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The Hair Boom Air is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of - II, males who have Norwood-Hamilton Classifications of Ila - V and for both. Fitzpatrick Classification of Skin Phototypes I to IV.

The Hair Boom Air diode laser is configured within an outer helmet and protective inner liner. The use 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. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria. Instead, it is an FDA 510(k) clearance letter and summary for a device called "Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom".

The document primarily focuses on establishing substantial equivalence to a previously cleared predicate device (K223862), also named "Hair Boom Air, Hair Boom 69, Ulike Hair UpUp". The changes to the device are described as minor (controller design change, new timer mode, and color changes for helmet and controller).

Therefore, I cannot provide the requested information. The document explicitly states:

• "No clinical studies were considered necessary and performed."
• The determination of substantial equivalence relies on the device being "substantially equivalent to this device in design, function, and technical characteristics" to the predicate.

This means there is no new study described in this document that would establish acceptance criteria or demonstrate performance against such criteria for the current submission. The provided text is a regulatory clearance document, not a clinical study report.

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The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use 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. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that the device meets them.

The document is a 510(k) Premarket Notification from the FDA, and it focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192425). It explicitly states:

• "No clinical studies were considered necessary and performed."
• The aim of the submission is "limited to the controller design change."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies for this submission. The basis for clearance is that the device, with its minor design change to the controller, is substantially equivalent to an already cleared device, and thus, new performance studies were not required by the FDA for this particular submission.

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The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila- V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.

The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use 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. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this document is a 510(k) summary for a minor modification to an already cleared device ("Hair Boom 69"). Therefore, it primarily focuses on demonstrating substantial equivalence to the predicate device rather than establishing new performance criteria through de novo clinical studies.

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

• Sample Size for Test Set: Not applicable. No new clinical performance data or test set was generated for this submission. The study relies on establishing substantial equivalence to a previously cleared predicate device.
• Data Provenance: Not applicable for a new clinical test set. The safety data provenance is from compliance with international standards (IEC, ISO) and the established safety/effectiveness profile of the predicate device.

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 was performed, there was no need for experts to establish ground truth for a test set. The regulatory determination relies on demonstrating equivalence to a device whose safety and efficacy were previously established.

4. Adjudication Method for the Test Set

• Not applicable. No new clinical test set requiring adjudication was used.

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

• No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on technological characteristics and safety testing, not on comparative clinical efficacy between human readers with and without AI assistance.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical LLLT device, not an AI/software algorithm that would require standalone performance evaluation.

7. The Type of Ground Truth Used

• Implied Ground Truth: The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (Hair Boom 69, K191154). Since the proposed device is technologically identical in function and intended use, its safety and effectiveness are deemed equivalent. The safety ground truth is also established through compliance with international standards (e.g., laser safety, electrical safety, biocompatibility).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" in this context.

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

• Not applicable. As above, there is no training set for this device.

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The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopeda who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.

The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use 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. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

The provided document is a 510(k) premarket notification for a medical device called "Hair Boom 69". It aims to demonstrate substantial equivalence to a previously cleared predicate device, also named "Hair Boom 69" (K182562), for Over-the-Counter (OTC) use.

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

Key Takeaway: The submission argues for substantial equivalence primarily based on the identity of the device itself (the new Hair Boom 69 is physically identical to the previously cleared prescription-use Hair Boom 69) and specific testing for OTC use, rather than a clinical performance study demonstrating efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the sense of predefined performance metrics (like sensitivity, specificity, or improvement in a clinical outcome) for this specific submission. Instead, the "acceptance criteria" for this 510(k) revolve around establishing substantial equivalence, particularly for an Over-the-Counter (OTC) indication.

The performance data presented is focused on demonstrating safety and usability for OTC use, given the device's technical identity with its predicate.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 30 female and male subjects were used for Over-the-Counter (OTC) Testing.
• Data Provenance: The document does not specify the country of origin for the OTC testing data. It is a prospective test, as it was "performed for this proposed submission."

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies assessing diagnostic accuracy, especially for image-based AI. For this submission, the "ground truth" for the OTC testing was established by observing and evaluating the subjects' performance in tasks related to "Self-Selection, Usability and Hazards & Precautions." No expert readers of medical images were involved.

