Search Results

EMS: The Compex Sport Elite 3.0 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the Compex Sport Elite 3.0 programs is not suitable for relabilitation or physiotherapy.

TENS: The Compex Sport Elite TENS is intended for:

• Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities:

• The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Compex Sport Elite 3.0 is an Over-the-Counter device to be used by adults only.

The Compex Sport Elite 3.0 is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Sport Elite 3.0 stimulates motor nerves to stimulate a muscular response. Depending on the parameters of theelectrical impulses (pulse frequency. duration of contraction, duration of rest, and totalsession duration). different types of muscle work can be imposed on the stimulated muscles. The Compex Sport Elite 3.0 may therefore be considered a technique of muscletraining.

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.

The Compex Sport Elite 3.0 system consists of these components:

• 1x Stimulator
• 1x Lead WireSet
• 2x Small Performance Snap Electrodepackages ●
• 2x Large Performance Snap Electrodepackages
• 1x Charging Cable ●
• 1x Carrying Case ●

These components are packaged together in a carrying case along with the user guide and a battery charger.

The electrodes are supplied by Axelgaard Mfg. Co., Inc. and cleared under K130987.

The stimulator is a microprocessor controlled 4-channel electro-stimulator. The stimulator drives each output channel independently based upon the parameters predefined for a program selected by the user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments ) Menu), tune a selected program (Stimulation Menu), andadiust the stimulation intensities (Level Menu).

The provided document is a 510(k) summary for a medical device, the Compex® Sport Elite 3.0. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials. Thus, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for AI/ML-based devices is not applicable to this specific document.

The document primarily addresses acceptance criteria in the context of non-clinical testing and comparison to the predicate device. The study proving the device meets these "acceptance criteria" is a demonstration of substantial equivalence rather than a clinical performance study.

Here's an analysis of the provided information within the context of a 510(k) submission, addressing the questions where applicable:

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

The document doesn't present "acceptance criteria" in the traditional sense of a performance study with specific numerical thresholds for accuracy, sensitivity, or specificity for an AI/ML device. Instead, the acceptance criteria are implicitly defined by the safety and performance standards the device was tested against and by its substantial equivalence to the predicate device.

The document provides a "Comparison Analysis" (Table 1: Characteristics, Table 2: Output Specifications, Table 3: Software Comparison Analysis) between the subject device (Compex® Sport Elite 3.0) and its predicate device (Compex Sport Elite, K170918). This comparison itself serves as the "reported device performance" against the "acceptance criteria" of being substantially equivalent to the predicate and meeting relevant safety standards.

Table 1: Comparison Analysis - Characteristics (Excerpt)

Table 2: Output Specifications Comparison Analysis (Excerpt)

Table 3: Software Comparison Analysis (Excerpt)

The "acceptance criteria" here are that the subject device performs identically or similarly to the predicate device in terms of critical functional and safety parameters, and any differences do not raise new issues of safety or effectiveness. For "Different" or "Similar" characteristics, the risk analysis justifies why these differences do not introduce new risks or even reduce existing ones (e.g., improved ingress protection).

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

• Sample Size: Not applicable. This is a medical device (muscle stimulator), not an AI/ML diagnostic or prognostic system that processes clinical data. The "testing" refers to bench testing and comparison to a predicate, not performance on a clinical test set of patient data.
• Data Provenance: Not applicable for clinical data. The provenance for the testing data would be from laboratory bench tests conducted by a Nationally Recognized Test Laboratory (Nemko Shanghai Ltd. Shenzhen Branch).

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

Not applicable. Ground truth as in expert consensus on disease status is not relevant for this type of device and submission. The "ground truth" for the device's technical specifications and safety conformity would be the industry standards (e.g., IEC 60601 series) and the specifications of the predicate device.

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

Not applicable. Adjudication methods are used in clinical studies, particularly for subjective assessments or when establishing ground truth from multiple readers. This is a technical comparison and safety conformity assessment.

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 an electrical stimulator, 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 algorithm-only device. Its function is direct physical electrical stimulation.

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

The "ground truth" for this 510(k) submission is based on:

• International safety and performance standards: e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, ANSI/AAMI/IEC 62304.
• Specifications and performance of the legally marketed predicate device (Compex Sport Elite, K170918): The core of the 510(k) submission is to demonstrate that the new device is "substantially equivalent" to this predicate.

8. The sample size for the training set:

Not applicable. There is no AI/ML component with a training set for this device.

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

Not applicable. There is no AI/ML component with a training set for this device.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a physical medical device (muscle stimulator). The "study that proves the device meets the acceptance criteria" refers to bench testing against recognized electrical safety and performance standards and a detailed comparison to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial or performance study typical for AI/ML-driven diagnostic devices.

Ask a specific question about this device

EMS: The Compex Sport Elite is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex is not suitable for rehable for rehabilitation or physiotherapy.

TENS: The Compex Sport Elite TENS is intended for:

· Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities

· They symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Compex® Sport Elite is an Over-The-Counter device to be used by adults only.

