(26 days)
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
The Safe-Steer™ Guide Wire System consists of the following:
- Safe-Steer™ 0.014" Guide Wire ●
- Safe-Steer™ OCR Unit with Display Monitor .
The Safe-Steer™ Guide Wire is similar to a conventional 0.014" coronary guide wire, except that it incorporates an optic fiber, which runs the length of the guide wire. The Safe-Steer™ Guide Wire is connected to the OCR Unit, providing information on the Display Monitor of the location of the distal tip relative to the vessel wall.
The provided text is related to a 510(k) submission for a medical device called the Safe-Steer™ Guide Wire System. This submission describes a modification to an existing cleared device and asserts substantial equivalence to its predicate device. This type of submission relies on demonstrating that the modified device performs as safely and effectively as the predicate, often through performance testing and biocompatibility.
However, the provided document does not contain the detailed information required to answer all parts of your request, especially regarding clinical study specifics like sample size, reader qualifications, or ground truth establishment in the context of diagnostic or prognostic performance. The device is a guide wire, which is an interventional tool, not an AI/ML diagnostic algorithm.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "The Safe-Steer Guide Wire has been subjected to performance testing to verify conformance to the requirements of the product specification." and "On the basis of the testing conducted on the Safe-Steer™ Guide Wire it may be concluded that the device satisfies safety and performance requirements when used in accordance with the Instructions for Use for the indicated patient population."
However, specific acceptance criteria values and reported performance metrics are NOT provided in this summary. For a guide wire, performance criteria would typically include:
- Mechanical Properties: Tensile strength, torque response, pushability, trackability, flexibility, kink resistance, tip integrity.
- Biocompatibility: Confirmation of non-toxic, non-irritating, non-sensitizing properties, often tested according to ISO 10993 standards.
- Dimensional Accuracy: Outer diameter, length, and other critical dimensions as per specifications.
- Integrity of Components: E.g., for this device, the integrity of the optic fiber within the guide wire.
- Connection/System Functionality: For the Safe-Steer™ system, this would include the OCR Unit's ability to accurately display the distal tip's location relative to the vessel wall.
Due to the lack of specific data in the provided text, a table can only indicate the types of testing performed, not quantitative results or acceptance thresholds.
| Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Biocompatibility | Conforms to ISO 10993-1 and FDA Guidance for biological safety |
| Mechanical Performance | Conforms to product specifications |
| Design Requirements | Conforms to Design Control Procedures (21 CFR 820) |
| Safety and Efficacy (Overall) | Satisfies safety and performance requirements for intended use |
| Substantial Equivalence to Predicate | Deemed substantially equivalent to the predicate device (K011986) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The text mentions "performance testing" and "biocompatibility testing" but does not detail the sample sizes for these tests, nor does it specify if any human clinical data (which implies provenance) was used for this particular modification. Given it's a device modification and a special 510(k), the primary focus would be on bench and possibly pre-clinical (animal) testing to confirm the changes don't adversely affect performance.
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 is not applicable or provided. The device is an interventional guide wire, not an AI diagnostic tool requiring expert interpretation for ground truth establishment. The performance testing would involve engineering and laboratory methods, not expert clinical readers interpreting outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable or provided. Since the device is a medical instrument (guide wire), not a diagnostic algorithm where human interpretation and adjudication are involved in a test set, this concept doesn't apply.
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 or provided. The device is an interventional guide wire with an optical coherence reflectometry (OCR) unit to help locate its tip. It's not an AI-powered diagnostic tool, and therefore, an MRMC study and AI assistance effect size are not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable or provided. The Safe-Steer™ Guide Wire System is a physical medical device, not a standalone algorithm. While the OCR unit processes data, its functionality is integrated into the guide wire's use by a clinician, meaning there is always a "human-in-the-loop."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for cancer detection) does not directly apply here. For a guide wire, the "truth" would be established through:
- Bench Test Standards: Adherence to engineering specifications and performance benchmarks (e.g., does it meet specified torque, trackability, or tensile strength values under defined conditions?).
- Biocompatibility Testing Standards: Compliance with ISO 10993 series through laboratory assays.
- Physical Measurement: Actual measurements (e.g., diameter, length) compared to design specifications.
- Functional Verification: For the OCR unit, verifying that the display accurately reflects the physical location of the guide wire tip as measured by other independent means (e.g., visual inspection in phantoms, specialized sensors).
8. The sample size for the training set
This information is not applicable or provided. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
This information is not applicable or provided. As above, it is not an AI/ML device.
§ 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.