(97 days)
The MLT - 1000 IR Laser 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 promoting relaxation of muscle.
The MLT - 1000 IR Laser System is an innovative, safe, easy to use, hand-held, non-invasive therapeutic device that provides continuous heat therapy. The System consists of a Control Unit that houses the electronics and controls and a treatment probe hand piece that delivers the infrared energy.
This document is a 510(k) premarket notification for the MLT - 1000 IR Laser System. It is focused on demonstrating substantial equivalence to predicate devices, not on a clinical study proving performance against acceptance criteria in the typical sense of a novel diagnostic or therapeutic device.
Therefore, many of the requested categories are not applicable or not provided in this type of submission. This 510(k) summary primarily focuses on functional performance and electrical safety testing to ensure the device is as safe and effective as existing, legally marketed devices.
Here's an analysis based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to a 510(k) substantial equivalence submission for an infrared lamp:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Summary in Document) |
|---|---|
| Functional Performance: "To generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain." | "The MLT-1000 has the same intended uses, with similar functional and performance characteristics [as predicate devices]." |
| "The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration." | |
| Electrical Safety: Compliance with applicable standards for medical devices. | "Testing... will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device." (Implies compliance was achieved and formed basis for conclusions, but specific results not detailed). |
| Intended Use Equivalence: Substantially equivalent to predicate devices for intended uses (temporary relief of minor muscle/joint pain/stiffness, minor arthritis pain, muscle spasm, increased local blood circulation, muscle relaxation). | "The MLT - 1000 IR Laser System is substantially equivalent to other infrared therapeutic lamps that are currently in commercial distribution." |
| "The MLT-1000 has the same intended uses, with similar functional and performance characteristics." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of a clinical performance study as typically understood for new therapeutic or diagnostic devices. This submission relies on "functional performance testing and electrical safety testing" which are engineering and bench tests, not patient studies with a "test set" of patient data.
- Data Provenance: Not applicable. The "testing" mentioned refers to engineering and safety testing of the device itself, not data collected from patients.
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. This submission does not describe a clinical study requiring expert-established ground truth. The "ground truth" for this device, in the context of a 510(k), is its ability to perform its stated function (topical heating) safely and similarly to predicate devices. This is established through engineering and safety evaluations, not expert clinical consensus on patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication process 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
- Not applicable. This device is an infrared lamp, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. There are no "human readers" interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device (infrared lamp) that delivers energy for topical heating. It does not involve an "algorithm" or standalone "algorithm only" performance studies. The device's performance is its physical output (heat) and its safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this 510(k) submission, the "ground truth" for the device's functional performance relates to its ability to produce infrared energy, elevate tissue temperature, and comply with safety standards. This is evaluated through engineering specifications, measurements of physical output (e.g., temperature, infrared spectrum), and compliance with electrical safety standards. The "ground truth" for its therapeutic claims (e.g., temporary pain relief) is based on the established mechanism of action of infrared heat therapy and the legally marketed predicate devices—not on novel outcomes data for this specific device in this submission.
8. The sample size for the training set
- Not applicable. This is a hardware device and not based on machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set is used.
§ 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.