The Compex® Sport Elite is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex® Sport Elite stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex® Sport Elite may therefore be considered a technique of muscle training.

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.

The Compex® Sport Elite system consists of these components:

• 1x Stimulator
• 1x Lead Wire Set
• 2x Small Performance Snap Electrode package ●
• 2x Large Performance Snap Electrode package
• 1x Battery Charger ●

These components are packaged together in a carrying case along with the user guide and a battery charger.

The stimulator is a microprocessor controlled 4 channels electro-stimulator. The stimulator drives each output channel independently based upon the parameters pre-defined for a program selected by the user. The user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments' Menu), tune a selected program (Stimulation Menu), and adjust the stimulation intensities (Level Menu).

The provided document is a 510(k) premarket notification for the Compex® Sport Elite, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices (Compex Sport Plus and Strive) rather than providing extensive clinical study data for acceptance criteria.

Therefore, the information requested regarding a study proving acceptance criteria for device performance is largely not available in this document. The document primarily describes the technical characteristics of the new device and compares them to predicate devices, along with adherence to electrical safety, electromagnetic compatibility, software verification, and usability standards.

Here's a breakdown of the available information based on your request:

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

The document does not explicitly state "acceptance criteria" for a study in numerical terms like sensitivity, specificity, or improvement effect size. Instead, it demonstrates compliance with recognized medical device standards and provides detailed comparisons of technical specifications to predicate devices. The "performance" is therefore reported in terms of these technical characteristics.

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

This information is not provided in the document. The performance testing described (electrical safety, EMC, software, usability) are typically internal validation tests and not clinical studies involving patient 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)

This information is not provided. The "ground truth" in this context would likely be compliance with engineering standards, software requirements, and usability principles, assessed by engineers and human factors specialists rather than medical experts for clinical outcomes.

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

This information is not provided. Standard engineering and software verification often involve peer reviews and structured testing, but specific adjudication methods like those used in clinical trials (e.g., 2+1 consensus) are not applicable or mentioned here.

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 MRMC comparative effectiveness study was done or reported. This device is a muscle stimulator, not an AI diagnostic tool, so this type of study is not relevant to its regulatory submission.

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

The device is a physical muscle stimulator and does not involve AI algorithms in the way described for "standalone performance" in AI/CADe devices. Its "standalone performance" is essentially its ability to meet the technical specifications and safety standards independently. This was assessed through the electrical safety, EMC, software verification, and usability testing, as detailed above.

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

The "ground truth" for this submission is compliance with:

• Recognized consensus standards (IEC 60601-1, -1-2, -1-11, -2-10, IEC 62366, ISO 14971, AAMI/ANSI/IEC 62304).
• Design requirements for software functionality.
• Usability requirements for safe and effective user interaction.

There is no mention of clinical expert consensus, pathology, or outcomes data being used as ground truth for this 510(k) submission, as the submission explicitly states: "This submission does not contain clinical data."

8. The sample size for the training set

This information is not applicable/not provided for this type of device and submission. The device is not an AI/machine learning model that requires a "training set."

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

This information is not applicable/not provided as there is no "training set" for this device.

Ask a specific question about this device

The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy.

The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction. duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.

Compex Wireless USA as a TENS device is used for:

• temporary relief of pain associated with sore and aching muscles due to strain from exercise or . normal household and work activities.
• the symptomatic relief and management of chronic, intractable pain and relief of pain associated ● with arthritis.

The Compex Wireless USA employs programs for neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS).

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.

The Compex Wireless USA device stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.

The device system is made up of a remote control. 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.

The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.

The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.

The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band.

It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings)

2. Send particular information from stimulation modules to remote control. like current stimulation level and stimulation module subsystem status,

3. Transfer binary data to stimulation modules, and

4. Allow synchronization from stimulation modules to remote control clocks.

The provided document is a 510(k) Summary for the Compex Wireless USA, a powered muscle stimulator. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance testing conducted. However, it explicitly states, "This submission does not contain clinical data." This means there is no study described in this document that proves the device meets specific acceptance criteria based on clinical outcomes or efficacy in human subjects.

Therefore, the response below will focus on the technical and safety acceptance criteria demonstrated by the performance testing, as clinical efficacy data is not present in the provided text.

Acceptance Criteria and Device Performance for Compex Wireless USA (K170903)

The Compex Wireless USA device, a powered muscle stimulator, demonstrates its compliance with acceptance criteria primarily through non-clinical performance testing related to electrical safety, electromagnetic compatibility, software validation, usability, and wireless coexistence. There is no clinical study information provided in this document to demonstrate the device meets acceptance criteria related to its intended physiological effects (e.g., muscle performance improvement or pain relief).

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not provide details on the sample sizes for the test sets used in the performance testing (Electrical Safety, EMC, FCC, Software, Usability, Wireless Coexistence). It also does not specify the country of origin of the data or whether the data was retrospective or prospective. These are typically technical bench tests or simulations rather than human subject studies.

