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The Motive™ Electrode is intended for use as a disposable, conductive, and adhesive interface between the user's skin and an electrical muscle stimulator. Motive Electrode is intended for adults of 22 years of age and older.

The Motive Electrode provides an electrically conductive interface between a neuromuscular electrical stimulator (muscle stimulator) and a user's skin. The Motive Electrode is provided nonsterile, is designed and intended for single patient use only, multiple application use, and is disposable. The electrode sheet is to be worn on the thigh covering the quadriceps muscles to apply electrical stimulation therapy when connected to a muscle stimulator. The electrodes are conductive pads that contact the skin. The electrical stimulation impulses are delivered through the electrodes on the skin in direct proximity to the muscles to be stimulated. The Motive Electrode consists of multiple layers. The skin-contacting layer of the electrode sheet is comprised of three separate medical grade, self-adhering, biocompatible, and conductive hydrogel (gel) pads. These gel pads are placed on a single polyester or polyethylene terephthalate (PET) sheet. These gel pads include two rectangular 2 inch x 4 inch (5.1 x 10.2 cm) and one circular. 2.165 inch diameter (5.5 cm) pads. The outermost layer of the electrode contains a magnetic connector housing for electrical connection to the muscle stimulator. Silver ink printed conductive electrical traces on the PET film are utilized to provide electrical conductivity from the muscle stimulator to the gel pads. When not in use, the electrode sheet is covered by a paper-backed release liner.

The provided text describes a 510(k) summary for the Motive™ Electrode and outlines non-clinical/bench studies conducted to demonstrate its substantial equivalence to a predicate device, the ASCEND Electrode. However, it does not include information about acceptance criteria and a study proving a device meets those acceptance criteria in the context of an AI/algorithm-driven device with human-in-the-loop performance, expert ground truth, or an MRMC study.

The information given pertains to a physical medical device (an electrode), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the requested categories (like effect size of human improvement with AI, number of experts for ground truth, training set details) are not applicable to the content provided.

Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study (Motive™ Electrode)

Based on the provided 510(k) summary, the "acceptance criteria" are implied by a series of non-clinical/bench studies designed to demonstrate the device's safety, effectiveness, and functional equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present "acceptance criteria" in a tabular format with corresponding "reported device performance" against specific quantitative metrics relevant to AI/ML device validation. Instead, it describes compliance with standards and successful completion of various tests for the physical electrode.

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

This is not applicable to the provided document, as it concerns a physical medical device (electrode) and not an AI/ML algorithm requiring a dataset for testing. The studies mentioned are primarily bench/non-clinical tests involving materials and device prototypes.

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

Not applicable. This document describes tests for a physical electrode, not an AI/ML diagnostic or assistive device that requires expert-established ground truth for performance evaluation.

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

Not applicable. Adjudication by multiple experts is typically relevant for establishing ground truth in clinical datasets for AI/ML performance evaluation. This document describes bench testing of a physical device.

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. The device is a cutaneous electrode, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI/ML algorithm. The studies focused on the performance of the physical electrode itself to deliver electrical stimulation.

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

For the non-clinical / bench studies, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 10993 for biocompatibility) and pre-defined engineering specifications for electrical and mechanical performance. Comparability to the established performance of the predicate device also serves as a benchmark for equivalence.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm or training set discussed in this document.

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

Not applicable. There is no AI/ML algorithm or training set discussed in this document.

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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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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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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 QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 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 Orthopedics QB1 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 QB1 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 OB1 NMES and TENS systems 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 QB1 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 OB1 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 OB1 system consists of a Conductive garment with an incorporated NMES pod, User Interface device with a battery charger, NMES electrodes, and electrode gel.

The QB1 device also offers a TENS program for pain management. The QB1 TENS system consists of a TENS pod. User Interface device with a battery charger. TENS electrodes, and electrode gel.

The QB1 User Interface is programmed with an embedded software to manage the treatment programs and communicate with the User Interface touchscreen, NMES conductive garment, and TENS pod. The User Interface allows the user to select a treatment from the available treatment programs stored in the memory component of the NMES conductive garment and TENS pod. The User Interface utilizes a touchscreen and tactile buttons for user control. The User Interface device is powered by an internal rechargeable 3.7 V Lithium Ion battery that, when fully charged, can deliver at least three-20 minute treatments before requiring a recharge. The QB1 USB charger can fully recharge the battery in approximately five hours.

The QB1 system accessories include:

• . OB1 electrodes for NMES application
• OB1 electrodes for TENS application
• QB1 electrode gel ●

The provided text describes a 510(k) premarket notification for the CyMedica Orthopedics QB1 Powered Muscle Stimulator System (NMES) & Transcutaneous Electrical Nerve Stimulator System (TENS). This document contains information about the device's indications for use, technological characteristics, and performance data, primarily focusing on non-clinical testing to demonstrate substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria for a study demonstrating device performance as requested in the prompt, nor does it specify a study with acceptance criteria being met.

