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The MicroCutter 5/80 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.

The size of the Dextera MicroCutter 5/80TM Blue Reload and Dextera MicroCutter 5/80™ Blue Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the Dextera MicroCutter 5/80™ White Reload and Dextera MicroCutter 5/80TM White Curved Tip Reload staple is compatible with tissue that can be easily compressed to 1.0mm. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The Dextera MicroCutter 5/80™ Reloads are deployed using the Dextera MicroCutter 5/80™ Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.

This document is a 510(k) premarket notification for a medical device, specifically surgical stapler reloads (Dextera MicroCutter 5/80™), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against acceptance criteria in the way a new, novel AI/software medical device might.

Therefore, the information requested to describe "the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software medical device is largely not present in this document.

However, I can extract the available relevant information and highlight what is missing based on your request.

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

This document does not provide a table of explicit acceptance criteria with corresponding performance metrics in a pass/fail format, as might be found for a software device. Instead, it lists types of bench tests performed.

Missing Information: Specific quantitative acceptance criteria (e.g., "loading force must be X-Y Newtons") and the precise measured performance values are not provided.

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

• Sample Size for Test Set: Not specified. The document only states "Bench testing... was performed." The number of reloads or test specimens used for each type of test is not detailed.
• Data Provenance: The testing was conducted by Cardica, Inc. (the device manufacturer) as part of their 510(k) submission. It's not relevant in this context to speak of "country of origin of the data" or "retrospective or prospective" as these terms typically apply to clinical studies involving human or animal subjects, or retrospective analysis of medical records for AI/software devices. For bench testing, it refers to internal laboratory testing.

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

This is not applicable to this type of device and study. The "ground truth" for mechanical integrity, staple formation, etc., is established directly by physical measurements and engineering standards, not by expert interpretation.

4. Adjudication method for the test set

This is not applicable to this type of device and study. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among human reviewers (e.g., radiologists, pathologists) when establishing ground truth for complex interpretations, typically in AI/software device studies. Bench testing relies on objective measurements.

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 is not applicable to this type of device and study. An MRMC study is relevant for AI-assisted diagnostic or therapeutic decision-making devices where human reader performance is a key metric. This medical device (surgical stapler reloads) is a surgical tool, not an AI/software diagnostic or assistant.

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

This is not applicable as this is not an AI/software medical device.

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

The "ground truth" for the performance evaluation in this 510(k) submission is based on:

• Engineering specifications and standards: For measurements like dimensions, forces, and heights.
• Physical properties and integrity: For tests like leak/burst pressure and staple formation.
• Comparison to predicate device performance: The ultimate conclusion is often that the new device performs "as intended" and is "substantially equivalent" to the predicate, implying it meets the same functional requirements.

8. The sample size for the training set

This is not applicable as this is not an AI/Software medical device that requires a training set.

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

This is not applicable as this is not an AI/Software medical device that uses a training set.

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The MicroCutter XCHANGE® 30 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatic surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.

The MicroCutter XCHANGE® 30 is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The size of the White Cartridge staple is compatible with tissue that can be easily compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

Here's a breakdown of the acceptance criteria and study information for the Cardica MicroCutter XCHANGE® 30, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, for the tissue burst pressure tests, the acceptance is implied by demonstrating "no statistical difference" compared to the predicate device. For the animal studies, the acceptance is based on an "uncomplicated 5-week postoperative course" and "unremarkable" histological evaluation with "no demonstrable difference between the two groups."

Therefore, the table below reflects the reported performance relative to the predicate, rather than explicit numerical acceptance criteria.

2. Sample Size and Data Provenance for Test Set (Bench Testing & Animal Studies)

• Bench Testing:

  • Sample Size: Not explicitly stated in the provided text for the bench testing. The results are described generally as "Tissue Burst pressure testing was conducted."
  • Data Provenance: Porcine carotid artery and porcine jugular vein were used, indicating animal tissue (ex vivo) for these specific tests. The country of origin is not specified, but it's likely a controlled laboratory environment. This is prospective data generation for the purpose of the 510(k).