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

Since the "studies" described are technical performance tests (e.g., electrical safety, EMC, software validation, usability), the concept of "ground truth" established by human experts in a clinical context is not applicable. For these technical tests, compliance is typically determined by accredited testing laboratories and engineers following the specifications of the relevant international and national standards. While these individuals are "experts" in their respective fields (e.g., electrical engineering, software engineering, human factors engineering), they are not referred to in the context of clinical ground truth or adjudication.

4. Adjudication Method for the Test Set

Not applicable, as the "studies" are technical performance tests based on compliance with established standards, not diagnostic or outcome-based clinical evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This submission does not contain clinical data." Therefore, there is no information on human readers, AI assistance, or effect sizes related to clinical performance. The focus of this submission is on demonstrating substantial equivalence based on technical specifications and non-clinical performance and safety.

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

The device is a physical powered muscle stimulator with TENS and NMES capabilities, not an algorithm, AI, or diagnostic software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The document describes the technical performance and safety of the device itself and its integrated software.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described is compliance with established engineering and medical device standards (e.g., IEC 60601 series, ISO 14971, FCC regulations). This is a form of technical or regulatory compliance ground truth, rather than expert consensus, pathology, or outcomes data related to clinical efficacy.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves its design, manufacturing, and calibration processes, guided by engineering principles and standards, not a data-driven machine learning approach.

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

Not applicable for the reasons stated in point 8.

Ask a specific question about this device

Prescription Use:
The Strive™ TENS device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.

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
• Relief of pain associated with arthritis

Over the Counter Use:
The Strive™ TENS device is used for:
-temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
-the symptomatic relief and management of chronic, intractable pain associated with arthritis.

The Strive device is a handheld Transcutaneous Electrical Nerve Stimulation (TENS) unit which delivers electrical pulses transmitted by electrodes to cutaneous (surface) and afferent (deep) nerves of the body for pain management. The device provides simple user interface and programming, and is aimed to be used with lead wires and electrodes. Strive will be marketed as either Prescription (RX for U.S. Only) or Over-the-Counter (OTC), with each configuration having its own set of labeling, as appropriate.

The Strive device utilizes electrodes which are single patient use only. The device embeds a rechargeable battery that cannot be removed. The device is inoperable while the battery is charging.

This document is a 510(k) summary for the Strive™ Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's characteristics and compares them to predicate devices to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" paired with "reported device performance" in a single table format. Instead, it presents performance testing results against recognized standards and claims substantial equivalence to predicate devices. The comparisons provided in Tables 1a, 1b, 2, 3, and 4 effectively serve as the device's reported performance against established benchmarks (predicate devices' specifications and general standards for TENS devices).

Here's a synthesized table based on the information provided, focusing on the Strive device's performance against relevant standards and the finding of substantial equivalence:

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

The document does not specify the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any of the performance tests (Electrical Safety and EMC, Software Verification, Usability/Human Factors, Coexistence Testing). These types of tests typically involve testing the device itself or a representative number of devices, rather than a clinical dataset of patients.

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)

The document does not mention the use of experts to establish a "ground truth" for any test sets in the way that would apply to diagnostic imaging or clinical trials. The tests performed are primarily engineering and simulated user environment tests.

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

No adjudication method is mentioned or implied, as the nature of the tests (electrical safety, software verification, usability, coexistence) does not typically involve human adjudication of results in the way a clinical study or expert review of images would.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a TENS unit for pain relief, not an AI-assisted diagnostic or interpretation device that would involve human "readers."

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

This question is not applicable. The Strive™ device is a medical device (TENS unit) that delivers electrical stimulation. It does not employ an "algorithm" in a diagnostic or interpretive sense that would operate "standalone" versus "human-in-the-loop." Its performance is about its physical outputs and safety, not an interpretive algorithm.

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

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not applicable here. The "truth" for the performance tests mentioned (electrical safety, software, usability, coexistence) is conformance to the specified standards or design requirements.

8. The sample size for the training set

This question is not applicable. The Strive™ device is a TENS unit, not an AI/machine learning model that requires a "training set."

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

This question is not applicable, as there is no training set for this device.

Ask a specific question about this device

The Chattanooga Revolution Wireless is a clinical electrotherapy device intended for use under the supervision of a Healthcare Professional.

Indications for Use:

As an NMES device, indications are for the following conditions:

• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation
• Prevention of venous thrombosis of the calf muscles immediately after surgery

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

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical and post-trauma acute pain

As a pulsed mode device, indications are for the following conditions:

• Relaxation of muscle spasm
• Increasing local blood circulation
• Retardation or prevention of disuse atrophy
• Maintenance or increase of range of motion

The Chattanooga Revolution Wireless is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Chattanooga "Revolution Wireless stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles.

The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.

The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.

The Chattanooga® Revolution Wireless stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450 [mAh] battery.

