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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.

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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.

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The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

The Compex® Sport Plus is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The Compex® Sport Plus 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 various types of muscle work that the Compex® Sport Plus can impose on the stimulated muscles are able to improve or facilitate muscle performance.

The Compex® Sport Plus may therefore be considered a technique of muscle training.

The Compex® Sport Plus system consists of these components:

• 1x Stimulator
• 1x Wire Set
• 2x Small Performance Snap Electrode package .
• 2x Large Performance Snap Electrode package
• . 1x Fast Charger

These components are packaged together in a carrying case along with the user manual, belt clip and a battery charger.

The stimulator is a microprocessor controlled 4 channels neuro-muscular 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 stimulator is housed in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular.

The LCD is located on the upper half of the rectangular face of the device, above the keypad. The display is a graphic display capable of showing alpha numeric characters (including lower case characters), most standard ASCII symbols, and graphics appropriate to assist the user in selecting a desirable exercise routine. The LCD is used to display system information to the user.

The device is equipped with a keypad composed of push buttons which is located below the LCD. The function is defined by a symbol on the LCD corresponding to the button below.

Power for the device is provided from a 4.6 Volt rechargeable Ni-MH battery pack. The power source is housed behind an operator access panel on the back of the device cover.

Each lead wire will connect the output of the stimulator to the electrodes for each output channel. Each lead wire will be connected to the stimulator using a high friction, forced fitting, mechanically shielded connector. Electrode connection shall be a mechanically shielded snap connector (Compliant with protected lead wire and patient cable safety requirements).

Electrode configurations are made up of existing electrodes are configured for the intended use applications and may be unique to one or more application. Up to four Active/Passive sets of electrodes are required. Each electrode set requires a lead/connector assembly. The electrode connector shall be compatible with the cable connector. The electrode assembly shall be compliant with regulatory requirements.

The electrodes (non sterile electrodes) are applied parts which conform to the BF classification of the IEC60601-1 standard and the particular safety standard for nerves and muscles stimulators: IEC60601-2-10.

It is not possible to connect the stimulator to the charger at the same time as the lead wires. Connecting a charger to the stimulator results in an automatic start of the charging procedure which is indicated by a symbol on the LCD showing the status of the battery pack. The battery pack of the stimulator shall be charged by a switching adapter able to supply an output current of 1.4 A +/-100 mA and an output voltage of 9 VDC +/- 2%. The primary plug shall be of American 2 pin AC type able to handle input voltage from 90 to 240 VAC and at a maximum input current of 0.5 A. The secondary plug, to be attached to the stimulator, shall be a straight jack plug with the following dimensions, outer diameter: 3.5 mm, inner diameter: 1.3 mm and length: 9 mm. The charger shall have short circuit protection. Maximum dimensions of the charger shall be 72 x 52 x 35 mm.

Here's an analysis of the provided text regarding the Compex® Sport Plus device's acceptance criteria and studies:

Summary of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the device's acceptance criteria are primarily centered around its intended use and functional equivalence to predicate devices, rather than specific quantitative performance metrics. The document explicitly states the device is "substantially equivalent" to predicate devices, implying that its performance is expected to meet similar standards.

Study Information:

The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data to prove the device meets novel acceptance criteria. Therefore, most of the requested information about a dedicated study proving acceptance criteria is not present in this document.

Here's what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance: See the table above for inferred acceptance criteria (based on intended use and general safety/performance expectations for this type of device) and performance described.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. The document does not describe a specific clinical "test set" or clinical study with patient data for this device. The demonstration of safety and effectiveness appears to be primarily through engineering and biocompatibility testing (implied by adherence to standards like IEC60601-1) and the successful claim of substantial equivalence.
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/Not provided. Since there's no described clinical "test set" with ground truth determination, this information is not relevant to this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/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: Not applicable. This device is a muscle stimulator, not an AI diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical muscle stimulator and does not rely on an algorithm for standalone diagnostic performance in the way described for AI/diagnostic devices. Its "performance" is its ability to deliver specified electrical impulses and elicit muscle responses, which is implicitly demonstrated through its design consistency with predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. For substantial equivalence, the "ground truth" is often the well-established performance and safety profile of the predicate device, demonstrated through years of safe marketing.
8. The sample size for the training set: Not applicable/Not provided. This device is not an AI/machine learning device that requires a "training set" in the conventional sense for developing an algorithm.
9. How the ground truth for the training set was established: Not applicable/Not provided.

Conclusion:

The 510(k) submission for the Compex® Sport Plus primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices (Compex® Sport K011880 and Globus Premium Sport and fitness Muscle Stimulators K061632). This pathway to market clearance does not typically involve new clinical studies with "test sets," "ground truth," or "training sets" as would be seen for novel devices, especially those incorporating AI or new diagnostic methods. Instead, the focus is on showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicates. The descriptions of its programs and components serve to illustrate these similarities.

