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510(k) Data Aggregation
(146 days)
Electrotherapy Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electrotherapy Electrodes are intended to be used with marketed Electrical Stimulators, (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation)) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.
Electrotherapy Electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, flexible structures composed of laminated materials commonly used in the application:
1st layer: Insulation material: Tan fabric
2nd layer: Double sides adhesive tape
3rd layer: Conductive film (Carbon Film)
4th layer: Self-adhesive conductive hydrogel
5th layer: Plastic release film
Connection: Leadwire/Snap button
The electrodes are designed for single-patient & single application use. Because of the adhesive nature of the conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
The provided FDA 510(k) clearance letter and summary for the Electrotherapy Electrodes (K250841) does not describe a study involving AI or human reader performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Therefore, many of the requested details about acceptance criteria for AI and human performance studies, expert involvement, adjudication, MRMC studies, standalone AI performance, and ground truth establishment cannot be found in this document.
However, I can extract the acceptance criteria and performance data related to the non-clinical tests that were performed to demonstrate substantial equivalence for this device.
Acceptance Criteria and Device Performance (Non-Clinical)
The device, Electrotherapy Electrodes (K250841), is a Class II cutaneous electrode. The study described focuses on demonstrating its substantial equivalence to a predicate device (ZMI Self-Adhesive Electrodes, K180865) primarily through non-clinical performance and biocompatibility testing. No AI component or human reader study is discussed.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Metric) | Acceptance Limit | Reported Device Performance (Result) | Study Description |
|---|---|---|---|
| Electrical Performance | |||
| A.C. Impedance | ≤ 160 ohms | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Electrical performance was evaluated under IFU (Instructions for Use) normal use conditions. This likely involved measuring the A.C. Impedance of the electrodes. The acceptance limit for the predicate device was <200 ohms, and the subject device's limit is ≤ 160 ohms, indicating a stricter passing criterion for the new device which it demonstrably met to claim SE. |
| Physical/Mechanical Performance | |||
| Adhesive Performance | Passed skin adhesion test | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Evaluated by performing a skin adhesion test. |
| Electrode Stability | Passed | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Evaluated by assessing electrical performance under IFU normal use conditions. |
| Packaging Labeling | Met requirements | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Method developed to test packaging labeling. |
| Product Appearance | Met requirements | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Method developed to test product appearance. |
| Dimension | Met requirements | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Method developed to test dimension. |
| Connection between electrode and electrode wire | Met requirements | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Method developed to test the connection. |
| Cross-sectional area of electrode connection wire | Met requirements | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Method developed to test the cross-sectional area. |
| Wire length | Met requirements | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Method developed to test wire length. |
| Plug insertion and unplugging force | Met requirements | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Method developed to test plug insertion and unplugging force. |
| Safety and Biocompatibility | |||
| Electrical Safety | Complies with IEC 60601-1 | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Testing performed per IEC 60601-1 and IEC 60601-2-2 Edition 6.0 2017-03. |
| Biocompatibility (Cytotoxicity) | Complies with ISO 10993-5 | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Testing performed per ISO 10993-5 (in vitro cytotoxicity). |
| Biocompatibility (Skin Sensitization) | Complies with ISO 10993-10 | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Testing performed per ISO 10993-10 (skin sensitization). |
| Biocompatibility (Irritation) | Complies with ISO 10993-23 | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Testing performed per ISO 10993-23 (irritation). |
| Shipping and Shelf Life | |||
| Performance Testing of Shipping Containers and Systems | Complies with ASTM D4169-23 | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Testing performed per ASTM D4169-23. |
| Shelf Life | Demonstrated | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Shelf life testing was performed. |
Based on the provided document, the following information is NOT available as the submission does not involve an AI or human reader performance study:
- Sample sizes used for the test set and the data provenance: Not applicable to this type of non-clinical device testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective measurements against engineering and safety standards.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, "ground truth" refers to compliance with established industry standards (e.g., IEC, ISO, ASTM) and internal performance specifications.
- The sample size for the training set: Not applicable (no AI model).
- How the ground truth for the training set was established: Not applicable (no AI model).
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