The docking station is the part on which all the other components (modules, remote and accessories) are stored when the Chattanooga Revolution Wireless system is not in use. The docking is continuously connected to an AC wall socket and it allows charging simultaneously the 4 stimulation modules and the remote control. The docking main part is intended to be fixed and not for transportation purposes, but the tablet may be removed and used as a portable charging station for the remote and modules. The docking station includes a removable tray where the user can store electrodes, quick start guide, the remote and modules for transportation.

The wireless protocol of the Chattanooga® Revolution Wireless Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to

1. Send particular information from remote control to stimulation modules (stimulation settings)

2. Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status,

3. Transfer binary data to stimulation modules, and

4. Allow synchronization from stimulation modules to remote control clocks.

The provided documentation describes the Chattanooga Revolution Wireless, a powered muscle stimulator and transcutaneous electrical nerve stimulator (TENS) device. The information details the device's characteristics, indications for use, comparison to a predicate device (Vectra Neo), and performance testing conducted for its 510(k) premarket notification.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table format with pass/fail values. Instead, the document discusses compliance with recognized standards and successful completion of various tests. The reported device performance is presented as a confirmation of compliance.

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

The document does not specify the sample sizes used for any of the performance tests (e.g., electrical safety, software verification, usability). There is also no mention of data provenance (e.g., country of origin, retrospective/prospective). The tests described are primarily engineering verification and validation studies rather than clinical trials with human participant data.

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

Given that the performance testing primarily involves engineering compliance with standards and functional verification, the concept of "ground truth" established by experts in the clinical sense (e.g., radiologists interpreting images) is not applicable here. The "ground truth" for these tests would be the specifications outlined in the recognized standards themselves, and the expertise would lie with the engineers and testers performing the measurements and assessments against those standards. No specific number or qualifications of such experts are provided beyond implied expertise in regulatory and engineering compliance.

4. Adjudication Method for the Test Set

As the studies described are compliance-based engineering tests and not clinical studies requiring expert consensus on complex outcomes, an explicit adjudication method like "2+1" or "3+1" is not mentioned or relevant. Compliance is typically determined by whether the device's performance meets the defined parameters of the relevant standards.

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

No MRMC comparative effectiveness study is mentioned. The device is a physical therapy device (stimulator), and the evaluation focuses on its safety and performance against established standards and a predicate device, not on assessing the improvement of human readers (e.g., doctors interpreting scans) with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The device itself is a physical medical device, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable. The performance studies are for the integrated device system.

7. Type of Ground Truth Used

The "ground truth" for the performance testing is implicitly defined by:

• Recognized Standards: Such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 62366, IEC 62304, ISO 14971.
• Design Requirements: For the software verification and usability testing, the device's own design requirements serve as the ground truth against which performance is measured.
• FCC Regulations: For radio frequency compliance.

There is no mention of pathology, clinical outcomes data, or expert consensus (in a diagnostic context) as ground truth.

8. Sample Size for the Training Set

This information is not provided. The document describes premarket notification for a physical medical device, not an AI/ML product that typically involves a "training set." The software verification mentioned refers to traditional software engineering verification, not machine learning model training.

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

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable to the provided document. The ground truth for the device's design and functionality is established through engineering specifications, regulatory standards, and intended use definitions.

Ask a specific question about this device

For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.
Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction

The VitalStim® Plus Electrotherapy System is a 2 Channel EMG and 4 Channel electrotherapy system used in treating patients with Oropharyngeal Dysphagia and disorders of the head and neck, with Bluetooth connection to PC software.

Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/algorithm-based device. Therefore, many of the requested points, especially those related to AI system validation (e.g., sample size for test datasets, expert ground truth, MRMC studies), are not applicable to this type of submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for an electrotherapy system, mainly through bench testing and technical comparisons, rather than clinical performance studies against a "ground truth" derived from expert consensus or pathology, as would be common for AI-driven diagnostic tools.

Acceptance Criteria and Device Performance (for an Electrotherapy System)

Since this is an electrotherapy system and not an AI/algorithm, the "acceptance criteria" are related to safety, electrical performance, and electromagnetic compatibility. The "reported device performance" demonstrates compliance with these standards.

Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The Compex Wireless USA may therefore be considered a technique of muscle training.

The Compex Wireless USA is a neuromuscular electrical stimulation (NMES) device, which stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.

The device system is made up of a remote control, 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.

The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.

The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.

The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band. It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings) 2) Send particular information from stimulation modules to remote control, like current stimulation level and stimulation module subsystem status, 3) Transfer binary data to stimulation modules, and 4) Allow synchronization from stimulation modules to remote control clocks.

The provided text describes the Compex Wireless USA device, its indications for use, and a comparison to a predicate device (Compex Sport Elite) for 510(k) clearance. However, it does not contain the acceptance criteria or results of a study that proves the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, or other clinical efficacy metrics as would be expected for an AI/ML or diagnostic device.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Identical Indications for Use.
• Similar technological characteristics in terms of basic device attributes and output specifications.
• Performance testing related to electrical safety, electromagnetic compatibility, FCC radio frequency, software verification, usability/human factors, and wireless coexistence, all against applicable standards.

