Search Results

This Zynex device has been designed for muscle re-education, prevention of disuse atrophy, increase local blood circulation, maintain, or increase range of motion, and relaxation of muscle spasms.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a device called "M-Wave," a powered muscle stimulator. It outlines the regulatory approval process and requirements but does not detail any performance studies, acceptance criteria tables, or specifics on how the device's efficacy was verified. Therefore, I cannot fulfill your request for that specific information based on the given input.

Ask a specific question about this device

Monitoring of the following parameters and their relative of relative of relative changes in fluid volume in adult patients:

• Bioelectrical Impedance
• ECG Amplitude
• PPG Amplitude
• Skin Temperature

The Zynex Monitoring System, Model CM-1600, simultaneously monitors various parameters of a patient's body. These parameters include Bioelectrical Impedance, Electrocardiogram (ECG) Amplitude, Photoplethysmography (PPG) Amplitude, and Skin Temperature. A Relative Index value is calculated as a combination of the changes in these parameters and is represented by a single number. The CM-1600 System is comprised of two (2) subsystems, the Wearable and the Monitor. The CM-1600 Wearable is designed and developed by Zynex Monitoring Solutions, and it collects physiological parameters and transmits those parameters to the CM-1600 Monitor via wireless communication. The CM-1600 Monitor is a Zynex-branded, third-party all-in-one medical grade tablet.

The provided text is a 510(k) summary for the Zynex Monitoring System, Model CM-1600. It describes the device, its intended use, a comparison to a predicate device, and performance data provided in support of substantial equivalence.

However, the provided document does not contain information regarding an AI/ML device, expert ground truth establishment, or specific details on studies proving the device meets acceptance criteria related to AI/ML performance metrics (like sensitivity, specificity, or AUC). The device described, the Zynex Monitoring System, Model CM-1600, monitors physiological parameters such as Bioelectrical Impedance, ECG Amplitude, PPG Amplitude, and Skin Temperature and calculates a "Relative Index" as a combination of changes in these parameters. This appears to be a traditional medical monitoring device, not a device incorporating artificial intelligence or machine learning for diagnostic or interpretive purposes.

Therefore, many of the requested points, such as AI/ML acceptance criteria, sample size for AI/ML test sets, expert adjudication methods, MRMC studies, or ground truth establishment for AI/ML models, cannot be answered from the provided text because the text does not describe an AI/ML device or studies typically associated with its validation.

The available information related to device performance and validation is summarized below:

Device: Zynex Monitoring System, Model CM-1600

Intended Use: Monitoring of Bioelectrical Impedance, ECG Amplitude, PPG Amplitude, and Skin Temperature, and their relative changes in fluid volume in adult patients. It provides numerical values to aid diagnosis by a physician; it is the physician's responsibility to make proper judgments based on these measurements.

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

The document does not specify "acceptance criteria" in terms of numerical performance thresholds (like accuracy percentages or error rates) for the physiological measurements themselves. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device through various performance tests.

Note: The document states "Animal Testing: No Testing Required" and "Clinical Testing: No Testing Required", indicating these were not part of the performance data submitted for this 510(k) clearance.

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

The document does not detail specific sample sizes for "test sets" in the way one would for an AI/ML algorithm. The performance testing (V&V/Predicate Testing) demonstrates that the device meets applicable requirements and is substantially equivalent to the predicate device. This typically involves engineering and functional validation, not data-driven performance assessments on patient cohorts for diagnostic accuracy. No information is provided regarding data provenance (country of origin, retrospective/prospective). Since clinical testing was not required/conducted, there isn't patient-specific data being referred to in this context.

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

Not applicable. The document does not describe the establishment of a "ground truth" by experts for diagnostic purposes or for validating an AI/ML model. The device provides raw physiological parameters and a "Relative Index," which are direct measurements or calculations, not interpretations requiring expert consensus for ground truth.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic or interpretive performance.

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 is not an AI-assisted diagnostic device, and no MRMC study was mentioned or conducted.

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

Not applicable. The device provides physiological measurements and a calculated index. There isn't an "algorithm only" component that generates a diagnosis or interpretation independent of human interpretation for which standalone performance would be relevant in the context of AI/ML.

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

Not applicable. For this type of physiological monitoring device, "ground truth" would relate to the accuracy of its direct measurements (e.g., how accurately it measures bioelectrical impedance or temperature) against a calibrated standard, not against expert consensus on a diagnosis, pathology, or outcomes data, as these are beyond the scope of a monitoring device providing raw or relative change data.

8. The sample size for the training set

Not applicable. The document does not describe the use of a "training set" for an AI/ML model for this device.

