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The S-Wire Guidewire System is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used in trans-catheter aortic valve implantation (TAVI) procedures.

The S-Wire Guidewire System is a sterile, single-use guidewire used for the placement of interventional devices within the aorta and the chambers of the heart. The S-Wire has a 0.035" diameter, and an overall length of 260 cm. The S-Wire construction consists of a nickel-titanium alloy core wire that is PTFE coated, ground and thermally formed. The S-Wire distal coil is made of 304V stainless steel: the distal and proximal ends of the stainless steel coil is bonded to the core wire. The distal portion of the S-Wire has silicone coating. The distal end of the S-Wire has a pre-formed double curve shape consisting of an approximately 360° bend with an outer diameter of approximately 3 cm, and a small S-curve at the distal tip of the wire that is fully contained within the 3 cm curved area. The S-Wire Guidewire System includes a disposable plastic 9 Fr introducer (6 inches long) that is used as an aid in loading the S-Wire into an intravascular catheter.

The provided text describes a medical device, the S-Wire Guidewire System, and its substantial equivalence determination by the FDA. However, the document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML algorithm or similar diagnostic tool where performance metrics like sensitivity, specificity, or accuracy would be relevant.

Instead, this document focuses on the regulatory clearance of a physical medical device (a guidewire) based on its comparability to a predicate device. The "performance testing" described refers to engineering and biocompatibility tests for the guidewire itself, not the performance of a diagnostic algorithm.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for an AI/ML study, nor details about sample sizes for test/training sets, expert qualifications, or adjudication methods related to diagnostic performance.

The "Performance Testing" section on page 5 details the types of tests conducted:

Performance Testing for the S-Wire Guidewire System (Physical Device):

• Measurement of physical characteristics and device integrity in accordance with FDA's Coronary and Cerebrovascular Guidewire Guidance and ISO 11070.
• Specific tests included:
  • Dimensional inspection
  • Tensile strength (guidewire and introducer)
  • Distal loop compression force
  • Distal tip shape retention
  • Tip stiffness
  • Coating integrity
  • Particulate evaluation
  • Catheter compatibility
  • Guidewire flex testing
  • Guidewire fracture testing
  • Corrosion resistance
• Additional testing included:
  • ISO 10993 biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, and pyrogen)
  • Sterile package integrity testing (pouch seal tensile strength and dye penetration)

Acceptance Criteria and Reported Device Performance (as described for this physical device):

The document states: "The Concert Medical S-Wire Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device." However, the specific numerical acceptance criteria (e.g., "tensile strength must be > X N") and the actual measured results for these tests are not provided in this summary. The comparison is made against a predicate device, but again, the detailed comparative results are not present in this document beyond the general statement of "compared favorably."

In summary, assuming the request pertains to the kind of "device" described in the input and not an AI/ML diagnostic algorithm, the answer would be:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the document. The document states that "The Concert Medical S-Wire Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device," but does not list the specific numerical criteria or results for each test (e.g., tensile strength values, corrosion resistance levels).
2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. For physical device testing, the sample size for each specific engineering test would be determined by the testing protocol, but this is not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not a diagnostic device or a study involving human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical guidewire would be defined by engineering standards and material properties, against which the manufactured guidewire's performance is measured.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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