(51 days)
The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrums 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 Maestro MDTL Laser System is a non-invasive, portable therapeutic medical laser designed to deliver light energy to the target tissue. The System operates by AC power and can be used with a variety of laser probes.
The Maestro MDTL Laser System is comprised of a Base Unit and select Laser Probes. The Control Unit houses the electronics, circuits and controls to power the Laser Probes. The Laser Probes are connected to the Control Unit by a cable, which plugs into the rear of the Control Unit. The Laser Probes house the laser diode and circuitry to deliver the light energy to the designated treatment areas.
The provided text describes a 510(k) premarket notification for the Maestro MDTL Laser System, which is an infrared lamp. This type of submission relies on demonstrating substantial equivalence to predicate devices rather than conducting extensive clinical studies with specific acceptance criteria and detailed performance reporting as might be expected for novel or high-risk devices.
Therefore, the information you've requested regarding specific acceptance criteria, a study proving the device meets them, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance does not apply to this 510(k) submission.
Here's an breakdown of the available information based on your request, highlighting what is not present in this document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated as such, but inferred from 510(k) process) | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence to Predicate Devices in intended use, technical, and performance characteristics | "The Maestro System and the named predicate devices have the same intended uses and similar technical and performance characteristics." |
| Compliance with International Standards | "ISO 9000:2000 EN46001 Directive 89/336 regarding electromagnetic compatibility" |
| Compliance with Applicable Performance Standards (e.g., 21 CFR 1010 and 1040) | "The System is designed to comply with applicable performance standards promulgated by Federal Food and Drug Administration, such as 21 CFR 1010 and 1040." |
| No new safety or efficacy issues raised | "The Maestro MDTL Laser System performs as intended and do not raise any new safety or efficacy issues." |
| Functional Performance Testing | "Testing of the System includes functional performance testing..." |
| Electrical Safety Testing | "...and electrical safety testing." |
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. This 510(k) submission describes functional performance testing and electrical safety testing of the device itself, not a clinical study involving a "test set" of patients or data in the sense of a diagnostic or prognostic device. The testing described is against engineering and safety standards, and comparison to predicate devices, not clinical efficacy trials.
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. As above, there is no "test set" requiring expert ground truth in the context of this 510(k) notification. The "ground truth" for this device's performance is compliance with electrical and functional standards and similarity to already cleared predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set or adjudication process is mentioned.
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. The Maestro MDTL Laser System is a therapeutic laser for pain relief, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study, AI assistance, or effect size on human readers is relevant or performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is hardware, a therapeutic laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) relies on:
- Engineering and Safety Standards: Compliance with ISO 9000:2000, EN46001, Directive 89/336, 21 CFR 1010, and 1040.
- Functional Testing: The device performing as per its specifications (e.g., emitting light in the specified spectrum, maintaining power output).
- Comparison to Predicate Devices: Demonstrating the new device has "the same intended uses and similar technical and performance characteristics" to previously cleared predicate devices.
8. The sample size for the training set:
- Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, there is no "training set" ground truth to establish.
In summary, this 510(k) notification demonstrates substantial equivalence by comparing the Maestro MDTL Laser System to existing predicate devices based on intended use, performance (functional and electrical safety testing), and compliance with relevant standards. It does not involve clinical studies with patient test sets, AI algorithms, or expert ground truth adjudication in the way your questions imply for diagnostic AI systems.
§ 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.