(95 days)
The SJM MediGuide Enabled Livewire™ steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The MediGuide Enabled Livewire™ Steerable Electrophysiology Catheter is used with a compatible gMPS™ system to enable real-time tip positioning and navigation.
The MediGuide System is indicated for use as an adjunct to fluoroscopy
The MediGuide Enabled Livewire Steerable Electrophysiology Catheter is designed to allow electrophysiological mapping at various endocardial and intravascular sites, including the inferior vena cava, superior vena cava, pulmonary veins and coronary sinus. The use of the MediGuide Enabled Livewire diagnostic mapping catheter in conjunction with the MediGuide gMPS system allows real-time tip positioning and navigation during routine diagnostic evaluation. When connected to the ECG, the MediGuide Enabled Livewire Catheter will transmit routine electrical signals while the passive sensor at the tip of the catheter is tracked by gMPS and is superimposed on any 2D X-ray image in real time ("Live") fluoroscopy mode (the actual 3D position of the catheter tip is projected on the real time 2D image).
The provided text is a 510(k) summary for the St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter. It describes the device, its intended use, and its equivalence to predicate devices. However, this document does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
The 510(k) summary is a regulatory document asserting substantial equivalence to previously cleared devices, rather than a report detailing a clinical trial or performance study with acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.
Based on the provided text, here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is NOT available in the provided 510(k) summary. The document asserts substantial equivalence to predicate devices based on design, technology, materials, and indications for use, without detailing specific performance metrics or acceptance criteria for a new study.
2. Sample size used for the test set and the data provenance:
This information is NOT available in the provided 510(k) summary. No specific test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is NOT available in the provided 510(k) summary. No study involving expert-established ground truth is described.
4. Adjudication method for the test set:
This information is NOT available in the provided 510(k) summary. No study involving 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:
This information is NOT available in the provided 510(k) summary. The document does not describe an AI-assisted device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is NOT available in the provided 510(k) summary. The device is a physical catheter used in conjunction with a gMPS system under human guidance. There is no mention of a standalone algorithm performance evaluation.
7. The type of ground truth used:
This information is NOT available in the provided 510(k) summary. No explicit ground truth is mentioned as it primarily focuses on comparing the device to existing predicate devices rather than validating performance against a 'true' reference standard.
8. The sample size for the training set:
This information is NOT available in the provided 510(k) summary. There is no mention of a training set as the device is a medical instrument, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
This information is NOT available in the provided 510(k) summary. As mentioned, there is no training set described.
Summary of what the document does provide:
- Device Name: St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter
- Intended Use: Used in the evaluation of cardiac arrhythmias from endocardial and intravascular sites. Used with a compatible gMPS system for real-time tip positioning and navigation, and as an adjunct to fluoroscopy.
- Basis for Clearance (510(k)): Substantial equivalence to predicate devices (St. Jude Medical Livewire Electrophysiology Catheter and MediGuide Guided Measurement Catheter (GMC)) based on similar technology, materials, design principles, dimensional characteristics, indications for use, and fundamental scientific technologies.
Therefore, to answer your questions fully, you would need different documentation, likely a dedicated clinical study report or a performance validation report, which is not part of this 510(k) summary.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).