• Chronic Animal Studies:

  • Sample Size: Not explicitly stated as a number of animals per group, but it involved two studies: "a study in which unilateral nephrectomies were performed and a study in which unilateral lobectomies were performed." "All animals" had an uncomplicated course, implying the sample size was sufficient for the study's conclusions.
  • Data Provenance: The studies were "chronic animal studies," meaning conducted in vivo on live animals. The type of animal (e.g., porcine, canine) is not specified. The country of origin is not specified. This is prospective data generation.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Not Applicable. The described studies are performance tests (bench and animal), not diagnostic or image-based studies requiring human expert interpretation as ground truth. The "ground truth" (or outcome assessment) was based on direct physiological measurements (burst pressure), macroscopic observation (postoperative course, stump condition), and microscopic histological evaluation. These evaluations would typically be performed by trained technicians, veterinarians, and pathologists, but they are not "experts" in the context of establishing diagnostic ground truth from images or clinical data.

4. Adjudication Method for Test Set

• Not Applicable. As mentioned above, the studies are performance tests and do not involve human interpretation or adjudication in the manner of, for example, multiple readers assessing medical images. Outcomes are based on objective measurements and pathological/histological findings.

5. MRMC Comparative Effectiveness Study

• No. The provided document describes bench testing and chronic animal studies, not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers and AI assistance. The device is a surgical stapler, not an AI-powered diagnostic tool.

6. Standalone Performance (Algorithm Only)

• No. The device is a surgical stapler. This concept primarily applies to AI/software as a medical device (SaMD) where an algorithm's performance is evaluated independently of human interaction.

7. Type of Ground Truth Used

• Bench Testing: Direct physical measurements (e.g., burst pressure) under controlled laboratory conditions, and comparison to a legally marketed predicate device.
• Chronic Animal Studies:
  • Macroscopic observation: Postoperative course assessment (complications, bleeding, infection), visual inspection of vascular and ureter stumps.
  • Microscopic evaluation: Histological assessment of tissue.
  • Comparison of these outcomes between the subject device and the predicate device.

8. Sample Size for the Training Set

• Not Applicable. This device is a mechanical surgical stapler. There is no AI or machine learning component that would require a "training set" in the conventional sense. The "development" or "training" of the device involves engineering design, material selection, and iterative physical testing, not data-driven algorithm training.

9. How Ground Truth for Training Set Was Established

• Not Applicable. As there is no AI/ML component, there is no "training set" or ground truth for it. The design and validation relied on established engineering principles, material science, and pre-clinical testing against known performance benchmarks from predicate devices.

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The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.

The MicroCutter XCHANGE™ 30 Stapler is a single patient use stapler that delivers two. double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The MicroCutter XCHANGE™ 30 Blue Staple Cartridge is available for deployment with the MicroCutter XCHANGE ™ 30 Stapler which delivers a blue staple (3.5mm) compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

The provided document is a 510(k) Summary for a medical device (MicroCutter XCHANGE™ 30 Blue Staple Cartridge) and describes its non-clinical performance data for demonstrating substantial equivalence to a predicate device. It is not a study proving the device meets clinical acceptance criteria or describing a comparative effectiveness study involving human readers and AI.

Here's an analysis of the provided information based on your request, highlighting what is present and what is missing because this document focuses on non-clinical data for a 510(k) submission:

1. Table of acceptance criteria and the reported device performance

The document provides a comparative table of technological characteristics between the predicate and subject devices and mentions various tests were conducted. However, it does not explicitly define acceptance criteria as a specific numeric or qualitative threshold for each test directly alongside reported performance data in a clear table format. It states that tests "met design specifications" or "passed."

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 sizes for the "test sets" for the listed non-clinical tests. It refers to "design verification testing."