Therefore, many of the requested details cannot be extracted directly from this document. The document describes several non-clinical tests conducted to establish safety, effectiveness, and substantial equivalence, but not a study designed to meet specific performance acceptance criteria in the way envisioned by the prompt.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

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

• Cannot be provided. The document lists various standards the device was tested against (e.g., IEC 60601-1, IEC 60601-2-10 for electrical safety, ISO 10993 for biocompatibility, IEC 62366 for usability), and states that the device "meets all standard requirements" or "complies" with these standards. It also mentions "low current and voltage values" and "maximum current densities of QB1 are lower than Kneehab XP and MediStim XP." However, it does not explicitly define specific "acceptance criteria" (e.g., a minimum sensitivity or specificity_ and then report the device's performance against those criteria. The performance reported is primarily compliance with established safety and efficacy standards and lower electrical outputs compared to predicates.

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

• Cannot be provided for performance metrics related to acceptance criteria. The document states that a "human factors and usability study was conducted to validate the usability of the QB1 system in the home environment." It doesn't specify the sample size for this usability study. For other tests (electrical safety, EMC, software verification, biocompatibility, risk management), these are typically bench tests or analyses, not studies involving human subjects with a "test set" in the sense of clinical performance 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/Cannot be provided. This question is typically relevant for studies evaluating diagnostic or prognostic algorithms where expert consensus establishes ground truth (e.g., image interpretation). This document describes a medical device (muscle stimulator) undergoing non-clinical testing for safety and functional equivalence, not a diagnostic algorithm.

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

• Not applicable/Cannot be provided. Similar to point 3, this is relevant for studies involving the interpretation of data, where multiple experts might disagree and an adjudication process is needed. The testing described here does not involve such a process.

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/No. This device is a muscle stimulator, not an AI-powered diagnostic or interpretive tool that assists human "readers" (like radiologists). Therefore, an MRMC comparative effectiveness study of the type described would not be relevant. The document's effectiveness claims are based on meeting safety standards and having comparable or lower electrical output parameters than predicate devices.

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

• Not applicable/No. This device is an electrotherapy device with hardware and embedded software. Its "performance" is its ability to deliver specified electrical stimulation safely and effectively. The tests are effectively "standalone algorithm" tests in that they evaluate the device itself (including its software), but not in the diagnostic performance sense often implied by this question. The device's operation inherently involves user interaction (e.g., selecting programs, adjusting intensity), so it's not strictly an "algorithm-only" performance without any human involvement for its intended use, but the testing focuses on the device's adherence to technical standards.

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

• Not applicable/Cannot be provided in the context of diagnostic "ground truth." For this device, "ground truth" would relate to the physical and electrical parameters it's designed to produce. Compliance with standards (e.g., IEC 60601-2-10 for nerve and muscle stimulators) and comparison to predicate device characteristics serve as the reference for its functional performance and safety.

8. The sample size for the training set

• Not applicable/No training set. This is a hardware medical device with embedded software, not a machine learning model that requires a distinct "training set." The software validation mentioned is about verifying requirements, not training a model.

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

• Not applicable/No training set. As above, there is no training set for this type of device.

Summary of available information regarding performance and testing (not explicitly "acceptance criteria met by a study"):

Device: QB1 Powered Muscle Stimulator System (NMES) & Transcutaneous Electrical Nerve Stimulator System (TENS)

Performance Data and Basis for Substantial Equivalence:

The submission relies on non-clinical testing data to demonstrate substantial equivalence, focusing on safety and function.

• Safety: The QB1 system was tested for:

  • Electrical safety: Compliance with IEC 60601-1, IEC 60601-2-10 ("Particular requirements for the basic safety and essential performance of nerve and muscle stimulator"), and IEC 60601-1-11 ("Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment"). The system "compiles with" these standards.
  • Electromagnetic compatibility (EMC): Compliance with IEC 60601-1-2. The system "compiles with" this standard.
  • Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), and ISO 10993-10 (irritation and skin sensitization).
  • Risk Management: Compliance with ISO 14971.
  • Usability: Compliance with IEC 60601-1-6 and IEC 62366. A "human factors and usability study was conducted to validate the usability of the QB1 system in the home environment." The "results of the study support the instructions for successfully using the device as intended" and "substantiates the acceptability of the risks identified."
  • Software Verification & Validation Testing: Validated in accordance with FDA Guidance (May 11, 2005). The tests "demonstrated that the software version meets its design requirements."

• Effectiveness/Functional Equivalence:

  • The document implies effectiveness by demonstrating that the QB1 system's electrical output parameters (waveform, shape, voltage, current, duration, frequency, etc.) are comparable to or "lower" than predicate devices (Kneehab XP, K110350, and MediStim XP, K082011), ensuring it "poses no new safety risks" and "is substantially equivalent to the predicate."
  • Specifically, in "OB1 Design Verification & Validation, QB-0030-034, Section 018", it is stated that "the maximum current densities of OB1 are lower than Kneehab XP and MediStim XP" despite differences in electrode size. It also notes that "OB1 waveforms are at lower voltage and current and therefore power levels than the Kneehab XP and MediStim XP."

This information focuses on technical compliance and comparative electrical characteristics rather than specific performance metrics against pre-defined acceptance criteria in a clinical study.

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