Search Results

The Expression MRI Patient Monitoring System (Model 865214) is intended to monitor vital signs for patients undergoing MRI procedures and to provide signals for synchronization for the MRI scanner. The Expression MRI Patient Monitoring System (Model 865214) is intended for use by healthcare professionals.

The Expression MRI Patient Monitoring System (Model 865214) is designed to assist clinicians in monitoring patient vital signs in the midst of the dynamic and evolving magnetic resonance (MR) environment. A combination of wireless communication, radio frequency (RF) shielding, digital signal processing (DSP), and adaptable mounting technologies address the challenges associated with patient monitoring in the MR environment. The Expression MRI Patient Monitoring System (Model 865214) includes monitoring capabilities for wireless electrocardiogram (ECG), wireless pulse oximetry (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, respiration, end-tidal CO2 (EtCO2), oxygen, and anesthetic agents.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Expression MRI Patient Monitoring System (Model 865214)

1. Table of Acceptance Criteria and Reported Device Performance

The device underwent verification and validation testing of its performance specifications. The results are summarized below:

MRI Susceptibility (MR Compatibility):

• 1.5T MR Imaging System (T1W FFFE, T1W IR, T2W SE EPI scans): Met performance specifications.
• 3.0T MR Imaging System (T1W FFE, T1W IR TSE, T2W SE EPI scans): Met performance specifications.
• Conditions of use (static magnetic field strength, specific absorption rate, scan duration, gradient field switching rate, device proximity to the magnet bore): Met MR conditions of use stated in labeling.

The document also mentions compliance with various voluntary standards for safety and performance (e.g., IEC 60601 series, ANSI/AAMI, ASTM, ISO) and hazard analysis/risk management (ISO 14971), all of which were "Pass."

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

The document does not explicitly state the numerical sample size used for the test set in the performance specification verification and validation. It mentions:

• General Performance Verification: "All patient monitoring parameters of the Expression MRI Patient Monitoring System (Model 865214) were verified according to the performance specifications."
• SpO2 Accuracy Validation: "Pulse oximetry (SpO2) accuracy... compared to arterial blood CO-oximetry for validation."

The data provenance is not specified (e.g., country of origin, retrospective or prospective), but the tests appear to be laboratory-based verification and validation studies using "patient simulators and test equipment" under "worst-case environment" and "actual use conditions."

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

The document does not mention the use of experts to establish ground truth for the test set. For the SpO2 accuracy, the ground truth was established by "arterial blood CO-oximetry." For other physiological parameters, the ground truth was likely derived from calibrated test equipment or patient simulators.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the testing described is primarily objective verification against predetermined specifications (e.g., "Pass" or "Fail" based on whether the device met the numerical specifications).

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 MRMC study was reported. This device is a physiological patient monitor, not an AI-assisted diagnostic tool, so such a study would not be applicable.

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

The performance testing described ("Verification and Validation of Performance Specifications" and "Validation of SpO2 Accuracy") represents standalone algorithm performance through testing the output specifications of the device against known inputs from simulators or blood analyses. Human interaction is for setup and interpretation, but the core measurement and display of parameters is algorithmic.

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

• SpO2 Accuracy: Arterial blood CO-oximetry.
• Other Physiological Parameters (Temperature, Pulse Rate, Anesthetic Agents, CO2, Respiration Rate): Implied to be established by calibrated reference standards, patient simulators, or test equipment.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning. The device's underlying technology and algorithms for physiological monitoring are based on established scientific principles and engineering, not a machine learning training paradigm.

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

As there is no mention of a training set for machine learning, this question is not applicable. The device's functionality relies on established physiological measurement principles.

Ask a specific question about this device

To be used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

Model BBD Breast Immobilization and Biopsy Device

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "Model BBD Breast Immobilization and Biopsy Device." This document primarily focuses on regulatory approval and substantial equivalence to a predicate device.

It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The letter confirms that the device can be marketed based on its substantial equivalence to previously approved devices, but it does not detail any performance metrics, study designs, sample sizes, or ground truth methodologies that would be required to answer your specific questions.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck that can be interpreted by a trained physician.

Model NVA-127-16-A Neurovascular Array Coil

This document is a 510(k) clearance letter from the FDA for a medical device called the "Model NVA-127-16-A Neurovascular Array Coil". This letter is NOT a study report and therefore does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The information provided in the document focuses on:

• Device Name and Manufacturer: Invivo Corporation, Model NVA-127-16-A Neurovascular Array Coil
• Regulation Information: 21 CFR 892.1000, Magnetic resonance diagnostic device, Class II, Product Code: MOS
• Date of Clearance: October 12, 2005
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck that can be interpreted by a trained physician."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as it is not present in the provided text.

Ask a specific question about this device

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician.

Model CAC-127-8 Cardiac Array Coil

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

Based on the provided text, it is a 510(k) clearance letter for a medical device: Model CAC-127-8 Cardiac Array Coil. This document is a regulatory clearance and does not contain the detailed study information typically found in a clinical study report or a scientific publication.

Therefore, most of the information requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study designs (MRMC, standalone) cannot be extracted from this 510(k) clearance letter.

The letter primarily states that the device is "substantially equivalent" to legally marketed predicate devices. This substantial equivalence is based on the device's technical characteristics and performance being similar to existing devices, implying that it meets the same safety and effectiveness standards. However, the specific details of how that performance was proven are not included.

Here's what can be inferred or directly stated from the document, along with what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in this document. A 510(k) clearance letter does not detail specific acceptance criteria or quantitative performance metrics. It confirms that the device has been reviewed and found substantially equivalent.

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

Not available in this document. The letter does not describe any specific test set or the characteristics of the data used for performance evaluation.

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

Not available in this document. The letter does not mention ground truth establishment or the involvement of experts in a testing phase.

4. Adjudication Method

Not available in this document.

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

Not available in this document. The letter does not discuss MRMC studies or the effect size of human readers with/without AI assistance. Given the device is a cardiac array coil (a hardware component for an MRI scanner), it's highly unlikely that an MRMC study for AI assistance would be relevant or performed for this specific device.

6. If a Standalone Performance Study Was Done

Not available in this document. The letter does not provide details of any standalone performance study. For a hardware component, standalone performance would likely relate to signal-to-noise ratio, homogeneity, artifact levels, etc., which are not detailed here.

7. The Type of Ground Truth Used

Not available in this document.

8. The Sample Size for the Training Set

Not available in this document. This device is a hardware component and not an AI/ML algorithm that would typically have a "training set."

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

Not available in this document. (Not applicable for this type of device and document)

Summary of what is known from the document:

• Device Name: Model CAC-127-8 Cardiac Array Coil
• Intended Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular system that can be interpreted by a trained physician."
• Regulatory Status: Substantially Equivalent (K051512) to a predicate device.
• Regulatory Class: Class II
• Product Code: MOS
• Date of Clearance: June 28, 2005

To obtain the detailed information you are requesting (acceptance criteria, study design, sample sizes, ground truth, expert qualifications), you would typically need to consult:

1. The original 510(k) submission document: This document, submitted by Invivo Corporation to the FDA, would contain the technical specifications, performance data, and comparison to predicate devices. These are usually not publicly available in their entirety.
2. Publicly available summaries of 510(k)s: The FDA sometimes publishes summaries, but often these do not include granular study details.
3. Scientific publications: If the performance data was significant enough, it might have been published in a peer-reviewed journal.
4. Clinical trial reports: If any specific trials were conducted beyond typical substantial equivalence testing, their reports would contain this data.

Ask a specific question about this device