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The Laser Headband is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, or frontal, both with Fitzpatrick Skin Types I to IV.

Similar to the Hair Laser Helmet, the Hair Laser Headband is a low-level laser device and is intended/indicated for over- the-counter use. The device emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp at 655 +/- 5 nanometers with an individual laser output of 5mW per laser diode. The lasers are configured inside a headband, designed for hands-free operation during treatment. The laser headband is for portable use with rechargeable battery.

Here's a breakdown of the acceptance criteria and study information for the Hair Laser Headband, based on the provided FDA 510(k) summary:

This device (Hair Laser Headband) is claiming substantial equivalence to a predicate device (Hair Laser Helmet, K160728). Therefore, the provided documentation focuses on demonstrating that the new device performs similarly to the predicate, rather than presenting a new clinical study with specific acceptance criteria related to efficacy beyond what was established for the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

• Risk Management activities performed to ISO 14971:2012; all residual risks found acceptable.
• Bench testing indicates the Hair Laser Headband shares the same output parameters and dose rate characteristics as the Hair Laser Helmet. |
  | Maintain efficacy characteristics of predicate device (Hair Laser Helmet) | - Bench testing indicates the Hair Laser Headband shares the same output parameters and dose rate characteristics as the Hair Laser Helmet.
• Modifications (size/dimensions, reduced diodes) have no effect on efficacy, as users are instructed to move the device in three sections of the head to achieve the same surface treatment as the Hair Laser Helmet.
• "In all instances, the Hair Laser Headband performed as intended." |
  | Meet intended use and indications for use of predicate device | - Exact same indications for use as the Hair Laser Helmet. |
  | Share fundamental scientific/technological characteristics with predicate device | - Same wavelength (655 +/- 5 nm), individual laser output (5mW per diode), treatment regimen (20 min, 3x/week), materials, delivery method, helmet-like design, single on/off button, rechargeable battery. |

No specific numerical acceptance criteria (e.g., "improvement in hair count by X%") are provided in this submission for the Hair Laser Headband, as its clearance is based on substantial equivalence to a previously cleared device. The implicit acceptance criterion is that its performance (safety and efficacy) is equivalent to the predicate device.

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

The document does not describe a separate clinical "test set" in the traditional sense for the Hair Laser Headband's efficacy. Instead, it relies on:

• Bench Testing: To verify output parameters and dose rate characteristics. No sample size for this is specified, but it would typically involve a small number of manufactured units.
• Risk Analysis: Performed to ISO 14971:2012.
• Design Verification and Validation: Performed per 21 CFR 820.30.

The data provenance for these activities would be internal to Pulsaderm LLC, likely in the US, and prospective as part of the device's development and validation.

For the predicate device (Hair Laser Helmet, K160728), a clinical study would have been conducted to establish its efficacy, but details about that study (sample size, provenance, etc.) are not included in this 510(k) summary for the Hair Laser Headband.

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

Not applicable. This submission does not describe a clinical test set requiring expert ground truth for the Hair Laser Headband's efficacy. Its performance is compared to the predicate device through bench tests and design controls.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set described that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a laser treatment device for hair growth, not an AI-assisted diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the Hair Laser Headband itself, the "ground truth" for its performance is established through:

• Bench Test Results: Demonstrating equivalent output parameters and dose rate to the predicate.
• Compliance with Standards: (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971).
• Design Verification and Validation: Performed according to regulatory requirements.
• Risk Analysis: Ensuring safety.

The efficacy "ground truth" is implicitly linked to the predicate device's prior clearance, which would have been based on clinical data (likely hair counts, photographic assessment, patient self-assessment) from a study on the Hair Laser Helmet. Details of that ground truth are not provided here.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

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

Not applicable, as there is no training set.

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The Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are intended for over the counter use for the treatment of mild to moderate acne.

Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are class II Medical Devices that use Light Emitting Diodes to apply low power monochromatic and non-coherent light in the red and blue range, to treat mild to moderate acne. The devices are powered by Ni-MH rechargeable batteries.

The provided document is a 510(k) summary for the Pulsaderm Acne Mask 28 and 37. It describes the device, its intended use, and its substantial equivalence to a predicate device (Illumask Acne Light Therapy System, K123999). However, it does not contain information related to specific acceptance criteria for device performance in terms of clinical effectiveness (e.g., reduction in acne lesions) nor a study proving the device meets such criteria.

The "Performance Data" section primarily addresses compliance with electrical, electromagnetic compatibility, photobiological safety, and biocompatibility standards, as well as a lay-user study for usability and self-selection. It does not provide data on the clinical efficacy of the device in treating acne.

Therefore, many of the requested details cannot be extracted from this document, as the focus is on demonstrating substantial equivalence through technical characteristics and safety, rather than presenting clinical trial results against pre-defined efficacy acceptance criteria.

Here's an attempt to answer the questions based only on the provided text, with clear indications where information is not available:

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

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific percentage reduction in acne lesions) for the Pulsaderm Acne Mask. The "acceptance" in this context refers to demonstrating substantial equivalence to the predicate device and compliance with safety standards and design specifications.
• Reported Device Performance: The document reports on compliance with various safety standards and the results of a lay-user study for usability. It does not report clinical performance metrics for treating acne.

