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The MyOnyx System is intended for use as a powered muscle stimulation device for relaxation of muscle spasms and muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

The MyOnyx System may also be used for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET) for the symptomatic relief of acute and chronic intractable pain.

The MyOnyx System is a multi-functional, palm-sized, 4-channel device with embedded firmware and accessories designed for use in physical therapy and rehabilitation under medical supervision. The system that is subject to this 510(k) provides pre-loaded programs and allows users to define programs for electrical muscle stimulation (EMS), transcutaneous electrical nerve stimulation (TENS), and microcurrent stimulation (MET).

Biofeedback and incontinence-related indications for use of the device have been cleared under K201014.

The device can send a gentle, clinician-adjustable electrical current to underlying nerves and muscles via off-the-shelf surface electrodes cleared by the FDA for this purpose. EMG signals may also be acquired using off-the-shelf, FDA-cleared surface EMG electrodes.

The device may be used for muscle and nerve stimulation in one of the following operating modes:

• . As a standalone device (autonomous mode); or
• . With the MyOnyx Mobile App running on an off-the-shelf tablet (remote control mode).

The device is operated via a graphical interface on an LCD screen and a capacitive touch pad with haptic and audio feedback. The connection to a tablet is wireless, via Bluetooth®. Visual, audio and voice feedback and prompts are provided to facilitate device operation.

Stimulation data are not recorded. When used in remote control mode, the device can record on the tablet root-mean-square (RMS) EMG signal data at 20 samples/s.

The device is powered by an internal rechargeable Li-ion polymer battery or via a medical grade power supply / battery charger. The internal battery offers up to 8 hours of autonomous device operation.

The MyOnyx System is a multi-functional, palm-sized, 4-channel device with embedded firmware and accessories designed for use in physical therapy and rehabilitation. It is intended for use as a powered muscle stimulation device and for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET).

Here's an overview of the acceptance criteria and the study performance for the MyOnyx System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provided details of verification and validation testing of system specifications, basic safety, and essential performance, conforming to recognized consensus standards.

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

The document does not specify a distinct "test set" in the context of clinical or performance data for AI/ML algorithms. The performance data section refers to "verification and validation testing of system specifications, basic safety and essential performance" conducted in conformance with recognized consensus standards. These are typically engineering and bench tests, not evaluations involving human subjects or clinical data in the way a diagnostic AI might be.

The provenance of data for these non-clinical tests would typically be from the manufacturer's internal testing labs. The document does not provide details on country of origin for any data or whether it was retrospective or prospective, as these are not relevant for the type of testing described (which is not a clinical study on diagnostic accuracy).

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

This information is not applicable to the provided document. The evaluation of the MyOnyx System primarily focused on engineering and performance standards (e.g., electrical safety, EMC, software reliability, usability) rather than clinical accuracy or diagnostic capabilities requiring expert-established ground truth. No experts for ground truth establishment are mentioned.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in clinical studies or studies evaluating the accuracy of AI algorithms against a reference standard with human expert disagreement. The tests described are engineering validations against predefined specifications and regulatory standards.

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

No. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence for this device type. The clinical literature supports the safety and clinical utility of the stimulation modes for the stated indications for use." Therefore, an MRMC comparative effectiveness study was not conducted or reported.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, in essence, the majority of the reported "Performance Data" represents a standalone evaluation of the device's technical specifications and compliance with standards. The tests such as "Electrical safety," "EMC," "Basic safety and essential performance of nerve and muscle stimulators," "Verification of hardware device controls and interfaces," "Software life-cycle processes," and "Stimulation firmware unit testing" are all evaluations of the device's inherent performance as an algorithm-driven system or hardware.

The usability testing (IEC 60601-1-6 / IEC 62366-1) involves human interaction but evaluates the device's interface and the safety of that interaction, not the diagnostic or therapeutic performance in a "human-in-the-loop" clinical decision-making context with an AI.

