Search Results

The Capillus laser domes 82, 202, 272 Pro, 272 OfficePro, 302, 312, and 352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in 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 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 salon/spa use (Capillus272 OfficePro). The Capillus82, Capillus202, Capillus302, Capillus312, and Capillus352 are exactly the same as the Capillus272 Pro with the exception of the number of diodes which are respective of model (e.g. 82 diodes in Capillus82).

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 document describes the acceptance criteria and the study conducted for the Capillus laser domes (Capillus 82, 202, 272 Pro, 272 Office Pro, 302, 312, and 352) to support their clearance for Over-the-Counter (OTC) sale.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 55 adult subjects.
• Data Provenance: Not explicitly stated regarding country of origin, but it describes a study designed to assess "real-world capability of the average adult, 'retail customer'". The study appears to be prospective, designed specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. The study described is a usability test for OTC sales, not a clinical efficacy study requiring expert-established ground truth for a medical condition. The criteria evaluated were self-selection and user instruction comprehension.

4. Adjudication Method for the Test Set:

• Not Applicable. As this was a usability test on self-selection and comprehension, not a diagnostic or efficacy study, an adjudication method in the traditional sense (e.g., for medical image interpretation) was not used. The pass rates were objectively determined based on subjects' responses to the test components.

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

• No. An MRMC comparative effectiveness study was not done. The study conducted was a usability test for OTC use, not an effectiveness study comparing human readers with and without AI assistance for a diagnostic task.

6. Standalone (Algorithm Only) Performance Study:

• No. This device is hardware-based (laser domes) for hair growth and does not involve an "algorithm only" component in the sense of AI or software for diagnosis or analysis. The performance data presented refers to the device's physical and user-interface compliance.

7. Type of Ground Truth Used:

• For the usability study, the "ground truth" was established by pre-defined correct responses for self-selection (interpreting box labeling) and user instruction comprehension. This is based on pre-established criteria for user understanding and compliance, not a medical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set:

• Not Applicable. There is no mention of a "training set" as this is not an AI or machine learning algorithm requiring training. The document describes a usability study testing the device's instructions and labeling.

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

• Not Applicable. As no training set for an algorithm was used, this question is not relevant.

Ask a specific question about this device

The Capillus302, Capillus312, and Capillus352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in 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 Capillus302, Capillus312, and Capillus352 consist of 302, 312, or 352 (respectively) 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. These models are exactly the same as the (predicate) Capillus family of devices (Capillus272, Capillus202, Capillus82) with the exception of the number of diodes.

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.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not detail a specific clinical test set with a sample size for the Capillus302, Capillus312, and Capillus352 devices. The "Performance Data" section primarily discusses compliance to design specifications and recognized standards.

The efficacy rate of "51% (calculated)" is listed in the comparison table for the candidate devices. However, the accompanying text does not describe this as coming from a new clinical study for these specific models. Given the context of a 510(k) where the new devices are considered substantially equivalent to existing cleared devices with minor changes (number of diodes), it's highly probable that the "51% (calculated)" efficacy rate, if from a study, would stem from an earlier study that contributed to the predicate device's clearance and is being referenced here to support the equivalence claim.

Therefore, the sample size and data provenance for a test set specific to these exact models for efficacy are not explicitly provided in this document.

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

Since a dedicated clinical test set for these specific models (Capillus302, 312, 352) to establish new efficacy data is not described in the provided text, there is no information on experts, their number, or qualifications used to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

As no specific test set for the current models is detailed for efficacy, there is no information on an adjudication method.

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

A MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on technological characteristics and substantial equivalence to previously cleared devices.

6. Standalone (Algorithm Only) Performance Study

These devices are hardware-based laser caps for hair growth, not algorithms or AI. Therefore, a "standalone algorithm-only performance study" is not applicable and not mentioned.

7. Type of Ground Truth Used

For the efficacy claim (if the "51% calculated" refers to a study), the ground truth for hair growth studies typically involves objective measurements like hair count (total, terminal, vellus), hair density, and sometimes photographic assessment by experts, or patient/physician global assessment. However, the document does not explicitly state the type of ground truth used for the "51% (calculated) efficacy rate" beyond the implication that it's related to hair growth. Given the context of Low-Level Laser Therapy (LLLT) for androgenetic alopecia, hair count metrics are common.

8. Sample Size for the Training Set

Since these devices are hardware-based and not AI/ML algorithms, the concept of a "training set" in the context of machine learning is not applicable here. The document does not describe AI development.

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

As above, the concept of a "training set" for an AI/ML algorithm is not applicable.

Ask a specific question about this device

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

The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.

The Capillus82 consists of 82 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.

The provided document is a 510(k) summary for the Capillus 82 device, which is indicated for promoting hair growth in females with androgenic alopecia. This document asserts substantial equivalence to a predicate device (Capillus 272 Pro) and other reference devices, rather than presenting a new study for the Capillus 82 that establishes its own acceptance criteria and performance against those criteria.

