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The Shoulder PacemakerTM electrotherapy device is intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for the Shoulder PacemakerTM device are:

• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Maintaining or increasing range of motion.

The device is intended for adults and adolescents age 14 and older.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

• conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation;
• saver protection, interposed between the stimulator and the patient's arm. -

The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.

The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

The provided text describes a 510(k) submission for the Shoulder PacemakerTM device, focusing on expanding its indications for use to include adolescents aged 14 and older. The submission primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (K210674), which is also the "Shoulder PacemakerTM" from the same manufacturer, NCS Lab Srl.

The core of the submission addresses the device's safety and effectiveness through non-clinical testing and leveraging existing clinical data through pediatric extrapolation, rather than conducting a new clinical study.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the traditional sense for a new clinical study comparing the device to a threshold or another device. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to the predicate device (K210674) and compliance with relevant medical device standards. The "reported device performance" is primarily the affirmation that the device meets these standards and is functionally identical to the predicate for all characteristics except the expanded age range.

The "performance data" section states: "All non-clinical, BLE module, battery, electrical safety, EMC and software testing was reviewed in K210674. No substantial changes have been made to the device since it was cleared by the FDA on August 24, 2021 that would affect prior testing results."

This implies that the device's performance aligns with the predicate device, which had already met the necessary performance criteria for its original clearance.

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

There was no new clinical "test set" or study conducted for this specific 510(k) submission in the traditional sense of prospectively enrolling patients for direct device performance testing. The clinical evaluation for the expanded age indication was based on pediatric extrapolation as per FDA guidance. This means:

• Sample Size: Not applicable for a new clinical test set. The submission relies on existing clinical literature and real-world use data.
• Data Provenance: The text mentions "Published literature and real-world use data." The specific countries or whether this data was retrospective or prospective from the original studies are not detailed within this summary, but it generally refers to existing, previously collected data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No new clinical test set was created, and thus no new ground truth was established by experts for this specific submission. The clinical evidence for pediatric extrapolation relied on published literature.

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

Not applicable. No new clinical test set requiring adjudication was conducted.

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. This device is a powered muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical medical device (muscle stimulator), not an algorithm in the context of standalone diagnostic performance. The device does operate in a "stand-alone mode" (uncontrolled by a wireless tablet) but this refers to its operational mode, not a standalone algorithm performance test.

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

For the pediatric extrapolation, the "ground truth" would be considered the established clinical outcomes data from published literature and real-world use for NMES devices in both adult and pediatric populations, as well as the comparison of patient, disease, and device characteristics. This is a form of outcomes data and literature-based evidence analyzed to support equivalence in a younger population.

8. The sample size for the training set

Not applicable. This submission concerns a hardware device with an expanded indication for use, not an AI/ML algorithm requiring a training set in the typical sense. The software validation mentioned (IEC 62304) involves testing against design requirements, not training on a dataset.

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

Not applicable. There was no training set for an AI/ML algorithm.

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The Motive™ Knee Wrap device is intended to strengthen the quadriceps muscle stimulation to provide symptomatic temporary pain relief associated with knee arthritis.

The Motive™ Knee Wrap device is indicated for adults of 22 years of age and older.

The Motive Knee Wrap device (Motive device) is an over-the-counter (OTC) electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) for relief of knee pain associated with knee arthritis. The Motive device is used to apply an electrical current through a power regulated output closed-loop feedback NMES system to provide relief of knee pain associated with arthritis. The stimulator continuously contracts quadricep muscle groups for strengthening of the muscles and knee pain relief. The stimulator is placed over the thigh muscle and just above the knee.

The provided text describes CyMedica Orthopedics, Inc.'s Motive Knee Wrap device and its 510(k) summary (K220738). It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. The document primarily details non-clinical bench testing, software validation, usability studies, and a comparison of technological characteristics with predicate devices.

Therefore, many of the requested details about acceptance criteria and a study proving those criteria are not explicitly present as a separate clinical study for the Motive Knee Wrap itself. Instead, the justification for effectiveness relies on the equivalence to a predicate device (CyMedica IntelliHab System, K210604) for which clinical data was previously submitted.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a formal table of "acceptance criteria" for a clinical study with corresponding reported device performance outcomes for the Motive Knee Wrap. The performance information provided is primarily related to non-clinical (bench) testing of electrical and physical characteristics to meet safety and performance standards.

