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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.

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The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV

The LX-100 is a stationary low-level laser device that promotes hair growth and provides adjunctive treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp. The LX-100 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+1%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.

The provided text is a 510(k) summary for the LX-100 Hair Growth Stimulation System. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving the device meets them in the way a clinical trial report would.

Here's an analysis based on the provided document, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" for clinical performance. Instead, it demonstrates technological equivalence to predicate devices in terms of physical characteristics and clinical equivalence based on the predicate devices having already met therapeutic results standards.

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

The document does not describe a new clinical study. It relies on the equivalence to previously approved devices. Therefore, there is no "test set" in the sense of a new patient cohort for the LX-100. The performance is based on the established performance of the predicate devices. There is no specific data provenance mentioned in terms of country of origin or retrospective/prospective for a study of the LX-100 itself.

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

This information is not applicable as no new clinical study to establish performance for the LX-100 is presented. The "ground truth" for the efficacy of low-level laser therapy for androgenetic alopecia in females is implied to have been established by the predicate devices' approval through their own studies.

4. Adjudication Method for the Test Set

Not applicable as no new clinical study to establish performance for the LX-100 is presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not described or implied in the document, as it focuses on demonstrating substantial equivalence based on technological and intended use similarities to existing devices, not on comparing performance with and without AI assistance or human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to the LX-100, as it is a physical medical device (a hair growth stimulation system) and not an AI algorithm. Its performance is inherent to its physical operation and biological effect, not an algorithmic output requiring standalone evaluation.

7. The Type of Ground Truth Used

For the LX-100, the "ground truth" for its acceptance is based on its substantial equivalence to existing legally marketed predicate devices. The efficacy and safety claims of low-level laser therapy for androgenetic alopecia in females, which the LX-100 aims to meet, were presumably established by the predicate devices through clinical trials (pathology, clinical observable outcomes, or other relevant data for hair growth). The current document does not detail the specific ground truth used in those predicate studies.

8. The Sample Size for the Training Set

Not applicable. The LX-100 is a hardware device; it does not utilize a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this device.

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