(64 days)
The Neuron MAX System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Neuron MAX System is an additional configuration to the currently available Neuron Intracranial Access System. The Neuron Max System provides a larger lumen to assist in utilizing contrast injections to further optimize anatomical visualization while maintaining a flexible distal tip. This larger lumen also accommodates larger therapeutic devices like the Penumbra System® and Penumbra Coil 400™ devices. The devices are provided sterile, non-pyrogenic, and intended for single use only.
The provided text describes the non-clinical testing performed for the Penumbra Neuron™ MAX System to demonstrate its safety and effectiveness and substantial equivalence to predicate devices. It does not contain information about studies conducted on diagnostic devices with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. Therefore, I cannot provide a table of acceptance criteria and reported device performance in that sense.
However, I can summarize the acceptance criteria and the studies performed to meet those criteria based on the provided text for the Neuron™ MAX System, which is a medical device (catheter) for introducing interventional devices.
Here's a breakdown of the information that can be extracted:
1. Table of Acceptance Criteria and the Reported Device Performance
For this type of device, "acceptance criteria" are generally that the device "Met established criteria" and "Reported device performance" is the outcome of the tests.
| Test Category | Specific Test / Attribute | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | In Vitro Cytotoxicity | No evidence of cell lysis or toxicity | No evidence of cell lysis or toxicity |
| Sensitization | Non-Sensitizing | Non-Sensitizing | |
| Acute Intracutaneous Reactivity (Irritation) | No evidence of irritation | No evidence of irritation | |
| Acute Systemic Toxicity | No evidence of systemic toxicity | No evidence of systemic toxicity | |
| Rabbit Pyrogen Study | No evidence of material-mediated pyrogenicity | No evidence of material-mediated pyrogenicity | |
| Hemo-compatibility (In Vitro Hemolysis) | Non-Hemolytic | Non-Hemolytic | |
| Hemo-compatibility (In Vitro Coagulation - PT, PTT) | Coagulation times not significantly different than corresponding control | Coagulation times are not significant different than corresponding control | |
| Hemo-compatibility (Partial Thromboplastin Time (PTT) Assay) | Non-Thrombogenic | Non-Thrombogenic | |
| Complement Activation | No greater biological response than corresponding control | No greater biological response than corresponding control | |
| Dog Thrombogenicity | Non-Thrombogenic | Non-Thrombogenic | |
| Genotoxicity (Mouse Lymphoma) | Non-Mutagenic | Non-Mutagenic | |
| Genotoxicity (Ames Mutagenicity) | Non-Mutagenic | Non-Mutagenic | |
| Genotoxicity (In Vivo Mouse Micronucleus) | Non-Clastogenic | Non-Clastogenic | |
| Bench-top Testing | Pouch Seal Strength | Met established criteria | Met established criteria |
| Dimensional / Visual Inspection | Units meet all inspection criteria for release of finished goods (clinically acceptable) | Met established criteria | |
| Simulated Use (Intracranial Access & Vessel Access Entry Performance) | Units meet all inspection criteria for release of finished goods (clinically acceptable) | Met established criteria | |
| Hub / Shaft & Mid-shaft or Shaft Tensile Strength (MAX 088 Delivery Catheter / Dilator, 6F Select Catheter) | Met established criteria | Met established criteria | |
| Hub Air Aspiration (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator) | Met established criteria | Met established criteria | |
| Burst Test (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator) | Met established criteria | Met established criteria | |
| Particulate Testing (Hydrophilic Coating) (MAX 088 Delivery Catheter) | Met established criteria | Met established criteria | |
| Friction Force (MAX 088 Delivery Catheter / 8F Sheath compatibility, etc.) | Met established criteria | Met established criteria | |
| Flow Rate (MAX 088 Delivery Catheter / 6F Select Catheter) | Met established criteria | Met established criteria | |
| Elongation to Failure (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator) | Met established criteria | Met established criteria | |
| Corrosion (MAX 088 Delivery Catheter / 6F Select Catheter / Dilator / RHV / HVA) | Met established criteria | Met established criteria | |
| Torsion (MAX 088 Delivery Catheter / 6F Select Catheter) | Met established criteria | Met established criteria | |
| Animal Study | Vessel injury on final angiograms | No vessel injury noted | No vessel injury was noted |
| Gross or histology findings in test vessel segments | No abnormal gross or histology findings noted | No abnormal gross or histology findings were noted | |
| Significant vascular response | No significant vascular response in experimental conditions | The use of the Neuron MAX System resulted in no significant vascular response |
2. Sample size used for the test set and the data provenance
- Biocompatibility: The sample size for each specific test (e.g., number of cell cultures, animals for sensitization/toxicity tests) is not explicitly stated in the provided document. The data provenance is described as "All studies were conducted pursuant to 21 CFR, Part 58, Good Laboratory Practices," indicating a regulatory framework for the testing, likely conducted in the USA or adhering to international standards.
- Bench-top Testing: The sample size for each test is not explicitly stated. The testing was conducted internally based on "standard test methods." Data provenance is not specified beyond being "Design Verification (Bench-Top Testing)."
- Animal Study: The sample size is referred to as "a swine model," meaning the study involved pigs. The number of animals is not specified. Data provenance is not specified beyond being "an animal study."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the provided document, as it describes the testing of a medical device (catheter) for physical, mechanical, and biological compatibility, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3. Performance criteria are based on objective measurements and observations in laboratory and animal settings, not on expert consensus or adjudication.
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
This information is not applicable. The device is an interventional catheter, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable, as the device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the Neuron™ MAX System, the "ground truth" or reference for evaluating performance was:
- Biocompatibility: Established ISO 10993-1 guidelines, ASTM methods, and USP methods, focusing on biological responses (e.g., cell lysis, irritation, systemic toxicity, hemolysis, thrombogenicity, mutagenicity). The "ground truth" is adherence to these established biological safety profiles.
- Bench-top Testing: "Standard test methods" for physical and mechanical properties. The "ground truth" is meeting pre-determined engineering and functional specifications.
- Animal Study: Direct observation during and after the procedure (e.g., angiograms for vessel injury) and histopathological examination of tissues for gross or histology findings. The "ground truth" is the pathological and angiographic findings in the swine model.
8. The sample size for the training set
This information is not applicable, as the device is not an AI algorithm requiring a training set. The descriptions pertain to R&D and verification testing, not machine learning model development.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).