Table: Performance Summary from Non-Clinical Testing

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

• Test Set for Clinical Performance: Not applicable as a new clinical study was not conducted for the Motive Knee Wrap itself. The document states: "Clinical data submitted in the predicate device application, IntelliHab System, K210604 applies to the subject Motive device." No details of that predicate study's sample size or provenance are provided in this document.
• Test Set for Human Factors/Usability Study: A "self-selection study and human factors study" was conducted to validate usability for OTC and home use. The specific sample size is not provided in this document.
• Data Provenance: Not explicitly stated for any clinical data. For the human factors study, it doesn't specify country of origin or whether it was retrospective/prospective.

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

• This information is not provided as a specific clinical study for establishing ground truth for the Motive Knee Wrap was not conducted. The clinical effectiveness is deferred to the predicate device's data.

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

• This information is not provided as a specific clinical study for the Motive Knee Wrap was not conducted directly.

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 conducted. This device is an electrical muscle stimulator, not an AI-assisted diagnostic imaging device for human readers.

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

• Not applicable in the context of typical algorithm performance for diagnostics. The device's "performance" is its ability to deliver the specified electrical stimulation consistently and safely, which was assessed via bench testing (Section 15) and regulated power output/closed-loop feedback (Section 11).

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

• For the non-clinical performance tests (electrical, EMC, battery), the ground truth is defined by the standards themselves (e.g., IEC 60601-1, FCC CFR47 Part 15).
• For the usability study, the ground truth is derived from the study participants' ability to successfully use the device per instructions and labeling.
• For the clinical effectiveness, the document states that "Clinical data submitted in the predicate device application, IntelliHab System, K210604 applies to the subject Motive device." The type of ground truth for that predicate study is not described in this document.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning model that requires a "training set" in the conventional sense. The "training" for this device involved its design, development, and bench testing to meet engineering specifications and regulatory standards.

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

• Not applicable for the same reason as point 8.

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Shoulder PacemakerTM is an electrotherapy device intended for neuromuscular electrical stimulation (NMES).

The Indications for Use for Shoulder PacemakerTM are:

• Prevention or retardation of disuse atrophy;
• Muscle re-education;
• Maintaining or increasing range of motion.

The device is intended for adults only.

The Subject device, Shoulder Pacemaker, is a wearable muscle stimulator, powered by an internal battery, used for rehabilitation/physiotherapy purposes to produce muscle contraction, through the passage of electric current, by means of conductive electrodes positioned on the body area of interest, in patients with shoulder functional pathologies.

The Shoulder Pacemaker device is intended to be used as a shoulder muscle stimulation tool to reduce and eliminate related functional pathologies.

The subject device can be used in stand-alone mode or in wireless mode.

The Shoulder Pacemaker should be used in combination with:

• conductive electrodes, that are applied directly to the patient's skin to ensure muscle electrostimulation;
• saver protection, interposed between the stimulator and the patient's arm.

The device is equipped with a goniometer (product code KQX, Class I, 510 (k) exempt), which can record the acceleration and angular velocity data of the device and allows to estimate the movement of the subject's arm. In this way, the device automatically detects the elevation angle of the arm and based on that information it can modulate the electrical stimulation.

The Shoulder Pacemaker is a prescription device and is intended to be used following the directions of a healthcare provider; additionally, the device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

The provided text describes a 510(k) summary for a medical device called "Shoulder Pacemaker™," an electrotherapy device for neuromuscular electrical stimulation (NMES). It outlines the device's characteristics, indications for use, comparison to predicate devices, and performance data to support its substantial equivalence.

However, the document does not contain the level of detail typically found in a clinical study report or a formal acceptance criteria document for an AI/ML medical device. Specifically, it lacks information regarding:

• Quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). The document focuses on electrical safety, EMC, and compliance with standards rather than clinical performance metrics for a specific diagnostic or therapeutic outcome.
• A "study" that proves the device meets acceptance criteria in the context of clinical effectiveness with quantitative results. The performance data section refers to non-clinical testing (electrical safety, EMC, software validation) and compliance with standards, not a clinical trial or performance study involving a test set, ground truth, or expert readers.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods as these pertain to clinical performance studies.
• MRMC studies or standalone algorithm performance as these are relevant for AI/ML devices analyzing complex data like images, which is not the primary function described for this NMES device.

