(133 days)
The THOR VR Single Diode Laser Treatment Probe 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 temporary relaxation of muscles.
The THOR VR Single Diode Laser Treatment Probe is non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy. The probes are intended to be placed directly on the skin to provide heating.
The provided text is a 510(k) Premarket Notification Summary for the THOR VR Single Diode Laser Treatment Probe. It outlines the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and performance studies.
Specifically, the document states: "Testing of the THOR VR Single Diode Laser Treatment Probe will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device." but it does not specify the actual acceptance criteria, the results of these tests (beyond a general conclusion of similarity to predicate devices), or details about the ground truth, sample sizes, or expert involvement as you've requested.
Based on the provided text, here's what can be extracted and what remains unknown:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document generally refers to "functional performance testing and electrical safety testing in accordance with all applicable standards." | The device has "the same intended uses, with similar functional and performance characteristics" as the predicate devices. It "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." |
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 specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: No, this type of study is not mentioned as the device is a therapeutic laser rather than an imaging or diagnostic AI-assisted device. The "testing" mentioned is focused on functional and electrical safety.
- Effect Size of AI Assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable, as this is related to AI/algorithm performance. The device is a therapeutic physical device. The "performance" assessment focuses on its physical characteristics and ability to generate heat, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly stated. The document refers to "generally accepted therapeutic heat performance specifications" and "level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration," implying a reliance on established scientific literature and regulatory standards for therapeutic heating rather than a specific clinical "ground truth" derived from patient outcomes or pathology in this submission.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. This device is not an AI/machine learning device that requires a training set.
Summary of Limitations:
The provided 510(k) summary is typical for a Class II medical device seeking substantial equivalence. It focuses on comparing the new device's technical characteristics and intended use to existing predicate devices, along with ensuring safety and functional standards are met. It does not contain the detailed clinical study data often found for novel or higher-risk devices, or for devices incorporating AI/machine learning, which would typically involve the kind of "acceptance criteria" and "ground truth" analysis you are asking about for diagnostic performance.
§ 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.