(458 days)
The catheter is indicated for electrophysiological mapping of cardiac structures in adult patients; i.e., stimulation and recording only.
The MultiCath* and the AcQRate Dx Fixed Curve Catheter are pre-shaped multipolar catheters for sensing of intracardiac signals and diagnostic pacing, in combination with an electrophysiological investigation and recording device.
The device consists of a catheter body with a distal curve, an array of platinum/iridium (PtIr) electrodes, and a proximal multipolar connector. Multiple electrode configurations are available with various numbers of electrodes and electrode spacing.
- Unless otherwise noted, the term "MultiCath" is used throughout to represent either MultiCath or the AcQRate Dx Fixed Curve Catheter.
The provided text is a 510(k) Summary for the BIOTRONIK MultiCath and AcQRate Dx Fixed Curve Catheter, and related MPK patient cables. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.
However, the document does NOT describe a study that proves the device meets specific acceptance criteria in terms of AI/algorithm performance (e.g., sensitivity, specificity, accuracy). The device in question is an electrophysiological catheter and patient cables for cardiac mapping and recording, which are hardware devices, not AI/algorithm-based diagnostic software.
Therefore, I cannot fulfill your request for information related to AI/algorithm performance, acceptance criteria for such algorithms, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The provided text focuses on the following types of performance data for a medical device (hardware):
- Nonclinical Bench Testing: This includes design verification (dimensional, visual inspection, functional/compatibility, mechanical, corrosion testing) and design validation (usability testing).
- Biocompatibility Testing: To ensure the materials are safe for human contact.
- Sterilization, Shelf Life, and Packaging Validations: To ensure the device remains sterile and functional over time.
The acceptance criteria are implicitly that the device passes these various engineering and safety tests and demonstrates substantial equivalence to the predicate device in terms of functionality and safety. The reported device performance is "pass" for all listed tests.
To directly answer your request based only on the provided text, while acknowledging the mismatch with an AI/algorithm context:
1. A table of acceptance criteria and the reported device performance:
| Test Performed | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensional and Visual Inspection | Requirements of EN ISO 10555-1 met and correspond to defined specifications. | Pass |
| Functional and Compatibility Testing (including leakage currents) | Leakage currents below limits of IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012; proper functionality and compatibility with external generators. | Pass |
| Electrical and Mechanical Testing | Applicable requirements of EN ISO 10555-1, EN 62366-1, and EN ISO 60601-1 met to ensure safety. | Pass |
| Shelf Life (functional performance, sterile barrier pouch integrity - seal strength, bubble per ASTM F88, ASTM F2096) | Confirmation of device functional performance and sterile barrier pouch integrity with accelerated aging and simulated distribution (ASTM 4169-16). | Pass |
| Packaging (integrity, transport simulation, preconditioning, seal strength, peel, bubble testing) | Evaluation of sterile barrier package integrity against transport simulation and relevant tests. | Pass |
| Biocompatibility | Requirements of ISO 10993 "Biological evaluation of medical devices - Part 1" and 2020 FDA Biocompatibility guidance met. | Pass |
| Sterilization Validation (Full Revalidation of Sterilization Process Performance Qualification ISO 11135:2014) | Requirements of ISO 11135:2014 met for ethylene oxide sterilization. | Pass |
| Functional testing of MPK (visual inspection, dimensional verification, electrical continuity and resistance, mechanical characteristics after real-time aging) | Product properties validated after 25 months real-time aging; visual inspection, functional test, electrical measurement all pass. | Pass (a, b, c) |
| Reprocessing Validation (MPK cable) | Cable can be reprocessed up to 50 times. | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes (N) for each individual test. It states "All bench testing was conducted on the MultiCath Catheters necessary for Electrophysiological Diagnostics."
- Data provenance: Not explicitly stated, but implies internal company testing (BIOTRONIK / VascoMed GmbH in Germany) for the devices. It is non-clinical bench data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is hardware testing against engineering standards, not a diagnostic algorithm requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable; standard engineering and laboratory testing protocols are followed, where pass/fail is determined by objective measurements against predefined specifications.
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 device is a catheter and cables, not an AI-assisted diagnostic tool. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For hardware, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, IEC, ASTM) and the manufacturer's own validated design specifications. The performance is objectively measured against these, not against human expert consensus or clinical outcomes data in the context of this 510(k).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a 510(k) submission for a physical medical device (catheter and cables), not an AI/ML-based diagnostic software. Therefore, many of the questions regarding AI/ML performance metrics, data sets, and expert involvement are not relevant to this document's content.
§ 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).