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The infrared lamp is intended to emit energy in the 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, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is a non-invasive, portable infrared lamp designed to deliver light energy in the infrared spectrum to the target tissue. The light energy is emitted by a built-in Halogen lamp. rated 110-130 Vac. which is enclosed by plastic enclosure, except front panel which is a ceramic / glass plating. Power on/off switch and time setting button is provided in front panel, with which, operator can turn on or off the device and set the treatment time. The treatment time is control by software and shown on the LCD display. The device is connected to mains via a non-detachable power supply with attachment plug. It also includes fuse current, thermal protector and cooling fan as safety component.

The provided 510(k) summary describes a therapeutic heating device (Infrared Lamp) and its equivalency to existing predicate devices. The "acceptance criteria" in this context are not explicitly defined as specific numerical targets for performance metrics (like sensitivity/specificity for a diagnostic device). Instead, the acceptance criteria are implicitly that the device's performance, particularly its heating capability, is similar to or better than a legally marketed predicate device and that it meets relevant safety standards.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1 (Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995)
• IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests; Edition 2.1)
• UL 60601-1, first edition, 2003, deviations to IEC 60601-1. |
  | The difference in intended use (prescription vs. OTC) for the FIR 51, SN-51 model (K110721 vs K102149) does not raise new questions of safety and effectiveness. | The labeling of the subject device (K110721) is "readable and understandable for over-the-counter use." The difference does not raise new questions of safety and effectiveness, leading to a substantial equivalence determination. |
  | The differences in technological characteristics (e.g., wavelength) between the FIR 51, SN-51 and the TDP CQ-27 Heat Lamp do not raise new questions of safety and effectiveness. | The subject device uses 600 nm - 2000 nm infrared (Near-infrared and Short-wavelength infrared), while the predicate uses 2 to 25 microns (Long-wavelength infrared and Far infrared). The submission claims that "The different wavelength will not affect the effectiveness of device." It also argues the subject device might have "less" burn risk due to visible heating. A comparison test showed both devices achieve the therapeutic temperature range of 41-45°C. Risk management report shows all risks are under control. |
  | The device maintains safety when used by layperson users (for OTC use). | "As identical predicates of these devices have been in safe and effective applications by layperson users. Over-The-Counter variance is requested." (Refers to the prior model K102149.) The new device passes safety testing and the risk management report indicates controlled risks. |

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

• Test Set (Performance Testing): The description refers to "a person" for the performance testing of the subject device. This implies a very limited sample size, possibly n=1, or at most a very small convenience sample. It does not specify a statistically significant sample size.
• Data Provenance: The testing was conducted by the manufacturer, Foshan Gaunying Electronics Co., Ltd., in China. It appears to be prospective testing specifically for this submission, not retrospective data.

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

• This device is a therapeutic heating device, not a diagnostic device that requires expert consensus for "ground truth" on medical findings. The "ground truth" for its performance is objective physical measurement (temperature increase).
• No experts are mentioned as establishing ground truth in the traditional sense for diagnostic accuracy.

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

• Not applicable. The performance testing involved direct temperature measurement using an electronic thermometer, not subjective interpretation requiring adjudication.

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 is a therapeutic physical device, not an AI-assisted diagnostic tool involving human "readers."

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

• Not applicable. This is a therapeutic physical device, not an algorithm. Its performance is inherent to its physical operation.

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

• The "ground truth" for the device's performance is objective physical measurement:
  • Skin temperature increase measured by an electronic thermometer.
  • Compliance with international electrical safety and EMC standards.
  • Comparison of heating efficacy against a legally marketed predicate device.

8. The sample size for the training set

• Not applicable. As a physical therapeutic device, there is no "training set" in the context of machine learning or AI models. The device's design and manufacturing are based on engineering principles and standards, not data training.

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

• Not applicable, as there is no training set for this type of device.

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The Gaunying Infrared Lamp ( Model #: IL50) is intended to emit energy in the 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, or muscle spasm; the temporary increase in local blood circulation.

Gaunying Infrared Lamp (Model#: IL50) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.

Here's an analysis of the Gaunying Infrared Lamp (Model IL50) based on the provided 510(k) summary, aiming to answer your specific questions.

Important Note: This device is a basic therapeutic heating lamp. The acceptance criteria and testing described are for physical performance and safety, not for diagnostic accuracy or complex AI performance metrics like those seen in medical imaging.