7. The Type of Ground Truth Used

For the engineering and performance tests, the "ground truth" is defined by the technical specifications outlined in the relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2) and the internal hardware and software design specifications of the MyOnyx System. The device's outputs and functionalities are measured and compared against these established technical criteria and limits.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of AI/ML or a clinical study. The device contains "embedded firmware" and "pre-loaded programs," which implies pre-determined algorithms and settings rather than adaptive AI models that undergo continuous training with a dataset.

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

This information is not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided document. The device uses pre-programmed logic for its stimulation modes.

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The MyOnyx System is indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the pelvic floor muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence.

The MyOnyx System includes a palm-sized, multi-functional, 4-channel device with embedded firmware and accessories designed for use under medical supervision to provide:

• electromyographic (EMG) biofeedback;
• pressure biofeedback from pelvic floor muscles;
• electrical stimulation (ES); and
• ES with EMG biofeedback (EMG-triggered stimulation or ETS).
  Up to two stimulation programs may run simultaneously. The device can send a gentle, clinician-adjustable electrical current via surface electrodes on purpose-designed probes. The specified off-the-shelf probes are suitable for EMG biofeedback and electrical stimulation. A small electronic pneumatic pump and pressure sensor device is used with a vaginal provide biofeedback from pelvic floor muscles.
  The MyOnyx device may be used in one of the following operating modes:
• as a standalone device for electrical stimulation only (autonomous mode); or
• with the MyOnyx Mobile App running on an off-the-shelf tablet for biofeedback, electrical stimulation and EMG-triggered stimulation (remote control mode); or
• with the company's BioGraph® Infiniti software running on a personal computer for biofeedback only (computerized mode).
  The device is operated via a graphical interface on an LCD screen and a capacitive touch pad with haptic and audio feedback. The connection to a tablet or personal computer is wireless, via Bluetooth". Visual, audio and voice feedback and prompts are provided to facilitate device operation on the standalone device, the MyOnyx Mobile App and the BioGraph® Infiniti software.
  When used in remote control mode for biofeedback or EMG-triggered stimulation, the device can record on the tablet root-mean-square (RMS) EMG signal and pressure data at 20 samples/s. Stimulation data are not recorded.
  When used in computerized mode, up to 4 devices may be connected to a personal computer for physiological data acquisition and biofeedback. In this mode, the device can record on the PC raw EMG and pressure data at 2048 samples/s. For use in this mode with the BioGraph® Infiniti software the device must be configured through a firmware parameter setting ('extended' configuration).
  The device is powered by an internal rechargeable Li-ion polymer battery or via a medical grade power supply / battery charger. The internal battery offers up to 8 hours of autonomous device operation.

The provided document, a 510(k) summary for the MyOnyx System (K201014), primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about a clinical study involving human participants or a multi-reader multi-case (MRMC) comparative effectiveness study, which would typically involve human experts for ground truth and evaluation of AI assistance.

Therefore, many of the requested details, such as sample size for test and training sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, and MRMC study effect sizes, are not present in this document because the device clearance was based on non-clinical engineering and performance testing rather than a clinical efficacy trial.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

The document provides a table outlining acceptance criteria for various non-clinical tests. The "Reported Device Performance" is generally stated as "Conformity to applicable requirements" or meeting specific design specifications. While the table clearly lists the acceptance criteria, the detailed quantitative results of the tests themselves are not provided within this summary document, only the conclusion that they were met.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests conducted by the manufacturer, Thought Technology Ltd. These include electrical safety, electromagnetic compatibility (EMC), biocompatibility, hardware verification, usability, and software life-cycle processes, as detailed in the "Summary of Non-Clinical / Performance Testing" section on page 5.

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

• Sample Size: Not applicable in the context of human patient data for an AI/ML device, as this summary describes engineering and performance testing of the device hardware and software, not a clinical trial with patient data. The "sample size" here refers to the number of units or components tested. This information is not specified in this summary document.
• Data Provenance: Not applicable in the context of patient data. The tests are general engineering and performance tests of the device itself.

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

• Not applicable as this is a non-clinical submission. Ground truth, in the AI/ML context, usually refers to labeled data for diagnostic tasks established by human experts. Here, "ground truth" for the device's technical performance is the expected behavior and measurements based on engineering specifications and international standards (e.g., IEC standards).

