(87 days)
The Approach CTO Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
The Approach CTO Wire Guide is manufactured using a stainless steel wire with a PTFE coating and a stainless steel and platinum distal tip. The maximum outside diameter is 0.0142-inch and will be available in 135, 190 and 300 cm lengths. It will be supplied sterile, intended for one-time use.
The provided text describes a 510(k) premarket notification for the "Approach CTO Wire Guide." This is a medical device, and the submission focuses on demonstrating substantial equivalence to predicate devices, rather than conducting a detailed clinical study with human readers and AI. Therefore, many of the requested elements pertaining to AI performance metrics, expert reviews, and large-scale clinical trials are not applicable to this type of regulatory submission.
Here's an analysis of the provided information in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The submission lists several tests performed. The "acceptance criteria" are implied by the successful completion of these tests as stated: "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide." Specific quantitative acceptance criteria or detailed results are not provided in this summary document.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device integrity under tensile stress | Tensile Test (Successfully performed; specific results not provided) |
| Ability to withstand tip loads | Tip Load Test (Successfully performed; specific results not provided) |
| Resistance to fracture | Fracture Test (Successfully performed; specific results not provided) |
| Durability under flexing | Flexing Test (Successfully performed; specific results not provided) |
| Resistance to bending | Bending Test (Successfully performed; specific results not provided) |
| Strength under torsional forces | Torque Strength Test (Successfully performed; specific results not provided) |
| Responsive to torque input | Torque Response Test (Successfully performed; specific results not provided) |
| Resistance to corrosion | Corrosion Resistance Test (Successfully performed; specific results not provided) |
| Biocompatibility with biological systems | Biocompatibility Testing (Successfully performed; specific results not provided) |
| Microbial load within acceptable limits | Bioburden Testing (Successfully performed; specific results not provided) |
| Endotoxin levels within acceptable limits | Endotoxin Testing (Successfully performed; specific results not provided) |
| EtO residuals within acceptable limits | EtO Residual Testing (Successfully performed; specific results not provided) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The tests performed are likely engineering bench tests on a sample of devices, not clinical trials with human subjects.
- Data Provenance: The tests were conducted internally by Cook Incorporated. This is not a clinical study, so concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the "test set" here refers to physical device testing, not a clinical dataset requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the "test set" here refers to physical device testing. Adjudication methods are relevant for clinical studies or image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The Approach CTO Wire Guide is a physical medical device, not an AI diagnostic tool.
- Effect size of human readers improving with AI vs. without AI assistance: Not applicable for the reasons stated above.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? No. This is not an AI algorithm. The device is evaluated for its physical performance and safety characteristics.
7. Type of Ground Truth Used
- The "ground truth" for the device's performance is established by engineering specifications and recognized standards for wire guides. The device is expected to meet predefined physical and biological characteristics (e.g., tensile strength, corrosion resistance, biocompatibility). Successful completion of the listed tests confirms adherence to these engineering "ground truths."
8. Sample Size for the Training Set
This is not applicable. There is no AI model being trained for this device. The "training" for a physical device involves its design, manufacturing processes, and quality control, not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated above.
§ 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.