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The Synchrony (20-3000) is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES).

• Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES).

• Maintenance and/or increase of hand range of motion.
• Prevention and/or retardation of disuse atrophy.
• Increase in local blood circulation.
• Reduction of muscle spasm.
• Re-education of muscles.

The Synchrony (20-3000) system is a functional electrical stimulation (FES) device and a powered muscle stimulator. It is specifically designed to enhance hand functionality in patients with arm paresis through a range of customizable therapies. The system integrates five major components: the Stimulator, Sensor, Patient Interface (electrodes), Motor Point Probe, and Clinician App. The therapies are directed and programmed by a clinician through an iOS based application and then the patient may apply the therapy at their home with the Stimulator and Sensor.

The Synchrony system supports three primary therapeutic modes: Contralaterally Controlled Electrical Stimulation (CCFES), cyclical Neuromuscular Electrical Stimulation (CNMES), and Functional Task Practice (FTP). The CCFES mode uses sensor data from the patient's unimpaired side to control the timing, intensity, and movement of the paretic hand/arm, synchronizing stimulation with natural motor patterns. The cyclical NMES mode delivers repetitive stimulation to targeted muscles, aiding in muscle re-training, as described in the systematic review of research studies using cyclic NMES. The FTP mode allows for direct control of hand movements during task-oriented exercises, using real-time sensor feedback and stimulator output.

Stimulation is delivered through up to four electrodes placed on identified motor points, using symmetric balanced biphasic pulses. The system offers preset stimulation amplitudes of 20mA, 40mA, and 60mA, with a pulse width adjustable between 1-250 µsec, providing high precision with 1 µsec resolution. The device's enclosure is constructed from biocompatible ABS Cycoloy, ensuring durability and patient safety, and is rated IP22 for ingress protection.

The stimulator can operate independently or in conjunction with the Synchrony Sensor, depending on the therapy mode selected. The Sensor, which communicates wirelessly with the Stimulator via Bluetooth Low Energy (BLE), uses a Class I laser that is compliant with 21 CFR 1040.10 and 21 CFR 1040.11 to measure hand opening and closure distances, enabling accurate therapeutic adjustments. Both the Stimulator and Sensor are wirelessly charged using an FCC Part 15 compliant charging pad, enhancing ease of use and handling.

The Synchrony system is engineered for ease of use with user-friendly control interfaces for both patients and clinicians. It incorporates a range of safety mechanisms to ensure effective and safe operation, making it a versatile and reliable tool for improving hand functionality through personalized therapeutic interventions.

The provided FDA 510(k) clearance letter for the Synchrony (20-3000) device does not contain information about acceptance criteria or a specific study proving the device meets those criteria.

The letter primarily focuses on establishing substantial equivalence to predicate devices, referencing adherence to recognized standards, and outlining performance differences between the new device and the predicates without providing specific acceptance criteria or study details.

However, based on the information provided, we can infer some details and highlight the missing information:

Key Takeaways from the document relevant to performance and safety:

• Substantial Equivalence: The primary method for demonstrating safety and effectiveness is through substantial equivalence to predicate devices (K123636 and K960457).
• Standards Compliance: The device claims compliance with numerous IEC, ISO, ASTM, and ANSI standards related to safety, essential performance, usability, electromagnetic compatibility, software lifecycle, risk management, biological evaluation, laser safety, battery testing, shipping, cleaning processes, wireless coexistence, and cybersecurity. These standards inherently contain their own acceptance criteria that the device must meet.
• Performance Differences: The comparison tables highlight differences in technical characteristics and output specifications. The rationale for these differences consistently asserts "No impact on safety and effectiveness."
• Clinical Data: The document explicitly states: "No clinical data were reviewed in this submission in support of the subject device." This is a crucial piece of information indicating that clinical trials were not part of this 510(k) submission for performance validation against specific clinical outcomes or acceptance criteria.

Inferred and Missing Information:

Since dedicated acceptance criteria and a study proving the device meets them are not explicitly detailed in the provided text, the table below will reflect what is implied by the substantial equivalence and standards compliance, and explicitly state where information is missing.

