(176 days)
The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.
The MMS Guide Catheter is a small diameter tubular device. It is inserted into the vasculature using standard access techniques and advanced over a guidewire to the physician desired location. The MMS Guide Catheter can be used as a pathway for other diagnostic or therapeutic devices to enter the vasculature. The distal end has a standard luer fitting.
This appears to be a 510(k) summary for the MMS Guide Catheter, making a case for substantial equivalence to a predicate device (Marksman Catheter, K111490). The document describes non-clinical testing to demonstrate performance, not diagnostic performance of an AI/ML device. Therefore, a direct answer to the request regarding "acceptance criteria and reported device performance" in the context of an AI/ML device is not applicable for this document.
However, I can extract the general acceptance criteria and performance reported for the MMS Guide Catheter as presented in the document, treating "acceptance criteria" as the planned tests and "reported device performance" as the outcome of those tests.
Here's an analysis based on the provided text, adapted to the closest interpretations:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Found to be biocompatible |
| Sensitization | Found to be biocompatible |
| Acute Systemic Toxicity | Found to be biocompatible |
| Hemolysis Extract | Found to be biocompatible |
| Hemolysis Direct Contact | Found to be biocompatible |
| Pyrogen | Found to be biocompatible |
| Complement Activation | Found to be biocompatible |
| Canine Thrombogenicity | Found to be biocompatible |
| Animal Testing (Simulated Clinical Performance): | Performed to specification |
| Cadaver Experience (Simulated Clinical Use): | Performed to specification |
| Non-Clinical Testing: | |
| Dimensional verification | Met all acceptance criteria |
| Surface Review | Met all acceptance criteria |
| Leak | Met all acceptance criteria |
| Tracking | Met all acceptance criteria |
| Flow | Met all acceptance criteria |
| Flex/Kink | Met all acceptance criteria |
| Torque | Met all acceptance criteria |
| Tensile | Met all acceptance criteria |
| Packaging | Met all acceptance criteria |
| Overall Performance Data: | All necessary verification and validation testing has been performed to assure substantial equivalence to the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document does not specify sample sizes for mechanical or biocompatibility tests. It briefly mentions "Animal testing" and "Cadaver testing" but provides no details on the number of animals or cadavers used, let alone their provenance or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a guide catheter, not a diagnostic AI/ML system requiring expert ground truth for its performance evaluation (e.g., image interpretation). The "ground truth" for this device's performance would be engineering specifications and biological reactions, evaluated through laboratory and preclinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. Performance is assessed against predetermined engineering and biological 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 is not an AI/ML device, nor does it involve human readers in a diagnostic context. This is a medical device clearance submission for a guide catheter.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (catheter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the MMS Guide Catheter, the "ground truth" for demonstrating its performance relies on:
- Engineering Specifications: Defined physical and mechanical properties (e.g., dimensions, tracking, flex/kink, torque, tensile strength).
- Biocompatibility Standards (ISO 10993): Established tests for biological safety.
- Simulated Clinical Performance: Performance in animal models and cadaveric vasculature against expected functionality.
- Predicate Device Comparison: Establishing substantial equivalence by comparing technological characteristics and intended use to an already cleared device.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).