(86 days)
The AXON IR Heat Lamp System 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, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
The AXON IR Heat Lamp System is intended for use as a therapeutic heat lamp. The System is a non-invasive device that emits light energy to the skinsurface of the human body for the purpose of causing the therapeutic elevation of tissue temperature.
The AXON IR Heat Lamp System deliver invisible laser light beams at 810 and 915 nm wavelengths using gallium arsenide (GaAs) diode sources. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers. The tissue to be treated is illuminated by a non-therapeutic green laser guide light with 3 mW of power. TThe System consists of 2 main hardware sub-systems: 1) the control console and 2) the treatment handpiece probe with its connecting cable.
The control consoles are made of standard medical PVC material and are designed to be placed in the vicinity of the patient to be treated. The console houses the user interface, which is a pressure activated membrane and an LCD display.
The treatment probes are made of standard medical grade PVC. The laser energy for heat treatment is delivered to the treatment probe via fiberoptic cables. The probes contain a protective lens at the aperture, which is made of qlass suitable for medical applications.
The provided documentation describes a 510(k) premarket notification for the AXON IR Heat Lamp System, an infrared lamp intended for therapeutic heating. The submission focuses on demonstrating substantial equivalence to predicate devices and provides non-clinical performance data related to its heating capabilities.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This document describes a relatively simple medical device (an infrared heat lamp). Therefore, the "acceptance criteria" and "study" are focused on demonstrating its ability to produce therapeutic heat safely and effectively, rather than complex diagnostic or treatment algorithms that would typically involve AI, expert ground truth, or MRMC studies. The questions in the prompt are more suited for AI/ML device evaluations. This submission primarily relies on bench testing and basic human subject testing for thermal performance.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Therapeutic Heating:
| Criteria | Reported Device Performance (AXON IR Heat Lamp System) |
|---|---|
| Ability to achieve therapeutic temperature range | Achieves 40-45 degrees Celsius. |
| Increase in topical heating of tissue level | At least 5 degrees Celsius increase reached within 1 minute. |
| Maintenance of therapeutic temperature | Maintained for the 10-minute testing time. |
| Average warm-up time to therapeutic temperature | Less than 2 minutes. |
| Compliance with international safety and performance standards | Complies with IEC 60601-1, IEC 60825-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 63204, ISO 14971. |
Study Proving Acceptance Criteria:
The study conducted was a non-clinical bench test with limited human subject data collection to evaluate the thermal performance of the AXON IR Heat Lamp System.
- Study Title/Description: "Non-Clinical Performance Data" for the AXON IR Heat Lamp System on Page 7.
- Objective: To demonstrate that the AXON IR Heat Lamp System can achieve and maintain a therapeutic temperature range accepted by the FDA (40-45 degrees Celsius) and produce at least a 5-degree Celsius increase in topical tissue temperature within one minute.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Human Subjects): 3 subjects.
- Data Provenance: The document does not explicitly state the country of origin for the human subject data. The device applicant is Crystal Medtech, LLC, located in Schofield, Wisconsin, USA, which suggests the study was likely conducted in the USA.
- Retrospective or Prospective: The study appears to be prospective as it describes conducting temperature measurements on subjects after the device was built.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable in the context of this thermal performance study.
- Qualifications of Experts: The "ground truth" (therapeutic temperature range of 40-45 degrees Celsius) is stated to be "as accepted by the FDA." This is a regulatory standard, not established by individual experts for this specific device test.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This study measures physical temperature outputs, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic imaging AI tools where human readers are interpreting images. The AXON IR Heat Lamp is a therapeutic device, and its performance evaluation focused on physical parameters (temperature).
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- Standalone Performance: Yes, the described "bench testing" and "temperature versus time measurements" are essentially a standalone performance evaluation of the device's ability to generate heat and maintain temperature, without a human actively interpreting or modifying the output in a typical AI "human-in-the-loop" sense. The device is the algorithm in this context – it delivers heat as designed.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's performance is the regulatory standard for therapeutic heating temperature range (40-45 degrees Celsius), as "accepted by the FDA." It is based on established medical understanding of what constitutes therapeutic heat for the stated indications, rather than expert consensus on individual cases, pathology, or outcomes data from a specific study for this device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is an infrared heat lamp; it does not appear to employ machine learning or AI models that require a "training set" in the conventional sense. Its "training" would be the engineering design and iteration process.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no mention or indication of a machine learning "training set" for this device. The design and performance targets would be based on established medical and engineering principles for heat therapy devices.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.