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

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The Cionic Neural Sleeve NS-200 is intended to provide ankle dorsiflexion and/or plantarflexion and/or eversion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-200 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion and/or eversion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The Cionic Neural Sleeve NS-200 may also:

• Facilitate muscle re-education
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow

As a powered muscle stimulator the Cionic Neural Sleeve NS-200 is indicated for the following conditions:

• Relaxation of muscle spasm

As a biofeedback device the Cionic Neural Sleeve NS-200 is indicated for the following conditions:

• Biofeedback, relaxation and muscle re-education purposes

Same as the primary predicate device, the Cionic Neural Sleeve NS-100 (K221823), the Cionic Neural Sleeve NS-200 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-200 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance.

The Cionic Neural Sleeve NS-200 system sales carton consists of the following components:

1. SL-200 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in four sizes: extra-small, small, medium, and large.

2. DC-200 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-200. The DC-200 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app").

3. Power supply and cable to recharge the DC-200 and connect the DC-200 to a user's computer when required.

4. Adhesive, electrically conductive and replaceable electrode pads.

5. Electrode cover sheets.

6. Instructions for Use documents.

Components are available as accessories to the Cionic Neural Sleeve NS-200 system:

• Replacement electrode pads.

The Cionic Neural Sleeve NS-200 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-200 iOS and Android users.

The Cionic Neural Sleeve NS-200 system consists of a software and hardware architecture that enables users to access a library exercise and programs. Programs can be added and removed from the user's mobile app by the user. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.

The following minor hardware/mechanical changes have been made to the NS-100 (K221823) and incorporate in the NS-200:

1. Simplified Sleeve Electronics
   By relocating the electromyography (EMG) circuitry to the Control Unit (DC-200), the redesigned Sleeve (SL-200) is now lighter, more streamlined, and requires less power—delivering a more comfortable and efficient experience for users.

2. Enhanced Control Unit Grip
   The Control Unit (DC-200) now features integrated side grips, making it easier to connect and disconnect from the sleeve cable—while maintaining the same compact form factor users love.

3. More Secure Fit, All Day Comfort
   Enhanced Velcro sections on the Sleeve (SL-200) offer improved adherence and a more secure fit, supporting confident wear and optimal electrode positioning throughout the day.

The provided text is a 510(k) clearance letter and summary for the Cionic Neural Sleeve NS-200. It describes the device's technical characteristics and its substantial equivalence to predicate devices. However, the document does NOT contain information about acceptance criteria or specific study results that prove the device meets performance criteria, especially concerning the new functionality of advanced biofeedback within the NS-200.

The document states:

• "The tests listed have been conducted to demonstrate that the Cionic Neural Sleeve NS-200 performs as intended and is substantially equivalent to both predicate devices."
• "The Cionic Neural Sleeve NS-200 has been verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware."

This indicates that testing was done, but the details of the acceptance criteria, specific performance metrics, and the results of those tests are not included in this publicly available clearance letter. For example, while it mentions "Stimulation Output Waveforms" and "Stimulation Output Specifications" as tests conducted, it doesn't provide the target waveform characteristics (acceptance criteria) or the measured waveform characteristics (reported performance).

Similarly, for the "New Functionality in NS-200" related to biofeedback (Visual Biofeedback Mode and Muscle Activated Stimulation Mode), the document describes how it works but doesn't provide any quantitative acceptance criteria for its performance (e.g., accuracy of sEMG detection, latency of stimulation trigger).

Therefore, based solely on the provided text, I cannot fulfill most of your request for specific acceptance criteria and study results. The information is simply not present in this type of FDA document, which focuses on substantial equivalence for market clearance rather than detailed performance study reporting.

However, I can extract and infer some high-level information and point out what is missing:

Inferred/Missing Information based on the Provided Text:

Based on the nature of a 510(k) clearance and the information provided, the "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting relevant safety and performance standards. The "study" mentioned is primarily focused on non-clinical bench testing and software validation.

Table of Acceptance Criteria and Reported Device Performance (Inferred/Missing)

Specific Information Requested and What is Available/Missing:

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

   • Acceptance Criteria: Mostly implicit compliance with safety standards (IEC 60601 series, 21 CFR 898) and technical specifications (e.g., voltage/current ranges, EMG parameters) for substantial equivalence to predicates. Explicit, quantitative acceptance thresholds for performance tests are not provided.
   • Reported Device Performance: Specific quantitative results from testing (e.g., "The measured output voltage was XV, meeting the Y-V criterion") are not provided. The document states that tests "have been conducted" and the device "has been verified and validated successfully," implying compliance, but no actual performance data is listed. The tables compare specifications between devices, not measured performance results.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not provided. The testing described is primarily non-clinical bench testing and software validation, not typically expressed in terms of "sample size" of subjects/patients.
   • Data Provenance: The "Summary of Literature Clinical Data" references an article (https://www.medrxiv.org/content/10.1101/2022.04.27.22273623v2.full), which would be the source of any clinical data used to support the new indication for foot eversion. The document itself does not provide details on the study design or provenance of the data within that article.
   • Retrospective/Prospective: Not specified for the non-clinical tests. For the referenced clinical article, it would depend on the study design of that external publication.

