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The BioPhotas Celluma3 is 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. The Celluma3 is intended to emit energy in the red and infrared spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Celluma3 is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with biocompatible material, which uses specific wavelengths of light to manage aesthetic and musculoskeletal conditions. Celluma3 produces light in the near infrared region of the spectrum (880nm) intended to provide topical heating to tissue for pain relief. Blue light (464nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) in combination with infrared light is intended to improve the appearance of wrinkles. Note that the Cellumad and the Celluma predicate device are technologically identical; only the indications for use have been revised to add treatment of periorbital wrinkles.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BioPhotas Celluma3, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the Acceptance Criteria and Study Details:

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

• Sample Size:
  • Initially, 50 test subjects were recruited across seven aesthetician locations.
  • The final test subject count was 42, as one site and seven test subjects dropped out.
• Data Provenance: The document does not explicitly state the country of origin. It indicates that test subjects visited "a study center" and "seven esthetician locations," implying a prospective clinical study.

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

• Number of Experts: Three Clinical Investigators.
• Qualifications of Experts: Board Certified Dermatologists. One of them also served as the Principal Investigator.

4. Adjudication Method for the Test Set

• Adjudication Method: It was an independent evaluation followed by a majority consensus. All three Clinical Investigators independently evaluated the test subjects' photos. The success criterion was met if "at least two out of three Clinical Investigators agreed that a majority of test subjects have experienced a one point or greater reduction." This is a form of 2-out-of-3 consensus adjudicated by experts.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing AI with human readers or human readers with and without AI assistance was not done. This study focused on the device's efficacy for treating periorbital wrinkles, with expert assessment of before-and-after photos.

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. The Device, Celluma3, is an LED light therapy device, not an AI algorithm. The study evaluated the device's effectiveness in humans, with human experts performing the evaluation.

7. The Type of Ground Truth Used

• Ground Truth Type: Expert consensus based on professional visual evaluation of photographs, applying the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital).

8. The Sample Size for the Training Set

• The document describes a clinical study to confirm device efficacy, not an AI algorithm training process. Therefore, there is no specific "training set" mentioned in the context of machine learning. The device itself (Celluma3) is a physical light therapy device, not an AI model requiring a training set.

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

• As there is no AI algorithm training set mentioned, this question is not applicable. The device's efficacy was established through the prospective clinical study described above.

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The Biophotas Celluma® device is 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 is intended to reduce mild to moderate inflammatory acne vulgaris.

The BioPhotas Celluma® is a therapeutic device using wavelengths of polychromatic energy produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and body conditions. It is a pain-free means to address a variety of musculoskeletal concerns. The Celluma® spectrum is intended 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; promotion of relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue light spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat various conditions, specifically indicated to treat mild to moderate inflammatory acne vulgaris.

The BioPhotas Celluma® is a portable, ACpowered, software operated device intended for use on areas of the body such as the back, face, knees or other areas where the therapeutic light may be beneficial. Drawing electrical energy through an AC power adaptor to a lightweight, flame-retardant plastic user interface console that connects by a cable to a flexible panel within which is mounted an array of LEDs which provide red light (640 nm) and near IR (880 nm) wavelengths necessary, the Celluma® provides topical heating to elevate tissue temperature for the temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain or muscle spasms and to provide a temporary increase in local blood circulation.

Blue LEDs, adjacent to the other LEDs, mounted within the flexible panel provide blue spectrum light (463 nm) intended to reduce mild to moderate inflammatory acne vulgaris.

The flexible panel is designed to conform to the contour of the treatment site providing for ease of use for sites that may be difficult to reach for larger, more cumbersome devices. The patient-facing surface of the panel may contact the tissue of the patient, and is therefore composed of biocompatible Poron material.

The provided text describes the BioPhotas Celluma® device and its 510(k) summary, which outlines the device's characteristics, indications for use, and nonclinical testing. However, it does not contain a study that proves the device meets specific acceptance criteria with reported device performance metrics like sensitivity, specificity, or AUC.

The document states that "Biophotas has performed a Usability Study to ensure the understanding of the proper use as well as any risks of misuse of the Celluma® by the public as an over-the-counter medical device product." It further mentions that "The study data show that the device design essentially mitigates anticipated risks of misuse and misunderstanding of the instructions for use." This is the only mention of a "study" in the context of device performance, and it is related to usability, not clinical or diagnostic performance.

