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The YOLO CURVE is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

The YOLO CURVE has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply, controls and optional treatment probes that contain the visible radiating elements. The YOLO CURVE generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The YOLO CURVE generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The YOLO CURVE generator is supplied with 2 completely independent outputs for using two treatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments.

The provided text describes a 510(k) summary for the YOLO CURVE, an infrared lamp device. However, it does not contain information related to acceptance criteria, specific performance data with numerical results, or detailed study methodologies that would typically be associated with proving a device meets acceptance criteria through a clinical trial or extensive performance testing.

Instead, the document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway for lower-risk medical devices.

Here's an analysis based on the information available in the text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The text states "Performance data is attached which showed that elevated skin temperature as required for this type of device. (Please See Appendix III)", but Appendix III is not included in the provided excerpt. Therefore, no specific acceptance criteria or numerical performance metrics are available.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided. The document makes a general statement about "Performance data" but does not specify any test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document does not describe any test set where ground truth would need to be established by experts.

4. Adjudication Method for the Test Set

This information is not provided. As there's no described test set requiring expert ground truth establishment, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided document. The focus is on substantial equivalence to existing devices rather than a comparative study with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the YOLO CURVE is described as a medical device (infrared lamp) for direct therapeutic application, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant to this device description.

7. The Type of Ground Truth Used

This information is not provided. No specific test data or ground truth establishment is detailed. The performance data mentioned (likely about elevated skin temperature) would imply physiological measurements as "ground truth," but the specifics are absent.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set" as this device is not described as involving machine learning or AI algorithms that would require such data.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable as there is no training set described for an AI/ML algorithm.

Summary of Device and Regulatory Context (Based on available text):

The YOLO CURVE is an infrared lamp cleared through the 510(k) pathway, which means it demonstrated "substantial equivalence" to legally marketed predicate devices (LAPEX BCS K081962 and LUCIA K102375). Its intended use is to emit visible and infrared energy for topical heating to provide temporary relief of minor muscle/joint pain, stiffness, arthritis pain, or muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscle.

The argument for substantial equivalence relies on the device having the "same intended use as and similar technological characteristics" as the predicate devices, specifically utilizing laser diodes to elevate tissue temperature. While "Performance data is attached which showed that elevated skin temperature as required for this type of device," the details of this data, including acceptance criteria and specific results, are in an unprovided "Appendix III."

In conclusion, the provided text from the 510(k) summary focuses on the regulatory clearance process through substantial equivalence and does not offer the detailed performance study information with acceptance criteria and numerical results that your request outline specifies.

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