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

   • Not applicable / Not provided. The document describes non-clinical and software validation tests. There is no mention of "ground truth" adjudicated by experts for a test set in the context of AI/ML performance evaluation, as this is a medical device (neuromuscular stimulator) rather than an AI diagnostic algorithm.

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

   • Not applicable / Not provided. As above, this type of adjudication is typically for establishing ground truth in image interpretation or similar expert-driven data labeling, which is not described for this device's clearances.

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 / Not done (as described). An MRMC study is relevant for AI-assisted diagnostic tools. The Cionic Neural Sleeve is a functional neuromuscular stimulator; its clearance focuses on its mechanism of action, safety, and functionality, not its ability to assist human "readers" in interpreting data.

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

   • Not explicitly stated as such. The device does have a software component with "advanced biofeedback capabilities." The software validation (IEC 62304) would assess the standalone performance of the algorithms. However, "standalone performance" in the context of AI often refers to metrics like AUC, sensitivity, specificity, etc., which are not provided here for any specific task. The document only confirms that the software was "verified and validated successfully."

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

   • For the non-clinical bench testing: The "ground truth" would be established by reference standards, calibrated equipment, and engineering specifications. For instance, a voltage meter would provide "ground truth" for output voltage.
   • For the software validation: "Ground truth" would be defined by the software's design specifications and expected behavior.
   • For the clinical support: The document references a published article ("Augmenting Gait in a Population Exhibiting Foot Drop with Adaptive Functional Electrical Stimulation"). The ground truth within that study would depend on its specific methodology (e.g., kinematic analysis, clinical outcome measures). The 510(k) does not perform primary ground truth establishment for clinical outcomes itself but rather leverages existing literature.

8. The sample size for the training set:

   • Not provided (and likely not applicable in the traditional AI/ML sense). The software features described (Visual Biofeedback Mode, Muscle Activated Stimulation Mode) are based on sEMG functionality. While such systems might involve some level of calibration or adaptive algorithms, the document doesn't mention a "training set" in the context of a machine learning model that learns from large datasets. Any internal calibration routines would be part of the software's inherent design, not a separate "training set" for a generalizable AI model.

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

   • Not applicable / Not provided for the reasons stated above.

In summary, this FDA 510(k) clearance document primarily serves to demonstrate substantial equivalence to existing devices based on technical specifications and compliance with recognized safety and performance standards via non-clinical bench testing and software validation. It is not a detailed clinical study report or an AI/ML algorithm validation report that would contain the specific performance metrics and ground truth establishment details you requested.

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For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.

As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:

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

As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:

• Helps to relearn voluntary motor functions of the extremities.

TrainFES' Advanced intended population is anybody aged 22 or over.

Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.

Platform: TrainFES is a battery-powered, wireless device, accessible through software.

TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.

TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.

The provided document describes the FDA 510(k) premarket notification for the "TrainFES Advanced" device, a neuromuscular electrical stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (Stella BIO, K210002).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the device's performance in a quantitative manner (e.g., target accuracy, sensitivity, specificity). Instead, the substantial equivalence justification relies on demonstrating that the TrainFES Advanced device performs similarly to or meets the safety and effectiveness standards of the predicate device, K210002.

The table below summarizes the comparison of key technical characteristics between the TrainFES Advanced and its predicate, Stella BIO, highlighting where "performance" is discussed in terms of meeting relevant standards or being considered equivalent. The reported "performance" for TrainFES Advanced is intrinsically linked to its compliance with these standards and the assertion that differences do not raise new safety or effectiveness concerns.

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The NeuStim NN-01 is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES):

Improvement of hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C5 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES):

• · Maintaining or increasing hand range of motion;
• · Prevention or retardation of disuse atrophy;
• · Increasing local blood circulation;
• · Relaxation of muscle spasms; and
• · Muscle re-education.