Given that the device is a Powered Muscle Stimulator (Product Code IPF) intended for NMES, its performance evaluation focuses on electrical parameters, safety, and functional equivalence to predicate stimulators, rather than diagnostic accuracy as one might expect from an AI/ML imaging device.

Therefore, I cannot populate all sections of your requested outline based on the provided text. I will, however, extract the relevant information regarding acceptance criteria (as implied by the testing performed) and the "study" (non-clinical testing) that demonstrates compliance.

Acceptance Criteria and Device Performance for Shoulder Pacemaker™

Based on the provided 510(k) Summary, the acceptance criteria and performance are primarily related to electrical safety, electromagnetic compatibility (EMC), software validation, and general functional equivalence to predicate devices. There are no explicit quantitative performance metrics (e.g., sensitivity, specificity, or accuracy scores) for a clinical outcome mentioned for the Shoulder Pacemaker™, as it is a muscle stimulator focused on electrical stimulation parameters rather than a diagnostic AI/ML device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

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The Intellihab system is intended to strengthen the quadricep muscle stimulation to provide symptomatic temporary pain relief associated with knee osteoarthritis and improvement of the knee joint mobility when the recommended treatment regimens are followed.

In addition, the Intellihab System is indicated for the following:

• Retardation or prevention of disuse atrophy
• Evaluation of joint mobility by measuring and recording range of motion .

The Intellihab System is indicated for adults of 22 years of age and older.

Intellihab System is a remote monitoring electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) with an integrated digital goniometer for osteoarthritis pain relief and joint mobility improvements. Intellihab device is used to apply an electrical current through a power regulated output closed-loop feedback NMES system to provide relief of knee pain associated with osteoarthritis. The stimulator is intended for medical purposes that continuously contracts muscle groups for an intended therapeutic application and allows for remote monitoring of therapeutic data by the healthcare Providers. The stimulator is provided with an integrated battery powered digital goniometer that allows for measurement of knee joint range of motion. The stimulator along with the digital goniometer is placed over or in proximity to affected joint. The Intellihab System includes a provider portal allowing for remote monitoring of collected patient data through Intellihab mobile app and API interface.

The CyMedica Intellihab System is an electrical muscle stimulator with an integrated digital goniometer for osteoarthritis pain relief and joint mobility improvements, and for the retardation or prevention of disuse atrophy.

1. Table of Acceptance Criteria & Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" with specific numeric thresholds that the Intellihab system had to meet for each performance metric, as might be specified for a new device submission. Instead, it aims to demonstrate substantial equivalence to a predicate device (CyMedica e-vive® System, K163067) and supports its new indications for use through clinical study results.

The clinical study evaluated the effectiveness and safety of the device. The "acceptance criteria" for effectiveness are implicitly tied to demonstrating statistically significant and clinically meaningful improvements in pain, stiffness, and function compared to sham treatment, particularly in a "Per Protocol Therapy Compliant (PPTC)" population.

Here's a summary of the effectiveness results in the PPTC population where statistical significance was observed, which could be interpreted as meeting certain performance "criteria":

For safety, the acceptance criterion was "no serious adverse events directly attributed to the device that introduced a new risk compared to the predicate device."
Reported Safety Performance: 9 (8.5%) adverse events in the Treatment group and 3 (6.1%) in the sham group. Only 3 device-related adverse events (1.9%) were reported in the treatment group, and none were serious or led to study discontinuation. These events (calf muscle spasms, pain consistent with electric shock, skin marks consistent with burn) were consistent with the predicate device and did not introduce new risks.

2. Sample Size for Test Set and Data Provenance:

• Sample Size (Clinical Study - Test Set):
  • Total subjects screened: 177
  • Total subjects enrolled: 159
  • Total subjects randomized: 156
    • Treatment NMES group: 106 subjects
    • Sham Low Voltage NMES group: 50 subjects
  • Per Protocol Therapy Compliant (PPTC) population (Treatment NMES): 69 subjects at week 4, 61 at week 8, and 45 at week 12 (61.3% of ITT Treatment NMES group). The sham group in the PP population analysis remained the same as the ITT sham population (50 subjects).
• Data Provenance: The study was a "randomized, sham controlled, double-blind, multi-center study performed at 7 sites in the USA." This indicates the data is from the USA and is prospective.

