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Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris.

Intended to emit energy in the red and infrared spectrum for the treatment of periorbital and full face wrinkles.

The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The device emits specific wavelengths of low level, narrow band light for the treatment of certain dermatological and musculoskeletal indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

The Dermalux® Flex MD enables treatment of the face and the body via a flexible LED Array. The system is operated by a capacitive touch Controller, which allows one of 3 treatments to be selected through selecting various wavelengths. The light is generated by Light Emitting Diodes (LED's) that are contained within the flexible LED Array. The LED Array can be placed into the Base, holding in the appropriate position to administer a facial treatment. For use on the body, the LED Array is removed from the Base unit and placed over the appropriate body part.

The provided document is a 510(k) summary for the Dermalux Flex MD device. It describes the device, its intended use, and its comparison to predicate devices to demonstrate substantial equivalence. However, this document does NOT contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device, which is what your request is asking for.

The Dermalux Flex MD is a light therapy device, not an AI/ML-driven diagnostic or therapeutic device. The performance testing mentioned is entirely bench testing for electrical safety, electromagnetic compatibility, software lifecycle, photobiological safety, and usability of the hardware. There are no animal or clinical studies performed or referenced for the Dermalux Flex MD in this document, let alone studies involving AI/ML performance, ground truth establishment, or human reader effectiveness.

Therefore, I cannot extract the information you requested about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

To answer your request, a different type of FDA submission document, typically a De Novo application or a more extensive 510(k) for an AI/ML device, would be required. Those documents would detail the clinical validation studies, including the metrics, ground truth, and statistical analyses relevant to AI/ML performance.

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The BioPhotas Celluma RESTORE system is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

The BioPhotas Celluma RESTORE system uses visible red light (640nm) and is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

In addition, the Biophotas Celluma RESTORE is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (blue, 465nm red, 640nm and Near infra-red, 880nm) produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and musculoskeletal conditions as previously cleared under K122237, K131113, K152280 and K171323.

The system comprises of a flexible, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device.

The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes "Hair", "Wrinkles", and "Aches and Pains", and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.

The provided text is a 510(k) summary for the Biophotas Celluma RESTORE device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a standalone performance study.

Specifically, the document does not contain the acceptance criteria or a study that directly proves the device meets specific performance metrics for hair growth in the same way a clinical trial might for a new drug or a direct performance study for a diagnostic AI. Instead, it relies on demonstrating that the device is "substantially equivalent" to previously cleared devices (predicates) that have already been deemed safe and effective for the indicated use.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or not directly addressed in this type of submission. This document highlights non-clinical testing for safety and electrical performance, and a usability study, but not a study proving the efficacy of hair growth directly.

Here's an analysis based on the information provided:

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

• No explicit performance acceptance criteria (e.g., % increase in hair count, specific hair density) for efficacy are listed or tested.
• The document primarily focuses on safety and technological equivalence.
• Safety and Electrical Performance:
  • Acceptance Criteria (Implied): Compliance with IEC 60601-1 (Electrical safety) and IEC 60601-1-2 (EMC testing).
  • Reported Performance: "The Biophotas Celluma RESTORE successfully passed testing per internal verification/validation requirements and national/international standards... The Biophotas Celluma RESTORE, and the predicate device have satisfied product safety testing to the IEC 60601-1 standard, and the electromagnetic safety testing to the IEC 60601-1-2 standard."
• Software Validation:
  • Acceptance Criteria (Implied): Compliance with IEC 62304 and FDA Guidance document; software safety classification of Class A (low risk) and "Minor" level of concern.
  • Reported Performance: Software has been classified and validated accordingly.
• Usability:
  • Acceptance Criteria (Implied): No new use errors, hazards, or hazardous situations discovered; no suggested revisions to the user manual; comprehension and understanding of the User Manual.
  • Reported Performance: "No new use errors, hazards, hazardous situations, or hazard-related use scenarios were discovered. Further improvement of the user interface design as it relates to safety was deemed unnecessary and there were no suggested revisions to the version of the user manual tested."

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

• For Efficacy: Not applicable, no direct efficacy test set in this submission.
• For Usability: 25 test subjects.
• Data Provenance: Not specified for the usability study. The document describes the device itself and its testing to standards, not a clinical trial with patient data.

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 for efficacy data.
• For the usability study, "experts" in establishing ground truth (i.e., correct understanding of the manual) are not explicitly mentioned in terms of their qualifications or number. The "ground truth" for usability here would be the intended correct understanding of the manual.

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

• Not applicable for efficacy data.
• Not specified for the usability study.

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 or comparative effectiveness study was done or reported in this 510(k) submission as it is not an AI-assisted diagnostic device, but rather a therapeutic device. The submission focuses on technological equivalence and safety, not on human interpretation or an AI component improving human performance.

