(239 days)
The Amplatz Support Wire Guide with Apex Curve is used to facilitate the placement of devices during diagnostic and interventional procedures. The Amplatz Support Wire Guide with Apex Curve is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within trans-catheter aortic valve procedures.
The Amplatz Support Wire Guide with Apex Curve, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device utilizes a fixed core design. The Amplatz Support Wire Guide with Apex Curve is available with an outside diameter of 0.035 inches, a length of 260 centimeters, a curved tip, and an exterior coating. The Amplatz Support Wire Guide with Apex Curve is a packaged, sterile device intended for single patient use.
The provided text is a 510(k) summary for the "Amplatz Support Wire Guide with Apex Curve." It details the device's characteristics, intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device. However, this document does not describe a study involving an AI/Machine Learning device or a performance study with human readers.
The studies mentioned are engineering and bench tests, along with an animal model evaluation, to demonstrate the physical and functional performance of a medical guidewire. They are not clinical studies designed to assess the performance of an AI algorithm in assisting human readers or as a standalone diagnostic tool.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test sets involving human readers, expert ground truth establishment, MRMC studies, or training set details as these kinds of studies were not conducted or reported in this document for K171445.
Here's a breakdown of what can be extracted or inferred from the text regarding the device's acceptance criteria and the studies that met them, even though it's not an AI device:
1. A table of Acceptance Criteria and Reported Device Performance
The document states that for each test, "The predetermined acceptance criteria were met." It does not provide the specific numerical acceptance criteria or the numerical performance results. It only affirms that the criteria were satisfied.
| Acceptance Criteria Category (Test Type) | Reported Device Performance |
|---|---|
| Biocompatibility Testing | Met predetermined acceptance criteria (in accordance with ISO 10993-1:2009). |
| Corrosion Testing | Met predetermined acceptance criteria (in accordance with Annex B of ISO 11070:2014). |
| Flexing Test | Met predetermined acceptance criteria (in accordance with Annex G of ISO 11070:2014). |
| Fracture Testing | Met predetermined acceptance criteria (in accordance with Annex F of ISO 11070:2014). |
| Radiopacity Testing | Met predetermined acceptance criteria (in accordance with ASTM F640-12). |
| Tip Flexibility Testing | Performed for characterization purposes (in accordance with FDA Coronary and Cerebrovascular Guidewire Guidance). No specific acceptance criteria mentioned as it was for characterization. |
| Tensile Testing of the Union of the Core Wire and Coil of the Guide Wire | Met predetermined acceptance criteria (in accordance with applicable values of ISO 11070:2014, Annex H). |
| Performance Testing of Aged Devices | Met predetermined acceptance criteria (in accordance with ISO 11070:2014, Section 4.3 and Annex G). |
| Acute Performance Evaluation (Animal Model) | All test articles evaluated met the predetermined acceptance criteria for all performance parameters. |
Regarding the requested information that cannot be provided for this device:
- Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI device. For the physical tests, sample sizes would be according to ISO standards or internal protocols, but not specified here. The animal model study would have a sample size of animals, but this is not disclosed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on physical measurements and functional evaluations against engineering specifications.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this was not an AI device requiring such a study.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this was not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the reported tests would be based on established engineering specifications, material properties, and functional performance metrics (e.g., force required to fracture, flexibility measurements, corrosion resistance). For the animal study, it would be based on observed device performance within the animal model against predefined success criteria.
- The sample size for the training set: Not applicable, as this is not an AI device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI 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.