(154 days)
As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.
A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.
The provided text describes the Myo-trode SG disposable electrodes and its FDA 510(k) submission. It includes information about safety and effectiveness, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.
The document primarily focuses on establishing substantial equivalence to predicate devices and addressing potential hazards like skin irritation.
However, I can extract the information that is present and indicate where requested information is not available in the given text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Not an irritant | Patient contact materials tested by an independent testing laboratory and found to be "not an irritant." |
| Biocompatibility: Cytotoxicity | Certified to meet current standards for cytotoxicity (implied passing). |
| Biocompatibility: Allergic Potential | Certified to meet current standards for allergic potential (implied passing). |
| Effectiveness: Conductive Interface | Effectiveness demonstrated through impedance testing. (Specific thresholds or quantitative results for impedance are not provided) |
| Substantial Equivalence: Design and Manufacture Similarity | "No significant differences between the design and manufacture of the cited equivalent devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective/prospective). The document mentions "an independent testing laboratory" for biocompatibility testing, but no further details.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable/Not specified. The assessment primarily relied on laboratory testing (biocompatibility, impedance) rather than expert-established ground truth for a test set in the traditional sense of clinical or diagnostic studies.
4. Adjudication Method for the Test Set
- Not applicable/Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study (MRMC) is generally relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Myo-trode SG is a disposable electrode for muscle stimulation, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Not applicable. This device is a physical electrode, not software or an algorithm with standalone performance.
7. The Type of Ground Truth Used
- Laboratory test results: Biocompatibility testing (irritation, cytotoxicity, allergic potential) was performed against established standards (ISO 10993).
- Impedance testing: Used to demonstrate effectiveness as a conductive interface.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).