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert labeling of clinical data, which is not relevant for this type of non-clinical device clearance. The "adjudication" for these tests would be the comparison of test results against predefined acceptance criteria.

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. The document makes no mention of an MRMC study or AI assistance. The device in question is a biofeedback and electrical stimulation system for incontinence, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable in the context of AI/ML algorithm performance. The "standalone" mode mentioned in the document (page 4) refers to the device's ability to operate for electrical stimulation only without being connected to a mobile app or computer. This is a functional description, not an AI/ML performance metric.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (e.g., ISO, IEC), and established medical device testing protocols. For example, for biocompatibility, the ground truth is "noncytotoxic, non-sensitizing, non-irritant" as defined by ISO standards. For electrical safety, the ground truth is "conformity to applicable basic safety and performance requirements" of IEC standards.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set of patient data. The "firmware development" mentioned (page 5) refers to traditional software engineering processes, not machine learning model training.

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

• Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for it.

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The MyoTrac Infiniti system is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscle through reflexive mechanisms, strengthening of pelvic floor muscle. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.

The MyoTrac Infiniti system is also indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention or retardation of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Biofeedback, Relaxation & Muscle Re-Education purposes.

The MyoTrac Infiniti device is a non-implanted electrical stimulator for urinary incontinence, it is intended to re-train the urinary continence mechanisms by way of electrical stimulation applied to the pelvic floor musculature and surrounding structures. The device is indicated for treatment of patients with stress incontinence, urge incontinence or mixed incontinence (a combination of stress and urge incontinence). The indications for this use and labeling will be a subset of the overall indications for use. The MyoTrac Infiniti is an electrical muscle stimulator for contraction of muscles as well.

The MyoTrac Infiniti 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 re-education, relaxation and EMG biofeedback.

The provided text describes the MyoTrac Infiniti system and its substantial equivalence to predicate devices, focusing on technical characteristics and intended use. However, it does not include a study that proves the device meets specific acceptance criteria in the way you've outlined for performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the document details a 510(k) premarket notification, which is a regulatory submission to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing technical specifications and intended use rather than conducting new clinical performance studies with acceptance criteria, sample sizes, and ground truth as would be done for a novel or high-risk device.

Therefore, many of your requested points cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and what information is missing:

The device described is the MyoTrac Infiniti System, a non-implanted electrical continence device, powered muscle stimulator, and biofeedback device.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of a clinical performance study with specific acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance values. The document focuses on demonstrating substantial equivalence through a comparison of technical characteristics and intended use with predicate devices.

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

• Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical test set or study with human subjects for performance evaluation in the way you've asked. The "performance data" section (page 6) refers to "non-clinical tests" like verification of product specifications, system validation, safety, and EMC testing. Device equivalency is determined by comparing its functional and hardware specifications to predicate devices.
• Data Provenance: Not applicable.

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

• Not applicable/Not provided. No clinical test set with ground truth established by experts is described.

4. Adjudication method for the test set

• Not applicable/Not provided. No clinical test set requiring adjudication is 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

• Not applicable/Not provided. This device is an electrical stimulator/biofeedback device, not an AI-powered diagnostic or assistive tool for human readers, so an MRMC study is not relevant to its function.

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

• Not applicable/Not provided. This is a physical medical device for treatment and biofeedback, not an algorithm. Its performance is inherent in its hardware, software, and physical interaction, not a standalone algorithmic output.

7. The type of ground truth used

• Not applicable/Not provided. For the purposes of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established safety and efficacy of the predicate devices and the MyoTrac Infiniti's ability to match their intended use and technical specifications. There is no mention of pathology, expert consensus, or outcomes data used to establish ground truth for a performance study of the MyoTrac Infiniti itself.

8. The sample size for the training set

• Not applicable/Not provided. This is not a machine learning or AI-driven device that requires a training set in that context.

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

• Not applicable/Not provided.

Summary of Device Acceptance/Equivalency based on the document:

The MyoTrac Infiniti system's "acceptance criteria" and "proof" are based on its substantial equivalence to existing legally marketed predicate devices, as demonstrated through a comparison of their technical characteristics and intended uses.

