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The Grivamax Family of Lasers , Models 272 and 148 are 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 Grivamax Family of Lasers, Models 272 and 148 consist of 272 diode lasers or 148 diode lasers configured within an outer cap 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. The Grivamax Family of Lasers, Models 272 and 148 are powered by a lithium-ion battery pack that contains an embedded controller chip.

This document is a 510(k) Summary for the Grivamax Family of Lasers, Models 272 and 148. The submission argues for substantial equivalence to previously cleared predicate devices, the Diode Laser Cap (K173678) and the Grivamax Hair Growth System (K171895).

Summary of Acceptance Criteria and Device Performance:

The primary basis for acceptance of the Grivamax Family of Lasers (Models 272 and 148) is its substantial equivalence to the predicate devices. The sponsor argues that the proposed devices are identical to the predicate devices in all relevant aspects. Therefore, the "reported device performance" for the proposed devices is effectively the performance demonstrated by the predicate devices.

Here's a table summarizing the shared characteristics and performance attributes that form the basis for substantial equivalence:

Study Information (or lack thereof, as per the submission):

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not applicable. No new clinical performance data was generated for this submission. The submission relies entirely on the demonstration of substantial equivalence to previously cleared predicate devices.
   • Data provenance: Not applicable for this submission. The predicates (Diode Laser Cap K173678 and Grivamax Hair Growth System K171895) would have had their own clinical data, but this information is not provided in this document.

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

   • Not applicable. No new clinical performance data or test set requiring expert ground truth establishment was conducted for this submission.

3. Adjudication method for the test set:

   • Not applicable. No new clinical performance data or test set requiring adjudication was conducted for this submission.

4. 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 laser therapy product for hair growth, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study.

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

   • Not applicable. This is a medical device for therapy, not a standalone algorithm.

6. The type of ground truth used:

   • Not applicable for this submission. The "ground truth" for the safety and efficacy of the device is implicitly taken from the prior clearance of the predicate devices based on their historical clinical studies (which are not detailed here).

7. The sample size for the training set:

   • Not applicable. No new training data or training set was used for this 510(k) submission.

8. How the ground truth for the training set was established:

   • Not applicable. No new training data or training set was used for this 510(k) submission.

Key Point:

The entire argument for the Grivamax Family of Lasers (K211192) meeting acceptance criteria rests on the assertion that it is "identical" to two previously cleared predicate devices (Diode Laser Cap K173678 and Grivamax Hair Growth System K171895) which are manufactured by the same company (Cosmo Far East Technology Limited) for private labeling. The submission explicitly states: "No clinical performance data was produced for this submission because the Grivamax Family of Lasers, Models 272 and 148 are the same device as the Cleared predicates... They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime."

Therefore, the "study that proves the device meets the acceptance criteria" in this case is a comparison of technical specifications and intended use demonstrating no differences from the predicate devices that would raise new questions of safety or effectiveness. The previous clearances of the predicate devices implicitly contain the studies and acceptance criteria that established their safety and efficacy.

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The Grivamax Hair Growth System 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 Grivamax Hair Growth System consists of 272 diode lasers configured within an outer cap 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. The Grivamax Hair Growth System is powered by a lithium-ion battery pack that contains an embedded controller chip.

It appears there's a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for a medical device called the "Grivamax Hair Growth System," which is an infrared lamp to promote hair growth.

The document states very clearly in Performance Data section on page 4: "No clinical performance data was produced for this submission because the Grivamax Hair Growth System is the same device as the predicate, the Illumiflow Laser Cap, cleared under K162071. Both the Grivamax Hair Growth System and Illumiflow Laser Cap are the IDENTICAL same device offered for PRIVATE LABEL by the manufacturer, Cosmo Far East Technology Limited."

Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on its own clinical performance data within this submission. The clearance is based on its substantial equivalence to a predicate device for which performance data was previously submitted.

However, the document does describe an Over-The-Counter (OTC) Testing Program for consumer comprehension and usability. This is a study designed to meet acceptance criteria for informed self-selection, correct usage, and hazard comprehension for an OTC device. I will describe this study and its acceptance criteria as it is the only "study" described in the provided text.

OTC Testing Program: Acceptance Criteria and Study Details

The provided document describes an Over-The-Counter (OTC) Testing Program conducted to evaluate consumers' ability to understand and correctly use the Grivamax Hair Growth System without professional assistance. This is a crucial component for OTC medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Self-Selection: Making the correct decision to purchase the product or not, based on understanding the Intended Use.
• Usability: Correctly assembling and using the product.
• Comprehension: Understanding the hazards and maintenance procedures for the device.

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

• Sample Size: 40 subjects.
• Data Provenance: Not explicitly stated regarding country of origin, but the context implies it was conducted within the jurisdiction where the FDA regulates, likely the USA. The study design ("volunteer subjects," "interview conducted by interviewer") suggests a prospective study for this specific OTC testing.

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

• Ground Truth Establishment: The ground truth for this OTC test was based on the "correct" answers to 26 questions derived from the product's standard retail package and full owner's manual. The "experts" defining these correct answers would likely be the device manufacturer's design team and regulatory affairs personnel, who developed the manual and packaging, in conjunction with regulatory guidelines for consumer comprehension. No specific number or qualifications of "experts" are stated in this document for creating the questionnaire's correct answers, as it's assumed these would be inherent to the device's design and labeling.

4. Adjudication Method for the Test Set

• Adjudication Method: "If the questions were answered correctly, they were given a P for PASS. If any questions were answered incorrectly, they were given an F for FAIL." This indicates a simple Pass/Fail adjudication per subject based on answering all questions correctly. No multi-reader, multi-expert consensus or 2+1/3+1 methods are described, as this was a direct consumer comprehension test against predefined correct answers.

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

• No MRMC study was done focusing on clinical effectiveness. The device is cleared based on substantial equivalence to a predicate device, not on new clinical performance data from a comparative effectiveness study within this submission.
• The OTC testing was for consumer comprehension and usability, not for clinical efficacy or comparative effectiveness in promoting hair growth.

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

• Not applicable. This device is a physical infrared lamp for hair growth. There is no "algorithm" in the sense of AI or image analysis being tested for standalone performance. The "standalone" aspect here relates to the consumer's ability to use the device without professional assistance, which was tested by the OTC program.

7. The Type of Ground Truth Used

• Ground Truth: For the OTC testing, the ground truth was the correct answers to 26 questions derived from the device's retail packaging and owner's manual regarding its intended use, assembly, operation, hazards, and maintenance. This is a form of expert-defined truth based on the product's design and regulatory requirements for user comprehension.

8. The Sample Size for the Training Set

• Not applicable. This document describes an OTC testing program involving human subjects, not an AI/machine learning model that requires a "training set."

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

• Not applicable. As above, there is no AI/machine learning model or training set described in this document.

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