The NeuStim NN-01 is intended for use on the right arm/right hand only.

The NeuStim Model NN-01 (herein Device) consists of a voltage-controlled generating source that connects to disposable electrodes that are worn by the patient on the anterior and posterior forearm and around the thumb, these are named the Flexor, Extensor and Thumb Disposable Electrodes respectively. The disposable electrodes consist of multiple contacts that can stimulate the muscles in different areas of the forearm and thumb with 10kHz voltage pulses generated by the NeuStim voltage-controlled stimulator.

The Device is classified as a Functional Stimulation (FES) and NeuroMuscular Electrical Stimulation (NMES) device. The Device uses galvanic electrical energy to evoke muscle contractions.

The Device has 181 addressable electrode contacts enabling fine spatial resolution of stimulation to the patient. The Device allows manual electrode scanning to facilitate rapid mapping of effective stimulation points, which can be stored for use in future sessions. This rapid scanning capability is enabled through the use of solid-state relay technology embedded in the flexible patches that mate directly with the disposable electrodes. The motion of the user's (i.e. licensed healthcare professional) finger on the screen of the NeuStim" Tablet electronically steers the stimulation point through the use of a solid-state relay matrix in each patch and thumb dongle, while lighting LED indicators on the back of the patch/dongle under control. This allows immediate, dynamic visual indication of the stimulation location which facilitates rapid mapping (i.e. user can quickly find and return to useful stimulation points). When the user observes desired muscle activations and associated wrist, hand, or finger movements, the related stimulation locations can be stored as a pattern. Up to three of these stored patterns can then be combined into a compound move where the stimulator will continuously time multiplex between them to allow for compound motion. Finally, up to three compound moves or patterns can be combined into a sequence where each of the selected compound moves or patterns are applied for a user configurable number of seconds.

The Device uses a stimulation pulse repetition rate of 50 Hz. The stimulation pulse is comprised of a multiphasic (5 cycle) waveform with a total duration of 0.5 ms. The stimulation output (peak) voltage is less than 65V (500 Ohm load) and less than 120V (10,000 Ohm load). The stimulation output power will not exceed 0.25 W/cm^2 (averaged over one second) into a 500 Ohm Load.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Neuvotion NeuStim (NN-01) device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary does not explicitly detail a table of acceptance criteria with specific quantitative thresholds. Instead, it references compliance with various national and international standards. The "Results" column consistently states "Passed" for each test, indicating that the device met the requirements of these standards.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not include information about the sample size used for a test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The studies listed are primarily non-clinical, focusing on device safety, performance, and compliance with standards. There is a "Summary of Clinical Testing: Not Applicable" statement, which further confirms the absence of a test set derived from human subjects.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since "clinical testing is not applicable" and no human test set is described, there is no information provided regarding experts used to establish ground truth or their qualifications. The ground truth for the non-clinical tests is established by meeting the requirements of the specific engineering and safety standards referenced.

4. Adjudication Method for the Test Set

As there is no described test set involving human subjects and clinical outcomes, an adjudication method is not applicable and not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission explicitly states "Summary of Clinical Testing: Not Applicable," indicating that no clinical studies (which would include MRMC studies) were performed for this 510(k). The comparison provided is between the subject device's technical specifications and the predicate device's general characteristics, not a clinical effectiveness study.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The Neuvotion NeuStim (NN-01) is an external functional neuromuscular stimulator, a physical device that delivers electrical stimulation. It leverages software/firmware control for its operation but is not an AI algorithm that makes diagnostic or treatment decisions in a standalone manner without human interaction. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable here. The software verification and validation are part of the overall device performance, which is intrinsically human-controlled (by a licensed healthcare professional).

7. Type of Ground Truth Used

The ground truth used for the reported studies is primarily compliance with established regulatory standards and engineering specifications. For example:

• Safety and Essential Performance: Defined by standards like ANSI/AAMI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10.
• Biocompatibility: Defined by ISO 10993-1 (specifically Parts 5 and 10).
• Battery Safety: Defined by IEC 62133-2.
• Software Requirements: Defined by the software verification and validation process against predefined requirements.
• User Needs, Device Requirements, Coexistence, Shelf-Life, Adhesive Performance, Current Distribution/Electrode Impedance: These are validated against internal design specifications, user requirements, and relevant standards (e.g., IEEE/ANSI C63.27 for coexistence).

