Search Results

HUANQIU Heating lamp, including CQ-27, CQ-29 and CQ-67, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.

The device consists of heating head, swing arm, control box and pedestal with extension. It is used to provide topical heating to the body and is specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,000 to 1500 hours of usage. 110 volt power, 250 watts. There are two different types of control: standard control and digital display control.

The HUANQIU Heating Lamp (models CQ-27, CQ-29, and CQ-67) is an infrared lamp device. The study to prove the device meets acceptance criteria is a substantial equivalence comparison to the predicate device, the TDP CQ-27 Heat Lamp manufactured by Lhasa Medical, Inc. This type of submission (510(k)) does not typically involve clinical trials in the way a pharmaceutical might, but instead focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HUANQIU Heating Lamps are based on demonstrating substantial equivalence to the predicate device in terms of components, power, spectrum ranges, warming up time, total working hours, operating timer, number of fuses, inner cover diameter/width, number of casters, and skin temperature at specific distances.

Note for Skin Temperature: The skin temperature results for the new device are presented in a slightly different order and combination across the tables for each model. For CQ-67, the temperatures at 10" and 12" are slightly different from the predicate at identical distances, but still within a very similar range. This is considered acceptable for substantial equivalence, as minor variations are expected.

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

The document indicates a substantial equivalence study was performed. For this type of submission, a "test set" in the sense of a clinical trial with a defined sample size of patients is generally not applicable, as the equivalence is primarily demonstrated through technical specifications and adherence to standards.

The data provenance is from the manufacturer's internal testing according to GB 9706.1-1995 (which is identical to IEC 60601-1). This is a retrospective comparison against the known specifications of the predicate device. The country of origin for the manufacturing and potentially the testing is implicitly China, given the device name "HUANQIU" and the location of the applicant and correspondent.

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

Not applicable. For a substantial equivalence claim based on technical specifications and international standards (IEC 60601-1), "ground truth" is established through engineering and performance testing rather than expert clinical consensus. The standards themselves are developed by expert committees, but this is not the type of "expert ground truth" typically associated with diagnostic AI studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is a technical specification comparison, not a clinical study requiring adjudication of findings.

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

Not applicable. This device is an infrared heating lamp, not a diagnostic imaging device utilizing AI.

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

Not applicable. This is a physical medical device, not an algorithm. Device performance is assessed based on its physical characteristics and output (e.g., heat, spectrum).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this substantial equivalence study is the technical specifications and performance characteristics of the legally marketed predicate device (TDP CQ-27 Heat Lamp), as well as adherence to recognized international safety and performance standards (GB 9706.1-1995 / IEC 60601-1). The new device is shown to have comparable (substantially equivalent) specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable.

Ask a specific question about this device