(97 days)
The Vevazz is a device that emits energy in the infrared spectrum and is to be used to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle.
The Vevazz device is a moderately complex device that consists of a base unit that plugs into 120 VAC or 240 VAC main power with Ground (earth) and a 2 amp 250 VAC Fuse. The base unit can support up to 16 large LED paddles and 4 small LED paddles. The connections on the base are female phono jacks that are low voltage having a maximum electrical output of 16 VDC @ .5 amps for a total of 8 Watts per port. The large paddles consist of 28 LEDs in a series/parallel electrical connection that has a cord with a male phono jack. Small paddles consist of 4 LEDs and have matching electrical characteristics as the large paddles. Each LED produces 50 mw/cm2 of light energy with a wavelength of 650 nm: +/- 25 pm uniformly over the treatment area without producing hot spots.
The provided FDA 510(k) summary for the Vevazz LED Heat Lamp describes the device, its intended use, and a comparison to predicate devices, but it does not contain the level of detail typically found in a clinical study report regarding acceptance criteria and study methodology for proving the device meets those criteria.
However, based on the limited information available in the "9. Clinical Testing Summary" section, I can extract and infer some points regarding acceptance criteria and the "study" that supports it:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document explicitly states acceptance criteria only for temperature performance. Other characteristics are described but not presented with pass/fail criteria from a specific study.
| Performance Characteristic | Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Heat Performance | Reach an idle temperature of 40°C and maintain that temperature throughout the treatment for a minimum duration of 10 minutes ±2°C. (Implicitly, without producing hot spots). | Reached 41°±2°C (as stated in the "Target Skin Temperature" table, which aligns with the "idle temperature of 40°C" and "maintain temperature...±2°C" mentioned in the clinical testing summary, suggesting it falls within the acceptable range and is consistent with predicates). |
| LED Energy Output | (No explicit acceptance criteria stated as a threshold to be met in a test, but values are given for comparison to predicates) | 50 mW/cm² (as stated in device description and comparison table) |
| Wavelength | (No explicit acceptance criteria stated) | 650 nm +/- 25 nm (as stated in device description and comparison table) |
| Treatment Area | (No explicit acceptance criteria stated) | 7.5 cm² (as stated in comparison table) |
| Treatment Time | (No explicit acceptance criteria stated) | 17 minutes (default) (as stated in comparison table) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "monitor skin temperature and uniformity on the abdominal region and multiple skin types" but does not quantify the number of subjects or tests.
- Data Provenance: Prospective, as it describes testing carried out specifically for the Vevazz device. No specific country of origin is mentioned for this "human test data," though the submitter is based in California, USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not mentioned. The "clinical testing summary" describes a performance test (temperature measurement) rather than a diagnostic accuracy study requiring expert adjudication of ground truth.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. This type of performance testing (temperature measurement) does not involve adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The document does not describe a study involving human readers or comparative effectiveness with or without AI assistance. This device is a therapeutic lamp, not a diagnostic imaging AI system.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study in the context of an algorithm's diagnostic accuracy was not done. This device is a physical therapeutic device, not an algorithm. The "clinical testing" described focuses on the device's physical performance (temperature generation).
7. Type of Ground Truth Used
- The "ground truth" for the performance "study" was the actual measured temperature of the skin using an IR camera, confirming the device's ability to achieve and maintain a specific temperature range. This is a direct physical measurement, not an expert consensus, pathology, or outcomes data in the usual sense of a diagnostic or therapeutic clinical trial.
8. Sample Size for the Training Set
- Not applicable. This device is a hardware product, and the described "testing" is a physical performance verification. There is no mention of a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an algorithm, this question is not relevant to the provided text.
§ 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.