8. Sample Size for the Training Set

There is no mention of a training set sample size. Training sets are typically associated with machine learning or AI models. The NeuStim NN-01, while having software, is not described as an AI/ML device that requires a data training set in the context of this 510(k) submission. Its functionality relies on pre-programmed parameters and user-defined stimulation patterns.

9. How the Ground Truth for the Training Set Was Established

Since there is no training set mentioned, there is no information on how its ground truth was established.

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MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses:

Functional electrical stimulation (FES)

Improvement of arm and hand function and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES) for general rehabilitation for:

• · maintenance and/or increase of arm and hand range of motion,
• · prevention and/or retardation of disuse atrophy,
• · increase in local blood circulation,
• · reduction in muscle spasm, and
• · re-education of muscles.

MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove 2.0 Systems.

The MyndMove and MyndMove 2.0 Systems are neuromodulation devices that deliver short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove and MyndMove 2.0 systems comprise the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software.

The Functional Electrical Stimulators in the MyndMove 2.0 are eight-channel devices with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided.

Each MyndMove/MyndMove 2.0 Stimulator is connected, via an IEEE 802.11 a/b/g/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove 2.0 ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols.

MyndMove and MyndMove 2.0 use surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand.

MyndMove and MyndMove 2.0 are based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove or MyndMove 2.0 protocols achieve a wide range of functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the MyndMove/MyndMove 2,0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting a movement. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.

The provided text is a 510(k) summary for the MyndMove and MyndMove 2.0 electrical stimulation devices. It aims to demonstrate substantial equivalence to previously cleared predicate devices (MyndMove K170564 and MyndMove 2.0 K212149).

The key takeaway is that no new acceptance criteria, performance studies, or clinical data were generated or required for this 510(k) submission (K233006). The submission explicitly states: "No additional non-clinical performance testing was conducted because there was no change to the hardware or software since clearances of MyndMove (K170564) and MyndMove 2.0 (K212149)."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific submission (K233006) refer to the previously established criteria and studies for the predicate devices. The document essentially argues that since the new submission's devices are identical in technological characteristics and therapy protocols to the cleared predicates, they inherently meet the acceptance criteria validated by the predicate studies.

However, to answer your request fully, I will extrapolate the "acceptance criteria" and "reported device performance" based on the "Substantial Equivalence Discussion" table, which compares the subject devices (MyndMove and MyndMove 2.0) to their predicates across various technical specifications. The acceptance criteria, in this context, are the specifications of the predicate devices that the subject devices are claiming to be identical to.

1. Table of Acceptance Criteria and the Reported Device Performance

Since the submission explicitly states there are no changes to the technological characteristics of MyndMove or MyndMove 2.0, the "reported device performance" for the subject devices (MyndMove and MyndMove 2.0 in K233006) is asserted to be identical to the predicate devices. The "acceptance criteria" are the specifications of the predicate devices.

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The EvoWalk 1.0 System is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stoke, damage to pathways to the spinal cord). The EvoWalk 1.0 System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension; thus, it also may improve the individual's gait.

The EvoWalk 1.0 system is a wearable non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion in adult individuals with muscle weakness related to upper motor neuron diseaselinjury (e.g., stroke, damage to pathways in the spinal cord), thus providing treatment for foot drop. EvoWalk 1.0 can be used in a healthcare facility and home settings.

The EvoWalk 1.0 system consists of the EvoWalk device with an elastic band and built-in rechargeable lithium polymer battery, and the accessories including the EvoWalk mobile application, micro USB type charge cable with charge port, lead cables (one single channel and one dual channel), eight sets of electrodes for each channel, instructions for use (IFU), and a carrying case.

The provided text describes the EvoWalk 1.0 System, an external functional neuromuscular stimulator, and its submission for FDA 510(k) clearance. However, it does not include specific acceptance criteria and detailed study results to demonstrate the device meets those criteria in a format that allows for a direct population of the requested table. The document primarily focuses on establishing substantial equivalence to a predicate device (Bioness L300 Go System) through a comparison of technological characteristics and a summary of nonclinical tests performed.