3. Number of Experts and Qualifications for Ground Truth:
The document describes a clinical study using patient-reported outcome measures (VAS, WOMAC, KOOS JR) and functional tests. The ground truth for effectiveness is based on these patient-reported scores and objective functional assessments, not on expert adjudication of diagnostic images or interpretations. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of diagnostic accuracy studies (e.g., radiologists interpreting images) is not directly applicable here. The study design implicitly relies on the established validity and reliability of the chosen clinical assessment tools.

4. Adjudication Method for the Test Set:
Not applicable in the context of this device and study type. There was no adjudication panel for the primary and secondary endpoints, as these involved patient self-reporting (pain, stiffness, function) and objective physical assessments (e.g., TUG test, chair rise test).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study evaluated the direct effectiveness of the device as a therapeutic intervention against a sham control, not the improvement of human readers' performance with AI assistance.

6. Standalone (Algorithm Only) Performance:
The document mentions a "remote monitoring electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) with an integrated digital goniometer for osteoarthritis pain relief and joint mobility improvements." The effectiveness study was performed with patients using the device, which is a therapeutic device intended for human use, not solely an algorithm for diagnostic interpretation in a standalone mode. The Intellihab system comprises a hardware device (stimulator, goniometer, garment) and software components (mobile app, web services). While the software controls aspects of the therapy and data collection, the "performance" evaluated in the clinical study is that of the integrated system and its therapeutic effects on the patient, not a standalone algorithm.

7. Type of Ground Truth Used:
The ground truth for effectiveness was established through:

• Patient-reported outcome measures: Visual Analog Scale (VAS) for pain (nominated activity, general, walk, rest), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for pain, stiffness, and function, and Knee Injury and Osteoarthritis Outcome Score (KOOS JR) for pain, stiffness, and function.
• Objective functional assessments: Isometric quadriceps strength, Timed Up and Go (TUG) test, repeated chair rise test, and three-minute walk test.

8. Sample Size for the Training Set:
The document describes a clinical study for evaluating the device's effectiveness, not a study for training an AI/ML algorithm. Therefore, there is no "training set" in the context of this submission. The term "training set" typically applies to machine learning models.

9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set for an AI/ML algorithm in this submission.

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ViMove2 is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.

ViMove2 is a wireless electronic device used by healthcare professionals to accurately measure, record and analyze movement and muscle activity of the lower back. The device obiectively measures, records and analyzes angular movement and muscle activity.

Under the direction of the healthcare professional, the software quides the patient through a series of dynamic movements and static postures in standing and sitting positions. ViMove2 then measures the range of motion and muscle activity, streams the data live via BTLE to a host device, e.g. PC, tablet or smart phone, and generates a personalized assessment report including comparisons to normative values.

ViMove2 is comprised of the following key components:

• · 4 Wireless Sensors (2 movement and 2 muscle activity)
• · Disposable Application Pads for attaching sensors to the patient.
• · ViMove software package

The provided text describes a 510(k) submission for the ViMove2 device, which is a wireless system for measuring movements and muscle activity of the lower back/lumbar spine. The submission aims to demonstrate substantial equivalence to a predicate device (ViMove, K142494).

However, the provided text does not contain acceptance criteria or detailed results of a study proving the device meets specific performance criteria beyond general compliance with standards. It states that "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but it does not present the specific acceptance criteria for these assessments or the numerical results from such testing.

Therefore, I cannot fulfill all parts of your request with the information provided. I will fill in the available information and indicate where data is missing from the text.

Acceptance Criteria and Device Performance (Based on available information)

The document primarily focuses on establishing substantial equivalence for the ViMove2 device to its predicate ViMove, emphasizing changes in size, components, and wireless technology. It mentions that "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but does not provide specific quantitative acceptance criteria or the reported performance data against such criteria.

Study Details (Based on available information):

The document mentions "testing was performed to validate ViMove2 for assessment of lumbo-pelvic range of motion (ROM) and posture," but it doesn't provide specific details about this "validation testing" that would allow us to answer all your questions.

