Search Results

This device is to be used for general relaxation training when used with supported amplifier/encoders.

This software-only component of an EEG biofeedback system uses industry-accepted standard Microsoft Windows-based computers to accept EEG data from external FDAapproved amplifier/encoders and provide biofeedback information. The software does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data. The device processes EEG information, separates it into user-specified frequency bands, and displays the results as biofeedback indications to a user.

The provided 510(k) summary for EEGer4 does not contain the kind of detailed study information typically requested for AI/ML-based medical devices or those requiring performance validation against acceptance criteria. This submission is for a much simpler software-only device that processes EEG data for biofeedback, without making diagnostic claims.

Therefore, many of the requested categories cannot be answered from the provided text. The device's "performance" is primarily described by its specifications and comparison to predicate devices, rather than a clinical study establishing diagnostic accuracy.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, a software-only EEG biofeedback system, the "acceptance criteria" are implied by its functional specifications and substantial equivalence to predicate devices, rather than specific accuracy metrics for a diagnostic task. The performance revolves around its ability to process EEG data and display biofeedback.

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

• Not Applicable / Not Provided. This document does not describe a clinical performance study using a test set of patient data, as it's a software for biofeedback, not diagnosis. The "test" in such a context would typically involve software verification and validation (V&V) against functional requirements, but this detail isn't in the summary.

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 ground truth establishment by experts is described for a test set, as no such study is presented.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or adjudication process 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

• No. An MRMC study was not done. This device is not an AI-assisted diagnostic tool; it's a biofeedback display software.

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

• Not Applicable / Not Provided. While the software operates "standalone" in the sense that it processes data and displays it, this refers to its direct functional performance in processing and displaying EEG data according to its specifications, not in making an independent diagnostic decision. The document doesn't detail specific standalone performance metrics in a study context.

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

• Not Applicable / Not Provided. No ground truth for a diagnostic or classification task is used because the device expressly states it "does not provide any diagnostic conclusions nor provide any index, classification, diagnosis, or clinical interpretation of the data."

8. The sample size for the training set

• Not Applicable / Not Provided. This device is not described as an AI/ML model that would require a training set. It is a deterministic software that processes and displays EEG data using established signal processing techniques (separating into frequency bands).

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

• Not Applicable / Not Provided. As noted above, there is no mention of a training set or ground truth establishment for such a set.

Ask a specific question about this device

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.

Ask a specific question about this device