(86 days)
For use in right atrial electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems alone (i.e., linear mapping catheters). The Constellation Multiple Electrode Recording and Pacing Catheter System may also be used for delivery of externally generated pacing stimuli.
The Boston Scientific/EP Technologies (EPT) Constellation® Multiple Electrode Recording and Pacing Catheter is a sterile, single use device used to detect and record electrical potentials from the endocardial surfaces of the heart, and to deliver externally generated pacing stimuli. The distal, expandable "basket" assembly is, in essence, eight miniature octapolar "catheters". The basket assembly contains an array of 64 electrodes mounted along eight resilient support structures called "splines". Two configurations are available, unipolar (electrodes evenly spaced) and bipolar (electrodes evenly distributed into 32 pairs). EPT furnishes the Constellation® Catheter either with or without the Duraflo® coating (Baxter CVG). EPT also furnishes accessories that include EPT Constellation Accessory Cables (sterile, re-useable), an EPT Constellation Pacing Switchbox (non-sterile, re-useable), and EPT Constellation extension cables (nonsterile, re-useable).
The provided document is a 510(k) summary for a medical device (Constellation® Multiple Electrode Recording and Pacing Catheter). It describes the device, its intended use, and comparison to a predicate device. However, it does not contain acceptance criteria for specific device performance metrics, nor does it detail a study proving the device meets particular acceptance criteria in the way a performance study for, for example, an AI/ML diagnostic would.
The "Abstract of the Clinical Data" section briefly mentions a clinical study (IDE G940162) used to support a previous 510(k) (K983171) for the Constellation catheter, where it was used in the right atrium of 116 patients. This study focused on reporting complication rates of the device compared to standard catheters, but it does not evaluate specific performance metrics or acceptance criteria related to its primary electrophysiological recording and pacing functions.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this type of information is not present in the provided text. The document focuses on regulatory submission details, device description, and a general safety overview from a prior clinical study.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test set sample size: 116 patients (for the Constellation Group in the clinical data abstract), and 25 patients (for the standard catheter group).
- Data provenance: Not specified in terms of country of origin. The study was part of IDE G940162, which implies it was a prospective investigational device exemption study.
- Additional details: The data was for the Constellation catheter used in the right atrium.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the document. The clinical study described recorded complication rates, not performance metrics requiring expert ground truth in the context of, for example, diagnostic image interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- 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 device is an electrode catheter, not an AI/ML driven diagnostic device that would involve human readers interpreting output.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrode catheter used by clinicians, not a standalone automated algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The clinical data abstract reports "complication rates," which are a form of outcomes data. No specific ground truth for performance metrics is mentioned.
- The sample size for the training set: Not applicable. This is a hardware device; no "training set" in the context of AI/ML algorithms is mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 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).