• Acceptance Criteria (Implicit for 510(k)): The MyoTrac Infiniti System must have the same intended use and similar technological characteristics as predicate devices such that any differences do not raise new questions of safety or effectiveness.
• Study Proving Acceptance: The main "study" (or rather, the demonstration for regulatory clearance) is the comparison table of technical characteristics and the statement of intended use.
  • "Performance Data": The document explicitly states (page 6): "Non-clinical tests were performed consisted of verification of the product specification, system validation, safety and EMC testing. Device equivalency is determined by a direct comparison of the device functional and hardware specifications of MyoTrac Infiniti system with the legally marketed predicate devices..."
  • Biocompatibility: The related sensors underwent laboratory testing for material safety.
  • Conclusion: "The MyoTrac Infiniti system is safe and effective for its intended use. The MyoTrac Infiniti system is substantially equivalent to the predicate devices." (page 6)

The document lists multiple predicate devices (Pathway CTS 2000, InCare PRS Pelvic Floor Therapy System, Evadri Bladder Control System, K.E.A.T., and Detrusan 500 Incontinence Therapy System) and provides a detailed table comparing various features like frequency, pulse intensity, pulse width, ramp settings, duty cycle, session duration, programmable features, probe types, power density, EMG ranges, bandwidth, signal processing, detection, and feedback modes. The "acceptance" is based on these comparisons demonstrating similarity to devices already cleared by the FDA.

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The MyoTrac Infiniti system is indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Relaxation & Muscle Re-Education purposes.

The MyoTrac Infiniti device is an electrical muscle stimulator for contraction of muscles as indicated below. The MyoTrac Infiniti 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 re-education, relaxation and biofeedback.

Here's an analysis of the provided text regarding the MyoTrac Infiniti System, focusing on acceptance criteria and supporting studies:

This 510(k) premarket notification (K053266) for the MyoTrac Infiniti System does not contain specific acceptance criteria or a dedicated study designed to prove the device meets such criteria in the conventional sense of a clinical trial demonstrating performance metrics against quantitative thresholds.

Instead, the submission focuses on substantial equivalence to predicate devices. The "performance data" section primarily refers to non-clinical tests verifying product specifications, system validation, safety, and EMC testing, along with biocompatibility assessments of electrodes. The core argument for equivalence is a direct comparison of functional and hardware specifications with legally marketed predicate devices.

Therefore, many of the requested categories within your prompt cannot be directly answered from the provided text. I will address what is available and indicate when information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" (e.g., "sensitivity > X%", "accuracy > Y%") are not presented in this 510(k) summary. The "performance" is demonstrated through substantial equivalence to predicate devices based on technical specifications and safety testing.

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

• Sample Size for Test Set: Not applicable. This document describes a 510(k) submission for substantial equivalence based on technical comparisons and non-clinical testing, not a clinical study with a "test set" of patient data.
• Data Provenance: Not applicable for a patient data test set. The data provenance for component testing (e.g., biocompatibility) would be laboratory testing reports.

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

• Not applicable. There is no clinical "test set" with ground truth established by experts discussed in this submission.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical "test set" requiring an adjudication method.

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. This device is a biofeedback and muscle stimulation system, not an AI-assisted diagnostic tool that would typically undergo an MRMC study with human readers interpreting results.

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

• This device is not an algorithm-only medical device. It is a physical medical device (stimulator and biofeedback unit) used with human-in-the-loop operation.
• The "standalone performance" is addressed by the comparison of its technical specifications to predicate devices and verification of its own product specifications.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the purpose of this 510(k) submission, the "ground truth" for proving substantial equivalence is the technical specifications and established safety/effectiveness profiles of the predicate devices, along with the results of internal non-clinical tests (verification, validation, safety, EMC). There is no patient-reported outcomes, pathology, or expert consensus used to establish ground truth for a novel performance claim in this documentation.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ an AI algorithm requiring a "training set" of data.

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

• Not applicable, as there is no training set for an AI algorithm.

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