(358 days)
The AIRNERGY+® Stream is indicated for use to emit energy to provide topical heating for the purposes of elevating tissue temperature for temporary relief of minor muscle and joint pain, temporary relief of minor arthritis pain and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where applied.
Like the predicate devices the AIRNERGY+® Stream is a lamp that has the same indication for use and equivalent technology. The device electrical and mechanical design is for use and convenience of the users. The red light is generated by LEDs (light emitting diodes) at a wave range between 600 and 650 nm.
The provided text is a 510(k) summary for the AIRNERGY+® STREAM device, which is an infrared lamp. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with specific performance metrics against pre-defined acceptance criteria as would be found for more complex devices or novel technologies.
Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for training set) is not present in the provided document.
Here's an analysis of what can be extracted and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The general "acceptance criteria" for a 510(k) submission for this type of device is demonstrating substantial equivalence to a predicate device in terms of intended use and technology, and proving safety and effectiveness.
- Reported Device Performance:
- "Tests have proven that the AIRNERGY+® is safe and effective with respect to its intended use and does not depict any risk to the user."
- "Performance data has proven that it performes safe and effectively with respect to its intended use."
- "It conforms to applicable ISO standards."
- "It has the same indication for use and same technology as the predicate devices."
Summary Table (based on available information):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe for intended use | "Tests have proven that the AIRNERGY+® is safe...and does not depict any risk to the user." "Performance data has proven that it performes safe..." |
| Effective for intended use | "Tests have proven that the AIRNERGY+® is...effective with respect to its intended use." "Performance data has proven that it performes safe and effectively with respect to its intended use." |
| Conforms to standards | "It conforms to applicable ISO standards." (Specifically mentions IEC 60601-1 and IEC 60601-1-2 as voluntary standard compliance). |
| Substantially equivalent to predicate in intended use | "It has the same indication for use...as the predicate devices." (Intended use is to emit energy for topical heating for temporary relief of minor muscle and joint pain, arthritis pain, muscle spasm, relieving stiffness, promoting muscle relaxation, and temporarily increasing local blood circulation.) |
| Substantially equivalent to predicate in technology | "Like the predicate devices the AIRNERGY+® Stream is a lamp that has the same indication for use and equivalent technology." "The red light is generated by LEDs (light emitting diodes) at a wave range between 600 and 650 nm." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document refers to "tests" and "performance data" but does not specify the nature, sample size, or provenance of these tests/data. This is typical for infrared lamps seeking 510(k) clearance, where substantial equivalence often relies on electrical, mechanical, and emission characteristic testing rather than human clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This type of information is relevant for AI/imaging devices involving expert review for ground truth. The AIRNERGY+® STREAM is an infrared lamp, and its safety and effectiveness assessment would not typically involve expert clinical adjudication in this manner for a 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. See point 3.
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, not done/Not applicable. This is a medical device, but it is an infrared lamp for topical heating, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided in detailed form. For an infrared lamp, "ground truth" would relate to its physical properties (e.g., wavelength emission, temperature output), electrical safety, and potentially biocompatibility, along with demonstrating that these properties are consistent with devices already on the market with the claimed intended uses. The document states "Tests have proven..." but does not detail the nature of these tests or their 'ground truth' methodologies beyond referencing compliance with IEC standards.
8. The sample size for the training set
- Not applicable/Not provided. This device is not an AI learning system.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This device is not an AI learning system.
In summary: The provided 510(k) summary for the AIRNERGY+® STREAM is for an infrared lamp, a physical medical device. The 'study' referred to is a demonstration of substantial equivalence to predicate devices, supported by compliance with electrical safety and performance standards (IEC 60601-1, IEC 60601-1-2) and general "tests" and "performance data" validating its safety and effectiveness for its intended use. It does not involve the type of clinical trial data, AI performance metrics, or ground truth establishment relevant for AI-powered diagnostic or assistive technologies.
§ 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.