4. Adjudication Method for the Test Set

The document does not describe an "adjudication method" in the context of expert review for medical decision-making. For the OTC testing, the results likely involved pass/fail criteria assessed by the researchers or observers conducting the usability study, rather than expert adjudication of conflicting interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical performance data was produced for this submission because the Hair Boom 69 is an identical device in optical, electronic and mechanical function as well as recommended clinical treatment regime, to the predicate device, the Hair Boom 69." (Page 4).

This means there was no study comparing human readers' (e.g., clinicians') performance with and without AI assistance, as "Hair Boom 69" is a physical device (an infrared lamp) and not an AI algorithm assisting human interpretation.

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

This question is not applicable. "Hair Boom 69" is a physical device, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

For the OTC testing, the "ground truth" was established based on the performance and understanding of the subjects themselves in relation to the device's instructions for use, self-selection criteria, and safety precautions. It's direct observation and evaluation of user interaction, not clinical outcomes or expert consensus on a medical diagnosis.

For the efficacy claim (hair growth), the ground truth is implicitly tied to the previous clinical data submitted for the predicate device (K182562) for its prescription use. This current submission leverages the substantial equivalence argument to inherit the efficacy claim from the predicate.

8. The Sample Size for the Training Set

The document does not mention a "training set" for an algorithm. There is no AI component described in this device submission.

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

Not applicable, as there is no training set for an AI algorithm.

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The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I – II, males who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use 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. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

The provided document describes a 510(k) premarket notification for the "Hair Boom 69" device. The submission asserts substantial equivalence to a predicate device, the "HairMax Laser 80," rather than presenting a new study with acceptance criteria and device performance. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available because the submission is based on demonstrating substantial equivalence to a predicate device, not on a new clinical study with specific acceptance criteria that the device's performance was measured against.

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

Not applicable. No new clinical test set was used for the Hair Boom 69 as part of this 510(k) submission. The device's equivalence is based on its technological characteristics and the predicate device's existing clearance.

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

Not applicable. No new ground truth was established for a test set for the Hair Boom 69 in this submission.

4. Adjudication Method for the Test Set:

Not applicable.

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

No. An MRMC comparative effectiveness study was not done as part of this 510(k) submission.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a hardware product (laser helmet) and does not involve an algorithm with standalone performance.

7. Type of Ground Truth Used:

Not applicable to the Hair Boom 69 itself in this submission. The "ground truth" for its efficacy relies on the prior clearance of the predicate device, HairMax Laser 80, which presumably established its efficacy through its own studies.

8. Sample Size for the Training Set:

Not applicable. No training set was used for this device as it's a hardware device demonstrating equivalence, not an AI/ML algorithm.

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

Not applicable.

Summary of the K182562 Submission for Hair Boom 69:

The document focuses on establishing substantial equivalence of the "Hair Boom 69" to the "HairMax Laser 80" (K180885). This means the Hair Boom 69 did not undergo a new clinical trial to define and meet specific acceptance criteria. Instead, its safety and effectiveness are inferred from the predicate device's prior clearance based on similar intended use and technological characteristics.

Key points from the submission regarding "performance":

• No clinical performance data was produced for this submission because the Hair Boom 69 is an equivalent device in optical, electronic, and mechanical function, as well as recommended clinical treatment regime, to the predicate device.
• The Hair Boom 69 was tested to internationally recognized non-clinical standards (IEC, AAMI/ANSI, ISO standards for laser safety, basic safety, EMC, home use, software, risk management, and biological evaluation). These standards demonstrate the device's safety and quality manufacturing, but do not directly assess clinical efficacy in terms of hair growth.
• The submission highlights that both devices use Class IIIa/3R laser systems (by IEC standard) and have similar adverse event profiles.
• The only ergonomic design distinction mentioned is that the Hair Boom 69 is a helmet design, while the HairMax Laser 80 is a cap design, which the sponsor believes does not affect therapeutic value or safety.
• Both devices share the same treatment regime: 30 minutes, every other day, on non-consecutive days, or three times per week for 16 weeks.

In essence, the "study" proving the device meets acceptance criteria (in this context, substantial equivalence to the predicate) is the comparison chart and the assertion that "the Hair Boom 69, is substantially equivalent to the HairMax Laser 80 and based upon the equivalent technological designs of the compared devices." The acceptance criteria for this type of submission are legal and regulatory (meeting the requirements for substantial equivalence to a legally marketed predicate) rather than specific clinical performance metrics for the new device.

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