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

• Sample Size: For the lay-user study, the specific number of participants is not provided. It refers to "the majority of lay users."
• Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective). However, the study was conducted with IRB approval and oversight, implying a prospective study design for the usability testing.

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 / Not Provided: This question is typically relevant for studies involving expert review of objective data (e.g., medical images). The lay-user study described here focused on user comprehension and device operation, not expert-adjudicated clinical outcomes. There is no mention of experts establishing a "ground truth" in the clinical sense within this document.

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

• Not Applicable / Not Provided: As in point 3, this refers to expert review processes, which are not described for the studies mentioned in this document.

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: The document does not describe an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. This device is a light therapy mask, not an AI diagnostic tool.

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

• Not Applicable: This refers to the performance of an algorithm without human intervention, typically in AI/diagnostic device contexts. The Pulsaderm Acne Mask is a physical medical device for treatment, not an algorithm.

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

• For the lay-user study, the "ground truth" was whether users could successfully read instructions, self-select for use, and operate the device as intended. This was assessed by the study design and likely recorded through observations, questionnaires, or task completion metrics, overseen by an IRB. It does not involve expert consensus, pathology, or clinical outcomes data in the traditional sense for effectiveness.
• For clinical efficacy (treating acne), no such ground truth or study is described in this document. The claim of "treatment of mild to moderate acne" is based on substantial equivalence to the predicate device, which presumably demonstrated efficacy in its own submission.

8. The sample size for the training set

• Not Applicable / Not Provided: This question usually applies to machine learning models. No training set is mentioned as this is a physical light therapy device.

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

• Not Applicable / Not Provided: As in point 8, this is not relevant to the information provided about the Pulsaderm Acne Mask.

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The Pulsaderm Wrinkle Mask 28 and 72 are intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I,II and/or III.

The Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 72 are over the counter devices and consist of a collection of red and infrared diodes for the treatment of facial wrinkles. Pulsadern Wrinkle Masks 28 and 72 are powered rechargeable Ni-MH batteries. To receive treatment, the user simply places the mask over the face for a specific period to receive treatment.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Pulsaderm Wrinkle Mask 28 and 72.

It's important to note that this document is a 510(k) Summary, not a full study report. Therefore, it provides a high-level overview and justifications for substantial equivalence rather than detailed experimental results. The FDA's issuance of a substantial equivalence determination means they agreed the device is as safe and effective as a legally marketed predicate, not necessarily that new, extensive clinical trials proving efficacy outright were conducted for this specific device.

Acceptance Criteria and Study Details for Pulsaderm Wrinkle Mask 28 & 72

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for clinical efficacy in the way one might expect for a new drug or novel medical device. Instead, the performance is primarily evaluated against predicate devices to demonstrate substantial equivalence, focusing on similar technological characteristics and the ability of lay users to understand product labeling and use the device.

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

A "lay-user study and self-selection study" was conducted.

• Sample Size: Not explicitly stated. The document only mentions "the majority of lay users."
• Data Provenance: This was a prospective study described as a "lay-user study and self-selection study." The country of origin is not specified, but the submission is to the U.S. FDA.

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

• Number of Experts: Not applicable/not stated in the context of the lay-user study. The ground truth for this usability study was based on the ability of lay users to comprehend instructions and self-select, rather than expert judgment on clinical outcomes.
• Qualifications of Experts: No experts were directly used to establish "ground truth" for the lay-user study's primary outcomes (comprehension and self-selection).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The lay-user study focused on user comprehension and self-selection, which doesn't typically involve an adjudication process between multiple expert readers. The results were likely binary (understood/didn't understand, self-selected correctly/incorrectly) or rated on a simple scale.

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

• Was it done? No, an MRMC comparative effectiveness study was not done. This document focuses on demonstrating substantial equivalence to predicate devices, not on proving a specific clinical improvement or comparing performance with and without AI assistance (which is not relevant for this device type).

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

• Was it done? This question is not directly applicable to the Pulsaderm Wrinkle Mask, as it is a physical light therapy device, not an AI algorithm. Its performance is inherent in its design and operation, not an "algorithm only" component. The "performance data" refers to its physical characteristics and safety compliance, as well as the lay-user study.

7. The Type of Ground Truth Used

• Ground Truth for Lay-User Study: For the usability aspects of the lay-user study, the "ground truth" was likely established by pre-defined criteria for correct understanding of labeling and ability to follow instructions, assessed against an objective standard of "correct use" and "correct self-selection" based on the product's intended use and contraindications.
• Ground Truth for Clinical Efficacy: For the clinical efficacy aspect (reduction of wrinkles), the submission relies on the established efficacy of the predicate devices and the documented similarity of the Pulsaderm device's technological characteristics. No new clinical efficacy ground truth was established specifically for the Pulsaderm device within this 510(k) summary.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a hardware product, not a machine learning model, so there is no "training set."

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

• How Established? Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.

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