Search Results

sEMG:

Biofeedback, Relaxation & Muscle Re-Education purposes;

NMES (muscle stimulation) and sEMG triggered stimulation (Including ETS, PAS and MIRROR Mode):

1. Relaxation of muscle spasms;

2. Prevention or retardation of disuse atrophy;

3. Increasing local blood circulation;

4. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;

5. Maintaining or increasing range of motion;

6. Stroke Rehab by Muscle re-education.

The Nerve and Muscle Stimulator (model: XFT-2003K) is an electrical muscle stimulator for contraction of muscles as indicated above. The Nerve and Muscle Stimulator (model: XFT-2003K) is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle reeducation, relaxation and biofeedback.

Nerve and Muscle Stimulator (model: XFT-2003K) is powered by MAINS SUPPLY AC 100-240V, 50-60Hz, and used together with Electrode cup (including Sponge).

The device is used for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Nerve and Muscle Stimulator:

The provided document is a 510(k) Summary for a medical device (Nerve and Muscle Stimulator, model XFT-2003k) seeking substantial equivalence to a predicate device (MYOTRAC INFINITI, K053266). This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving its absolute safety and effectiveness through extensive new clinical trials.

Therefore, direct acceptance criteria and a "study that proves the device meets the acceptance criteria" in the traditional sense of a de novo device approval are not present in this document. Instead, the document provides a comparison to a predicate device and relies on adherence to recognized standards and the established safety and effectiveness of the predicate.

Here's a breakdown of the requested information based on the provided text, with explanations where direct answers are not available:

1. Table of acceptance criteria and the reported device performance

As mentioned, there are no explicit "acceptance criteria" presented as specific performance metrics and thresholds for the subject device to meet independently. The core of this 510(k) submission is to demonstrate substantial equivalence to the predicate device. The "performance" reported is primarily in terms of compliance with recognized electrical safety, EMC, and biocompatibility standards, and a detailed parameter-by-parameter comparison with the predicate device.

Here's a table summarizing the reported device performance in relation to the predicate, as presented in the "SE Comprehensive Comparison Table" and "SE General Specification Comparison Table":

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

• Sample size for test set: Not applicable (N/A). The submission explicitly states "Brief discussion of clinical tests: N/A." The evaluation is based on non-clinical testing (bench testing, standards compliance) and a comparison to a predicate device, not on a clinical test set from a study.
• Data provenance: N/A for clinical data. Non-clinical testing data would be generated in Shenzhen, China (manufacturer's location).

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)

• Number of experts and qualifications: N/A. No clinical test set with human-established ground truth was used. The ground truth for substantial equivalence is derived from the predicate device and established medical device standards.

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

• Adjudication method: N/A. No clinical test set was used requiring adjudication.

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

• MRMC study: N/A. This is an electrical stimulator, not an imaging device with human readers or AI assistance in the way typically discussed for MRMC studies.

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

• Standalone performance: The assessment for this device is essentially "standalone" in that it's the device's technical specifications and electrical outputs being compared to standards and the predicate. There isn't an "algorithm-only" component as might be found in AI/ML submissions. Its performance is evaluated on its inherent properties and safety characteristics.

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

• Type of ground truth: The "ground truth" in this 510(k) context is the established safety and effectiveness of the legally marketed predicate device (Thought Technology Ltd. MYOTRAC INFINITI, K053266) and adherence to recognized performance and safety standards for powered muscle stimulators (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993). The "truth" is that the predicate is safe and effective for its intended use, and the new device is substantially equivalent if it meets similar technical specifications and standards.

8. The sample size for the training set

• Sample size for training set: N/A. There is no mention of a training set for an algorithm, as this device is a hardware-based electrical stimulator, not an AI/ML device.

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

• How ground truth for training set was established: N/A. No training set was used.

In summary: The provided document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device, not to prove de novo safety and effectiveness through clinical trials. Therefore, many of the questions related to clinical studies, test sets, ground truth establishment by experts, and AI performance are not applicable to this type of regulatory submission as presented. The "study" that proves the device meets the (implied) acceptance criteria is the non-clinical testing demonstrating compliance with relevant international safety and performance standards (e.g., IEC 60601 series, ISO 10993) and the detailed comparison of its technical specifications to those of a legally marketed predicate device.

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Nerve and Muscle Stimulator (Model: XFT-2001EA) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the Nerve and Muscle Stimulator (Model: XFT-2001EA) electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.

Nerve and Muscle Stimulator (Model: XFT-2001EA) is a wearable and DC 3.7V rechargeable lithium battery powered multifunction device, and integrated metal (stainless-steel) electrodes, offering Functional Electrical Stimulation (FES) in device. It can be attached to the leg just below the knee, near the head of the fibula. During a gait cycle, the Nerve and Muscle Stimulates the common peroneal nerve via metal electrode, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.

The Nerve and Muscle Stimulator is a microprocessor-controlled device, and uses a smart phone operating application (APP) to store device, user and configuration information via Bluetooth. it can be operated by both smart phone application and the control panel of the device.

