(21 days)
The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used with evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with . MediGuide™ Technology to enable real-time tip positioning and navigation. The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy.
The SJM 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 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 SJM Livewire™ Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at the proximal end of the catheter.
Here's an analysis of the provided text regarding the acceptance criteria and study for the St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter:
Important Note: The provided document is a 510(k) summary for a medical device. 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than proving a new clinical benefit or detailed performance against specific acceptance criteria for a novel AI algorithm. Therefore, many of the questions you've asked, which are more relevant to AI/ML device evaluations, may not be fully answerable from this type of document.
Acceptance Criteria and Reported Device Performance
The document describes an amendment to an existing device, primarily related to a "buckle force requirement." This suggests the "acceptance criteria" discussed are likely engineering and design specifications rather than clinical performance metrics in the way AI/ML devices are typically evaluated (e.g., sensitivity, specificity, AUC).
The table above focuses on technical specifications related to the mechanical performance ("buckle force requirement") of the catheter. There are no clinical performance metrics (like accuracy, sensitivity, specificity, etc.) reported in this document that would typically be associated with an AI device's ability to 'diagnose' or 'identify'.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Buckle force requirement | Historical bench test data evaluated |
| Fundamental design | No alteration |
| Packaging | No alteration |
| Biocompatibility | No alteration |
| Sterilization | No alteration |
| Labeling | No alteration |
Study Details (Based on the provided text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "Historical bench test data."
- Data Provenance: Not explicitly stated. Given it's "historical bench test data," it would be internal to the manufacturer (St. Jude Medical) and likely generated in a laboratory setting. It is retrospective in nature regarding the setting of new specifications based on existing data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. The "ground truth" here relates to a mechanical specification ("buckle force"), which is typically measured objectively via engineering tests rather than expert interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. This is irrelevant for mechanical bench testing.
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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 steerable electrophysiology catheter, and the "MediGuide Enabled" aspect refers to real-time tip positioning and navigation using a gMPS system as an adjunct to fluoroscopy. It is not an AI diagnostic or assistive device that would involve "human readers" interpreting images or data for diagnostic purposes with and without AI assistance. Therefore, an MRMC study and effect size for AI assistance are not applicable.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. The device described is a physical catheter used with a navigation system (MediGuide Technology) and with human operators (physicians). There is no "algorithm only" performance reported in the context of an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "buckle force" change, the ground truth would be quantitative measurements from mechanical engineering tests. The document refers to "historical bench test data."
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The sample size for the training set:
- Not applicable/Not stated. This document describes establishing a "proposed buckle force specification" based on "historical bench test data." There isn't a "training set" in the context of an AI/ML model for this type of device submission.
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How the ground truth for the training set was established:
- Not applicable/Not stated. As above, there's no mention of a "training set" or "ground truth" being established in the context of an AI model for this device. The data is mechanical test data.
Summary of what the document does indicate:
The document, a 510(k) summary, asserts that the modified St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K150631) is substantially equivalent to its predicate device (K101955). The core change mentioned is to a "buckle force requirement." This change was supported by an evaluation of "historical bench test data." The manufacturer states that this change does not alter the fundamental design, packaging, biocompatibility, sterilization, or labeling, maintaining substantial equivalence. The device's function is for electrophysiological mapping and real-time tip positioning/navigation as an adjunct to fluoroscopy, not as an AI diagnostic tool.
§ 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).