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

• This device is a therapeutic light device, not an AI algorithm. Therefore, "standalone algorithm performance" is not applicable. The "performance" is its ability to emit light within specified parameters and its safety.

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

• For Efficacy: No direct efficacy ground truth is discussed as no clinical efficacy study on hair growth is presented here. The "ground truth" for substantial equivalence is the previously cleared predicate devices and their established safety and efficacy.
• For Usability: The ground truth would be the intended correct interpretation and safe use of the device and its manual, as determined by the manufacturer's design and instructions.

8. The sample size for the training set

• This document does not describe the development of an AI model, so there is no "training set" in the context of machine learning.

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

• As there is no AI training set, this question is not applicable.

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The BioPhotas Celluma3 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full face wrinkles.

The Biophotas Celluma is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (blue, 465nm red, 640nm and Near infrared, 880nm) produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and musculoskeletal conditions. The Celluma' uses a combination of visible red light (640mm) in combination with near infrared light (880nm) and is intended to improve the appearance of full-face wrinkles. Near infra-red (880nm) is intended to provide topical heating tissue temperature: for the temporary relief of minor muscles and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum (465nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The Biophotas Celluma' is intended for use on areas of the body such as the full face, back, chest, knees or other areas where the therapeutic light may be beneficial. The system comprises of a semi-rigid, shape-taking frame upon which is mounted an array of LEDs, this allows the device to be contoured to the treatment area. The LEDs are embedded within a biocompatible Poron® foam covering that holds a transparent polycarbonate cover recessed within it. The biocompatibility nature of Poron® allows the device to be placed in contact with the skin. Nevertheless, the design of the device provides for maintaining a small distance between the surface of the skin and the surface of the device. The flexible LED panel is permanently connected by a three-foot long cable attached to a control panel that contains the circuitry and software that controls the device. The control panel contains several push buttons beneath a sealed cover. A power button that switches the device ON/OFF, a mode button that allows the user to select from 3 preprogrammed treatment modes; "Acne", "Wrinkles", and "Aches and Pains", a pulse button which allows the user to switch between pulse (default setting) or non-Pulse and a Start button that activates the desired treatment mode. The control panel receives its power from a separate cable that connects via an AC adaptor for 110-220 Volts to a standard U.S. electrical power outlet. The control panel contains an automatic shut-off safety feature.

The provided text is a 510(k) summary for the Biophotas Celluma3, a device intended for the treatment of full face wrinkles. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with reported performance metrics.

Therefore, the following information regarding acceptance criteria and a study proving the device meets these criteria cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• The sample size for the training set
• How the ground truth for the training set was established

The document primarily relies on non-clinical performance testing and a comparison of technological characteristics to assert substantial equivalence. It explicitly states: "Biophotas Celluma' is technologically identical to the previously cleared Biophotas Cellumas device (K152280). In this application, only the indication for use has been revised to expand the treatment of periorbital wrinkles to include full face wrinkles, a logical extension given the fact that the subject device in both submission has a large panel covering the entire face. In addition, the mechanism of action of low level light therapy for the treatment of "wrinkles" is well known to be the same irrespective of area that is being treated."

The provided text details non-clinical performance testing to demonstrate safety and effectiveness for the Biophotas Celluma system, but this is distinct from a clinical study to prove efficacy in meeting acceptance criteria for wrinkle reduction.

Non-Clinical Performance Testing Summary:

The Biophotas Celluma3 underwent several non-clinical performance tests in line with recognized standards to demonstrate safety and effectiveness and substantial equivalence to predicate devices. These tests addressed general requirements, biocompatibility, electrical safety, and software.

• Electrical safety and safety standards: The device passed testing per:
  • IEC 60601-1:2012 (Electrical safety)
  • IEC 60601-1-2:2007 (EMC testing)
• Software verification and validation testing:
  • The software was classified as Class A according to IEC 62304:2006 (Medical device Software - software life cycle process).
  • The FDA level of concern matrix classified the device software as "Minor."
• Biocompatibility: Based on transient and limited contact with intact skin, Biophotas Inc believes the device is safe and compliant with ISO 10993 and the FDA - Blue Book Memorandum #G95-1, supported by ISO 10993-1:2009 annex B.
• Usability Study: Per IEC 62366.

The document argues that "Where there are slight differences in technological parameters, these fall within the range of the predicate devices and those devices cleared under the OHS device code, or have been negated by non-clinical performance testing." This indicates that the non-clinical tests were used to negate potential differences from predicate devices, rather than to establish new performance criteria for wrinkle reduction through a standalone clinical study.

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