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Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Levina Incontinence Stimulation Electrodes are used to treat incontinence when paired with compatible, FDA-cleared electrical stimulators. The probes are intended to provide electrical stimulation to pelvic musculature and for the purpose of rehabilitation of pelvic floor muscles and restoration of neuromuscular control during treatment. The probes come in different models and are available for both vaginal and rectal insertion. The probes are used directly by the patients for home care and are for single-patient, repeat-use. The device comes non-sterile and should be cleaned before and after each use with water and mild soap or neutral detergent.

The provided text describes the 510(k) summary for the Levina Incontinence Stimulation Electrodes. However, it does not describe studies involving AI, human readers, or image analysis for diagnostics. The device is a physical electrode used for electrical stimulation and EMG feedback in treating urinary incontinence.

Therefore, many of the requested points regarding acceptance criteria and study details for an AI-powered diagnostic device, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone algorithm performance, and effect sizes of AI assistance, are not applicable to this submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:

1. Indications for Use: Identical.
2. Technological Characteristics: Similar, with minor differences in materials, electrode surface area, probe length, and diameter, which are deemed not to raise new questions of safety or effectiveness.
3. Non-clinical Performance Testing: Primarily focused on biocompatibility, reprocessing instructions, and electrical/mechanical integrity (e.g., visual inspection, size measurement, impedance testing, stability tests like cycling, bending, and tensile strength of lead wires).

Given this, I cannot provide a table of acceptance criteria and reported device performance in the context of an AI-driven diagnostic as requested. The "performance" for this device relates to its physical and functional integrity, not to diagnostic accuracy metrics like sensitivity, specificity, or AUC which would be relevant for an AI system. No ground truth establishmen or adjudication methods as they relate to diagnostic interpretation are present in the document.

Summary of what can be extracted from the document:

• Device Name: Levina Incontinence Stimulation Electrodes
• Intended Use: To provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
• Key Comparison Points for Substantial Equivalence:
  • Identical: Product Code, Regulation Number, Regulation Name, Regulatory Class, Indication for Use, Prescriptive or Over-The-Counter Use, Electrode Placement, Environment of Use, Target Population, Usage Conditions, Sterility.
  • Similar (with justification for equivalence): Materials (medical grade PC, Stainless Steel vs. ABS, Stainless Steel), Reprocessing-Cleaning.
  • Different (with justification for equivalence): Electrode Surface Area, Probe Length, Probe Diameter. These differences are described as being "within the normal range for other cleared devices of this device type."

Regarding "Acceptance Criteria" for this specific device:

The acceptance criteria here are implicitly met through the non-clinical testing demonstrating the device's physical and electrical safety and performance in line with recognized standards and similarity to the predicate. The "study" proving this involves the specific bench testing outlined:

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

For this type of device (electrodes), the "acceptance criteria" are not reported as specific numerical cutoffs for diagnostic performance, but rather as successful completion of required testing for safety and functional integrity.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI diagnostic with a test set of data. The testing involves actual device units. The number of samples for each bench test is not specified in this summary, but typically involves a representative sample size per standard requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic interpretation is not relevant for this device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic AI. The "ground truth" for this device is its adherence to physical specifications, material properties, and electrical integrity, verified by standard bench testing and material analyses.

8. The sample size for the training set: Not applicable. This is not an AI diagnostic device.

9. How the ground truth for the training set was established: Not applicable.

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