Therefore, I cannot directly extract and provide the exact acceptance criteria and reported device performance from the given text in a tabular format, nor can I provide information on sample sizes for test and training sets, data provenance, expert ground truth establishment, or clinical study details as requested. The document explicitly states "Summary of Nonclinical Tests Submitted," indicating that only nonclinical (bench and software) tests were submitted, not clinical studies involving human performance metrics against specific acceptance criteria.

The information that can be extracted relates to the nonclinical testing performed to demonstrate safety and effectiveness and substantial equivalence.

Here's a breakdown of what is available and what is missing from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided document. The document lists the general nonclinical tests performed but does not provide specific quantitative acceptance criteria or the numerical performance results of the EvoWalk 1.0 System against such criteria.

2. Sample size used for the test set and the data provenance:

• Sample size for the test set: Not specified. The document mentions "nonclinical testing" and "bench testing" but does not detail sample sizes for any specific components or tests.
• Data provenance: Not applicable as no clinical test set data is described. The tests are nonclinical (bench and software validation).

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

• Not applicable. The document describes nonclinical tests and software validation, which do not typically involve expert review for ground truth in the same way clinical image analysis or diagnostic AI studies would.

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

• Not applicable. This relates to clinical studies involving human observers, which are not detailed in this document.

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:

• No, an MRMC comparative effectiveness study was not done according to the provided text. The document focuses on the device's technical performance and substantial equivalence to a predicate, not how human readers improve with AI assistance.

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

• Yes, implicitly, for specific functionalities. The document mentions "Motion analysis to validate the gait event detection algorithm" and "Software validation according to IEC 62304." These are standalone algorithm performance evaluations without human-in-the-loop. However, specific performance metrics are not provided. The device itself is a functional electrical stimulator, and its core function is to deliver stimulation based on algorithms detecting gait events.

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

• For the nonclinical tests, the ground truth would be based on engineering specifications, established standards (e.g., IEC 60601 series for electrical safety, EMC, and neuromuscular stimulators), and internal verification protocols. For the "gait event detection algorithm," the ground truth would likely be established through sensor data from controlled movements where gait events are precisely known or measured independently. No specific external expert consensus, pathology, or outcomes data are mentioned for ground truth.

8. The sample size for the training set:

• Not specified. The document does not discuss a training set for the device's algorithms, implying that the algorithm might be rule-based or trained using internal data without explicit mention of size.

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

• Not specified, as no training set is explicitly discussed.

Summary of Nonclinical Tests Mentioned:

The document primarily relies on nonclinical testing to support the safety and effectiveness and substantial equivalence of the EvoWalk 1.0 System. The tests performed include:

• Technological Characteristics of Powered Muscle Stimulation Stimulation Output Waveforms
• Motion analysis to validate the gait event detection algorithm
• Electrical Safety according to IEC 60601-1; IEC 60601-1-11
• Muscle and Nerve Stimulators according to IEC 60601-2-10
• Electromagnetic compatibility according to IEC 60601-1-2
• Software validation according to IEC 62304

The document concludes that "Evolution Devices believes the EvoWalk 1.0 system is substantially equivalent to the Bioness L300 GO system (K173682), and does not raise any new issues or concerns of safety or effectiveness. The evidence presented in the bench testing and non-clinical testing is sufficient to support the safety and effectiveness of the device."

In essence, the provided text details the regulatory context (510(k) summary) and the types of nonclinical tests conducted to support substantial equivalence, but it does not contain the detailed quantitative results and specific acceptance criteria that would be found in a full clinical study report or a detailed test report.

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The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease /injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The Cionic Neural Sleeve NS-100 may also:

• Facilitate muscle re-education
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow

The Cionic Neural Sleeve NS-100 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-100 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance.

The Cionic Neural Sleeve NS-100 system sales carton consists of the following components:

• 1. SL-100 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in two sizes: small, and medium.
• 2. DC-100 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-100. The DC-100 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app").
• 3. Power supply and cable to recharge the DC-100 and connect the DC-100 to a user's computer when required.
• 4. Adhesive, electrically conductive and replaceable electrode pads.
• 5. Electrode cover sheets.
• 6. Instructions for Use documents.

Components are available as accessories to the Cionic Neural Sleeve NS-100 system:

• o Replacement electrode pads.
  The Cionic Neural Sleeve NS-100 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-100 iOS and Android users.

The Cionic Neural Sleeve NS-100 system consists of a software and hardware architecture that enables users to access a library exercise and augmentation programs. Programs can be added and removed from the user's mobile app. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.

