Search Results

The Softcure TM 96 is intended to emit energy in the visible spectrum (red 635mm) to provide topical heating for the purpose of elevating tissue temperature for the temporary relief/reduction of minor muscular and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.

The Wellray® Medical Laser Softcure™ 96 is a therapeutic device using wavelengths of monochromatic light produced by semiconductor laser diodes to treat a variety of musculoskeletal concerns. The Softcure ™ 96 is a portable and wearable, battery powered, software controlled device intended for use on the body such as the back, legs, chest, arms or other areas where therapeutic light may be beneficial. A flexible pad, drawing power through an electrical cable from a carry able battery pack, emits red (635nm) light by means of semiconductor laser diodes to the desired body area. The flexible pad is designed to conform to the contour of the treatment site providing uniform treatment dosage over nonplanar body physique. The semiconductor laser diodes are monitored for temperature and light output by a microprocessor and cooled by variable speed fans to ensure the optimum light output. The lasers are allowed to energize only when four separate failsafe monitoring systems sense that the flexible pad is brought into close contact with the user's body. These failsafe systems include capacitive proximity sensors, body temperature sensors, an ambient light sensor and reference voltage monitoring.

The provided text describes a 510(k) premarket notification for the Softcure™ 96 device, an infrared therapeutic heating lamp. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) submission for a novel device.

As such, the document does not contain the level of detail typically associated with acceptance criteria and a study proving device performance for an AI/ML-based medical device. Specifically, it does not involve:

• A table of acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC).
• Sample sizes for a test set in the context of AI model evaluation.
• Data provenance for AI training/test sets.
• Number of experts or their qualifications for establishing ground truth for AI.
• Adjudication methods for AI ground truth.
• MRMC comparative effectiveness studies.
• Stand-alone AI performance studies.
• Ground truth types like pathology or outcomes data for AI.
• Training set sample sizes or how their ground truth was established for AI models.

Instead, the document focuses on demonstrating the physical device's performance against its specifications and existing standards, primarily for electrical safety and its ability to generate therapeutic heat.

Here's a breakdown of the information that is available in the document, framed as closely as possible to the requested structure, while acknowledging the inherent differences:

Description of Device Performance and Acceptance Criteria (as per 510(k) equivalency)

The Softcure™ 96 is an infrared therapeutic heating lamp. Its performance evaluation is geared towards demonstrating its safety and ability to provide topical heating, which aligns with the intended use of known predicate devices.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: For the non-clinical performance testing (temperature measurements), "8 subjects" were used. This is explicitly stated.
• Data Provenance: The document does not specify the country of origin for the subjects or whether the study was retrospective or prospective. It implies a prospective bench or in-house non-clinical test.

3. Number of Experts and Qualifications for Ground Truth

This type of information is not applicable to this 510(k) submission. The "ground truth" for this device relates to physical parameters (temperature) and compliance with engineering standards, not diagnostic interpretations from experts. The "acceptance" of the temperature range (40-45 degrees Celsius) is stated as "accepted by the FDA," implying a regulatory standard rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Not applicable. There were no subjective interpretations requiring adjudication as would be the case for image-based diagnostic AI.

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

Not applicable. This device is a therapeutic heating lamp, not a diagnostic imaging aid that would typically involve human readers interpreting cases with or without AI assistance. The study described is a non-clinical performance test for the device itself.

6. Standalone Performance (Algorithm Only)

Not applicable. The Softcure™ 96 is a physical device, and its "performance" is its ability to generate heat and operate safely, not the output of a standalone algorithm.

7. Type of Ground Truth Used

• For the therapeutic heat performance, the ground truth was measured temperature readings from the device applied to subjects' skin, compared against a pre-defined therapeutic temperature range (40-45 degrees Celsius) "accepted by the FDA."
• For electrical and functional safety, the "ground truth" was compliance with established international and national standards (e.g., FDA 21 CFR J 1040.10, AAMI/ANSI ES 60601-1, IEC 60601-1-2).

8. Sample Size for the Training Set

Not applicable. This document does not describe the development of an AI/ML algorithm that would require a "training set." The device's operation is based on established physical principles and engineered controls, not learned from data in an AI sense.

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

Not applicable (as explained in point 8).

Ask a specific question about this device