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The Medcomp .010" Vascular Guidewires are indicated for general intravascular use, including the peripheral vasculature, to facilitate the selective placement of medical devices in the vessel anatomy. This device is not intended for coronary or cerebrovascular use.

The Medcomp .010" Vascular Guidewires are sterile, single-use devices used to facilitate intravascular medical device insertion. The proposed devices will be packaged and labeled as sterile accessories in individual pouches, or as part of kit configurations. The Medcomp .010" guidewires consist of a stainless steel core wire, which forms the proximal shaft of the guidewire - reducing in size from the proximal to the distal end, with a smooth transition to the coiled floppy distal tip secured to the end of the core. The .010" Vascular Guidewires have an outside diameter of 0.010" and are available in 45, 80 and 120cm lengths, with coil lengths of 4cm or 9.5cm. The .010" Vascular Guidewires are uncoated, or are available with a hydrophilic coating or a silicone fluid coating. The hydrophilic and silicone coatings reduce friction during use. Radiopacity of the distal coil region facilitates fluoroscopic visualization.

Despite the length of the provided document, the crucial information needed to answer the request comprehensively regarding acceptance criteria and the study proving adherence to them is not present.

The provided text is a 510(k) Summary for a medical device (Medcomp .010" Vascular Guidewires). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details on performance testing against specific acceptance criteria.

Here's what can be inferred and what is explicitly stated, along with what's missing:

1. A table of acceptance criteria and the reported device performance:

• Missing. The document states that "Physical testing was performed on the Medcomp .010" Vascular Guidewires following the guidance of ISO 11070 and FDA's Coronary and Cerebrovascular Guidewire Guidance (1995) to assure design integrity and performance for the intended use." However, it does not detail:
  • The specific acceptance criteria derived from these guidances.
  • The actual quantitative results or performance metrics of the Medcomp guidewires against those criteria.
  • Inference: It is implied that the device met some unstated criteria, as the submission was successful. However, the specific criteria and performance values are not reported.

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

• Missing. The document states "Physical testing was performed," but there's no mention of the sample size used for these tests. Data provenance (country of origin, retrospective/prospective) is also not applicable as this was physical testing, not clinical data.
• Inference: For physical testing, the "test set" would typically refer to the number of guidewire units subjected to various tests. This information is not provided.

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

• Not applicable. This question pertains to studies involving human interpretation or clinical endpoints. The described testing is physical performance testing of a device's mechanical properties, not clinical or image-based assessment requiring expert ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Similar to point 3, this relates to human interpretation or clinical studies, not physical device testing.

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. This device is a vascular guidewire, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

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

• Not applicable. This device is a physical medical instrument, not an algorithm.

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

• Not applicable (in the way it's usually understood for diagnostic devices). For physical performance testing, "ground truth" would be established by the specifications of the tests themselves (e.g., a certain force to cause breakage, a certain friction coefficient limit). The document states testing was done "following the guidance of ISO 11070 and FDA's Coronary and Cerebrovascular Guidewire Guidance (1995)," implying these guidances define the "truth" for acceptable physical performance attributes.

8. The sample size for the training set:

• Not applicable. There is no "training set" for this type of medical device's performance testing, as it is not an AI or machine learning algorithm.

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

• Not applicable. As above, there is no training set.

Summary of available information regarding performance evidence:

• Acceptance Criteria (Implied): Derived from ISO 11070 and FDA's Coronary and Cerebrovascular Guidewire Guidance (1995) for physical performance, and ISO 10993 for biocompatibility.
• Reported Device Performance: The submission's approval implies the device met these criteria, but specific performance data or numerical results are not provided in this 510(k) summary.
• Study Type: Physical performance testing and biocompatibility testing.
• Rationale for no Clinical Studies: "No clinical studies were performed as part of the 510(k) process as the product is comparable to products currently cleared for marketing and can be applied under the substantial equivalence claim." This is a key aspect of 510(k) submissions where clinical data is often not required if substantial equivalence can be demonstrated through technological characteristics and non-clinical testing.

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