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The Neurolase™ devices are an infrared lamp per 21 CFR 890.5500 that emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature to provide temporary relief of minor muscles and joint pain and stiffness, minor pain and stiffness associated with arthritis, or muscle spasm. These devices may temporarily increase blood circulation, and may be used to promote relaxation of muscle tissue.

The Neurolase™ devices consist of a control unit and a handpiece The control unit houses the power supply, control electronics, calibration port, and infrared radiation source. The source is coupled to a fiber optic cable that delivers the energy to the patient through the handpiece.

The provided text does not describe acceptance criteria, nor does it detail a study performed to prove a device meets acceptance criteria for the Neurolase™ Series device.

Instead, this document is a 510(k) pre-market notification summary for the Neurolase™ Series device, outlining its substantial equivalence to previously marketed infrared lamps.

Here's a breakdown of what the document does state regarding testing and performance, and why it doesn't fit the requested criteria:

Performance Data Section (Section 6, Page 1 of 2):

• "The differences in the specifications of the Neurolase™ devices and the predicate devices result in enhanced performance for the Neurolase™ devices and do not raise new questions of safety or efficacy."
  • Comment: This statement claims enhanced performance but provides no specific metrics, acceptance criteria, or study results to back this up. It's a general assertion rather than a demonstration of meeting predefined criteria.

Testing Section (Section 7, Page 2 of 2):

• "Prototype units have undergone preliminary testing to ensure compliance with UL2601 and FCC Part 15 requirements."
  • Comment: This refers to preliminary testing for electrical safety and electromagnetic compatibility standards, not performance or clinical efficacy against specific acceptance criteria for its intended use (pain relief, increased blood circulation).
• "Once marketing clearance is granted, safety and emissions testing will take place at a registered body."
  • Comment: This indicates future testing for safety and emissions, again not performance against acceptance criteria for its therapeutic claims.
• "Production units will each be run through an Acceptance Test Procedure to ensure compliance with the System Specification."
  • Comment: This mentions an "Acceptance Test Procedure" and "System Specification" for production units, implying internal quality control checks. However, the document does not provide the specific acceptance criteria defined in this System Specification, nor does it present the results of such a procedure or a study proving compliance.
• "All components have been chosen to ensure compliance with the aforementioned standards."
  • Comment: This is a statement about component selection, not a study or performance data.

Conclusion:

The submission focuses entirely on establishing substantial equivalence to predicate devices based on intended use and general device characteristics. It explicitly states that "The differences in the specifications...do not raise new questions of safety or efficacy," implying that extensive new performance studies beyond basic safety/emissions compliance were not deemed necessary for this 510(k) clearance.

Therefore, since the document does not contain the requested information, the table and other points cannot be filled out as requested.

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The Dynatron Solaris Series of products, including Solaris 709, 708, 706, and 705, provide electrical stimulation, ultrasound and/or combination electrical stimulation and ultrasound, as well as infrared therapy.

1. Electrical Muscle stimulation therapy for: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion
2. Transcutaneous electrical nerve stimulation and Interferential Current Therapy for: Symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.
3. Ultrasound therapy for: Applying therapeutic deep heat within body tissues for the treatment of selected medical conditions such as: Relief of pain Muscle spasms Joint contractures
4. Infrared therapy to provide topical heating for: Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Muscle spasms Minor pain and stiffness associated with arthritis

The Dynatron® Solaris™ Series (Model numbers 709, 708, 706, and 705) provide electrical stimulation, ultrasound, and/or electrical stimulation and ultrasound, as well as optional infrared therapy. Components: System console, containing software and control electronics with alpha-numeric displays Ultrasound transducer, infrared probe, and multi-probe for administering electrotherapy Accessories such as patient cables, electrodes, transducer gel and elastic straps.

The Dynatron® Solaris™ Series (models 709, 708, 706, and 705) are therapeutic devices offering electrical stimulation, ultrasound, and/or infrared therapy. The document K031329 confirms their safety and effectiveness through substantial equivalence to predicate devices, following the FDA's 510(k) premarket notification process.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" in the typical sense (e.g., a specific sensitivity or specificity threshold for a diagnostic device). Instead, the acceptance criteria are implicitly met through demonstrating Substantial Equivalence (SE) to legally marketed predicate devices. The "reported device performance" is the confirmation of this substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of a prospective clinical study with a defined sample size. The substantial equivalence determination is based on a comparison to existing predicate devices.

• Sample Size for Test Set: Not applicable or not explicitly stated as a separate test set with specific patient data. The "sample" is effectively the design, specifications, and performance characteristics of the new devices being compared to existing, cleared devices.
• Data Provenance: Not applicable in the sense of patient data. The "data" pertains to the technical specifications, intended uses, and safety/performance characteristics of the devices themselves, derived from their design documentation, manufacturing processes, and compliance with performance standards. This is not retrospective or prospective patient data from a clinical trial.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document does not describe a study involving human experts establishing "ground truth" on a test set of patient cases. The "ground truth" for predicate devices is established by their prior clearance through the FDA and their safe and effective use in the market.

4. Adjudication Method for the Test Set

This information is not applicable as there is no specific "test set" and no "ground truth" arbitration process described for a diagnostic or AI performance study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done and is not described in the document. This type of study is typically performed to evaluate the impact of an AI diagnostic tool on human reader performance, which is not the subject of this 510(k) submission.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

A standalone performance study was not done and is not described. The devices in question are physical therapeutic devices (electrical stimulators, ultrasound, infrared) and not AI algorithms or diagnostic software that would undergo standalone performance testing.

7. Type of Ground Truth Used

The "ground truth" in this context is established by the prior FDA clearance of the predicate devices. The new devices (Dynatron Solaris Series) are deemed safe and effective because they are substantially equivalent to devices already recognized as safe and effective by regulatory bodies. It's not based on pathology, outcomes data, or expert consensus on new patient data for the new devices, but rather on the established performance and regulatory status of the predicate devices.

8. Sample Size for the Training Set

This information is not applicable. The devices are not AI or machine learning models that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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