Therefore, the following information is not directly available from the provided text for the Capillus 82:

• A new table of acceptance criteria and reported device performance from a new study for the Capillus 82. Instead, the document argues that the Capillus 82 meets the same safety and efficacy profiles as its predicate device due to similar technology and reduced "dose."
• Sample sizes used for testing.
• Data provenance, number of experts, qualifications of experts, or adjudication methods for establishing ground truth from a new study.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm-only performance study (as this is a physical device, not an AI algorithm).
• Details on the sample size for the training set or how ground truth was established for a training set (again, not an AI algorithm context).

However, the document does provide information that relates to performance and criteria through its comparison to predicate devices and adherence to existing standards. I can extract this information and present it in a way that addresses your request where possible, clarifying when the information refers to the predicate device or general standards rather than a new study for the Capillus 82.

Here's a breakdown of the available information based on your requested categories:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" and "reported device performance" for a new study of the Capillus 82 itself. Instead, it claims substantial equivalence based on the technological characteristics and conformity to standards. The closest representation of "performance" relates to its intended use and efficacy, which is inferred to be similar to predicate devices, albeit with potentially slower results due to fewer diodes.

Study Proving Acceptance Criteria:

The document describes the Capillus 82 as a modification of the previously cleared Capillus 272 Pro (K143199). The "study" for the Capillus 82 is primarily focused on design control activities, verification, and validation to demonstrate that the reduction in the number of lasers does not introduce new safety concerns and that the device still performs its intended function, albeit potentially with slower efficacy.

The key points regarding how the device meets acceptance criteria are:

• Substantial Equivalence Argument: The core of the submission is the claim that Capillus 82 is substantially equivalent to predicate devices (Capillus 272 Pro, Theradome Laser Helmet, MEP-90) and reference devices (Hairmax Lasercomb). This implies that if the predicate devices met their acceptance criteria, and the Capillus 82 is sufficiently similar, it also meets criteria.
• Design Control Activities (21 CFR 820.30): The manufacturer followed design control procedures. This involved:
  • Risk Assessment: Identified and assessed risks of reducing diodes; found no significant changes or risks for the Capillus 82 compared to the Capillus 272 Pro.
  • Verification: Activities were performed to assess the impact of the change (reduction of laser diodes). Laser diode output remained the same, but dosage was reduced.
  • Validation: Feedback from specialists and consumers indicated acceptance of a lower-cost alternative with potentially slower efficacy, understanding that treatment is indefinite.
• Conformity to Standards:
  • IEC-60825-2007-03: The device conforms to this standard for laser safety, establishing it as a Class 3R laser with an AEL of 5mW maximum.
  • IEC 61959: The charger conforms to this standard.

The document explicitly 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." (Page 6)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a new clinical "test set" for the Capillus 82. The verification and validation activities are primarily engineering and risk-based, comparing the modified device to the established performance of the predicate. Data provenance for the original predicate device's studies is not detailed in this 510(k) summary.

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)

Not applicable. This is not a diagnostic device or an AI algorithm requiring expert ground truth for a test set in the traditional sense. "Ground truth" for efficacy of this type of device is typically established through clinical trials (which would have been done for the predicate devices). "Feedback from hair restoration specialists and consumers" was used for design validation (page 5), but details on the number or qualifications are not provided.

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 a physical device, not an AI system.

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

Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the efficacy claim (promoting hair growth) of this technology (Low-Level Laser Therapy) would have been established through clinical trials for the predicate devices and other similar devices, likely using outcomes data such as hair count measurements and photographic assessments. For the Capillus 82 itself, the ground truth is essentially the established performance and safety profile of the predicate device, against which the modifications are evaluated for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not an AI algorithm.

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

Not applicable. This is not an AI algorithm.

Ask a specific question about this device

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

The Capillus272 Pro is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV

The Capillus272Pro consists of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner. The use of this specific number of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. 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 assembled into a proprietary battery pack. Both the battery cells, pack and charger are fully compliant to recognized, international standards.

The Capillus 272 Pro is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.

Here's an analysis of the provided information regarding the Capillus 272 Pro, organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., a certain percentage increase in hair count for FDA clearance). Instead, the performance is reported as an "effectiveness" measure relative to a placebo.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a single number, but there were subjects in both the Capillus 272 Pro (active) group and the placebo group.
• Data Provenance:
  • Country of Origin: United States (multi-center, two sites).
  • Retrospective or Prospective: Prospective.

3. Number of Experts for Ground Truth and Qualifications

This information is not provided in the document. The study describes a "placebo-controlled, prospective trial" but does not detail how the ground truth for hair growth was assessed (e.g., by experts, automated systems, etc.).

4. Adjudication Method

This information is not provided in the document.

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

This information is not provided in the document. The study was a comparison of the device to a placebo, not an assessment of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The device described is a physical light therapy device, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned.

7. Type of Ground Truth Used

The document implies that the ground truth for "hair growth" was established by measurements of terminal hair counts and observations of "positive results" for an increase in these counts. However, the exact methods for these measurements (e.g., photographic assessment, dermatoscopic analysis, direct counting) and who performed them are not detailed.

8. Sample Size for the Training Set

This information is not provided in the document. The study described is a clinical trial to evaluate the device's efficacy, not a study to train a new algorithm. "Training set" is typically relevant for AI/machine learning models.

9. How Ground Truth for Training Set Was Established

This information is not provided and is not applicable as there is no mention of a training set for an algorithm in this context.

Ask a specific question about this device