Nerve and Muscle Stimulator has 3 working mode, Walk Mode, Training Mode and Evaluation Mode. The walk mode and training mode which can give certain electrical pulses through metal electrode to the proposed area of the leg where the Nerve and Muscle Stimulator are placed. There is no electrical stimulation in the evaluation mode, it is intended to collect the tilt angle data generated by the Stimulator during the patient's walking, and can calculate the recommend parameters based on the collected data.

The control panel of the device has the operating elements of ON/OFF touch button, OLED display, mode selection touch button, intensity touch button and USB port for battery charging. The OLED display can show battery power, selected mode, current intensity and indication of a pause.

The stimulator will connect the APP via Bluetooth, user can set the parameters, mode selection, and intensity adjustment of the stimulation by APP. Logout of the APP or disconnect the Bluetooth, the stimulator can continue to work.

This FDA 510(k) summary is for a medical device (Nerve and Muscle Stimulator, Model: XFT-2001EA) seeking clearance based on substantial equivalence to a predicate device (XFT-2001D). The document primarily focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing a detailed study proving it meets specific clinical or diagnostic acceptance criteria for a novel functionality.

Given the nature of a 510(k) submission for substantial equivalence where clinical data is often not required for device performance, the document relies heavily on comparison to a predicate device and compliance with established electrical, biocompatibility, and performance standards. It does not contain information typically found in a clinical study report that would establish specific acceptance criteria for diagnostic performance or treatment efficacy.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, ground truth establishment for test/training sets, adjudication methods, MRMC studies, standalone performance) are not present in this type of regulatory submission. The document focuses on bench testing and comparisons to established safety and performance parameters rather than human-centric performance metrics.

However, I can extract the relevant information regarding acceptance criteria and the "study" (which in this context refers to non-clinical testing performed for regulatory clearance) that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds within the document, but are implicitly defined by compliance with specified international and national standards, and by showing equivalence or acceptable differences compared to the predicate device. The "reported device performance" is largely demonstrated through successful completion of these compliance tests.

Detailed Breakdown of Requested Information (based on the provided document):

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

   • Acceptance Criteria: As detailed in the table above, the acceptance criteria are largely defined by compliance with specific international and national standards (e.g., IEC 60601 series, ISO 10993 series, ANSI/IEEE C63.27, FCC regulations) and by the demonstration that any differences from the predicate device do not raise new safety or effectiveness concerns.
   • Reported Device Performance: The reported performance is the successful passing of all listed non-clinical tests based on these standards and the justification for differences from the predicate.

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

   • This document describes non-clinical bench testing. It does not involve a "test set" in the context of patient data. Therefore, sample size, data provenance, and retrospective/prospective nature are not applicable or detailed for human-subject data. The "test sets" would refer to the specific units of the device models (XFT-2001E, XFT-2001EA) used for the various bench tests.

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. This is a 510(k) submission for a non-diagnostic, therapeutic device, and the clearance is based on non-clinical testing and substantial equivalence, not on expert-adjudicated performance against a "ground truth" derived from patient data. The "ground truth" here is compliance with engineering and biocompatibility standards, assessed by testing laboratories.

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

   • Not applicable. There is no human-reader adjudication for performance of this device in this submission.

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

   • Not applicable. This device is a nerve and muscle stimulator, not an AI-powered diagnostic tool. No MRMC study was performed or mentioned.

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

   • The "standalone performance" in this context refers to the device itself meeting the performance and safety standards through bench testing. The document states that the proposed device "passed safety testing" and "passed biocompatibility tests" and "conducted and passed performance testing-bench." This directly addresses the standalone performance of the physical device.

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

   • The "ground truth" for this regulatory submission is compliance with established international and national medical device safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, FCC regulations) and FDA guidance for similar devices. It is based on objective, quantifiable measurements performed during bench testing by accredited laboratories and assessed against the requirements of these standards.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning device that requires a training set in the conventional sense.

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

   • Not applicable, as there is no training set for an AI/machine learning algorithm described in this submission.

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Over-The-Counter Use: TENS[ (Program 19, Program 15 (Frequency 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. NMES[ (Program 1014, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities. Prescription Use: XFT-2000 is intended for the following use: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).The instrument has two independent channels, easy to operate and use. It can relieve muscle spasm, prevent or delay disuse muscle atrophy, promote local blood circulation, promote muscle function recovery, stimulate calf muscle after surgery to prevent venous thrombosis and maintain or increase the range of activity, and assist in the management of post-operative and post-traumatic acute pain problems. Nerve and Muscle Stimulator (model: XFT-2000) is powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode. The device is for both prescription and over the counter. It is neither for lifesupporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nerve and Muscle Stimulator (model: XFT-2000), extracted from the FDA 510(k) summary (K193275).

