(211 days)
The ProRhythm™, Inc. ProMap Coaxial Mapping Catheter is an intracardiac electrophysiology recording catheter. The ProMap is designed to be used to record cardiac electrograms for the evaluation of cardiac arrhythmias from endocardial and intravascular sites during invasive cardiac electrophysiology procedures. The ProRhythm ProMap is to be used with the ProMap Connection Cable.
The ProRhythm™ ProMap is to be used for the evaluation of cardiac arrhythmias from endocardial and intravascular sites. The ProMap Coaxial Mapping Catheter is typically used in Electrophysiology clinical procedures.
ProRhythm's ProMap Coaxial Mapping Catheter records pulmonary vein potentials when used with electrophysiology recording equipment. The device has 6 electrodes mounted at the distal end. A passive mechanism at the distal end conforms into the shape of a ring ranging from 15 to 25 mm in diameter. The electrodes are spaced either evenly. The handle at the proximal end of the device allows the device to be manipulated into position within the left atrium. A connector at the proximal end of the device enables connection to the ProMap Connection Cable.
The ProMap Coaxial Mapping Catheter is designed to be inserted through a delivery sheath catheter and into the left atrium to record electro grams. The distal end extends past the delivery sheath catheter and forms into a circular ring that is optimized for use in the pulmonary veins. Electrodes mounted at the distal end and spaced uniformly along the circular ring allow recording of pulmonary vein potentials in the left atrium.
The ProMap Coaxial Mapping Catheter can be withdrawn and reinserted (without excessive friction) while the delivery sheath catheter can be deflected. This enables the electro physiologist to perform other functions through the sheaths lumen, such as contrast injections to obtain venograms.
The provided text focuses on the 510(k) summary for the ProRhythm, Inc. ProMap Coaxial Mapping Catheter. It describes the device, its intended use, contraindications, and claims substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or a dedicated study designed to prove the device meets those criteria in the way one might expect for an AI/ML powered device.
Medical devices, especially those under a 510(k) pathway, often demonstrate safety and effectiveness through pre-clinical testing, sometimes in-vivo, to show that the device performs as intended and is substantially equivalent to a legally marketed predicate device. The text alludes to this but does not provide specific performance metrics or detailed study designs.
Here's an attempt to answer your questions based solely on the provided text, with acknowledgement of missing information where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative or tabular format, nor does it provide specific performance metrics for the ProMap Coaxial Mapping Catheter in terms of sensitivity, specificity, accuracy, or other quantifiable measures.
Instead, the "Performance Data" section makes a general statement:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functioned as intended | In all instances, the ProMap Coaxial Mapping Catheter functioned as intended and met all pass criteria as expected. |
| Met all pass criteria | In all instances, the ProMap Coaxial Mapping Catheter functioned as intended and met all pass criteria as expected. |
This implies that the device successfully performed its function of recording cardiac electrograms and conforming to a circular shape, consistent with its design and intended use, during pre-clinical in-vivo testing. The "pass criteria" are not specified.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Pre-clinical in-vivo testing further provided validation that the device performed as intended."
- Sample Size for the Test Set: Not specified. The phrase "in-vivo testing" suggests animal or human subjects, but the number is not provided.
- Data Provenance: "Pre-clinical in-vivo testing." This typically implies studies conducted in animal models or possibly cadavers, or early human feasibility studies, but the specific country of origin or whether it was retrospective or prospective is not mentioned. Given it's "pre-clinical," it's prospective by nature of being a designed test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the text. Given the nature of a mapping catheter, the "ground truth" would likely be the actual electrical activity recorded by the catheter itself, validated against established electrophysiology principles and potentially compared with other diagnostic tools or expert interpretation of the readings. However, no specific number of experts or their qualifications for establishing ground truth are mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the text. There is no mention of how potential discrepancies or interpretations of the "in-vivo testing" results were adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a physical mapping catheter, not an AI/ML algorithm or software that assists human readers in interpreting data. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable to this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone comparison for an algorithm was not done. This device is a physical catheter for electrophysiological recording, not an algorithm. Its performance is inherent in its ability to physically map and record electrical signals.
7. The Type of Ground Truth Used
The type of "ground truth" would be the actual physiological electrical signals measured by the catheter during the "pre-clinical in-vivo testing." The statement "The ProMap Coaxial Mapping Catheter records pulmonary vein potentials when used with electrophysiology recording equipment" implies that the physical recordings themselves, validated by the electrophysiology equipment and expert interpretation (though experts are not specified), serve as the ground truth for its function.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is not an AI/ML device requiring a training set.
Summary of missing information and reasons:
The provided document is a 510(k) summary for a physical medical device (mapping catheter), not an AI/ML-powered software. Therefore, many of your questions, particularly those related to AI/ML specific methodologies like sample sizes for test/training sets of AI, expert adjudication, MRMC studies, or specific performance metrics like sensitivity/specificity, are not addressed because they are not typically part of the regulatory submission for this type of device. The focus for such devices is often on pre-clinical testing to demonstrate mechanical integrity, biocompatibility, and intended functional performance compared to predicate devices.
§ 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).