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The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women. The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.

The provided text is a 510(k) summary for the Levina Pelvic Floor Muscle Stimulator, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria based on clinical outcomes or diagnostic accuracy. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics (like sensitivity, specificity, human reader improvement with AI, etc.) is not present.

However, the document does contain information about "Non-Clinical Testing" with "pre-determined acceptance criteria" which were met. I will extract and organize the available information based on your request.

Here's a breakdown of the available information:

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

The document states: "All pre-determined acceptance criteria were met." but does not provide specific numerical targets or the results from the non-clinical tests in a detailed table format. It lists the types of tests performed.

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

This document primarily discusses non-clinical engineering and software testing. It does not refer to "test sets" in the context of clinical data (e.g., patient cases) or population-based data. Therefore, this information is not applicable or available in this document.

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

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.

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

This information is not applicable as the document does not describe a clinical study involving adjudication of a test set.

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:

This information is not applicable. The device is a "Pelvic Floor Muscle Stimulator," an electrical therapy device, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable as the device is a physical stimulator and not an algorithm-only diagnostic or AI solution. The "Software Verification and Validation Testing" refers to the embedded software in the device, not a standalone AI algorithm for interpretation.

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

For the non-clinical tests, the "ground truth" would be defined by the technical specifications and requirements outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series). For example, electrical safety "ground truth" would be the specified limits for leakage current or dielectric strength. There is no clinical "ground truth" discussed in this document.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device and its non-clinical engineering and software testing, not a machine learning model that would require a "training set."

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

This information is not applicable for the same reasons as point 8.

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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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ZMI Self-adhesive electrodes are intended for use as a reusable, conductive interface between the patient's skin and the 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.

ZMI Self-adhesive 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, reusable, flexible structures composed of laminated materials commonly used in the application:

Top laver: Insulation material: Fabric/foam/tan fabric
Middle layer: Conductive film (Silver coated Carbon film/Aluminum foil film)
Bottom layer: Biocompatible self-adhesive conductive hydrogel
Connection: Leadwire/snap button/magnetic button

The electrodes are designed for single-patient & multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.

The provided document, a 510(k) Premarket Notification for ZMI Self-Adhesive Electrodes (K180865), is a regulatory submission to the FDA. It does not describe studies proving a device meets acceptance criteria for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices for a physical medical electrode.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) as it is not present in the document. The document focuses on material composition, intended use, and physical/electrical performance tests relevant to an electrode, not on studies involving AI/ML algorithms, image analysis, or human reader performance.

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