1. Table of Acceptance Criteria and Reported Device Performance

• Sensor (skin) temperature never exceeded 45°C. |
  | | Temperature Homogeneity/Consistency (implied by predicate comparison) | Device "tracks temperature readings" of the predicate device, indicating comparable heat output. |
  | Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, UL 60601-1 standards. | Device is "manufactured to comply" with these standards. (No specific test results detailed, but compliance is stated). |
  | Usability | Operating Instructions (OI) are clear and allow safe and effective operation by lay people. | Initial study showed questions, but revised OI led to no difficulties for a new study group. Concluded OI clear and effective. |
  | Equivalence to Predicate | Similar intended use and comparable performance (specifically heat output characteristics). | Same intended use. Wavelength difference considered not to affect effectiveness. Bench test showed temperature readings tracked predicate device. Concluded "as safe and effective as the predicate device" and "substantially equivalent." |

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

• Functional Performance Test: 2 devices (Gaunying Infrared Lamp Model IL50).
  • Data Provenance: Not explicitly stated, but implies internal bench testing conducted by the manufacturer, likely in China (where the company is based). This is a retrospective evaluation of a manufactured product.
• Usability Test: An initial group of 10 people (5 females, 5 males). A second group of 10 people for re-testing.
  • Data Provenance: Not explicitly stated, but implies internal testing by the manufacturer. This would be a prospective user study.
• Comparison Temperature Test: Not explicitly stated, but assumed to be 1 subject device (IL50) and 1 predicate device (Xinfeng Heating Lamp).
  • Data Provenance: Not explicitly stated, but implies internal bench testing. This is a retrospective evaluation.

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

There are no "experts" in the traditional sense of medical specialists establishing ground truth for this type of device. The ground truth for functional performance (temperature output) is based on instrument measurements (digital temperature sensor) and engineering specifications (e.g., target temperature ranges).

For the Usability Test, the "ground truth" was an observable measure of user comprehension and ability to operate the device based on the Operating Instructions, observed by the study facilitators. No specific "experts" in usability were mentioned, but the observers effectively served this role.

4. Adjudication Method for the Test Set

• Functional Performance Tests: No explicit adjudication method described. The results are quantitative measurements from instruments. The two devices in the initial heat output test tracked "near 100%", implying consistency without needing further adjudication.
• Usability Test: The adjudication was based on direct observation of user interaction and their verbal feedback/questions. The Operating Instructions were revised based on this feedback. The re-test observed a lack of difficulties, effectively adjudicating the revised instructions as clear. There's no "2+1" or similar method, as it's a qualitative observation of user behavior.

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

No. This device is an infrared lamp for therapeutic heating, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Yes, in essence. The functional performance and comparison tests were standalone in the sense that they evaluated the device's physical output (heat generation) directly through measurement, without human intervention affecting its output. The "algorithm" here is the device's internal mechanism for generating infrared light and heat. Its performance was measured intrinsically.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Functional Performance:
  • Instrumental Measurements: Digital temperature sensor readings served as the primary ground truth for heat output.
  • Engineering/Physiological Specifications: The desired effective temperature (>40°C) and the safety threshold (

Ask a specific question about this device

The Gaunying Infrared Lamp ( Model #: FIR 51, SN-51) are intended to emit energy in the 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, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Gaunying Infrared Lamp (Model#: FIR 51, SN-51) has a high-quality glass ceramic plate (ceramic infrared). Glass ceramic plates are also used on hobs and when used in conjunction with illuminants guarantee intensive and safe infrared radiation.

The Gaunying Infrared Lamp (Model#: FIR 51, SN-51) is intended to emit energy in the infrared spectrum to provide topical heating. The acceptance criteria and the study proving the device meets these criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document describes "a performance testing with the subject device" and "a comparison testing with the subject device and predicate device." However, specific sample sizes (e.g., number of units tested, number of measurement points per unit) are not explicitly stated. Instead, it refers to conducting tests on "the subject device" at various distances.
• Data Provenance: The tests were conducted by the manufacturer, Foshan Gaunying Electronics Co., Ltd., in China. The data appears to be retrospective relative to the 510(k) submission date, as the testing reports are cited within the summary.

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

This section is not applicable as the evaluation primarily involved performance and safety testing against objective physical parameters (temperature measurements, compliance with electrical standards), not diagnostic interpretations requiring expert consensus. The "ground truth" for efficacy was established through demonstrating the ability to raise tissue temperature to a known therapeutic range.

4. Adjudication Method for the Test Set:

This section is not applicable as there was no expert review or adjudication of diagnostic findings. The tests involved direct physical measurements.

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 section is not applicable. The device is an infrared lamp for therapeutic heating, not a diagnostic imaging device involving human readers or AI assistance.

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

This section is not applicable. The device is a physical therapeutic device, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used was based on objective physical measurements (temperature readings) and established scientific understanding that a specific temperature range (41-45°C) is effective for the stated therapeutic purposes. Compliance with international electrical safety standards also served as a "ground truth" for safety.

8. The Sample Size for the Training Set:

This section is not applicable. As a physical device, there is no "training set" in the context of machine learning or AI models.

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

This section is not applicable for the same reason as above.

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