Search Results
Found 1 results
510(k) Data Aggregation
(125 days)
The MediLaser is an infrared lamp that 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, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
The MediLaser is a portable, hand held. AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MediLaser System, structured as requested:
Acceptance Criteria and Study for the MediLaser System (K063745)
The provided document is a 510(k) Premarket Notification Summary for the MediLaser System. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed clinical study results against specific acceptance criteria for performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Produce topical heating for the purpose of elevating tissue temperature. | Device emits energy in the infrared spectrum to provide topical heating, consistent with predicate devices. |
| Therapeutic Effect | Implicit: Achieve temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, temporary increase in local circulation, and muscle relaxation. | The device performs as intended for its stated indications for use, which are congruent with predicate devices. It is designed to comply with generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the FDA. |
| Electrical Safety | Meet relevant electrical safety standards. | Electrical safety testing was conducted. (No specific standards or results are detailed in this summary). |
| Software Functionality | No software required for operation. | No software is required to operate the device. |
| Safety and Efficacy | Not raise any new safety or efficacy issues compared to predicate devices. | The MediLaser performs as intended and does not raise any new safety or efficacy issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set with a specific sample size. The testing mentioned (functional performance and electrical safety) likely refers to bench testing and engineering verification, not human subject studies. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The submission is a 510(k) for an infrared lamp, demonstrating substantial equivalence to legally marketed predicate devices. It does not involve a clinical study with a ground truth established by medical experts for a diagnostic or treatment outcome. The "ground truth" here is the established performance characteristics and safety profile of the predicate devices in the infrared lamp category.
4. Adjudication Method for the Test Set
This information is not applicable, as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic imaging devices to compare the performance of human readers with and without AI assistance. The MediLaser is a therapeutic device (infrared lamp), and the submission focuses on substantial equivalence based on physical characteristics and intended use.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not applicable as the device is a hardware-based therapeutic infrared lamp, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is based on the established safety and effectiveness of legally marketed predicate devices (e.g., Thor IR Lamp System/ Super Nova/ Acubeam systems) and compliance with generally accepted therapeutic heat performance specifications. The device's performance aligns with the expected output and effects of these predicate infrared lamps, which have a long history of safe use for the stated indications.
8. The Sample Size for the Training Set
No training set for an algorithm was used or described, as this device does not involve AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there was no training set for an algorithm.
Ask a specific question about this device
Page 1 of 1