Therefore, for the information requested in your prompt, I can only provide what is available in the text, which mainly pertains to regulatory compliance and safety/performance against engineering standards, not clinical performance or artificial intelligence specific metrics.

Here's an analysis of the provided text in response to your questions:

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

The document does not present clinical acceptance criteria (e.g., accuracy, sensitivity, specificity) for a specific diagnostic task or AI performance. Instead, the "acceptance criteria" are implied by compliance with various regulatory and engineering standards, and performance testing confirming functionality and safety.

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

The document does not describe a clinical test set or data provenance in the context of typical AI/ML or diagnostic device studies (i.e., patient data, images, etc.). The mention of "Performance Testing" refers to engineering and software validation, not clinical validation on a patient cohort.

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)

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

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

This is not applicable as there is no described clinical test set or adjudication 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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a muscle stimulator, not a diagnostic imaging device with human readers.

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

This is not applicable in the sense of an AI algorithm making a diagnosis or prediction. The device itself is "standalone" in its operation of muscle stimulation, controlled by the user.

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

For the engineering and software validation tests performed, the "ground truth" would be the expected behavior and specifications defined by the design requirements and industry standards. For example, for "Software Verification," the ground truth is that the software performs its functions as designed. For "Electrical Safety," the ground truth is that the device passes specific tests outlined in the relevant IEC/AAMI standards. These are not clinical ground truths like pathology or outcomes data.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the common sense of machine learning.

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

This is not applicable.

In summary: The provided FDA 510(k) clearance document for the Compex Wireless USA is for a traditional medical device (a powered muscle stimulator). It demonstrates substantial equivalence to a predicate device and compliance with safety and performance standards through engineering tests. It does not present clinical performance data, AI/ML algorithm validation, or studies involving human readers, test sets, or ground truth establishment in the context of diagnostic or AI-powered devices.

Ask a specific question about this device

For VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)

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

Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HAN

• Symptomatic relief or management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

For DC Continuous Mode

• Relaxation of muscle spasm

For FES

• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait

For EMG triggered Stim

• Stroke rehab by muscle re-education
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increase local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion

For EMG

• To determine the activation timing of muscles for:
• Retraining of muscle activation
• Coordinating of muscle activation
• An indication of the force produced by muscle for control and maintenance of muscle contractions
• Relaxation muscle training
• Muscle re-education

For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

• Relief of pain, muscle spasms and joint contractures
• Relief of pain, muscle spasms and joint contractures that may be associated with :
• -Adhesive capsulitis
• Bursitis with slight calcification
• -Myositis
• Soft tissue injuries
• Shortened tendons due to past injuries and scar tissues
• Relief of sub-chronic and chronic pain and joint contractures resulting from:
• Capsular tightness
• Capsular scarring

For Infrared Lamp (laser)
To provide topical heating for the following:

• Temporary increase in local blood circulation
• Temporary relief of minor muscle and joint aches, pains and stiffness
• Relaxation of muscles
• Temporary relief of muscle spasms
• Temporary relief of minor pain and stiffness associated with arthritis

The Vectra Neo Clinical Therapy System is an electrotherapy product offering clinicians a modular design of muscle stimulation, ultrasound, laser and biofeedback modalities in one combination device. The Vectra Neo Clinical Therapy System is designed to give the most treatment options in one compact and integrated package.

The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides three storage drawers to conveniently house clinical essentials. The leadwire management system allows for easy, quick access in an uncluttered arrangement.

The electrotherapy module offers 12 waveforms: Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), Microcurrent, VMS, VMS Burst, VMS FR, Russian, High Voltage Pulsed Current, Symmetrical Biphasic (TENS), Direct Current, and HAN (TENS). The Vectra Neo Clinical Therapy System allows to sequence these waveforms for ease of use.

The Neo ultrasound module is dual frequency (1 MHz and 3.3 MHz) with selectable duty cycles of 10%, 20%, 50% and 100%, low BNR (5.0:1) {FDA method of measurement), pulse frequency 100Hz and selectable pulse durations of 1 mSec, ±20%; 2 mSec, ±20%; 5 mSec, ±20%.

The laser therapy module is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relaxation of muscles, temporary relief of muscle spasms, temporary relief of minor pain and stiffness associated with arthritis.

The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto a USB Thumb Drive. The sEMG features a clinician chosen trigger point that activates therapeutic stimulation. The sEMG feature is often used to treat stroke patients and for muscle re-education.

Online guided assistance is provided through Clinical Protocol Setup and On-Screen Indications to help guide therapy selections for electrotherapy waveform rationale, parameter selections, electrode placement images, laser and ultrasound applicator recommendations.

Combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3.3 MHz Ultrasound can be combined with Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), VMS, VMS Burst, VMS FR and High Voltage Pulsed Current.

Acceptance Criteria and Study for Vectra Neo Clinical Therapy System

This document outlines the acceptance criteria and the study that demonstrates the Vectra Neo Clinical Therapy System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vectra Neo Clinical Therapy System are primarily based on its substantial equivalence to predicate devices, Vectra Genisys (K062354) and Vectra Genisys Laser System (Intelect XT Laser System) (K040662). This equivalence is demonstrated by meeting recognized consensus standards and showing comparable performance characteristics.

