(203 days)
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
| Acceptance Criteria (Success Threshold) | Reported Device Performance |
|---|---|
| At least a one-point or greater reduction of wrinkle severity on the Fitzpatrick | At least two out of three Clinical Investigators agreed that a majority of test subjects experienced a one-point or greater reduction of wrinkle severity on the Fitzpatrick Classification of Facial Wrinkling (Perioral and Periorbital) 12 weeks following the completion of treatment. Clinical study results confirmed at least a full point reduction. |
| Classification of Facial Wrinkling (Perioral and Periorbital) 12 weeks following | High positivity rates from test subjects (though specific numeric rates are not provided in this document). |
| the completion of treatment for a majority of test subjects. | |
| Demonstrated efficacy and effectiveness. | Deemed efficacious and demonstrating effectiveness by the study. |
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.
§ 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.