(248 days)
Electrodes intended for use as reusable (by a single patient), cutaneous, flexible, conductive garment/fabric electrodes for interface between electrical stimulators such as interferential devices, galvanic devices, TENS, etc. and a patient's skin for the delivery of electrical stimulation.
The EMSI Garment Electrodes are a cloth type device weft knitted of a continuous fiber made up of 77% Nylon and 23% Silver. Each device is flexible, and is available in a range of sizes to ensure good patient contact. A male snap connector is placed within the fabric weave and is connected via the female snap connector to a short lead wire, The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The entire fabric is made up of conductive material to provide uniform current distribution when connected to a stimulator.
The provided text describes the 510(k) summary for the "EMSI Garment Electrodes." This device is a Class II medical device, product code GXY (Cutaneous Electrodes), intended for use as reusable cutaneous, flexible, conductive garment/fabric electrodes for electrical stimulation.
Based on the provided information, the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove novel performance against specific acceptance criteria. Therefore, most of the requested fields related to a performance study will not be applicable or cannot be extracted from this document, as a typical clinical performance study with AI algorithms is not described.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that are typically associated with AI-based diagnostic or prognostic devices. Instead, the "acceptance criteria" are related to demonstrating substantial equivalence through specific tests.
| Acceptance Criteria (Implied) | Reported (or Demonstrated) Device Performance |
|---|---|
| Biocompatibility: Safe for intended use. | Biocompatibility: Confirmed (implies successful testing against relevant standards, though details are not provided). |
| Impedance: Low impedance to treatment signals. | Bench Testing: Demonstrated "very low impedance to the treatment signals compared to the patient and the other electrode impedances in the circuit." |
| Durability (Wash Cycles): Maintain performance after washing. | Bench Testing: Verified "the garments to maintain performance specifications up to 30 wash cycles." (Specific performance specifications maintained after washing are not detailed, but it implies the functional integrity for continued use). |
| Technological Characteristics: Similar to predicate device. | Comparison: Made up of similar fabrics and in similar configurations. |
| Intended Use & Indications: Identical to predicate device. | Comparison: Intended use and indications are identical to the predicate device. |
| Surface and Connector Resistance: Substantially equivalent to predicate device. | Comparison: Demonstrated the EMSI Garment Electrodes to be "substantially equivalent to the predicate device" through comparison of surface and connector resistance with the predicate device. (Specific values for resistance, for both subject and predicate, are not provided). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes bench testing and biocompatibility testing, not a clinical study on a patient test set using an AI algorithm.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
Not applicable. This device is an electrode garment, not an AI algorithm. Its performance is related to its physical and electrical properties, not an algorithmic output.
7. Type of Ground Truth Used
For the bench tests and substantial equivalence claims, the "ground truth" (or reference standard) would implicitly be:
- Biocompatibility: Adherence to established biocompatibility testing standards (e.g., ISO 10993).
- Impedance/Resistance: Measurements against electrical engineering principles and comparison to the predicate device's measured values.
- Durability: Functional testing after wash cycles, likely comparing pre-wash and post-wash electrical characteristics and structural integrity to predefined specifications or those of the predicate.
8. Sample Size for the Training Set
Not applicable. This is not an AI device with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI device with a training set.
§ 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).