This 510(k) submission (K221823) from Cionic, Inc. is a Special 510(k) submission to add compatibility of the Cionic Neural Sleeve to support the Android operating system and minor software updates to improve overall stability and performance. As such, the submission primarily focuses on software verification and validation, along with wireless coexistence testing. The claim of substantial equivalence is made with respect to the predicate device, also the Cionic Neural Sleeve NS-100 (K213622).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The provided 510(k) summary does not detail specific sample sizes for the test sets. For software validation and wireless coexistence, these typically involve testing on the device itself and against relevant communication standards. No patient data or clinical study details are provided in this summary. Therefore, there's no information on the country of origin of data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This submission is for a software/OS compatibility update and does not involve clinical performance assessment requiring expert opinion for ground truth establishment.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are primarily engineering and software validation tests (wireless coexistence, software validation) and do not involve subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This submission is for a software and OS compatibility update, not for establishing clinical effectiveness or comparing human reader performance with and without AI assistance.

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

Not explicitly stated in terms of "standalone performance" in the context of an algorithm assessing medical images or data without human input. However, the software validation and wireless coexistence tests verify the system's technical functionality, which is an evaluation of the system's independent operation (without direct human user intervention during the specific test runs, although the device is designed for human interaction). There's no separate mention of an algorithm's standalone performance in a diagnostic or clinical decision-making capacity.

7. The Type of Ground Truth Used:

For the software and wireless coexistence tests, the ground truth would be defined by the technical specifications and standards (e.g., IEC 62304 for software, FDA guidance for wireless coexistence, Bluetooth Low Energy specifications for communication). The purpose of the tests is to verify that the device's software and communication capabilities adhere to these established technical requirements.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device submission in the sense of a new algorithm being trained. The submission refers to "minor software updates" and "stability and performance" improvements. Therefore, there's no mention of a training set or machine learning model training in this context.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm mentioned in this submission.

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The MyoCycle is intended for general rehabilitation for:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Maintaining or increasing range of motion
5. Muscle re-education

The MyoCycle is a stationary Functional electrical stimulation (FES) cycle ergometer which is composed of:

1. a motorized cycle ergometer
2. an FES controller /stimulator
3. a stimulation cable which connects the controller / stimulator to cutaneous electrodes (at maximum 20 cutaneous electrodes for 10 channels)
4. cutaneous electrodes

This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilized FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The electric motor inside the MyoCycle ensures that the pedals always rotate at 35 revolutions per minute (r/min) (isokinetic cycling), so it automatically assists or resists the patient, depending on the magnitude and direction of the torque applied to the crank by the patient.

The system software has four different configurations:

1. Pro – allows for multiple users by storing unique user data that can be accessed by a unique user identification code; extended FES parameter adjustability; up to six channels of stimulation
2. Home – only stores data for one user; limited FES parameter adjustability; up to six channels of stimulation
3. Pro Plus (+) – same as Pro but allows for up to ten channels of stimulation and uses patient cabling with additional leads
4. Home Plus (+) – same as Home but allows for up to ten channels of stimulation and uses patient cabling with additional leads

The provided document is an FDA 510(k) clearance letter for the MyoCycle MC-2 device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics (numerical results), details about a test set (sample size, provenance), expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance data.

The document primarily focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use: Showing the MyoCycle MC-2 has substantially equivalent indications to the predicate device, with an added "muscle re-education" indication that is standard for this type of device and does not raise new safety/effectiveness questions.
• Comparison of Technological Characteristics: Highlighting similarities and minor differences (e.g., increased stimulation channels, wider parameter range, larger touchscreen, wireless communication, database interface) that do not raise new safety/effectiveness questions.
• Performance Data (Bench Testing): Stating that testing was conducted to ensure equivalent functionality and verify performance to specifications, primarily through a review of documentation and bench testing against recognized consensus standards (e.g., electrical safety, EMC, usability).

Therefore, I cannot populate most of the requested sections as the information is not present in the provided text.

