(197 days)
The ML830®TP is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.
The ML830 TP is a non-invasive, easy to use hand-held therapeutic device consisting of a probe containing battery-powered electronics that activate a single diode which delivers infrared energy. The probe is intended to be placed on or near the surface of the skin to provide temporary relief from pain.
The provided text is a 510(k) premarket notification summary for the ML830®TP Infrared Lamp. It does not describe a study with acceptance criteria and reported device performance in the way typically expected for an AI or software device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
Here's a breakdown of why many of your requested items cannot be provided from this text, and what information is available:
This document does NOT describe a typical "study that proves the device meets acceptance criteria" in the context of an AI/software device evaluation. This is a regulatory submission for a physical medical device (an infrared lamp) and focuses on demonstrating substantial equivalence to already cleared devices. Therefore, many of your requested fields related to AI/software performance studies, ground truth, and expert evaluation are not applicable or present in this document.
Information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated as Criteria for a Study (The document focuses on substantial equivalence to predicate devices, rather than predefined performance metrics for a novel study). | Substantial Equivalence to Predicate Devices: The ML830®TP is stated to have the same intended uses and similar functional and performance characteristics as cleared predicate devices (Powerlaser by Powermedic APS (K070516, K030692) and Thor VR Single Diode Laser Treatment Probe (K070024). |
| Safety and Efficacy | "The ML830®TP is manufactured and performs as intended and does not raise any new safety or efficacy issues." |
| Compliance with Therapeutic Heat Performance Specifications | "The ML830®TP is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature as reported in literature and accepted by the U.S. Food & Drug Administration." |
| Functional Performance Testing | "Testing of the ML830®TP will include functional performance testing..." (Specific criteria or results are not detailed). |
| Electrical Safety Testing | "... and electrical safety testing in accordance with all applicable standards for this type of medical device." (Specific criteria or results are not detailed). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a regulatory submission for a physical device, not an AI or software device that would typically involve a "test set" of data. The testing mentioned (functional, electrical safety) refers to the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth establishment by experts is described in the context of a "test set" for performance evaluation, as this is not an AI/software device.
4. Adjudication method for the test set
- Not Applicable. No "test set" or adjudication method 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 is a physical device, not an AI system that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used
- Not Applicable. No ground truth in the context of performance evaluation (like pathology, outcomes data, or expert consensus) is discussed for this physical device. The "ground truth" for regulatory clearance is substantial equivalence to legally marketed predicate devices based on intended use, technology, and performance specifications.
8. The sample size for the training set
- Not Applicable. This is a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment for a training set is relevant to 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.