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NMES Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle Re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion

EMG Triggered Stimulation (ETS) (nonimplanted electrical continence device only) Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detrusor muscles through reflexive mechanisms of pelvic floor muscles Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)

TENS Symptomatic relief and management of chronic (long-term), intractable pain Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain

EMG Biofeedback, relaxation muscle training and muscle re-education

Levator Elite(Model LE9011) is a single channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The device contains EMG biofeedback, TENS (Transcutaneous Electrical Nerve Stimulation), ETS (EMG triggered stimulation) and NMES (Neuromuscular Electrical Stimulator). Each of them has pre-set and custom programs. The parameters of the device are controlled by the buttons, the levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers.

The device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrode pads applied on the skin or through a vaginal probe/rectal probe (for incontinence treatment protocols only). It can be used with or without linkage to a PC. Connecting the device with the PC via USB cable, the data can be transmitted between PC and device (It needs purchase the PC software Nu-Tek System and USB connection cable).

For EMG biofeedback, EMG is for detecting the signal of muscle, which display muscle strength via EMG biofeedback bar graph or waveform format viewed on the LCD screen of the unit. Surface EMG is used for recording from superficial muscles in clinical or kinesiological protocols, where intramuscular electrodes are used for investigating deep muscles or localized muscle activity.

For NMES is the elicitation of muscle contraction using electric impulses. The impulses are generated by a device and delivered through the electrodes in direct proximity to the muscles to be stimulated or via the probe. The impulses mimic the action potential coming from the central nervous system, causing the muscles to contract. NMES is both a form of electrotherapy and of muscle training. Neuromuscular Stimulation has been used to stimulate muscle and nerve fibers for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilization, selective muscle retraining.

For ETS (i.e. EMG triggered stimulation), ETS involves initiating a voluntary contraction for a specific movement until the muscle activity reaches a threshold level. As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins which helps to support the contracted muscle. A microprocessor connected to the surface electrodes, vaginal probe or rectal probe monitors the EMG activity levels as well as administers the neuromuscular stimulation. The target threshold could be set to automated regime, when it goes up and down depending on the running muscle performance.

For TENS, the device provides a non-invasive, low-risk nerve stimulation in order to reduce pain (both acute and chronic). In TENS, mild electrical impulses are transmitted through the skin via surface electrodes to relieve muscle pain by modifying the body's pain perception. TENS does not cure problematic physiological conditions: it only helps to control the pain perception.

LE9011 consists of the following elements:

• Main device
• Pedestal
• Lead wire
• Electrode pad
• Vaginal probe
• Rectal probe (optional)
• PC Software(optional)
• USB Cable(optional)

The provided text does not contain acceptance criteria or a study that proves the device meets acceptance criteria in the way typically expected for a medical device's clinical performance.

Instead, this document is a 510(k) Summary for a medical device (Levator Elite Model LE9011), which aims to demonstrate substantial equivalence to previously cleared predicate devices. The focus is on comparing the proposed device's technical characteristics, indications for use, and performance data (primarily non-clinical) to those of the predicate devices.

Here's a breakdown of what is and isn't present, based on your request:

What's missing that you asked for:

• Acceptance Criteria for clinical performance: The document does not specify quantitative clinical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or specific thresholds for clinical improvement).
• Study Proving Device Meets Acceptance Criteria: There is no clinical study described that directly evaluates the device's performance against predefined clinical acceptance criteria.
• Reported Device Performance (against clinical criteria): Because there are no clinical acceptance criteria or clinical studies described, there's no reported device performance in those terms.
• Sample size for test set: No test set of patients/cases is described for clinical evaluation.
• Data provenance (country, retrospective/prospective): Not applicable as no clinical study is presented.
• Number of experts for ground truth & qualifications: Not applicable.
• Adjudication method for test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted.
• Effect size of human readers with/without AI assistance: Not applicable as it's not an AI-assisted diagnostic device and no MRMC study was done.
• Standalone (algorithm-only) performance: Not applicable as it's a physical electrical stimulator, not an algorithm-based diagnostic tool.
• Type of ground truth used: Not applicable as no clinical study is presented.
• Sample size for training set: Not applicable as it's not an AI/ML device that requires a training set in that context.
• How ground truth for training set was established: Not applicable.

What is provided regarding "Performance Data" in the 510(k) Summary (Section 6):

The "Performance Data" section focuses on non-clinical testing to ensure the device is safe and performs as intended, and that any technological differences from predicates do not raise new questions of safety or effectiveness.

1. Biocompatibility testing:

   • Acceptance Criteria (implicit): Compliance with ISO 10993-1.
   • Reported Performance: "The biocompatibility evaluation for the accessories (Electrode pad, Vaginal probe and Rectal probe) was conducted in accordance with the International Standard ISO 10993-1..."
   • Tests Conducted: Cytotoxicity, Sensitization, Irritation.
   • This is not a "study that proves" clinical effectiveness, but rather a demonstration of material safety.

2. Electrical safety and electromagnetic compatibility (EMC):

   • Acceptance Criteria (implicit): Compliance with relevant IEC standards.
   • Reported Performance: "The system complies with the IEC 60601-1, IEC60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC."
   • This is technical performance testing, not clinical.

3. Software Verification and Validation Testing:

   • Acceptance Criteria (implicit): Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
   • Reported Performance: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." "The software for this device was considered as a 'Moderate' level of concern."
   • This ensures the software functions correctly and safely, not clinical effectiveness.

4. Output waveform Testing:

   • Acceptance Criteria (implicit): Verification of output specifications according to IEC 60601-2-10.
   • Reported Performance: "oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10."
   • This confirms the device delivers the specified electrical output, which is a technical performance aspect.

Conclusion from the document:

The document concludes that the device is substantially equivalent to the predicate devices and that any technological differences do not raise new questions regarding safety and effectiveness. This is the premise of a 510(k) submission – to demonstrate equivalence to an already cleared device, often without new clinical studies if non-clinical data suffice.

In summary, based only on the provided text, a comprehensive response to your structured request for acceptance criteria and clinical study details is not possible because the document focuses on non-clinical performance and substantial equivalence rather than a clinical trial demonstrating performance against specific clinical acceptance criteria.

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