Search Results

SLE Electrodes and Accessories are intended to be used applied directly to a patient's skin to record physiological signals including applications in EEG, EMG, nerve conduction velocity, evoked potential, and electronystagmography.

The SLE Electrodes and Accessories device is a cutaneous electrode.

The provided text describes a 510(k) submission for SLE Electrodes and Accessories, which is a cutaneous electrode. However, it does not contain information about acceptance criteria, device performance testing, or studies proving the device meets specific criteria.

The document is a typical 510(k) clearance letter from the FDA, confirming substantial equivalence to predicate devices, and outlining regulatory requirements. It focuses on the classification, intended use, and general controls applicable to the device, rather than detailed performance study results.

Therefore, I cannot fulfill your request to describe acceptance criteria and the study proving the device meets them because this information is not present in the provided input.

Ask a specific question about this device

SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.

The SLE EMG Electrodes and Accessories device consists of a variety of needle electrodes and accessories to be used in eletromyographic applications.

This FDA 510(k) K981004 for "SLE EMG Electrodes and Accessories" indicates that the device was cleared based on substantial equivalence to predicate devices, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this document. The FDA's 510(k) clearance process for this type of device at the time focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new performance studies.

Here's a breakdown of why this information is missing based on the provided text:

• No new clinical or performance study was conducted or reported. The document repeatedly emphasizes substantial equivalence to existing devices.
• The "Technological Characteristics" section specifically states: "The design, materials, H. composition, packaging, and other chemical technological characteristics of the subject device are considered to be the same as the technological characteristics of the predicate devices." This means the manufacturer didn't claim novel technology requiring new performance metrics.
• The FDA clearance letter confirms: "We have determined the device is substantially equivalent...".

However, if we were to hypothesize what would be required for such a device if a performance study were conducted, and how the information would be presented in a typical regulatory submission (though not present here), it might look like this (purely illustrative, based on common neurophysiology electrode testing):

(Hypothetical, as this information is NOT in the provided document)

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size (Hypothetical):
  • Bench Testing: 50 units for electrical performance (impedance, SNR, drift). 10 units for durability.
  • Biocompatibility: Standard number of animal samples as per ISO 10993.
  • Clinical Use (if a new clinical study were required for substantial difference, not equivalence): 30 healthy volunteers and 20 patients (diagnosed with EMG-relevant conditions).
• Data Provenance (Hypothetical):
  • Bench Testing: In-house lab testing (United Kingdom).
  • Biocompatibility: Third-party certified lab (e.g., USA).
  • Clinical Use (if applicable): Prospective study conducted in a single neurology clinic in the UK.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts (Hypothetical): 3 Neurologists/Clinical Neurophysiologists.
• Qualifications (Hypothetical): Each expert would be a board-certified neurologist or clinical neurophysiologist with at least 10 years of experience in performing and interpreting EMG studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method (Hypothetical): For any subjective clinical assessments (e.g., signal quality grading, artifact presence, patient comfort), a consensus method would likely be used, where all 3 experts would independently assess and then meet to discuss and resolve any disagreements, reaching a final consensus. In some cases, if 2 of 3 agree, that might be taken, or a fourth adjudicator brought in (2+1, if 3 are primary readers). Given the nature of EMG, quantitative metrics are often primary, with experts providing qualitative input.

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:

• MRMC Study: Not applicable to this device. This is a basic EMG electrode. MRMC studies are relevant for diagnostic algorithms (e.g., AI for image interpretation) where human readers interact with the output. This device is a passive sensor directly collecting physiological signals, not an interpretive AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Study: Not applicable to this device. As above, this is a passive electrode, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth (Hypothetical):
  • Electrical Performance: Established metrology standards and calibrated equipment (e.g., oscilloscopes, impedance meters).
  • Biocompatibility: ISO 10993 standards and lab results.
  • Clinical Performance (if applicable): Expert interpretation by the neurologists based on standard EMG diagnostic criteria, comparison against signals obtained from a legally marketed predicate device, and patient feedback.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device is a passive electrode, not an machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable. As no training set is used.

In summary, the provided FDA 510(k) documentation for K981004 does NOT contain the details of acceptance criteria or a dedicated study because the device was cleared under the "substantial equivalence" pathway, meaning it was deemed as safe and effective as existing legally marketed predicate devices without requiring new performance evaluation studies explicitly documented in this summary.

Ask a specific question about this device