(103 days)
Reprocessed diagnostic EP catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.
The provided text describes the reprocessing of Electrophysiology (EP) Catheters by Alliance Medical Corporation and their substantial equivalence to predicate devices, rather than a device with AI components. Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable to this submission.
However, I can extract information related to the performance data and the conclusion of substantial equivalence.
Here's the summary of the acceptance criteria and study findings based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (Implied for substantial equivalence) | Demonstrated through bench and laboratory testing. |
| Biocompatibility | Tested and demonstrated. |
| Validation of reprocessing | Tested and demonstrated. |
| Sterilization Validation | Tested and demonstrated. |
| Function Test(s) | Tested and demonstrated for appropriate function of components. |
| Packaging Validation | Tested and demonstrated. |
| Performance as originally intended (i.e., identical to predicate devices) | Demonstrated that Reprocessed EP Catheters perform as originally intended. |
| Design, materials, and intended use are identical to predicate devices | Stated as identical. |
| Mechanism of action is identical to predicate devices | Stated as identical. |
| No changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation | Stated as no changes. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document globally refers to "bench and laboratory testing" and "each individual electrophysiology catheter is tested," but does not provide specific numbers for the test set.
- Data Provenance: Not specified. It's laboratory testing, implying controlled environments, but the geographical origin of the data is not mentioned. It is prospective testing of reprocessed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/diagnostic imaging device that would typically involve expert ground truth for image interpretation. The "ground truth" for this device would be its physical and functional performance meeting specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of diagnostic interpretations. The performance testing involves objective measures (e.g., sterilization validation, function tests).
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:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device. The performance testing is for the physical medical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance validation is adherence to established engineering specifications and performance benchmarks, demonstrating that the reprocessed catheters function identically to their original, predicate counterparts (e.g., biocompatibility standards, functional electrical properties, sterility).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
§ 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).