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

   • Not provided. The document states "testing was performed," but does not specify the number of subjects or the data collection methodology (retrospective/prospective, country of origin).

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

   • Not provided. The document does not describe how the ground truth for the "validation testing" was established, nor does it mention the involvement or qualifications of experts for this purpose.

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

   • Not provided. No details on adjudication methods for establishing ground truth are mentioned.

4. 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 provided. The ViMove2 device is described as a measurement and reporting tool for movement and muscle activity, not an AI-assisted diagnostic imaging device that typically undergoes MRMC studies. The document does not mention any studies evaluating human reader improvement with the device.

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

   • The document implies that the device is a standalone measurement system that provides objective data and reports. The "validation testing" would likely represent standalone performance, but the specific metrics and results are not provided. The device quantifies movement and muscle activity; it's not an "algorithm" in the sense of an AI model interpreting complex data for a diagnosis.

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

   • Not explicitly stated/Provided. For ROM measurements, ground truth is typically established using highly accurate motion capture systems or goniometers. The document only mentions that testing was done to validate ROM and posture assessment but does not specify the ground truth method.

7. The sample size for the training set:

   • Not applicable/Not provided. The ViMove2 device is a sensor-based measurement system, not a machine learning/AI device that requires a "training set" in the typical sense for algorithm development. If there was any internal calibration or model fitting, the details are not provided in this public summary.

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

   • Not applicable/Not provided. (See point 7).

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The CyMedica e-vive System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).

Indications for Use:

• As an NMES device, indications are for the following conditions:
• Relaxation of muscle spasms
• Retardation or prevention of disuse atrophy
• Increasing local blood circulation
• Re-educating muscles
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion

As a TENS device, indications are for the following conditions:

• Symptomatic relief and management of chronic intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain

The CyMedica e-vive™ System is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that allows for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The principles of electrotherapy emulate the process observed during a voluntary muscle contraction. The e-vive™ system delivers stimulation based on the principles of NMES and TENS. NMES pulses stimulate motor points of target muscles, causing a muscle contraction. This can help re-educate and strengthen muscles following an injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.

The e-vive device is equipped with a goniometer (Class I, 510(k) Exempt), which is intended to measure and record joint range of motion.

e-vive™ electrical stimulation technology is based on the electrical stimulation technology developed for CyMedica QB1™ system. K150413. The e-vive™ electrotherapy programs are delivered to the patient directly by a User Interface controller integrated in a conductive garment. The stimulation programs are managed wirelessly using a mobile application developed for use on smart phones or tablets that interact with the User Interface controller.

The e-vive™ system are prescription devices in the USA and are intended to be used following the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

In NMES mode, the e-vive™ system provides two therapeutic treatment programs: Post-Operative and Strength. Its simplified programming makes the device convenient for home use; after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to a comfortable level to begin therapy. The evive™ NMES Post-Operative and Strength programs utilize an electrical stimulus that, when properly applied, activates specific muscles or muscle groups to help treat disuse muscle atrophy and to reeducate muscles. This is achieved via a closed loop feedback system that minimizes energy delivery to the targeted treatment areas.

In NMES mode, the e-vive™ system consists of a knee conductive garment with an incorporated Controller, docking receptacle, range of motion sensor, three electrodes, a USB-A to micro-USB-B cable for Controller charging, an electrode gel tube, and e-vive mobile app available for download from the App Store onto a patient's mobile device.

As a TENS device, the e-vive TENS treatment is a safe and effective method of providing a drug-free method of pain relief. Patients with recurring pain, can utilize the e-vive TENS treatment program for immediate and long-term pain relief.

The e-vive™ TENS system consists of a conductive garment with an incorporated Controller. docking receptacle, two electrodes, a USB-A to micro-USB-B cable for Controller charging, an electrode gel tube, and e-vive mobile app available for download from the App Store onto a patient's mobile device.

The e-vive electrogoniometer (battery powered goniometer) is capable of measuring and recording the joint range of motion by using two sensors to detect the knee range of motion. One sensor is located on the Controller board and the second sensor is located within the sensor pod, on a small electronic board. The sensor pod is contained within the conductive garment below the knee area opening. The sensor pod is connected wirelessly to the Controller using a BLE connection. The sensor data from the sensor pod and the Controller sensor is conveyed to the mobile device real time. The sensors can detect the knee extension/flexion angles, and associated range of motion angle through the use of the e-vive mobile app when initiated by the patient or healthcare provider.

