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MEN - The GroWell BT Hair Growth System ("GroWell") is designed to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V. WOMEN - The GroWell is designed to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin classifications of I-II. The GroWell is approved for Fitzpatrick skin types I-IV.

The GroWell BT Hair Growth System consists of 24 proprietary red light diode lasers and 39 proprietary red light super-luminescent diodes configured in a flexible panel which is inserted in an adult, baseball-style cap. The GroWell contains 655nm laser and LED diodes, which generates light after being excited by the internal power supply, the light is controlled and output by the control device, and directly and effectively irradiated to the treatment site, so as to achieve therapeutic effect. The GroWell's conbination of diode lasers and non-laser LED's provides for a full coverage of the head: i.e, the scalp area roughly from the top of the head to the top of the ears. The GroWell session will be "paused" and the light array will automatically turn off if the user removes the GroWell during use, and will resume when it is replaced on the 25 minute session, the lights will turn off and the GroWell will emit two audible beeps to signal that the therapy is complete.

The provided text is a 510(k) summary for the GroWell BT Hair Growth System. It states that non-clinical testing was conducted, but explicitly mentions no clinical data was used for performance verification. Therefore, it is impossible to infer acceptance criteria or details about a study proving the device meets those criteria from the provided document.

The document lists standards that the device complies with, but these cover general safety, electromagnetic compatibility, and biocompatibility, not performance related to hair growth efficacy.

Here's a breakdown of why the requested information cannot be provided from the text and what can be extracted:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document states "The clinical test is not applicable, there's no clinical data." This means there were no clinical performance acceptance criteria established or met.
• Sample sized used for the test set and the data provenance: Not applicable as there was no clinical test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

What can be extracted from the text regarding device verification:

The document states: "Non-clinical testing have been conducted to verify that the GroWell meets all design specifications which supports the conclusion that it's substantially equivalent to the predicate demonstrate that the subject device complies with the following standards:"

These standards relate to safety and electrical performance, not efficacy of hair growth.

• IEC 60601-1 Edition 3.2 2020-08: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
• IEC 60601-1-2 Edition 4.1 2020-09: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
• IEC 60601-1-11 Edition 2.1 2020-07: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral - Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
• IEC 62471 First edition 2006-07: Photobiological safety of lamps and lamp systems.
• IEC 60825-1: 2014: Safety of laser products - Part 1: Equipment classification, and requirements.
• Biocompatibility: Evaluated as per ISO 10993-1 Fifth edition 2018-08, and tested as per ISO 10993-5 Third edition 2009-06-01, ISO 10993-10 Fourth edition 2021-11 and ISO 10993-23 First edition 2021-01.
• Software evaluation: As per FDA guidance "Content of Premarket Submissions for Device Software Functions."

The conclusion provided is based on "analysis and tests" (referring to the non-clinical tests listed) and suggests substantial equivalence to predicate devices because of similar indications for use and technological characteristics (light source, design, wavelength, energy per diode). The differences noted (power supply, number of diodes, dimensions, and weight) were deemed not to raise safety or effectiveness issues due to compliance with international standards and core function (light output) not being affected.

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The Bosley Revitalizer 96 Laser Cap is indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic 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 Bosley Revitalizer 96 Laser Cap consists of 96 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 with the Bosley Revitalizer 272 and 164 Laser Caps, the 96 Laser Cap system can detect whether or not the device is in the correct position on the user's head and will automatically pause therapy if it is not. The device will resume therapy when the correct head position is re-established. The system is powered by rechargeable Lithium-ion battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant with recognized, international standards.

The provided text is a 510(k) Premarket Notification summary for the Bosley Revitalizer 96 Laser Cap. Based on the document, this is a Special 510(k) submission, meaning the device is a modification of a previously cleared device. Therefore, a new, independent clinical study to prove efficacy and safety against new acceptance criteria was not performed. Instead, the submission relies on the substantial equivalence to predicate devices and verification/validation activities to confirm that the modifications do not introduce new risks or significantly alter performance compared to the original design.

Here's an analysis of the requested information based on the provided text:

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

The document doesn't explicitly state numerical acceptance criteria for a new clinical study. Instead, it relies on the safety and efficacy of its predicate devices. The "performance" assessment is primarily focused on confirming that the modified device (with fewer diodes) still meets established safety standards and that its reduced "dose" is acceptable given the intended indefinite use and lower cost.

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

No new clinical study was conducted for this Special 510(k) submission. The performance assessment relied on verification and validation activities of the modified device and comparison to previously cleared predicate devices. Therefore, there is no "test set" in the context of a new clinical efficacy study, nor explicit sample size or data provenance from such a study.

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, as no new clinical study requiring ground truth establishment was conducted for this Special 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no new clinical study requiring adjudication was conducted for this Special 510(k) submission.

