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The Spectranetics Support Catheters are designed for use in the vascular system. The catheters are intended to support a guidewire during access of the vasculature, allow for exchange of guidewires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The Spectranetics Support Catheters are intravascular catheters, available in 3 models. Model 518-016 is a 0.014 inch guidewire compatible, 3.0 French (Fr.) outside diameter catheter. Model 518-017 is a 0.018 inch guidewire compatible. 3.4 Fr. outer diameter catheter. The new device, Model 518-028 is a 0.035 inch guidewire compatible, 4.8 Fr. outer diameter catheter. All models have a working length of 135 centimeters. All models have a radiopaque marker 2-3 mm from its tapered distal tip. A standard female luer is placed on the proximal end of each model. The distal 40 cm of each model is coated with a lubricious, hydrophilic coating.

The provided text describes a premarket notification (510(k)) for the Spectranetics 0.035" Support Catheter. This is a medical device submission, not an AI/ML device, and therefore the criteria typically associated with AI/ML device performance (like accuracy metrics, ground truth, expert adjudication, MRMC studies) are not applicable.

The "acceptance criteria" for a medical device in a 510(k) submission generally refer to demonstrating substantial equivalence to a legally marketed predicate device, proving it is safe and effective for its indicated use through non-clinical testing.

Here's a breakdown of the information relevant to this specific device, framed as best as possible to your request, but highlighting where AI/ML specific information is irrelevant:

1. Table of "Acceptance Criteria" and Reported Device Performance

Study Proving Device Meets "Acceptance Criteria":

The study proving the device meets the "acceptance criteria" is a series of non-clinical tests conducted as part of the Spectranetics New Product Introduction procedure, in concert with Quality System Regulations. The submission states: "The design validation protocols and risk analysis addressed all known aspects of the device including tensile strength, functionality, visibility, flow rate, sterility, and biocompatibility."

The conclusion is: "The results of the testing demonstrate that the Spectranetics 0.035" Support Catheter is substantially equivalent to the predicate devices and it will perform in a safe and effective manner when used as indicated."

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified in the provided text. The testing methods mentioned (tensile strength, functionality, visibility, flow rate, sterility, biocompatibility) suggest laboratory-based, non-clinical tests rather than human subject testing with a specific "test set" as understood in AI/ML.
• Data Provenance: The tests were conducted by Spectranetics Corporation as part of their internal design validation and quality system procedures. No information on country of origin for "data" (beyond being internal Spectranetics data) or retrospective/prospective status is relevant or available for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This concept is not applicable to this type of medical device submission. Ground truth for AI/ML models involves human expert annotations or independent verification of outcomes. For a physical device like a catheter, "ground truth" is established through engineering specifications, material science, and performance standards. The "experts" would be the engineers, quality control personnel, and potentially external laboratories conducting the specified tests. Their qualifications are inherent in their roles in medical device development and testing.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve discrepancies in expert labeling or diagnoses. For physical device testing, outcomes are typically quantitative measurements or pass/fail criteria based on predefined specifications.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to diagnostic imaging devices or AI/ML systems where human readers interpret medical images or data. The Spectranetics Support Catheter is a physical intravascular catheter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is not an algorithm. Its performance is evaluated intrinsically through physical and material tests, and its function involves human intervention for placement and use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For this physical medical device, "ground truth" is effectively defined by engineering specifications, material standards, and performance benchmarks verified through physical, chemical, and biological testing (e.g., tensile strength testing against a standard, biocompatibility testing per ISO standards). No expert consensus, pathology, or outcomes data in the AI/ML sense were used to establish the "ground truth" for these tests.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for an AI/ML algorithm.

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