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

Not applicable. As no training set for an AI/ML model is mentioned, the method for establishing its ground truth is not discussed.

Ask a specific question about this device

Monitoring of the following parameters and their relative changes, indicative of relative changes in fluid volume in adult patients.

• Bioelectrical Impedance
• Heart Rate
• ECG Amplitude
• PPG Amplitude

Cardiac Monitor, Model 1500 and accessories monitor a patient's parameters. These parameters include: Bioelectrical Impedance, Heart Rate, ECG Amplitude, and Skin Temperature.

The Cardiac Monitor, Model 1500, is intended to be used in a professional medical environment such as hospitals, clinics and research institutions. The Cardiac Monitor, Model 1500, is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance by the operator.

The user of the Cardiac Monitor, Model 1500, shall be a qualified operator. The operator shall have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

The provided text is related to a 510(k) submission for the Zynex Medical Cardiac Monitor, Model 1500. However, it does not contain specific acceptance criteria, reported device performance data, details of clinical studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods that would be required to fully answer the request.

The document primarily focuses on regulatory compliance, outlining the device's indications for use, its comparison to predicate devices, and adherence to general medical device safety standards. It emphasizes that the device provides numerical values and that a physician is responsible for making judgments based on these numbers, explicitly stating: "The device does not report any diagnosis, but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers." This indicates that the device itself is not making diagnostic claims that would typically require validation against a clinical ground truth for diagnostic accuracy.

Therefore, many of the requested items cannot be extracted from this document because the information is not present. The device is not an AI/ML device that would typically undergo the kind of detailed performance studies described in the prompt (e.g., MRMC studies, standalone algorithm performance against a clinical ground truth). Instead, it's a monitoring device whose performance is assessed against established safety and electrical standards.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot be answered:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics in a clinical study. The document focuses on compliance with general medical device standards.
• Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) are reported for the Cardiac Monitor, Model 1500. The document states that the device "met all applicable requirements" of the listed standards and is "substantially equivalent" to its predicates.

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

• Not Applicable / Not Provided: The document does not describe a clinical performance study with a "test set" in the context of an AI/ML device validating diagnostic accuracy. The evaluation appears to be based on adherence to safety standards and comparison to predicate devices' design and methodology.

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: There is no mention of experts establishing ground truth for a test set, as the device is for monitoring and not making diagnostic claims itself.

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

• Not Applicable / Not Provided: No adjudication method is mentioned because no clinical test set for diagnostic claims 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: No MRMC study was done, as this is a physiological monitoring device, not an AI-assisted diagnostic tool for human readers.

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

• Not Applicable: This is a hardware monitoring device, not an algorithm. Its "performance" is based on the accuracy and reliability of its physiological measurements, which are then interpreted by a qualified operator/physician. The document notes that "Operation is to be performed as uninterrupted patient surveillance by the operator" and "The device does not report any diagnosis, but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers."

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

• Not Applicable / Not Provided: Ground truth in the context of diagnostic accuracy is not relevant here. The device's "ground truth" would be the actual physiological parameters measured, validated through calibration and comparison to established measurement techniques, but specific details are not in this document.

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a "training set."

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

• Not Applicable / Not Provided: Not an AI/ML device requiring a training set.

Ask a specific question about this device

The InWave is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women.

Non-Implanted Electrical Continence Device, Model InWave.

This document is a 510(k) clearance letter from the FDA for a medical device (Non-Implanted Electrical Continence Device, Model InWave). It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) submission itself (which is not provided here) or in a separate clinical study report.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

Interferential Mode (IFC)

• . Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.
  Neuromuscular Electrical Stimulation Mode (NMES)
• . Muscle Re-education
• . Prevention or Retardation of Disuse Atrophy
• . Increasing Local Blood Circulation
• . Maintaining or Increasing Range of Motion
• . Relaxation of Muscle Spasms
  Transcutaneous Electrical Nerve Stimulation Mode (TENS)
• . Management and Symptomatic Relief of Chronic Intractable Pain, Posttraumatic and Post-surgical Pain.

Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave.

I am sorry, but the provided text from the FDA 510(k) letter for the Zynex Medical Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave (K111279) does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a letter from the FDA to Zynex Medical, informing them that their device has been found substantially equivalent to legally marketed predicate devices. It outlines the regulatory classification, general controls provisions, and refers to the indications for use.

Crucially, it does not describe any specific performance study, clinical trial data, or detailed technical specifications related to the device's accuracy, efficacy metrics, or statistical results that would allow me to populate the requested table and answer the study-related questions. The letter focuses on the regulatory determination of substantial equivalence, not on a detailed performance evaluation report.

Therefore, I cannot provide the requested information based on the text provided.

Ask a specific question about this device