(261 days)
The Varava Sport Model 200 is indicated/intended for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Varaya Sport Model 200 utilizes high powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and a control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adapter.
The provided 510(k) summary for the Varaya Sport Model 200 does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics through clinical trials. Instead, it relies on substantial equivalence to predicate devices and presents summary safety testing.
Here's a breakdown based on the information provided, highlighting the absence of the requested study details:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the submission. The submission states, "Formal clinical trials were not deemed necessary as device is using same or similar technology and intended use as predicate devices." Therefore, no specific acceptance criteria for clinical performance (e.g., pain reduction scores, circulation improvement percentages) are outlined, nor is there any reported device performance data against such criteria.
The submission does mention:
- "The Varaya Sport Model 200 meets the required tissue heating requirements (tests provided)." - However, the specific requirements and results are not detailed in this summary.
- "Information regarding testing safety and effectiveness in accordance with IEC 60601-1, IEC 60601-1-2 and ISO 10993 were provided." - These are safety and electromagnetic compatibility standards, not clinical performance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Since no clinical performance study was conducted, there is no test set sample size or data provenance (country of origin, retrospective/prospective) for device performance against clinical acceptance criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given the absence of a clinical performance study, there were no experts used to establish ground truth for a test set regarding the device's clinical efficacy.
4. Adjudication Method for the Test Set
As no clinical performance test set was used, there was no adjudication method for such a set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was conducted or reported. The submission explicitly states that formal clinical trials were not deemed necessary. Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone Study Was Done
No standalone study (i.e., algorithm only without human-in-the-loop performance) was conducted or reported, as this is a medical device for direct patient use, not an AI algorithm for diagnostic interpretation.
7. The Type of Ground Truth Used
For the purpose of substantial equivalence, the "ground truth" implicitly used is the established safety and efficacy profiles of the predicate devices. For safety testing (e.g., tissue heating, IEC standards), the ground truth would be adherence to specified engineering and safety standards. There is no clinical ground truth established through expert consensus, pathology, or outcomes data for this specific device's clinical performance.
8. The Sample Size for the Training Set
Since no clinical performance study was conducted, and the device is not an AI/ML algorithm that requires training data in the conventional sense, there is no training set sample size.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, there is no method described for establishing its ground truth.
§ 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.