(196 days)
The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
The adhesive electrode is placed onto human skin and connected with electrical stimulators by lead wires. The electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
This document, a 510(k) Premarket Notification from the FDA, deals with an adhesive electrode and aims to prove its substantial equivalence to a predicate device, not an AI/ML-based medical device. Therefore, the information typically required for describing acceptance criteria and a study proving an AI/ML device's performance (like AUC, sensitivity, specificity, human reader improvement, ground truth establishment methods, and sample sizes for training/test sets) is not present in this document.
The document focuses on the physical and material characteristics and biocompatibility of the adhesive electrode.
Here's a breakdown of what is available and why the requested information for AI/ML devices is not applicable:
Product: Adhesive Electrode (a physical, non-AI medical device)
Purpose of Document: 510(k) Premarket Notification to demonstrate substantial equivalence to a legally marketed predicate device.
Why the requested AI/ML-specific information is not in this document:
- AI/ML Performance Metrics: The performance of an adhesive electrode is not measured by metrics like AUC, sensitivity, or specificity, nor does it assist human readers in interpretation. Its performance is based on physical properties, biocompatibility, and electrical conductivity.
- Training/Test Sets: There is no AI model to be trained or tested in terms of image analysis or diagnostic accuracy.
- Experts/Adjudication for Ground Truth: No diagnostic interpretations are being made by the device that would require human expert consensus or adjudication to establish ground truth.
- MRMC Study: There's no human-in-the-loop component for the device's function that would necessitate a Most-Relevant-Multi-Case (MRMC) study.
- Standalone Performance: The device itself is a component in a larger system (electrical stimulation) and doesn't have "standalone performance" in the AI sense.
- Ground Truth Type: Ground truth for this device relates to material safety, electrical properties, and physical integrity, not diagnostic accuracy based on pathology or outcomes data.
However, I can extract the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this specific non-AI device as presented in the document.
The "acceptance criteria" here relate to demonstrating the device's safety and effectiveness compared to a predicate device through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance (Non-AI Context):
| Acceptance Criterion (Implicitly from Equivalence Claim) | Reported Device Performance (Subject Device) | Discussion/Conclusion from Document |
|---|---|---|
| Intended Use Equivalence: Same as predicate device. | "The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation)." (Matches predicate) | Substantially equivalent |
| Technological Characteristics Equivalence: Similar materials, design, and dimensions as predicate device, not raising new questions of safety/effectiveness. | Surface Area: Various rectangular and circular dimensions (listed extensively). Some overlap but also broader range than predicate's largest/smallest listed. | Substantially equivalent. "The surface area of the device does not alter its intended use." |
| Components: Substrate/Wire/Hydrogel/Scrim/Conductive Fiber/Carbon conductive film/Liner | Identical to predicate. | |
| Materials: Non-woven Fabric + Adhesive, Wire and Terminal coated PVC, Hydrogel, PET Fabric, Carbon fiber + Reinforcing fiber, Poly-isobutylene, Carbon Black, Graphite, Additives | Identical for many, Substantially equivalent for Poly-isobutylene (predicate listed "Carbon...Black"). | |
| Biocompatibility: Comply with ISO 10993 series. | "Comply with ISO 10993 series" | Identical to predicate. |
| Sterility: Non-sterile. | "Non-sterile" | Identical to predicate. |
| Re-usability: For single patient use. | "For single patient" | Identical to predicate. |
| Shelf Life: Adequate shelf life demonstrated. | "3 years" | Substantially equivalent (predicate listed "2 years"). Longer shelf life implies no new safety/effectiveness concerns. |
| Electrical Properties: (current, charge, power densities) | Current: 58.81 mArms | |
| Charge: 17.40 $\mu$C | ||
| Power Densities: 448.32 mW/mm2 | Not publicly available for predicate, so comparison is not made explicit in the table, but these values contribute to overall performance assessment. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for "functional" testing (pull test, conformability, fluid tolerance). For biocompatibility, the tests are typically performed on a limited number of samples (often 3-5) according to ISO standards, but the exact number isn't stated. Shelf-life testing involves stability studies over time, again without a stated sample size.
- Data Provenance: The document is a 510(k) submission from Shaoxing Yingtuo Healthcare Co., Ltd. in China. The tests cited (Biocompatibility, Shelf life, Product performance) would have been conducted by the manufacturer or accredited labs on their behalf. The data is implicitly prospective testing done for regulatory submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This is not an AI/ML device requiring expert interpretation of complex data (like medical images) to establish diagnostic ground truth. The "ground truth" here is compliance with safety and performance standards established by regulatory bodies (e.g., ISO, internal engineering specifications).
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication process is described or relevant for physical device testing. Test results (e.g., passing a pull force threshold, lack of irritation) are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is specific to AI/ML systems assisting human readers in diagnostic tasks. It is not relevant for an adhesive electrode.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This concept applies to AI algorithms. The "standalone performance" of an adhesive electrode would refer to its physical and electrical properties, which are indeed tested (e.g., pull test, electrical measurements), but not in the context of an AI algorithm operating independently of human intervention.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on established engineering standards, material science principles, and biological safety standards (e.g., ISO 10993 for biocompatibility). Performance is measured against specific thresholds (e.g., minimum pull force, maximum electrical impedance, absence of cytotoxic/irritation/sensitization response).
8. The Sample Size for the Training Set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. No training set exists.
In summary: The provided document is for a traditional medical device (an adhesive electrode) and therefore lacks the specific details related to AI/ML device validation that your questions are designed to elicit. The "study" mentioned refers to non-clinical laboratory testing (biocompatibility, shelf life, product performance) to demonstrate equivalence to a predicate device, as opposed to clinical AI algorithm validation.
§ 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).