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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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Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Hair Up shares great similarities with predicate device which is currently market cleared for promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Both Hair Up and its predicate device both 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 for a full coverage of the upper 1/3 of the head where commonly covered with stylized hair. The system will automatically pause therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down.

The provided document is a 510(k) summary for the "Hair Up" device, which is an infrared lamp for hair growth. This document primarily focuses on establishing substantial equivalence to a predicate device (iGrow-II Hair Growth System, K141567) based on technical characteristics and intended use.

However, the document does not contain the acceptance criteria or a study proving the device meets specific acceptance criteria related to its clinical efficacy (promotion of hair growth). The "Performance Data" section (number 6) only discusses non-clinical tests related to safety, electrical requirements, and risk management, which are typically standard compliance tests rather than clinical performance studies with acceptance criteria.

Therefore, most of the information requested in your prompt regarding acceptance criteria and studies proving the device meets them cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not state specific clinical acceptance criteria (e.g., minimum percentage increase in hair count or density) nor does it report the device's performance against such criteria. The "Performance Data" section describes non-clinical engineering and safety compliance tests, not clinical efficacy.

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

• Cannot be provided. The document does not describe any clinical study (test set) for evaluating the device's efficacy. The performance data mentioned refers to non-clinical technical tests, which do not typically involve patient "test sets."

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)

• Cannot be provided. No clinical test set or ground truth establishment process is described in the document.

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

• Cannot be provided. No clinical test set or adjudication method 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

• Cannot be provided. The "Hair Up" device is an infrared lamp for hair growth, not an AI-powered diagnostic imaging tool that would typically involve human readers or MRMC studies. This question is not applicable to the type of device described.

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

• Cannot be provided. The "Hair Up" device is an infrared lamp, not an algorithm. This question is not applicable.

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

• Cannot be provided. No clinical efficacy study or ground truth establishment for such a study is mentioned.

8. The sample size for the training set

• Cannot be provided. The device is not an AI algorithm that requires a training set. If referring to a clinical training set for users, none is described.

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

• Cannot be provided. This question is not applicable as there is no mention of a training set for an algorithm or a clinical study that would require a ground truth for a training set.

Summary of what the document does provide regarding performance (non-clinical):

The document states that non-clinical tests were performed to demonstrate that the device complies with relevant safety and performance standards. These include:

• Measurement of wavelength and average output power: "Testing conducted on the Hair Up shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11."
• Basic safety and essential performance: Tested and evaluated according to IEC 60601-1:2005.
• Effect to the device by electromagnetic disturbances: Tested and evaluated according to IEC 60601-1-2:2014.
• Safety of laser products: Evaluated according to IEC 60825-1:2014.
• Biological evaluation of medical devices: Tested and evaluated according to ISO 10993-5:2009 and ISO 10993-10:2010.
• Risk management: Recorded by referring to ISO 14971:2007.
• Usability: Documented referring to IEC 62366.

These are compliance standards for device design and manufacturing, not clinical efficacy acceptance criteria. The basis for clearance is substantial equivalence to a predicate device, which implies that because the predicate device was cleared, and the new device shares similar technical characteristics and intended use, it is also considered safe and effective for the stated indications.

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