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510(k) Data Aggregation
(256 days)
The weberneedle@basic laser is indicated to provide topical heating for the following:
- temporary increase of local blood circulation.
- temporary relief of minor muscle and joint aches, pains, and stiffness.
- temporary relaxation of muscles.
- temporary relief of muscle spasms.
- temporary relief of minor pain and stiffness associated with arthritis.
The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are non-invasive, portable therapeutic medical laser systems designed to deliver light energy to the target tissue. The red and infrared lamps provide continuous heat therapy at a fixed frequency. The System operates by AC power and is used with 8 up to 12 faser modules, as standard 4 red and 4 infrared modules. The system consists of a Control Unit / Power Supply that houses the electronics and controls the power and varies the frequency of the each laser module. The weberneedle®basic laser and the weberneedle®basic "compact edition" laser are equipped with single fibre optics to bring the emitted energy to the tissue. That allows treatment either of small or of expanded pain areas as well as both at the same time.
The provided document (K073352) describes the 510(k) premarket notification for the "weberneedle®basic laser" and "weberneedle®basic "compact edition" laser." It does not contain an acceptance criteria table or a study that proves the device meets specific acceptance criteria in the way typically expected for a diagnostic or AI-powered medical device.
This submission is for an infrared lamp, a therapeutic device that provides topical heating. The FDA determined substantial equivalence to legally marketed predicate devices, meaning it has the same intended uses and similar technical and performance characteristics. The testing described is "functional performance testing and electrical safety testing," rather than a clinical efficacy study with acceptance criteria for device performance against a ground truth.
Here's why the requested information cannot be fully provided based on the input:
- Type of Device: The weberneedle®basic laser is a therapeutic device (infrared lamp) for topical heating, not a diagnostic device or an AI-powered system that generates a "performance" metric (like sensitivity, specificity, AUC) against a ground truth.
- 510(k) Pathway: The 510(k) pathway for medical devices focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy against a specific quantitative acceptance criterion as might be seen for novel devices or high-risk devices.
Therefore, many of the requested fields are not applicable to this type of submission.
However, I can extract the closest information available:
1. A table of acceptance criteria and the reported device performance
The document states that the device 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 Federal Food and Drug Administration." It also says "The weberneedle®basic laser and the weberneedle®basic "compact edition" laser perform as intended and do not raise any new safety or efficacy issues."
No specific quantitative acceptance criteria or performance metrics (like temperature ranges, duration of heat, etc.) are provided in this summary. The "performance" is implicitly tied to its ability to function as an infrared lamp and deliver topical heating, and its equivalence to predicate devices for the stated indications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit quantitative criteria for therapeutic effect not stated in this document. | Explicit quantitative performance for therapeutic effect not stated in this document. |
| Functionality as an infrared lamp | Performs as intended, delivers light energy for topical heating. |
| Electrical Safety | Testing includes electrical safety testing. |
| Compliance with therapeutic heat performance specifications | Designed to comply by producing a level of tissue temperature reported in literature and accepted by FDA. |
| Substantial Equivalence to Predicate Devices | Has the same intended uses and similar functional and performance characteristics as predicate devices. |
2. Sample size used for the test set and the data provenance
The document refers to "functional performance testing and electrical safety testing." It does not describe a clinical study with a "test set" of patients or data in the way an AI/diagnostic device would. Therefore, sample size and data provenance are not applicable or described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as there is no "test set" requiring ground truth establishment by experts for a diagnostic performance evaluation.
4. Adjudication method for the test set
Not applicable.
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, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical therapeutic device, not an algorithm.
7. The type of ground truth used
Not applicable. For this type of device, "ground truth" would relate to its physical properties (e.g., emitted wavelength, power, temperature achieve d) and safety standards adherence, rather than a diagnostic label. The "ground truth" for substantial equivalence is derived from the characteristics and clearances of the predicate devices.
8. The sample size for the training set
Not applicable, as this device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
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