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The Cardica® C-Port® xA Plus Distal Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.

The Cardica® C-Port® xA Plus Distal Anastomosis System delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). An array of metal clips creates a complete, end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount

The provided text describes a Special 510(k) Premarket Notification for the Cardica® C-Port® xA Hybrid PLUS Distal Anastomosis System. This type of submission is for modifications to a legally marketed device that do not significantly alter its fundamental scientific technology or intended use. Therefore, the device is demonstrating substantial equivalence to its predicate device rather than undergoing extensive de novo clinical trials with acceptance criteria and a dedicated study design for proving performance against those criteria.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of acceptance criteria and the reported device performance:

Since this is a Special 510(k) for a modified device, the "acceptance criteria" primarily relate to demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the predicate device. The performance is assessed by confirming that the modified device remains substantially equivalent. No specific quantitative performance metrics (like sensitivity, specificity, or specific success rates) for a new device are presented as acceptance criteria for this submission.

The document states: "All the aforementioned modifications have been rigorously verified and validated using Cardica's Design Control process (Cardica procedures WD-0400 and 0401)... A battery of tests and evaluations was performed to assess the impact of the component material changes identified above to ensure that these modifications do not alter the validity of in vitro and in vivo testing and other design validation activities previously performed on the predicate Cardica® C-Port® xA PLUS Distal Anastomosis System and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device."

This indicates a process of verification and validation that confirmed the modified device still met the performance established by the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample size for a "test set" in the context of a new performance study. The testing performed was related to verifying the impact of material changes on the modified device relative to the predicate. The provenance of the data is not specified beyond "Cardica's Design Control process." Given the nature of a Special 510(k) for material changes, this would likely involve a combination of in vitro and potentially in vivo testing, but not a large-scale clinical trial to establish new performance metrics.

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 information is not applicable and not provided. The submission focuses on substantial equivalence based on engineering and performance testing of the device itself and its components, not on evaluation by human experts using diagnostic data.

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

This information is not applicable and not provided. As mentioned above, the evaluation is not based on human-expert assessment of "ground truth" to determine performance.

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 and not provided. This device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and not provided. This device is a physical surgical instrument, not an algorithm.

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

For the design validation activities mentioned, the "ground truth" would be established through engineering specifications, material properties, mechanical testing results (e.g., related to durability, force required to clamp, dimensional stability), and potentially animal in vivo models for anastomotic integrity, as was done for the predicate device. The document explicitly states: "ensure that these modifications do not alter the validity of in vitro and in vivo testing and other design validation activities previously performed on the predicate..." This implies relying on the established performance and safety profile of the predicate as the benchmark.

8. The sample size for the training set:

This information is not applicable and not provided. The device is not an AI algorithm that requires a training set.

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

This information is not applicable and not provided. The device is not an AI algorithm that requires a training set.

Summary of the Study and Acceptance:

The submission K101018 for the Cardica® C-Port® xA Hybrid PLUS Distal Anastomosis System is a Special 510(k). This means it's a notification for changes to a device already cleared by the FDA (the predicate K090872). The "study" isn't a new clinical trial to establish performance de novo, but rather a Design Change Impact Analysis and a battery of verification and validation tests to ensure that modifications (primarily material changes) do not alter the safety or effectiveness of the device and that it remains substantially equivalent to its predicate.

The key acceptance criterion for this submission is substantial equivalence to the predicate device (K090872). This is evaluated by demonstrating that the modified device:

• Has the same intended use.
• Has the same operating principle.
• Has the same basic device design and size.
• Has primarily the same materials (with changes rigorously tested).
• Uses the same manufacturing processes.
• Uses the same packaging and sterilization materials.
• Has essentially identical Instructions for Use.

The study proving this involved:

• Design Change Impact Analysis: Identifying potential ramifications of the material changes.
• Verification and Validation Testing: A "battery of tests and evaluations" performed based on Cardica's Design Control process (WD-0400 and 0401) to assess the impact of the material changes. These tests were designed to confirm that the modifications did not invalidate prior in vitro and in vivo testing and design validation activities conducted for the predicate device.
• Risk Management File review and Clinical Risk Benefit Analysis: Conducted to ensure continued safety and efficacy.

No specific sample sizes for these tests are provided in the summary, nor is detailed information on the specific in vitro or in vivo tests performed. However, the FDA's clearance indicates they were satisfied that the evidence presented supported the claim of substantial equivalence.

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