. The "ground truth" for the engineering performance would be the design specifications and regulatory standards.

8. The sample size for the training set: Not applicable. No machine learning training set is described.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on regulatory compliance through substantial equivalence to predicate devices, along with verification of design specifications and safety. It does not contain the details of a clinical study with specified acceptance criteria for efficacy or the related ground truth establishment, expert involvement, or sample sizes for such a study.

Ask a specific question about this device