The nonclinical testing section focuses on safety and electrical compatibility:

• Electrical and mechanical product safety to IEC 60601-1 standard (200 Edition)
• Electromagnetic compatibility to IEC 60601-1-2 standard
• Biocompatibility to applicable parts of ISO 10993 standard
• Software validation per FDA requirements

Therefore, I cannot provide a table of acceptance criteria and reported device performance for clinical efficacy, as this information is not present in the provided text. I also cannot address most of the requested points (sample size, ground truth, expert opinions, MRMC study, standalone performance) as a detailed study for clinical efficacy is not included in the provided 510(k) summary.

Based on the provided text, here is what can be inferred about the usability study and nonclinical testing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Usability Study: The text refers to "a random population of prospective users" for the usability study. No specific sample size is mentioned.
• Nonclinical Testing (Electrical, EMC, Biocompatibility, Software): These are engineering and lab tests, not using human "test sets" in the clinical sense.

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

• Usability Study: The text doesn't specify the number or qualifications of experts for evaluating the usability study's ground truth, beyond indicating the study aimed to ensure "understanding of the proper use as well as any risks of misuse."
• Nonclinical Testing: Experts would be involved in carrying out and interpreting the various engineering and safety tests, but the document does not detail their numbers or qualifications.

4. Adjudication method for the test set

• Not specified for the usability study. Not applicable for nonclinical technical tests.

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 is mentioned. This device does not involve AI or "human readers" in a diagnostic context.

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

• Not applicable as this is a light therapy device, not an algorithm.

7. The type of ground truth used

• Usability Study: Ground truth was likely defined by successful and safe operation of the device and correct comprehension of instructions by users.
• Nonclinical Testing: Ground truth was established by adherence to recognized international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993) and FDA requirements for software validation.

8. The sample size for the training set

• Not applicable for the usability study or nonclinical testing. This device is not an AI algorithm requiring a training set.

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

• Not applicable.

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The Biophotas LifeLight device is 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 the appearance of mild to moderate acne vulgaris.

The LifeLight® is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. LifeLight produces light in the near infrared region of the spectrum (880 nm) intended to provide topical heating to tissue. Blue light (464 nm) is intended to help reduce the appearance of mild to moderate acne. The console of the device contains the electronics of the device and an automatic shut-off safety feature. The LifeLight operates for 30 minutes per use.

The provided text describes a 510(k) submission for the Biophotas LifeLight® device. It outlines the device's intended use and compares it to a predicate device, but it does not include a comprehensive study that establishes specific acceptance criteria or provides detailed performance results against those criteria.

However, it does mention some nonclinical testing related to the infrared LED array's ability to elevate tissue temperature.

Here's an attempt to answer your request based on the available information, with significant limitations due to the lack of a dedicated study section:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific formal "acceptance criteria" and a detailed "reported device performance" table are not explicitly stated. The document primarily focuses on demonstrating substantial equivalence to a predicate device.

However, we can infer a non-clinical "performance" from the testing described for the infrared function:

It's crucial to note that this is an inference based on the description of a nonclinical test, not a formally defined acceptance criterion with a quantitative target. The blue light for acne indication does not have any performance data presented in this document.

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

The document does not specify a sample size for any test set for either the infrared or blue light indications. It broadly refers to "Device testing" for the infrared array.

The data provenance for this unquantified testing is implied to be from the manufacturer's internal "nonclinical" testing. There is no information regarding country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for any test set. The nonclinical test for the infrared function appears to be a direct physical measurement (temperature elevation), not requiring expert adjudication of outcomes.

4. Adjudication Method

Since no experts are mentioned and the performance data is a direct physical measurement (temperature), there was no adjudication method described or likely required for the presented (limited) testing.

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

No MRMC comparative effectiveness study was done or described. This document focuses on demonstrating substantial equivalence of a physical therapy device, not a diagnostic algorithm requiring human reader performance analysis.

6. Standalone (Algorithm Only) Performance Study

The Biophotas LifeLight® is a physical therapy device utilizing LEDs for therapeutic heating and acne treatment. It does not involve a standalone algorithm in the way an AI diagnostic device would. Therefore, a standalone (algorithm only) performance study (as understood in the AI context) was not performed or relevant to this type of device.

7. Type of Ground Truth Used

For the infrared indication, the "ground truth" for the nonclinical testing appears to be direct physical measurement (temperature elevation). For the blue light indication, no specific ground truth or performance data is presented in this document.

8. Sample Size for the Training Set

The device is not an AI/ML algorithm. Therefore, 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 training set for an AI/ML algorithm, this question is not applicable.

Summary of Limitations:

The provided document is a 510(k) summary for a physical therapy device. It aims to demonstrate substantial equivalence to a predicate, not to report a comprehensive clinical or non-clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML devices. The "performance" data is limited to a single non-clinical measurement for the infrared function, and no such data is present for the blue light acne indication.

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