The e-vive™ System incorporates a Bluetooth Low Energy, BLE 4.1 connection module to enable wireless communication and can be paired with a Bluetooth enabled mobile device running the e-vive™ App, available from the App stores. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user.

The Controller is connected to the conductive garment via a 16-pin interface. The Controller contains the primary safety controls for operation of the device and a push button is available for switching the unit on or off. The power button remains active and can be used in the event of loss of Bluetooth connection to power on/off the device or start/stop stimulation while performing stimulation sessions. The e-vive™ system contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and Bluetooth™ activity. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

The document provided is a 510(k) Summary for the CyMedica e-vive™ System, which focuses on demonstrating substantial equivalence to a predicate device (QB1 NMES & TENS System K150413) rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding a study design (sample size, expert qualifications, adjudication, MRMC study, standalone performance) is not available in these documents.

However, the document does list various non-clinical performance data and standards compliance to demonstrate safety and effectiveness.

Here's a breakdown of the available information:

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

The document implicitly uses compliance with recognized standards and substantial equivalence to a predicate device as its acceptance criteria. No specific numerical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) are provided for efficacy, as this is a non-clinical submission.

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

• Sample Size: Not applicable. The document describes non-clinical bench testing and compliance with standards, not a clinical study with a test set of patient data.
• Data Provenance: Not applicable.

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

• Not applicable, as this was a non-clinical submission.

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

• Not applicable, as this was a non-clinical submission.

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 study was not done. This device is an electrotherapy device, not an AI-assisted diagnostic tool involving human readers.

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

• The document implies that the device's electrical stimulation output parameters were tested independently to ensure they fall within safe and effective ranges as per relevant standards (IEC 60601-2-10). The goniometer's accuracy in measuring range of motion was also assessed independently. This could be considered standalone performance for the specific functions of stimulation delivery and goniometry.

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

• For the electrical safety and performance parameters, the "ground truth" was defined by recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FCC, ETSI) and an FDA guidance document for powered muscle stimulators.
• For the goniometer, the ground truth would be accepted methods of measuring flexion/extension angles.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device that requires a training set in the traditional sense. The software validation involved testing against design requirements.

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

• Not applicable.

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The sonoSens® is a non-invasive device indicated for use in real-time measurement of range of motion.
Continuous real-time measurement of range of motion.

The sonoSens® is a non-invasive device indicated for use in real-time measurement of range of motion. The measuring device consists of a monitor central processing unit (CPU), the power supply, and an infrared interface for data transfer. The device is connected to eight sensors via cables. Each sensor is directly attached to the skin with an adhesive pad.

The provided text is a 510(k) premarket notification for the sonoSens® device. It describes the device and its intended use, and states that FDA has determined it to be substantially equivalent to predicate devices. However, this document does not contain information about acceptance criteria, clinical studies, or performance data for the sonoSens® device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for any study.

This document is a regulatory approval notice, not a clinical study report. To obtain the information you've requested, you would typically need to refer to a separate clinical validation or performance study report, which is not included in the provided text.

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The Ortelius 800 is a prescriptive device intended to measure the angle of spinal deformity as an aiding tool for the diagnosis and monitoring of spinal deformities such as scoliosis and kyphosis.

The Ortelius 800 may be used in medical clinics/institutes.

The Ortelius 800 is a device designed for the measuring and monitoring spine deformities.

The Ortelius 800 enables the following features:

• · Spine curve reconstruction based on the points sampled by the Sensor.
• · Automatically calculated spine deformity angles of the primary curve.
• · Indication of the extreme vertebra from which the spine deformity angle was calculated.

The provided text describes the Ortelius 800, a goniometer intended to measure spinal deformity angles. However, it does not include detailed information regarding acceptance criteria, a specific study proving device performance against those criteria, or the methodology for such a study.

Therefore, I cannot populate the table or answer the specific questions requested, as the necessary information is not present in the provided document.

The document primarily focuses on:

• The device's general description and intended use.
• Its classification and regulatory aspects (510(k) submission, substantial equivalence to predicate devices).
• Compliance with general performance standards (IEC 60601-1, etc.) which are related to electrical safety and electromagnetic compatibility, not clinical performance for angle measurement accuracy.