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. The device is a laser cap for hair growth, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. The device is a hardware device for hair growth, not an algorithm.

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

Not applicable, as no new clinical study requiring ground truth was conducted for this Special 510(k) submission. The efficacy claims for the predicate devices would have been based on clinical trials measuring hair growth (e.g., hair count, global photographic assessment), but details of those specific ground truths are not provided in this document.

8. The sample size for the training set

Not applicable, as no new clinical study was conducted. No "training set" in the context of AI or a new clinical trial is mentioned.

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

Not applicable, as no new clinical study was conducted.

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The BOSLEY Revitalizer 272 and 164 Laser Caps are indicated to treat Androgenic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-3, or frontal; both with Fitzpatrick Skin Types I to IV.

The BOSLEY Revitalizer 272 and 164 Laser Caps are low level laser therapy (LLLT) devices designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 or 164 visible red light-emitting diodes at 650-nm and 5mW each. The lasers are contained inside a lightweight cap. The device is powered by an included battery pack and automatically turns off after 30 minutes.

The provided text describes a 510(k) submission for the BOSLEY Revitalizer 272 and 164 Laser Caps. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device were primarily related to OTC/Usability Testing and Biocompatibility.

• Material must not be a sensitizer for skin contact. | - Cytotoxicity tests demonstrated that the material used in the manufacturing of the caps is non-cytotoxic. The caps met the requirements of ISO 10993-1:2009, ISO 14971:2007, and FDA General Program Memorandum #G95-1, for surface devices with limited contact (

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The Hair Up is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.

The Hair Up is basically an identical device with the 510(k)-cleared device Hair Up (K172968). A new 510(k) clearance is applied this time with a new indications for use (IFU). Subject device, Hair up and its primary predicate device consist of 21 red visible laser diodes (LDs) and 30 red light emitting diodes (LEDs) configured within an outer helmet and protective inner liner. The use of LDs and LEDs provides full coverage of the upper 1/3 of the head which is commonly covered with stylized hair. The system will automatically pause therapy until the correct head position is re-established. At the end of the therapy cycle, the subject device Hair Up signals that therapy is complete and the device is ready to be powered down.

The provided text is a 510(k) summary for the "Hair Up" device, an infrared lamp intended to promote hair growth. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in terms of effectiveness in promoting hair growth.

The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technical characteristics and indications for use. The "Performance Data" section describes non-clinical tests related to safety, electrical requirements, and biological evaluation, not a clinical study on hair growth.

Therefore, I cannot provide the requested table and detailed study information based on the given input. The categories below are answered based on the information that is available in the document, and where information is not present, it is explicitly stated.

Acceptance Criteria and Device Performance Study Information for Hair Up

This 510(k) summary for the "Hair Up" device does not contain a clinical study with acceptance criteria and reported device performance related to its primary intended use of promoting hair growth. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable. No clinical test set is described for evaluating hair growth performance.
• Data Provenance: Not applicable.

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

• Not applicable. No clinical test set is described with expert-established ground truth for hair growth.

4. Adjudication method for the test set

• Not applicable. No clinical test set is described.

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

• No MRMC comparative effectiveness study was done as the device is an infrared lamp for hair growth, not an AI-based diagnostic or imaging device used by human readers.

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

• Not applicable. The "Hair Up" is a physical device (infrared lamp), not an algorithm.

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

• Not applicable for hair growth performance. The non-clinical tests mentioned (wavelength, power, safety, EMC, biological evaluation) would have their own defined test conditions and standards, but these are not 'ground truth' in the context of clinical efficacy for hair growth.

8. The sample size for the training set

• Not applicable. The device is a physical infrared lamp, not an AI or algorithm that requires a training set.

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

• Not applicable.

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The illumiflow Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV.

The illumiflow Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650-nm and 5mW each. The cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included Battery Pack.

The provided text describes the regulatory clearance for the "Illumiflow Laser Cap." However, it does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/human-in-the-loop system for a medical imaging device.

The document is a 510(k) summary for a low-level laser therapy (LLLT) device intended to promote hair growth. The studies mentioned are primarily:

• Biocompatibility testing: To ensure materials are safe for patient contact.
• Non-clinical performance testing: To confirm compliance with design specifications and electrical safety/EMC standards (e.g., IEC 60825-1, IEC 60601-1).
• Usability testing: To confirm that lay users can understand labeling and use the device safely and correctly.

There is no mention of:

• A table of acceptance criteria for diagnostic/AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets used to evaluate AI performance.
• Data provenance for such test sets.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or comparative effectiveness with human readers.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Training set details (size, ground truth establishment).

The device is a direct-to-consumer therapy device, not a diagnostic imaging device utilizing AI. Therefore, the detailed AI-related study information you requested is not present in this document.

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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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