• Same fundamental technology.
• Intended for the same target population and clinical environments. | - Indications for Use: The Vectra Neo Clinical Therapy System has the same Indications for Use as the Vectra Genisys (K062354) for electrotherapy (VMS, Russian, Monophasic Hi-Volt, Interferential, Premodulated, Microcurrent, TENS, HAN, DC Continuous Mode, FES, EMG triggered Stim, EMG) and Ultrasound. It also has the same Indications for Use as the Vectra Genisys Laser System (K040662) for Infrared Lamp (laser).
• Fundamental Technology: The device uses the same fundamental technology as the predicate devices, simply combining their functionalities.
• Target Population/Environment: Intended to be used by the same target population and in the same clinical environments. |
  | Safety and Performance (Bench Testing & Compliance) | - Compliance with relevant FDA-recognized international consensus standards for medical electrical equipment, ultrasonic physiotherapy, nerve and muscle stimulators, and laser safety.
• Software validation meeting FDA guidance.
• Usability validation demonstrating safe and effective use.
• Biocompatibility for patient-contacting accessories.
• Outputs (waveforms) comparable to predicate devices. | - Standards Compliance: The device was tested and found to comply with:
  • IEC 60601-1 (basic safety & essential performance)
  • IEC 60601-1-2 (EMC)
  • IEC 60601-2-5 (safety of ultrasonic physiotherapy equipment)
  • IEC 60601-2-10 (performance of nerve and muscle stimulators)
  • IEC 60601-2-22 (safety & performance of surgical, cosmetic, therapeutic & diagnostic laser equipment)
  • IEC 60601-2-57 (safety & performance of non-laser light source equipment)
  • IEC 60825-1 (safety of laser products)
• Software Validation: Software was validated per FDA guidance (May 11, 2005); tests demonstrated software meets design requirements.
• Usability Study: A Summative Validation study supported instructions for use and substantiated acceptability of risks.
• Biocompatibility: Evaluation per ISO 10993-1:2009 – Annex C for new accessories (Patient Remote) and equivalence to predicate materials for others, indicating safety.
• Outputs: Bench performance testing demonstrated the same waveforms and other outputs as predicate devices, passing all verification and validation activities. |
  | Minor Differences Impact | - Minor differences (e.g., user interface, updated components) do not raise new issues of safety or effectiveness and do not affect performance or efficacy. | - User interface simplified (16 buttons to 2 buttons + touchscreen), updated modern components, slightly modified outputs.
• These differences are minimal, do not affect performance or efficacy, and could only improve device safety.
• Bench testing confirmed comparable performance despite these changes. |

The study supporting these criteria involves a combination of engineering analysis, software validation, usability testing, biocompatibility assessment, and extensive bench performance testing against recognized standards and predicate device characteristics.

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

The provided 510(k) summary does not detail specific "test set" sample sizes in terms of patient data or clinical trials, as it's a device substantially equivalent to existing predicates.

• Test Sets:

  • Software Validation: The summary states "The software validation tests demonstrated that the software version meets its design requirements." This implies a set of test cases for software functionality, but the number of test cases or the data used for these tests is not quantified.
  • Usability Study: A "Summative Validation" usability study was conducted. Details on the number of participants or specific scenarios are not provided.
  • Bench Performance Testing: The summary mentions "Bench performance testing has demonstrated that the Vectra Neo Clinical Therapy System has the same waveforms and other outputs as the predicate devices and has passed all verification and validation activities." This would involve testing specific device parameters (e.g., BNR, ERA, frequencies, output power for ultrasound applicators, and various waveform outputs for electrotherapy) against their specifications and comparison with predicate data. No specific sample size for these tests (e.g., number of devices tested, number of measurements taken) is given, but it is implied to be sufficient for verification and validation.
  • Biocompatibility: For new accessories like the Patient Remote, a literature review was conducted and compared to existing predicate device materials. This is a review-based approach rather than a direct physical 'test set' sample size.

• Data Provenance: Not applicable in the context of a substantial equivalence submission relying primarily on bench testing, software validation, and a usability study for a therapy system. The data is generated internally by the manufacturer through testing and development processes. It is generally prospective relative to the device development but not retrospective clinical data. The document does not mention any country of origin for clinical data as no clinical trials were presented.

