(167 days)
The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Scientia Vascular's Aristotle Colossus Guidewire is a modification of Scientia Vascular's Aristotle 24 Guidewire. It is a 0.035" diameter, steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a single stiffness profile (standard) and is available in a range of lengths from 150 cm to 300 cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in tortuous vessels.
The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a rotating hemostasis valve (RHV)), and a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer, and torque device accessories are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The provided text describes a medical device, the Aristotle Colossus Guidewire, and its clearance process with the FDA. It details a comparison to a predicate device and reports on non-clinical performance tests. However, the document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth by experts for such a study. It specifically focuses on the physical and functional characteristics of a guidewire.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of an AI/human-in-the-loop performance evaluation. The document describes a traditional medical device clearance process based on material properties, functional performance, and biocompatibility.
Here's a breakdown of why I cannot fulfill your request based on the provided text, and what is present:
Information NOT present in the document which your request asks for:
- A table of acceptance criteria and reported device performance related to AI/human reader performance.
- Sample size used for a test set in the context of AI/human reader performance.
- Data provenance (country of origin, retrospective/prospective) for AI/human reader performance data.
- Number of experts used to establish ground truth for an AI/human reader test set or their qualifications.
- Adjudication method for an AI/human reader test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study (effect size of human readers with/without AI).
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data) in the context of AI interpretation.
- Sample size for a training set (for an AI model).
- How ground truth for a training set was established (for an AI model).
Information that IS present in the document (but is for a physical medical device, not an AI/Software as a Medical Device):
The document describes the acceptance criteria and performance study for the Aristotle Colossus Guidewire, which is a physical medical device (a guidewire for vascular procedures). The studies described are non-clinical (laboratory and simulated use) to demonstrate the device's physical and biological safety and effectiveness.
1. Acceptance criteria and reported device performance (for the physical guidewire):
The document states: "Results of tests performed on the Aristotle Colossus Guidewire demonstrate that it met the test acceptance criteria and meets the requirements of relevant standards and FDA guidance documents."
The "Table 3: Summary of Subject Device Functional Testing" lists the tests performed and consistently reports: "The Aristotle Colossus Guidewires met test acceptance criteria."
Here's a summary of the stated "acceptance criteria" through the lens of successful test outcomes for the physical guidewire:
| Acceptance Criteria (Implied by Test Name) | Reported Device Performance (Always "Met Acceptance Criteria") |
|---|---|
| Biocompatibility: | |
| Non-cytotoxic | Non-cytotoxic |
| Non-hemolytic | Non-hemolytic |
| No effect on Partial Thromboplastin Time | No effect on the PTT. The two samples are considered similar. |
| Similar or lower Complement Activation | Similar or lower potential to activate the complement system when compared to the predicate. |
| Similar Thrombogenic risk potential | Thrombogenic risk potential similar to the predicate. |
| Functional Testing: | |
| Dimensional conformance | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Sufficient Tensile Strength | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Resistance to Fracture and Flexing | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Acceptable Torqueability and Torque Strength | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Appropriate Tip Flexibility | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Tip Shape Retention | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Acceptable Coating Lubricity and Durability | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Coating Integrity | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Low Particulate Generation | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Performance in Simulated Use Model | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Favorable Usability Evaluation by Physicians | The Aristotle Colossus Guidewires met test acceptance criteria. |
| Sterilization & Shelf Life: | |
| Sterilization assurance levels (SAL) of at least 10^-6 | Not explicitly stated 'met', but implied by final conclusion for clearance. |
| Acceptable EO and ECH residuals | Not explicitly stated 'met', but implied by final conclusion for clearance. |
| Acceptable bacterial endotoxin levels | Not explicitly stated 'met', but implied by final conclusion for clearance. |
| Packaging integrity maintained through shelf-life | Not explicitly stated 'met', but implied by final conclusion for clearance and new 1-year shelf life. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified quantitatively for each test, but it refers to the physical guidewires tested. Standard engineering and biocompatibility testing typically involves a specific number of units per lot or batch, but these numbers are not detailed in this summary.
- Data Provenance: The studies are non-clinical performance tests conducted in a laboratory setting, likely by or for the manufacturer, Scientia Vascular, Inc. (West Valley City, Utah). They are simulations or bench tests rather than data derived from patients. The studies are prospective in the sense that they were designed and executed to evaluate this specific device for regulatory submission.
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):
This information is not applicable in the context of this device's testing. The "Usability Evaluation" involved "Physicians [who] evaluated subject and predicate guidewires for various performance characteristics in a human cadaver." The number and specific qualifications of these physicians are not provided. This is a usability assessment, not an expert panel for establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical device, and the "usability evaluation" doesn't describe a ground truth adjudication process in the manner seen for diagnostic AI.
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 guidewire, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a guidewire, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is established by engineering specifications, material science standards, and in vitro/ex vivo (cadaver) performance. For biocompatibility, it's established via standardized biological assays. There is no "ground truth" in the clinical diagnostic sense with expert consensus or pathology involved.
8. The sample size for the training set:
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.