(273 days)
The Gallieon-1 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
- . relief of minor pain and stiffness associated with arthritis
- relief of muscle spasm ●
- the temporary increase in local blood circulation
- . promoting relaxation of muscle/ligament
The Gallieon -1 SYSTEM is for prescription use only.
The device is indicated for emitting energy in the infrared spectrum to provide topical heating tissue temperature for temporary relief of minor muscle spasm, pain and stiffhess associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
Gallieon-1 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy in the health care centers, physical therapy laboratories, and family practices. It is composed of adjustable output powers, handpiece (emitter) for the delivery of light, on/off button to activate and deactivate the infrared emission. Also Gallieon-1 meets FDA requirement of the skin temperature test and the electromagnetic compatibility and electrical safety test.
The provided FDA 510(k) summary for the Gallieon-1 device does not include detailed information on acceptance criteria or a specific study proving the device meets performance criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technical characteristics, and safety standards, rather than providing a performance study with detailed acceptance criteria.
However, based on the available information, we can infer some aspects and highlight what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety | Conformance to applicable standards and FDA regulations (CFR 1040 part 820) | "The Gallieon-1 was tested extensively to ensure conformance to applicable standards and FDA regulations." "The Gallieon-1 meets the applicable requirement of CFR 1040 part 820, under design/change control, and verified/validated to applicable standards/guidance documents." Also mentions meeting "FDA requirement of the skin temperature test and the electromagnetic compatibility and electrical safety test." |
| Performance | To provide topical heating for the intended uses (temporary relief of minor muscle and joint pain/stiffness, relief of minor pain and stiffness associated with arthritis, relief of muscle spasm, temporary increase in local blood circulation, promoting relaxation of muscle/ligament). | "Gallieon-1 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy..." "Gallieon-1 generates infrared therapy for treatment of selected medical conditions and shares the same or similar basic characteristics and the same intended use as the predicate device." No specific quantitative performance metrics like temperature achieved, pain reduction scores, or circulation increase percentages are provided. |
| Technical Characteristics | Generation of infrared therapy, adjustable output powers, handpiece (emitter), on/off button. | "It is composed of adjustable output powers, handpiece (emitter) for the delivery of light, on/off button to activate and deactivate the infrared emission." "Gallieon-1 generates infrared therapy for treatment of selected medical conditions..." |
| Substantial Equivalence | Similar intended use, basic characteristics, and technology to predicate devices (K031612, K050070, K083560). | "Gallieon-1 generates infrared therapy for treatment of selected medical conditions and shares the same or similar basic characteristics and the same intended use as the predicate device." "Therefore, the proposed Gallieon-1 is substantially equivalent to Altlaser, Model VTR 75, cleared under K031612; to Klaser therapy probe, cleared under K050070; to ESPT (Expanded Spectrum Photo Therapy Device)-3X, cleared under K083560." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical study or performance test involving a specific "test set" in the context of assessing device efficacy or accuracy against ground truth. The evaluation is primarily focused on demonstrating safety through adherence to standards and substantial equivalence to existing devices. Therefore, these details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no specific "test set" for performance evaluation is described, information regarding experts for ground truth establishment is not applicable and not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no dedicated test set for performance evaluation is described.
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
The Gallieon-1 is an infrared lamp for therapeutic heating, not an imaging or diagnostic device that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC comparative effectiveness study is not relevant to this device type, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Gallieon-1 is a physical therapy device that delivers infrared energy. It does not contain an algorithm in the sense of AI or image processing that would have a "standalone" performance. Its "performance" would be related to its ability to generate heat and deliver infrared radiation within specified parameters, which is assessed through engineering and safety tests rather than an algorithm-only evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a device like the Gallieon-1, "ground truth" would primarily relate to its physical properties and safety parameters, such as:
- Irradiance/Power Output: Measured by calibrated optical power meters.
- Wavelength: Measured by spectrometers.
- Temperature Safety: Measured by thermocouples/IR thermometers on skin models or in-vivo studies (though no direct study with results is provided, only a statement of meeting the "skin temperature test").
- Electrical Safety & EMC: Determined by compliance with established electrical and electromagnetic compatibility standards, using specialized testing equipment.
The document states, "The Gallieon-1 was tested extensively to ensure conformance to applicable standards and FDA regulations," and "meets the FDA requirement of the skin temperature test and the electromagnetic compatibility and electrical safety test." This implies that the "ground truth" for safety and basic technical specifications were compliance with these established standards and validated physical measurements. There is no mention of clinical outcomes data or expert consensus on efficacy for the purpose of this 510(k) summary, as substantial equivalence is the primary pathway.
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 algorithmic development. Its design and manufacturing are based on established engineering principles and safety standards for infrared lamps.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this device.
§ 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.