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

• Software Validation: Ground truth is established by the documented software design requirements and specifications, which are typically developed by qualified software engineers and systems engineers. The number of such experts is not specified.
• Usability Study: A "Usability Study" was conducted. The "ground truth" for usability is typically established via human factors engineering principles and user feedback (often healthcare professionals or simulated patients). The number and qualifications of experts involved in designing the study, observing users, and interpreting results are not provided.
• Bench Performance Testing: The "ground truth" for technical performance parameters (e.g., BNR, ERA, waveform output) is established by recognized international standards (e.g., IEC 60601 series, IEC 60825-1) and the specifications of the predicate devices. The engineers and technicians conducting these tests are qualified in electrical engineering, biomedical engineering, and quality assurance. Their specific number and detailed qualifications are not disclosed in the summary.
• Biocompatibility: The "ground truth" for biocompatibility is established by ISO 10993-1:2009. Experts in material science and toxicology would be consulted or involved in the literature review process to assess material safety.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for interpretation of imaging or clinical endpoints by multiple readers. This type of adjudication is not applicable to the testing performed for the Vectra Neo Clinical Therapy System as described in the 510(k) summary. The testing consists of:

• Software Validation: Automated and manual testing against documented requirements.
• Usability Study: Observation and data collection from users performing tasks, with analysis against predefined success criteria. Not an adjudication of a clinical outcome.
• Bench Testing: Objective measurements against engineering specifications and international standards.

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

No MRMC comparative effectiveness study was performed or cited in this 510(k) submission. MRMC studies are typically done for diagnostic imaging devices where multiple human readers interpret cases, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy, sensitivity, and specificity. The Vectra Neo Clinical Therapy System is a therapeutic device, not a diagnostic one, and its equivalence was established through technical and performance comparisons with predicate devices and compliance with safety standards, rather than through comparative clinical effectiveness studies with human readers.

6. Standalone Performance Study

Yes, standalone performance (i.e., algorithm only without human-in-the-loop performance) studies were done for various aspects of the device:

• Software Validation: The software was validated as a standalone component to meet its design requirements.
• Bench Performance Testing: The device's various modules (electrotherapy, ultrasound, laser) were tested for their inherent performance characteristics (e.g., waveform accuracy, output power, BNR, ERA) against specifications and international standards. This demonstrates the device's capability to operate as intended independent of human interaction for its core therapeutic functions.
• Biocompatibility: The materials used in patient-contacting accessories were evaluated in standalone fashion (via literature review and comparison to established materials).

7. Type of Ground Truth Used

The ground truth used for demonstrating the device's performance and safety is multifaceted:

• Predicate Device Specifications: The technical specifications and established safety/efficacy profiles of the Vectra Genisys (K062354) and Vectra Genisys Laser System (K040662) serve as a primary ground truth for equivalence.
• International Consensus Standards: Recognized standards such as the IEC 60601 series, IEC 60825-1, and ISO 10993-1 provide objective, independently established ground truth for safety, essential performance, and biocompatibility.
• Internal Design Requirements: For software and specific hardware functions, the manufacturer's own detailed design requirements and specifications served as the ground truth for verification and validation.

No pathology, clinical outcomes data, or expert consensus (in the sense of clinical diagnostic agreement) was explicitly used or required for this 510(k) submission, as it relies on substantial equivalence to previously cleared devices through technical and performance testing.

8. Sample Size for the Training Set

Not applicable/Not mentioned.

The Vectra Neo Clinical Therapy System is a physical therapy device and not an AI/ML-driven diagnostic or predictive algorithm that typically requires a "training set" of data to learn patterns. The summary describes a system with pre-programmed waveforms, fixed ultrasound parameters, and biofeedback capabilities. There is no indication of machine learning or adaptive algorithms that would require a distinct "training set" of data in the conventional sense.

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

Not applicable/Not mentioned.

As there is no mention of a "training set" for an AI/ML algorithm, the method for establishing its ground truth is not relevant to this submission. The "ground truth" for the device's functionality is established by its engineering design specifications, compliance with international standards, and comparison with predicate device performance, as detailed in section 7.

Ask a specific question about this device

Prophylaxis for Deep Vein Thrombosis (DVT) for use in a clinical setting or in the home.

The Aircast VenaFlow Elite System is a prescription only, intermittent pneumatic compression device designed to apply rapid inflation with graduated sequential compression to a patient's calf, thigh or foot for the purpose of assisting blood flow in the veins. This rapid inflation and graduated, sequential compression device accelerates venous velocity and enhances fibrinolysis.

The Aircast VenaFlow Elite System provides two different modes for inflation. The system defaults to Standard Operation which inflates the cuffs one leg at a time, alternating between the two legs once every 30 seconds. The cuffs inflate within less than 0.5 seconds. The system has an alternate S Mode which inflates both cuffs at the same time, once every 60 seconds. The cuffs inflate in approximately 10 seconds.

The Aircast VenaFlow Elite System provides the user with an option of battery operation in addition to operation from the mains power. The Aircast VenaFlow Elite System is easy to use and provides the user with several cuff type options: calf, thigh and foot as well as combined compression of any combination of two cuffs.

The Aircast VenaFlow Elite System is available in two configurations. The CLINICAL configuration is for medical facilities and offers the full range of accessories including cuffs, varying tube lengths, optional battery and replacement kits. The HOME configuration is for home use and is provided with simplified patient instructions and offers a specific set of accessories limited to calf cuffs and tubing.

