(74 days)
The MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
The MedX LCS 100 Portable Laser (785 nm) is an infrared lamp, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
The MedX 1100 Console powers three different accessories the MedX LCT 100 (785 nm) and Duolight 100 (785 nm) & 500 Accessories. All therapeutic heating accessories are indication for use within the heating category, ILY, as applied for in this submission. The low level laser accessories use 785 nm GaAlAs (galliumaluminum-arsenide) infrared lasers diodes indicated for use where heat is indicated for topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, and minor pain and stiffness associated with arthritis.
The provided document is a 510(k) summary for the MedX 1100 Console and its accessories, categorizing them as an infrared lamp system. It largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials.
Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not available in this document. The submission explicitly states: "No research was conducted for this specific 510(k) submittal."
Based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from device classification and predicate) | Reported Device Performance (as stated in the document) |
|---|---|
| Safety: Meets international and US medical electrical equipment standards for safety. | Meets the requirements of international and US medical electrical equipment standards for safety. |
| Functional Requirements: Meets design and performance functional requirements. | Meets design and performance functional requirements. |
| Effectiveness (Indications for Use): Provides topical heating for temporary increase in local blood circulation; temporary relief of minor muscle and joint aches, pains, and stiffness; relaxation of muscles; muscle spasms; minor pain and stiffness associated with arthritis. | The devices are indicated for these uses. (Note: This is an assertion of indication, not a proven performance metric within this document, as no research was conducted). |
| Technological Characteristics: Substantial equivalence to predicate device K020017. | Technological characteristics are based on the predicate device – K020017. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document explicitly states "No research was conducted for this specific 510(k) submittal." This means there was no new test set with associated data provenance or sample size for this device's performance. The submission relies on demonstrating substantial equivalence to a previously cleared predicate device.
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. Since no new study or test set was conducted, there were no experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set, no adjudication method.
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 document is for an infrared lamp system, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is an infrared lamp system, not an algorithm. Standalone performance as typically described for AI/software devices is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided directly for this submission. The "ground truth" for this 510(k) relies on the prior regulatory clearance and established safety and effectiveness of the predicate device (K020017). The current device is deemed safe and effective because it shares "technological characteristics" and "indications for use" with the predicate, which presumably had its own ground truth established during its clearance process.
8. The sample size for the training set
- Not applicable / Not provided. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As no training set exists 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.