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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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