The provided document is a 510(k) summary for a medical device (Aircast VenaFlow Elite System). It describes the device, its intended use, and indicates that performance data was collected. However, it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative sense as typically expected for diagnostic or AI-based devices.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes, specifically after a device modification. The performance data mentioned relates to risk assessment, usability, and electrical safety, not clinical efficacy or diagnostic accuracy with specific metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested sections about acceptance criteria, study sample sizes, ground truth, expert involvement, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it describes a different type of evaluation.

Here's a breakdown based on the available information:

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

This information is not provided in a quantitative table format suitable for performance metrics like sensitivity, specificity, or predictive values. The document states:

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

This information is not provided in the document. The FMEA and usability studies are mentioned but no specifics on participant numbers or data collection methods (retrospective/prospective) are given.

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):

This information is not provided. The usability study would likely have involved user participants, but they are not described as "experts" establishing a clinical "ground truth" for diagnostic purposes.

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

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This type of study is not applicable and was not done. The Aircast VenaFlow Elite System is an intermittent pneumatic compression device, not an AI-based diagnostic tool. Therefore, there are no "human readers" to improve with "AI assistance."

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

This is not applicable. The device is a physical medical device, not an algorithm, and its performance is inherently human-in-the-loop (the patient and potentially caregivers/clinicians).

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

For the safety and usability tests mentioned:

• FMEA: Ground truth would be established by risk assessment methodologies and potentially known failure modes of similar devices or components.
• Human Factors and Usability Study: Ground truth would be established by observation of user interaction, user feedback, and comparison against established usability heuristics or safety standards.
• Electrical Safety & EMC: Ground truth is defined by compliance with the referenced IEC standards (IEC 60601-1 and IEC 60601-1-2).

8. The sample size for the training set:

This is not applicable as this is a physical device, not an AI model requiring a training set.

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

This is not applicable.

Ask a specific question about this device

As an NMES device, indications are for the following conditions:

• Retarding or preventing disuse atrophy
• Maintaining or increasing range of motion
• Re-educating muscles
• Relaxation of muscle spasms
• Increasing local blood circulation

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
• Relief of pain associated with arthritis

As a pulsed current device, indications are for the following conditions:

• Reduction of edema (under negative electrodes)
• Reduction of muscle spasm
• Influencing local blood circulation (under negative electrode)
• Retardation or prevention of disuse atrophy
• Facilitation of voluntary motor function
• Maintenance of increase of range of motion

The Empi Phoenix is a multifunctional electrotherapy device indicated for retarding or preventing disuse atrophy, maintaining or increasing range of motion, and re-educating muscles. The Empi Phoenix device provides two channels of neuromuscular electrical stimulation (NMES), transcutaneous electrical stimulation (TENS) for pain management, and a pulsed DC Edema program to increase local blood circulation and reduce edema (swelling). These programs allow the patient to receive electrotherapy throughout the recovery cycle using a single device.

Its simplified programming makes the Empi Phoenix 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 begin therapy. The device may be used with conventional leadwires and electrodes. For NMES treatment, it also may be paired with the Empi Phoenix™ Thigh Garment (provided as an accessory), which is designed to make electrode placement and treatment of the knee/quadriceps easier for the patient and clinician.

The provided text describes the Empi Phoenix, a multifunctional electrotherapy device. However, it does not contain the specific details about acceptance criteria, a comprehensive study proving device performance against those criteria, or most of the requested information regarding sample sizes, expert involvement, and ground truth establishment.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria.

Here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

Missing Information:

The provided document is a 510(k) summary and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with detailed performance metrics against pre-defined acceptance criteria. Therefore, most of the requested information about a specific study proving the device meets acceptance criteria is not available in this document:

1. Sample size used for the test set and the data provenance: Not mentioned for any clinical performance testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not 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 as this is not an AI-based diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is not an AI-based diagnostic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned for any clinical performance claims. The "performance testing" described primarily refers to software validation and compliance with safety and compatibility standards, not clinical efficacy or diagnostic accuracy.
7. The sample size for the training set: Not applicable as this is not an AI-based device and no such training set would exist in this context.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "studies":

The document mentions three types of "performance testing":

1. Software Validation: "The device's software has been validated... The software validation tests demonstrated that the software version meets its design requirements." This confirms internal software functionality but doesn't relate to clinical outcomes.
2. Human Factors and Usability Study: "A Human Factors and Usability Study was conducted to validate the usability of the Empi Phonix device in the home environment. The results of the Summative Validation support the instructions for successfully using the device as intended." This relates to user interaction and safety in the intended environment.
3. Compliance with Standards: The device was tested and found to comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10. These are engineering and safety standards, not clinical efficacy studies.

The document does not detail any clinical studies (e.g., randomized controlled trials, prospective observational studies) to prove the device's clinical efficacy (e.g., specific reductions in pain or edema, or improvements in muscle function) against quantifiable acceptance criteria for its intended use indications. The basis for effectiveness appears to be primarily through substantial equivalence to predicate devices that already have established clinical use and regulatory clearance for similar indications.

Ask a specific question about this device