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The Silverwear SilverPro Series Conductive Garments are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The knitted garment electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include hand (glove), wrist (sleeve), elbow or arm (sleeve), knee high stockings, ankle (sleeve), back band, and shoulder band.

The Silverwear SilverPro garment electrodes are conductive garments that are made from material which is knitted from primarily nylon yarn with minor amounts of lycra, spandex to achieve a stretch fabric for a snug garment fit polyester for tactile qualities and polyester sheathed carbon yarn and pure silver coated nylon fibers to provide conductivity. The knitting follows standard knitting procedures with the conductive knitted material being fabricated into wearable electrode garments which are provided in multiple sizes of various garment configurations including; gloves, bands, socks, and sleeves. The stretch characteristics of the material provide sufficient elasticity to ensure firm surface contact with the skin. The design of the devices is such that they can be used skin by reversing the surface contacting the skin. The entire surface of the garment electrode is very conductive having a resistance of less than 5 ohms per inch. This provides low current density with uniform current distribution to enable efficient use of these garment electrodes for use in TENS (transcutaneous electrical nerve stimulators) and NMES (powered muscle stimulator devices). The Silverwear SilverPro garment electrodes are non- sterile external devices which are designed for single patient, for multiple uses and are intended for OTC use with FDA Cleared TENS and NMES class II devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silverwear Silver Pro Garment Device, structured according to your request.

Please note that the provided document is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, not typically a detailed report of a new clinical study. Therefore, some of your requested information, particularly regarding specific clinical study methodologies, may not be explicitly stated or might not be applicable in the same way it would be for a novel device requiring extensive clinical trials.

Acceptance Criteria and Device Performance

The document describes the device's characteristics and compares them to predicate devices to establish substantial equivalence. The "acceptance criteria" here are implicitly linked to demonstrating equivalence to the predicate devices across key technological characteristics and safety.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes bench testing, not a clinical test set with human subjects.

• Sample Size for Test Set: Not explicitly stated as a number of devices. The testing was conducted on "the fabric used to fabricate the various forms" of the devices.
• Data Provenance: The testing was "bench testing" and "resistivity testing was conducted using standard industry testing." These are laboratory tests on the device materials and finished product. There is no indication of country of origin for data (as it's not a patient study), but the applicant and distributor are listed with US addresses (Englewood Cliffs, NJ). The testing appears to be conducted specifically for this device submission.

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

This question is not applicable in the context of the provided document. The "ground truth" for this type of submission is the measured technical performance (e.g., resistance, biocompatibility) of the device against established industry standards and comparison to predicate devices' known characteristics. It does not involve expert consensus on clinical findings or diagnoses.

4. Adjudication Method for the Test Set

This question is not applicable. "Adjudication methods" like 2+1 or 3+1 are used in clinical studies when multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved to establish a definitive ground truth. As noted above, this document describes bench testing, not human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The Silverwear Silver Pro Garment Device is a conductive electrode, not an AI-powered diagnostic tool, and its submission relies on demonstrably equivalent physical and electrical properties to predicate devices through bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the sense of an algorithm operating without human interaction was not done. The device itself is a passive conductive garment; it does not contain an algorithm. Its function is to deliver stimulation signals from another (TENS or NMES) device. Performance is assessed through physical and electrical bench tests.

7. The Type of Ground Truth Used

The "ground truth" for the acceptance criteria in this submission is established through:

• Direct Measurement: Bench testing provides quantitative measurements for characteristics like resistance.
• Industry Standards: Compliance with recognized international standards for biocompatibility (ISO 10993-5, ISO 10993-10).
• Predicate Device Characteristics: The known and accepted characteristics of the legally marketed predicate devices serve as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

This question is not applicable. The device is not an AI/machine learning algorithm, so there is no "training set" in the computational sense. The manufacturing process of the garment itself is based on conventional knitting procedures and material selection.

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

This question is not applicable for the same reason as point 8; there is no training set for this device.

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