It's important to note that this document is a 510(k) summary for substantial equivalence, not a detailed clinical study report. Therefore, some information, especially regarding specific clinical study methodologies, may be absent or generalized.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to predicate devices (K082011 and K162517) through compliance with recognized consensus standards and by showing that any differences do not affect safety or effectiveness. The reported device performance is presented as compliance with these standards and a detailed comparison of technical parameters to the predicate devices.

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

• Sample Size for Test Set: The document explicitly states "N/A" for clinical tests (Section 5.8). The evaluation primarily relies on non-clinical tests demonstrating compliance with recognized standards and a comparison of technical specifications to legally marketed predicate devices. Therefore, there isn't a "test set" here in the sense of patient data used for performance claims.
• Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to the technical specifications of the device itself and the predicate devices. This information is derived from the device's design and engineering specifications, and the publicly available information for the predicate devices (K082011, K162517). The manufacturer is Shenzhen XFT Medical Limited in China.

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

Not applicable. As noted above, no clinical "test set" with ground truth established by experts was conducted for this 510(k) submission. The performance comparison is based on engineering specifications and adherence to international standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was conducted.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device (Nerve and Muscle Stimulator) is a physical therapy device and not an AI-powered diagnostic or interpretive tool that would involve "human readers" or AI assistance in the way typically seen in imaging or other diagnostic fields. No MRMC study was mentioned or performed.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its electrical and mechanical design, validated through compliance with engineering standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is established through compliance with international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5, ISO 10993-10) and through demonstrating that its technical specifications and intended uses are substantially equivalent to legally marketed predicate devices whose safety and effectiveness have already been established. The comparison relies on documented device parameters and publicly available information for the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an algorithm or AI system that learns from data.

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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XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Stimulation (FES) may include prevention/retardation of disuse attophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.

Nerve and Muscle Stimulator (Foot Drop System) is a battery-operated, electrical stimulator that can be used for functional electrical stimulation (FES). Nerve and Muscle Stimulator (Foot Drop System) is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, Nerve and Muscle Stimulator (Foot Drop System) stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The Nerve and Muscle Stimulator (Foot Drop System) consists of the Patient Kit and the Clinician Kit. The Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System includes the Medical Records Management Software.

The provided text is a 510(k) summary for the XFT-2001D Foot Drop System, which seeks to demonstrate substantial equivalence to a predicate device (WalkAide, K123972). This document primarily details a comparison of the proposed and predicate devices' technical specifications and outlines the performance testing conducted to support safety and effectiveness. It does not present a study with specific acceptance criteria and reported device performance in the context of clinical efficacy or accuracy metrics for AI/ML-driven devices.

The "Performance Data" section (Page 10) focuses on regulatory compliance testing rather than clinical study results. It mentions:

• EMC and Electrical safety: Compliance with IEC 60601-1-2:2014, IEC 60601-1:2005, and IEC 60601-2-10:2012. These are standards for the basic safety and essential performance of medical electrical equipment, including electromagnetic disturbances and specific requirements for nerve and muscle stimulators.
• Biocompatibility: Evaluation of electrode pads (K132588) per ISO 10993-5:2009 (in vitro cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization).
• Software Verification and Validation: Conducted for a "MODERATE" level of concern software, following FDA guidance for software in medical devices.

Therefore, many of the requested elements for a deep dive into AI/ML study specifics (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this document.

However, I can still extract information based on the type of "acceptance criteria" and "study" described in the document, which are regulatory compliance focused.

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

1. Table of Acceptance Criteria and the Reported Device Performance

For this device, the "acceptance criteria" are compliance with established international standards for medical electrical equipment and software. The "reported device performance" indicates that the device met these standards.

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 document describes compliance testing for electrical safety, EMC, biocompatibility, and software V&V, which typically involve laboratory tests on devices and materials, not clinical "test sets" with patient data in the way an AI/ML diagnostic device would.

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 applicable for the type of testing described (regulatory compliance for an external functional electrical stimulator). Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes, which are not part of this submission's performance data.

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

This information is not applicable for the type of testing described.

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

An MRMC study was not done. This type of study is relevant for AI-assisted diagnostic or interpretive devices. The XFT-2001D is an external functional electrical stimulator, not an interpretive AI device.

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

A standalone performance study of an algorithm (in the context of AI/ML) was not done. The software V&V was conducted for the device's operational software at a "MODERATE" level of concern, indicating its impact on device function rather than a diagnostic performance.

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

For the specific performance data presented (EMC, electrical safety, biocompatibility, software V&V), the "ground truth" is defined by the standards themselves. For example, a device's electrical leakage current measurement must be below a certain threshold specified in IEC 60601-1. There isn't "ground truth" derived from patient outcomes or expert consensus in the way it's understood for AI/ML diagnostic tools.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML-driven diagnostic or predictive model in the context of the provided document. The software mentioned is for the device's operational control, not for "training" algorithms.

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

This information is not applicable as there is no "training set" in the context of an AI/ML model for this device's submission.

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