Search Results

This device is intended to be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and relaxation of muscles. In addition, the lamp may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The ULK-H and ULT-H lamps each contain a number of quartz bulbs with ceramic coatings that when heated emits infrared radiation with wavelengths from 8 to 40 microns (8.000 to 40.000 nanometers).

The provided text is a 510(k) summary for an infrared lamp, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the format requested. Therefore, much of the requested information is not available in the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not available in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, rather than presenting specific performance metrics against pre-defined acceptance criteria.

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

This information is not available. The 510(k) summary does not mention any clinical study or test set involving human subjects to evaluate the device's performance against specific pain relief claims.

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

This information is not available. Since no test set or clinical study is described, there's no mention of experts establishing ground truth.

4. Adjudication method for the test set:

This information is not available. As no test set is described, there is no adjudication method mentioned.

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

This information is not available. The device is an infrared lamp, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

This information is not available. This is not an algorithmic device.

7. The type of ground truth used:

This information is not available. No clinical study data is presented.

8. The sample size for the training set:

This information is not available. The device is an infrared lamp, and there is no mention of a "training set" in the context of device development or evaluation for this type of medical device.

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

This information is not available. Similar to the above, there is no training set for this type of device.

Summary of what is available from the 510(k) document:

• Device Name: TLC Infrared Lamp (Models ULK-H and ULT-H)
• Intended Use/Indications for Use: Temporary relief of minor muscle and joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation where applied, and relaxation of muscles. May also help muscle spasms, minor sprains and strains, and minor muscular back pain.
• Predicate Device: Model CGO-222B TDP infrared lamp (cleared in K020851).
• Technological Characteristics Comparison (basis of substantial equivalence):
  • TLC Lamp: Quartz bulbs with ceramic coatings, emitting infrared radiation with wavelengths from 8 to 40 microns (8,000 to 40,000 nanometers).
  • Predicate Device: Metal ceramic-coated plate, emitting infrared radiation with wavelengths from 1 to 25 microns (1,000 to 25,000 nanometers).

The 510(k) process primarily relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing indications for use, technological characteristics, and performance data if available and necessary. For devices like infrared lamps, the demonstration often focuses on the physical properties and safety rather than extensive clinical efficacy studies with ground truth establishment in the way an AI diagnostic tool would require.

Ask a specific question about this device