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The BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

The BIOPHOTAS Celluma CONTOUR is intended to deliver heat in the near infra-red 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 BioPhotas Celluma CONTOUR 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 CONTOUR is a Light emitting diode (LED) system that applies 640nm light for the purpose of reducing the circumference of the hips, waist, and thighs for aesthetic benefit, 640nm and 880nm light for the purpose of temporarily elevating skin temperature and 640nm and 880nm light for the purpose of treating full face wrinkles.

The BioPhotas Celluma CONTOUR 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.

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 "Contour" "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 FDA 510(k) summary for the Biophotas Celluma CONTOUR (K232977) does not contain comprehensive details on acceptance criteria and specific study results in a format that would typically be described for a diagnostic AI device. This document is a premarket notification for a Class II medical device (Low Level Laser System For Aesthetic Use), and the information presented focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance metrics through large-scale clinical trials with defined acceptance criteria and statistical proofs.

However, based on the information provided, I can extract and infer some points regarding performance testing and acceptance, particularly concerning safety and usability for an Over-The-Counter (OTC) device.

Here's a breakdown of the available information structured to address your questions, with the understanding that this device is not an AI diagnostic tool and thus many of your questions related to AI-specific metrics (e.g., MRMC, standalone algorithm performance, training set ground truth) are not applicable or explicitly stated for this type of device submission.

Description of Acceptance Criteria and Studies

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are mainly focused on demonstrating compliance with safety standards, usability for OTC use, and equivalence of technological characteristics to predicates. Performance is assessed through compliance with these standards and comparison to predicates.

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

• Usability/Label Comprehension Study:

  • Sample Size: 24 test subjects.
  • Data Provenance: Not explicitly stated, but typically these studies are conducted prospectively with recruited participants in a controlled environment. The country is not specified.

• For other non-clinical performance tests (electrical safety, EMC, software validation, biocompatibility), these are typically engineering tests performed on the device itself or its components (e.g., materials for biocompatibility) rather than human subjects. Thus, the concept of "sample size" for a test set (like for a diagnostic device) doesn't directly apply in the same way.

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

This question is largely not applicable as this device is not an AI diagnostic tool that requires expert ground truth for performance evaluation in the context of disease detection or measurement.

For the usability study, "ground truth" refers to whether lay users can correctly understand and operate the device safely based on labeling. This is assessed through questions and observation, not expert consensus on medical images or patient outcomes. The experts involved would be human factors engineers or usability specialists who design and analyze the study. The document does not specify the number or qualifications of such experts.

4. Adjudication Method for the Test Set

This question is not applicable for the type of studies described in this submission (safety, EMC, software validation, usability). Adjudication implies resolving disagreements among experts for ground truth establishment, which is relevant for diagnostic performance studies.

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

Not Applicable. This device is a light-emitting diode (LED) system for aesthetic and pain relief uses. It does not involve AI for diagnostic interpretation or human reader assistance.

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

Not Applicable. This device does not feature a standalone diagnostic algorithm. The software mentioned is for controlling the device's operational modes and safety features, not for standalone diagnostic performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For safety and performance characteristics (electrical, EMC, software): The "ground truth" is adherence to established international and national engineering standards (IEC 60601-1, IEC 60601-1-2, IEC 62304). Third-party testing labs or in-house engineering teams confirm compliance.
• For usability/label comprehension: The "ground truth" is the correct understanding and safe operation of the device by lay users, as measured by their responses to questions and observed interactions, compared against the intended use and safety protocols.
• For biocompatibility: The "ground truth" is the material's previously established biocompatibility or demonstration of compliance with relevant biocompatibility standards (e.g., ISO 10993 series), confirmed by testing (which was not repeated here due to material identity to cleared devices).

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML system that utilizes a training set for model development in the context of diagnostic performance. The software is noted as a Class A medical device software (lowest risk) and its validation focuses on life cycle processes and functional correctness, not machine learning training.

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

Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this device, this question does not apply.

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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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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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