Search Results

The Life Vessel™ is indicated to provide topical heating for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation.

The Life Vessel™ is a chamber in which the patient lays flat under the treatment light source and positions the part of the body to be treated under the light source. The system is also used for non-medical relaxation applications and for these purposes includes music and sound components for relaxation.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study that proves the device meets those criteria in a structured scientific manner, as one might expect from a medical device clinical trial report.

However, based on the information provided, we can infer the primary performance characteristic and the result of a study that addresses it.

Here's an interpretation based on the given text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It simply states "Performance data was submitted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The type of performance data described (skin temperature measurement) does not typically involve expert ground truth establishment in the same way an AI diagnostic device would.

4. Adjudication method for the test set

This information is not provided. Given the nature of the performance data (direct measurement of skin temperature), an adjudication method in the context of expert consensus or diagnostic agreement is likely not applicable or was not detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that an MRMC comparative effectiveness study was performed. The device is an infrared lamp for therapeutic heating, not an AI diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The "performance data" described is inherently a "standalone" performance of the device's ability to generate heat and increase skin temperature. There is no human-in-the-loop component described for this specific performance metric.

7. The type of ground truth used

The "ground truth" used is direct physiological measurement (skin temperature in degrees Celsius).

8. The sample size for the training set

The document does not provide information about a training set or its sample size. This type of device's performance demonstration typically relies on physical measurements rather than machine learning models that require training data.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned or implied for this type of device's performance evaluation.

Ask a specific question about this device