(63 days)
The RS Medical Conductive Garments and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower, middle and upper back.
The RS Medical Conductive Garments consist of the RS-LB™ Low Back Conductive Garment and RS-FBG" Full Back Conductive Garment. The RS-LB" Low Back Conductive Garment is a wrap designed for the low back that uses Velcro® closures to affix the garment around the waist and lower back. The garment contains eight conductive metal snaps onto which a snap cable can be connected to the outside of the garment. These snaps extend through the garment and an adhesive backed electrode pad is affixed to the snap surface on the inner surface of the garment. The garment allows for easy electrode placement and stabilization of electrode locations on the back for repeated electrostimulation treatments to facilitate treatment compliance. The RS-FBG" Full Back Conductive Garment is a similar vest type compliance accessory that has sixteen metal snaps spaced from the lower back on either side of the spinal column to the middle and upper back. The RS Medical Conductive Garments utilize the identical UltraStim® Electrode pads used with the predicate device.
The provided document describes a 510(k) submission for RS Medical Conductive Garments (RS-LB™ Low Back Conductive Garment, RS-FBG™ Full Back Conductive Garment). This is a premarket notification for a Class II medical device, indicating that its review focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on extensive clinical trials for effectiveness.
Therefore, the study did not involve human subjects, and many of the requested fields related to clinical study design and human reader performance are not applicable. The assessment primarily relied on non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Continuity | Met applicable specifications | Met applicable specifications (specific values not provided) |
| Attachment/Removal Force of Cable Sets & Safety Snap Covers | Met applicable specifications | Met applicable specifications (specific values not provided) |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not specified for the non-clinical tests. Typically, for such tests, a small number of representative units would be tested (e.g., 3-5 units).
- Data Provenance: Not applicable. The tests were non-clinical, likely conducted in a lab setting by the manufacturer, RS Medical, or a contracted testing facility (e.g., Underwriters Laboratories, Inc. is mentioned in the FDA letter).
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
N/A - This was a non-clinical performance study; therefore, no human experts were involved in establishing ground truth for clinical outcomes. The "ground truth" here would be the physical and electrical properties of the materials and design, evaluated against engineering specifications.
4. Adjudication Method for the Test Set
N/A - No human adjudication was involved. The tests were objective measurements against predefined engineering specifications.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
N/A - No MRMC study was conducted. The device is a conductive garment, not an imaging or diagnostic device requiring human interpretation of results. The study was focused on the device's physical and electrical performance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
N/A - This device is a conductive garment, not an algorithm or AI system. Its performance is assessed based on its physical and electrical properties.
7. Type of Ground Truth Used
For the non-clinical performance tests, the ground truth was established by engineering specifications for electrical continuity and mechanical forces (attachment/removal). These are objective, measurable parameters relevant to the device's function as a conductive garment.
8. Sample Size for the Training Set
N/A - This refers to a manufactured product; there is no "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set Was Established
N/A - Not applicable as there is no training set. The design and manufacturing processes for the garments would be guided by industry standards, material specifications, and internal engineering design documents.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).