(161 days)
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:
| Acceptance Criteria (Inferred) | Reported Device Performance (from Nonclinical Test) |
|---|---|
| Ability to elevate topical tissue temperature for temporary relief | Elevated skin to a temperature of between 40 – 45°C over the course of ten minutes of treatment. |
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.
§ 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.