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The Pain Therapy Light, model: PTL, is an Over-The-Counter hand held device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and the temporary relaxation of muscles.

Pain Therapy Light Model 1301 is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide infra-red light to the skin. Physical components include an LED array emitting 630, 660, 855 and 940nm respectively in a handheld "wand" configuration containing a simple "in/out" integrated chip with external, manual on/off switch, a single electronic resistor, and a removable 9 volt AC-to-DC power supply. Treatment times are as required by the user, and specified by the User's Manuals for product code ILY indications.

The provided document is a 510(k) premarket notification for a medical device called "Pain Therapy Light, Model 1301" (LightStim). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish efficacy or safety from scratch.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

• A table of acceptance criteria and reported device performance (as defined by specific metrics like sensitivity, specificity, accuracy).
• Sample sizes for test sets, data provenance, or details about training sets.
• The number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details of multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Specific types of ground truth used (e.g., pathology, outcomes data).

Instead, the submission relies on the concept of substantial equivalence to predicate devices that are already "in safe and effective commerce." The "study" proving the device meets acceptance criteria is implicitly the demonstration that its design, intended use, and performance characteristics are similar enough to existing, approved devices that no new clinical evidence is required.

Here's a breakdown of what the document does provide in relation to your request:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (Implicit - Substantial Equivalence): The primary acceptance criterion for a 510(k) submission is demonstrating that the new device is "substantially equivalent" to a predicate device. This means it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and the device is as safe and effective as the predicate.
• Reported Device Performance: The document states, "These products have been used safely and effectively in clinical testing applications within the United States, with no negative reports or claims submitted to FDA / CDRH, for over 7 years prior to the date of this submission." This acts as a general statement of performance and safety history rather than specific performance metrics from a controlled study. It also mentions compliance with performance standards for such devices under Section 878 of the Federal Food, Drug, and Cosmetics Act, and OSHA/NRTL listing for electrical and radiological products.

The document does NOT provide a table with specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) or the device's measured performance against such metrics.

2. Sample size used for the test set and the data provenance:

• No specific "test set" in the context of a performance study is mentioned. The submission relies on the historical safe and effective use of the device and its predicates.

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 mention of a diagnostic performance study requiring expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done for this submission. The focus is on substantial equivalence.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable, as this is a physical light therapy device, not a software algorithm.

7. The type of ground truth used:

• Not applicable in the context of a diagnostic performance study. The "ground truth" for the submission is the established safety and efficacy of the predicate devices for similar indications.

8. The sample size for the training set:

• Not applicable, as there's no mention of a machine learning algorithm or a training set.

9. How the ground truth for the training set was established:

• Not applicable.

In summary, this 510(k) submission for the "Pain Therapy Light, Model 1301" relies on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for a novel efficacy claim. The "study" mentioned is the historical use of the device and its predicates without negative reports, and compliance with applicable performance standards.

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