To provide the requested information, a document detailing the clinical or performance validation study would be required.

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The 3 Channel Knee Electronic Amplified Stethoscope is intended for use by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the three compartments (medial, lateral, and patellar) of the knee joint.

The device is intended for use by a physician as a noninvasive tool to amplify and record distinct sounds (vibrations) within the three compartments (medial, lateral, and patellar) of the knee joint.

The 3 Channel Knee Stethoscope System consists of three transducers, or sensors, to pick up the vibrations (sound) from three locations on the knee. The transducers are plugged into an amplifier box that is connected to a standard personal computer installed with Windows 3.1, or later version. A goniometer attachment is also plugged into the amplifier box. The system generates a metronome arrow that moves on the computer monitor screen (3 seconds per flex/extend cycle). The patient watches the arrow to pace the speed and direction of knee flexion and extension, while staying "in sync" with the metronome to maintain a 3 second cycle. Motion and sound vibrations are amplified, recorded in graph form, and stored in a patient database.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3 Channel Knee Electronic Amplified Stethoscope:

Acceptance Criteria and Study Analysis

Based on the provided documentation, the "acceptance criteria" for the 3 Channel Knee Electronic Amplified Stethoscope are primarily rooted in demonstrating substantial equivalence to existing legally marketed predicate devices. The device is not making claims of diagnostic capability, but rather as an adjunct tool for amplification and recording. Therefore, the "studies" presented are historical and foundational research on the broader concept of "vibration arthrography" rather than a direct, specific study proving the performance of this specific device against defined acceptance criteria.

The submission is a 510(k) for a Class II medical device, which typically relies on demonstrating equivalence rather than extensive clinical efficacy trials.

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) submission does not mention a specific test set or sample size used for the performance evaluation of this particular device. The "studies" cited are published papers on the general concept of "vibration arthrography" or electro-acoustical techniques for detecting knee joint noise, dating from 1976 to 1990. These papers are foundational for the field, but not direct performance studies of the Biomet 3 Channel Knee Electronic Amplified Stethoscope itself. Therefore, details like data provenance specific to this device's testing are not provided.

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

This information is not provided as there is no specific test set described for this device's performance evaluation. The cited published papers (e.g., Chu et al., Kernohan et al., McCoy et al., Mollan et al., Wallace et al.) in the "Published Papers" section would have involved experts in their respective studies, but these are not studies of this specific device's performance or a means to establish "ground truth" for its acceptance.

4. Adjudication Method for the Test Set

This information is not provided as there is no specific test set described for this device's performance evaluation.

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

No, an MRMC comparative effectiveness study was not done for this device as described in the provided text. The device is not claiming interpretative or diagnostic capabilities, and the focus of the 510(k) is on substantial equivalence for amplification and recording. There is no mention of human readers improving with or without AI assistance, as the device itself is a purely signal amplification and recording tool, not an AI-driven diagnostic system.

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

The concept of a "standalone" algorithm performance study is not applicable to this device in the way it's usually understood for AI/diagnostic algorithms. The device's primary function is to amplify and record, then display the data for a physician to interpret. It's a "human-in-the-loop" device by its very nature, where the human physician provides the interpretation. There is no algorithm that provides a standalone diagnostic output.

7. The Type of Ground Truth Used

Given the nature of the device (amplification and recording, not diagnosis), the concept of "ground truth" for its performance evaluation is not directly applicable in the sense of pathology, expert consensus on a diagnosis, or outcomes data. The "ground truth" for the device's acceptance is its ability to accurately amplify and record sounds and its substantial equivalence to predicate devices that perform similar functions. The historical research cited (e.g., "The Diagnosis Potential of Vibration Arthography," "Vibration Arthrography as a Diagnostic Aid") suggests that the field uses clinical findings, imaging, or surgical outcomes to correlate with vibration patterns, but this is for interpreting the data from such devices, not for validating the device's basic function of amplification and recording.

8. The Sample Size for the Training Set

This device does not contain a machine learning or AI algorithm in the contemporary sense that would require a "training set." Therefore, this information is not applicable and not provided.

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

As there is no training set for an AI algorithm, this information is not applicable and not provided.

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