Here's what can be extracted based on the document:

Acceptance Criteria and Study Details for MyoCycle MC-2

The FDA 510(k) submission for the MyoCycle MC-2 primarily relies on demonstrating substantial equivalence to a predicate device (MyoCycle MC-HP-1, K170132) rather than presenting new clinical performance data with numeric acceptance criteria for specific outcomes. The "performance data" referred to in the document pertains to bench testing against recognized consensus standards to ensure safety and functionality, not a clinical study to evaluate device effectiveness in patients.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes no specific quantitative acceptance criteria or reported device performance metrics in a clinical context (e.g., "device achieved X% accuracy," "device improved range of motion by Y degrees"). Instead, the "acceptance criteria" are implied to be the successful demonstration of:

• Substantially equivalent Indications For Use.
• Similar technological characteristics that do not raise new questions of safety or effectiveness.
• Compliance with recognized consensus standards for device safety and electrical performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a test set in the conventional sense of a patient-based clinical study. The "testing" mentioned is primarily non-clinical bench testing and review of documentation. Therefore, information on sample size and data provenance for a clinical test set is not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable, as no clinical test set requiring expert ground truth or adjudication is described.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not mentioned or described in the provided document. The submission focuses on substantial equivalence based on technological characteristics and bench testing, not on comparative clinical effectiveness with human readers/users.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The MyoCycle MC-2 is a physical medical device (an FES cycle ergometer) rather than a software algorithm intended for standalone diagnostic or interpretive performance. Its functionality is tied to its interaction with a user.

7. The Type of Ground Truth Used

For the bench testing and design verification, the "ground truth" would be established by the specifications defined for the device and the requirements of the recognized consensus standards. For example, an electrical safety standard dictates specific performance criteria that the device must meet, and this standard serves as the "ground truth" for compliance. There is no mention of patient-level "ground truth" (e.g., pathology, outcomes data) for clinical efficacy.

8. The Sample Size for the Training Set

Not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is described.

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MYNDMOVE is an electrical stimulation device indicated for the following uses:

Functional Electrical Stimulation (FES)

Improvement of ann and hand functions and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury.

NeuroMuscular Electrical Stimulation (NMES)

· Maintenance and/or increase of arm and hand range of motion

• · Prevention and/or retardation of disuse atrophy
• · Increase in local blood circulation
• · Reduction of muscle spasm
  · Re-education of muscles.

Myddlove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by Mynd Tec on the use of the MyndMove System.

The MyndMove 2.0 System is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove system comprises the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The MyndMove 2.0 Functional Electrical Stimulator is an eight-channel device with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided.

Each MyndMove Stimulator is connected, via an IEEE 802.11 a/b/q/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove 2.0 Therapy can only be administered by trained MyndMove Therapy professionals (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove system.

MyndMove 2.0 uses surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand.

MyndMove 2.0 is based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove 2.0 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the therapist and the MyndMove 2.0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting move and as the arm and/or hand is moved into the instructed position. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.

The provided text is an FDA 510(k) summary for the MyndMove 2.0 device, which is an electrical stimulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (MyndMove K170564) rather than providing a detailed study proving the device meets general acceptance criteria in a clinical performance context.

Therefore, many of the requested details about acceptance criteria for clinical performance and specific study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone algorithm performance, and training set details) are not present in this type of regulatory submission document. This 510(k) summary focuses on technical equivalence and safety standards compliance due to minor modifications to an already cleared device.

However, I can extract information related to technical performance and safety compliance acceptance criteria, and the study (testing) that proves the device meets these criteria, based on the provided text.

Here is a breakdown of the available information:

Acceptance Criteria and Device Performance (primarily technical and safety-related):

• Waveform Shape: Rectangular
• Max Output Voltage (+/- 10%): Positive: 160V @ 500Ω, 2kΩ, 10kΩ; Negative: 40V @ 500Ω, 2kΩ, 10kΩ (Identical to predicate)
• Max Output Current (+/- 10%): Positive: 20mA @ 500Ω, 2kΩ, 16mA @ 10kΩ; Negative: 5mA @ 500Ω, 2kΩ, 4mA @ 10kΩ (Identical to predicate)
• Pulse Width: Positive: 150-400 µs; Negative: 600-1600 µs (Identical to predicate)
• Frequency: 1Hz or 40Hz (Identical to predicate)
• Symmetrical phases: No (Identical to predicate)
• Net Charge (per pulse): 1.85µC (Identical to predicate)
• Maximum Phase Charge: 9.02µC (Equivalent to predicate)
• Maximum Current Density (RMS) using smallest electrode: 0.93 mA/cm2 (for 1x3 cm electrode). (Meets criteria

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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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