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"Compex® Sport" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

"Compex® Sport" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "Compex® Sport" training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The "Compex® Sport" electrical impulses allow triggering 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 various types of muscle work that "Compex® Sport" can impose on the stimulated muscles are able to improve or facilitate muscle performance. "Compex® Sport" may therefore be considered a technique of muscle training.

"Compex® Sport" is a portable, battery operated neuromuscular electrical stimulator. Equipped with four channels, it works with a rechargeable battery and offers an easy-to-read LCD display.

The acceptance criteria and the study proving the device meets them are described below:

1. Acceptance Criteria and Reported Device Performance

The provided document describes both the safety and effectiveness of the "Compex® Sport" device. Since this is a 510(k) submission, the primary acceptance criteria for the device are based on demonstrating substantial equivalence to a predicate device ("Compex® 2") and providing evidence of safe and effective use for its intended purpose.

While explicit, quantitative "acceptance criteria" are not presented in a typical table format for performance metrics in this 510(k) submission, the document details the safety and effectiveness as follows:

• Consumer complaints: 26 complaints, with only 3 related to reversible skin irritations (no serious physical injuries).
• Technical Safety Features: Biphasic rectangular impulses prevent electrochemical burns; programs start with nil intensity; four independent channels prevent power accumulation; constant current generator and "Electrode default" mechanism prevent skin burns/irritations.
• Measures to Prevent Misuse: Warnings (LCD, user manual, electrode packaging) for contraindications, off-label uses, electrode placement, deteriorated electrodes, and infection prevention. |
  | Effectiveness: Device effectively stimulates healthy muscles to improve/facilitate muscle performance. | - Mechanism of Action: "Compex® Sport" generates electrical impulses that trigger action potentials on motor nerve fibers, leading to mechanical muscle responses and various types of muscle work.
• Support from Peer-reviewed Articles: Efficacy for all proposed programs (Endurance, Resistance, Strength, Explosive Strength, Potentiation, Active Recovery) is supported by peer-reviewed scientific literature (referenced in Section 8.2.1-8.2.6 of the original 510(k) document, though not fully reproduced here).
• Specific Effectiveness Features: "Compex® Sport" Training Planner (CD-ROM) for appropriate use and high "space recruitment" of muscular fibers through specific technical features. |
  | Substantial Equivalence: Device is as safe and effective as a legally marketed predicate device. | - Technical Characteristics Comparison: Detailed table (Section 4.1) comparing "Compex® 2" (predicate) and "Compex® Sport" showing many 'same' characteristics (e.g., constant current generator, four independent channels, biphasic impulses, maximum current, battery, display type).
• Differences Justification: Minor differences in impulse width, maximum quantity of electricity, and pulse frequency range are explained and justified as not affecting safety or effectiveness for the new intended use (e.g., "Compex® Sport" doesn't need higher frequencies as it lacks TENS programs). |

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

The document does not describe a specific "test set" in the context of a formal clinical trial with a defined sample size for performance evaluation. Instead, the safety and effectiveness data are primarily based on:

• Post-market surveillance data: This involves the sales and complaint history of over 66,000 "Compex® Sport" devices already marketed in Europe.
• Data Provenance: Retrospective, post-market data from seven European countries (Switzerland, France, Italy, Belgium, Spain, Germany, and the Netherlands).

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

There is no mention of a "test set" for which ground truth was established by experts in the context of device performance metrics. The effectiveness claims are supported by peer-reviewed scientific articles (Section 8.2 of the 510(k) not fully detailed here). These articles would have their own methodologies for establishing ground truth regarding muscle performance changes, likely involving physiological measurements, but the number and qualifications of experts involved in those studies are not detailed in this submission.

4. Adjudication Method for the Test Set

Not applicable, as a specific "test set" for performance evaluation requiring adjudication of results is not described. The safety data relies on the direct reporting of consumer complaints to the manufacturer, followed by the manufacturer's internal investigation.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The device, "Compex® Sport," is a standalone physical product for muscle stimulation, not an AI or imaging diagnostic tool that would typically involve human readers interpreting cases.

6. Standalone Performance Study (Algorithm Only)

The "Compex® Sport" is a physical device, not an algorithm. Therefore, a standalone (algorithm only) performance study is not applicable. The core function of the device is to generate electrical impulses with specific parameters. Its "performance" is demonstrated through its technical specifications (Section 4.1) and the physiological effects those impulses are shown to produce, drawing on existing scientific literature.

7. Type of Ground Truth Used

The ground truth for the effectiveness claims is derived from peer-reviewed scientific literature (Sections 6.1 and 8.2 of the 510(k) submission). This literature supports the physiological effects of electrical muscle stimulation on various aspects of muscle performance (endurance, resistance, strength, etc.). For safety, the "ground truth" is defined by the absence of severe adverse events and the low incidence rate of minor complaints in the real-world usage of the device over several years.

8. Sample Size for the Training Set

Not applicable. This device is a physical product (neuromuscular electrical stimulator), not a machine learning model that requires a "training set."

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

Not applicable, as there is no "training set" for this device.

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