(268 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Usability | Device design should mitigate anticipated risks of misuse and misunderstanding of instructions for use. | Study data shown to mitigate anticipated risks of misuse and misunderstanding of instructions for use. |
| Electrical Safety | Compliance with IEC 60601-1 (200 Edition). | Passed testing without any failure. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2. | Passed testing without any failure. |
| Biocompatibility | Compliance with applicable parts of ISO 10993. | Passed testing without any failure. |
| Software Validation | Fully validated per FDA requirements. | Fully validated. |
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.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.