(23 days)
The Motive™ Electrode is intended for use as a disposable, conductive, and adhesive interface between the user's skin and an electrical muscle stimulator. Motive Electrode is intended for adults of 22 years of age and older.
The Motive Electrode provides an electrically conductive interface between a neuromuscular electrical stimulator (muscle stimulator) and a user's skin. The Motive Electrode is provided nonsterile, is designed and intended for single patient use only, multiple application use, and is disposable. The electrode sheet is to be worn on the thigh covering the quadriceps muscles to apply electrical stimulation therapy when connected to a muscle stimulator. The electrodes are conductive pads that contact the skin. The electrical stimulation impulses are delivered through the electrodes on the skin in direct proximity to the muscles to be stimulated. The Motive Electrode consists of multiple layers. The skin-contacting layer of the electrode sheet is comprised of three separate medical grade, self-adhering, biocompatible, and conductive hydrogel (gel) pads. These gel pads are placed on a single polyester or polyethylene terephthalate (PET) sheet. These gel pads include two rectangular 2 inch x 4 inch (5.1 x 10.2 cm) and one circular. 2.165 inch diameter (5.5 cm) pads. The outermost layer of the electrode contains a magnetic connector housing for electrical connection to the muscle stimulator. Silver ink printed conductive electrical traces on the PET film are utilized to provide electrical conductivity from the muscle stimulator to the gel pads. When not in use, the electrode sheet is covered by a paper-backed release liner.
The provided text describes a 510(k) summary for the Motive™ Electrode and outlines non-clinical/bench studies conducted to demonstrate its substantial equivalence to a predicate device, the ASCEND Electrode. However, it does not include information about acceptance criteria and a study proving a device meets those acceptance criteria in the context of an AI/algorithm-driven device with human-in-the-loop performance, expert ground truth, or an MRMC study.
The information given pertains to a physical medical device (an electrode), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the requested categories (like effect size of human improvement with AI, number of experts for ground truth, training set details) are not applicable to the content provided.
Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance Study (Motive™ Electrode)
Based on the provided 510(k) summary, the "acceptance criteria" are implied by a series of non-clinical/bench studies designed to demonstrate the device's safety, effectiveness, and functional equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly present "acceptance criteria" in a tabular format with corresponding "reported device performance" against specific quantitative metrics relevant to AI/ML device validation. Instead, it describes compliance with standards and successful completion of various tests for the physical electrode.
| Acceptance Criteria (Implied from Study Goals) | Reported Device Performance (Summary of Findings) |
|---|---|
| Biocompatibility: Meet ISO 10993-5 (In vitro cytotoxicity) and ISO 10993-10 (Irritation and skin sensitization) standards for patient-contacting materials. | Biocompatibility: The test results were acceptable, and the materials (conductive hydrogel, PET backing) were considered biocompatible per ISO 10993-5:2009 and ISO 10993-10:2021. |
| Shelf-Life: Maintain intended performance over labeled shelf-life via accelerated aging. | Shelf-Life: Accelerated aging shelf-life testing was performed, ensuring the Motive Electrode performs as intended over the course of its labeled 6-month shelf-life. |
| Electrical Performance: Acceptable impedance measurements, effective and safe delivery of electrical stimulation, comparable Max Current Density and Max Average Power Density to predicate. | Electrical Performance: Electrical tests demonstrated that the electrodes' impedance measurements were acceptable, and they performed effectively and safely in delivering transmitting electrical stimulation. Max Current Density and Max Average Power Density were acceptable and similar to the predicate device, ASCEND Electrode. |
| Mechanical Integrity: Maintain mechanical integrity of layers and components. | Mechanical Integrity: Mechanical testing demonstrated that the electrodes maintained mechanical integrity for different layers and components. |
| Visual Evaluation: Intact electrodes and proper interface with muscle stimulator. | Visual Evaluation: Visual evaluation demonstrated that the Motive Electrodes were intact and interfaced with the muscle stimulator. |
| User Needs/Specifications: Meet user needs as reflected in functional specifications. | User Needs/Specifications: Verification and performance testing further demonstrated that the Motive Electrodes meet user's needs as reflected in the product specification. |
| Substantial Equivalence: Demonstrate safety and effectiveness comparable to the predicate device. | Substantial Equivalence: Based on the nonclinical tests, the Motive Electrode is concluded to be as safe, as effective, and performs as well as the predicate device (ASCEND Electrode, K140586). Similarities noted in intended use, disposable nature, single-patient multiple application use, adhesive conductive hydrogel interface, multi-layer design, and fundamental composition (flex silver pads/traces on plastic film). Differences (number of electrodes, specific dimensions, connector type) were deemed not to raise issues in equivalency. |
2. Sample size used for the test set and the data provenance
This is not applicable to the provided document, as it concerns a physical medical device (electrode) and not an AI/ML algorithm requiring a dataset for testing. The studies mentioned are primarily bench/non-clinical tests involving materials and device prototypes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes tests for a physical electrode, not an AI/ML diagnostic or assistive device that requires expert-established ground truth for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication by multiple experts is typically relevant for establishing ground truth in clinical datasets for AI/ML performance evaluation. This document describes bench testing of a physical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a cutaneous electrode, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The studies focused on the performance of the physical electrode itself to deliver electrical stimulation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical / bench studies, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 10993 for biocompatibility) and pre-defined engineering specifications for electrical and mechanical performance. Comparability to the established performance of the predicate device also serves as a benchmark for equivalence.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm or training set discussed in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm or training set discussed in this document.
§ 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).