(19 days)
The THØR DDII 830CL3 Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
THØR DDII 830CL3 Laser System is a handheld, non-invasive, low energy, nonheating infrared therapeutic medical laser that is intended for use as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. The THØR 830CL3 Laser System incorporates three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90 milliwatts (mW) at 830 nanometer (nm) wavelength.
The provided text describes a 510(k) premarket notification for the THØR DDII 830CL3 Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a medical device meets specific performance acceptance criteria through clinical studies directly. Therefore, much of the requested information regarding sample sizes, expert ground truth, adjudication, and clinical study details (MRMC, standalone performance, training sets) is not applicable or not found within this type of regulatory submission.
However, based on the provided text, we can extract details related to the device's technical characteristics, intended use, and the regulatory pathway.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (as per regulatory compliance) and the Reported Device Performance:
| Acceptance Criteria (Regulatory Compliance) | Reported Device Performance/Compliance |
|---|---|
| Intended Use: Adjunctive use in temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome | Substantially Equivalent: Same intended use as predicate devices. The system is designed to comply with generally accepted therapeutic laser performance specifications for this indication. |
| Technological Characteristics: Low energy, non-heating infrared therapeutic laser, 3 x 30mW GaAlAs laser diodes, 90mW total output power, 830nm wavelength. | Substantially Equivalent: Similar technological characteristics to predicate devices (e.g., MicroLight 830 Laser System, Acculaser Pro, MedX LCS System). Uses infrared diodes to emit invisible photonic energy to tissue. |
| Safety and Efficacy: No new safety or efficacy issues raised. | Substantially Equivalent: Performs as intended without raising new safety or efficacy issues, based on testing and comparison to predicate devices. |
| European Standards Compliance: | EN60601-1: 1993 (Medical Electrical Equipment) |
| EN 60601-2-22:1996 (Medical Laser Equipment) | |
| EN60601-1-2: 1994 (EMC) | |
| IIb, Certificate No. C10151 issued by SGS (CE Marking Classification) | |
| 93/42/EEC Annex II (Medical Device Directive) | |
| Functional Performance Testing | Performed (details not provided on specific metrics) |
| Electrical Safety Testing | Performed (details not provided on specific metrics) |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not found. This 510(k) submission does not describe a clinical study with a "test set" in the context of an AI/algorithm-driven device. The equivalence is based on technical characteristics and intended use compared to legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not found. No ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not found. 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 / Not found. This device is a low-level laser system for pain relief, not an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not found. This device is a physical therapeutic laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not found. The "ground truth" in this context is established through the regulatory acceptance of predicate devices and the demonstration of substantial equivalence based on technical specifications and safety/performance characteristics. There isn't a direct "ground truth" for a diagnostic outcome being evaluated.
8. The sample size for the training set:
- Not applicable / Not found. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not found. This document does not describe a machine learning algorithm or a training set.
Summary of the Study (as presented in the 510(k) notification):
The "study" described is a Premarket Notification (510(k)) which aims to demonstrate that the THØR DDII 830CL3 Laser System is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway, not a clinical effectiveness study in the typical sense applied to diagnostic or AI devices.
The evidence presented for substantial equivalence consists of:
- Comparison of Intended Use: The device shares the identical intended use (adjunctive use in temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome) with predicate devices.
- Comparison of Technical Characteristics: The device utilizes similar physical principles (non-heating infrared lamps, infrared diodes emitting photonic energy) and specifications (e.g., 830nm wavelength, output power) to predicate devices.
- Compliance with Recognized Standards: The device was tested and found to comply with relevant European standards for medical electrical equipment, medical laser equipment, EMC, and the Medical Device Directive. This includes functional performance testing and electrical safety testing.
The conclusion is that the device "has the same intended uses, with similar functional and performance characteristics" and "performs as intended and does not raise any new safety or efficacy issues," thus establishing substantial equivalence to the predicate devices.
§ 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.