• Sample Size: Not specified for individual tests.
• Data Provenance: Not specified, but implied to be internal testing by Cardica, Inc. (Redwood City, California, USA). The tests are non-clinical bench tests.
• Nature: The testing described is prospective, as it was conducted to verify a design modification.

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

This information is not applicable to this document. The tests described are non-clinical (mechanical, biological, physical) and do not involve human experts establishing ground truth for a diagnostic algorithm.

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

This information is not applicable. No adjudication method is described as the tests are non-clinical engineering and biological assessments.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical testing for a surgical stapler, not an AI diagnostic device.

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

This information is not applicable. This document describes the performance of a physical medical device (surgical stapler component), not an algorithm.

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

For the non-clinical tests, the "ground truth" implicitly refers to engineering specifications, regulatory standards (e.g., ISO, ASTM, ANSI/AAMI), and established performance of the predicate device. For instance, 'Bioburden testing passed in accordance with ANSI/AAMI/ISO 11737-1' means the standard itself defines the acceptable reference. 'No statistical difference as compared to Covidien ENDO GIA Universal blue staple cartridge' means the predicate device's performance sets the benchmark.

8. The sample size for the training set

This information is not applicable. This document describes the testing of a physical medical device, 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. As no AI algorithm or training set is involved, there is no "ground truth for the training set" to establish.

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The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.

The MicroCutter XCHANGE™ 30 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The MicroCutter XCHANGE™ 30 White Cartridge is available for deployment with the MicroCutter XCHANGE ™ 30 Stapler and delivers a staple (2.8mm) compatible with tissue that can be compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

Here's a breakdown of the acceptance criteria and study information for the MicroCutter XCHANGE™ 30 White Cartridge, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the MicroCutter XCHANGE™ 30 White Cartridge (K140170) positions the device as substantially equivalent to the predicate MicroCutter XCHANGE™ 30 Blue Cartridge (K132581). Therefore, the "acceptance criteria" are generally defined by demonstrating equivalence or non-inferiority to the predicate for critical performance parameters.

Summary of Studies that Prove the Device Meets Acceptance Criteria:

The device's acceptance is primarily based on a combination of bench testing and a pre-clinical animal study, demonstrating substantial equivalence to the predicate device, especially in its adapted functionality for thinner tissues.

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

   • Bench Testing: The document does not specify the exact sample sizes for each bench test (e.g., reliability, sterility, packaging, pull-apart strength). It typically involves a sufficient number of units to demonstrate statistical significance and consistency, but specific numbers are not disclosed in this summary.
   • Animal Study: The document states a "chronic, pre-clinical evaluation of small intestinal anastomoses created in juvenile pigs." The number of animals used is not specified in the summary.
   • Data Provenance: Not specified, but generally, such studies are conducted in a controlled laboratory or vivarium setting. It's prospective in nature for the tests conducted.

2. 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 device is a medical stapler, not an AI/imaging device requiring expert interpretation of results to establish ground truth in the same way. The "ground truth" for its performance is objective physical and biological measurements (e.g., staple height, pull-part strength, leak pressure, integrity of anastomoses).
   • For the animal study, veterinarians and potentially veterinary pathologists would have been involved in assessing the anastomoses and animal health, serving as the "experts" in evaluating the biological outcomes. Their specific number and qualifications are not detailed.

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

   • Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical image interpretation or diagnostic studies where subjective expert opinion is harmonized. Here, the "ground truth" is based on direct measurements and observed biological outcomes.

4. 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 mechanical surgical instrument, not an AI-based diagnostic tool or an assist system for human readers.

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

   • Not applicable. This is a physical medical device, not an algorithm. Its performance is evaluated through direct bench and animal testing.

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

   • Bench Testing: Mechanical measurements (e.g., length, thickness), material properties, tensile strength (pull-apart), leak pressure. These are objective engineering and physical measurements.
   • Animal Study: Biological outcomes, specifically the integrity and healing of "small intestinal anastomoses." This would involve macroscopic and potentially microscopic (pathology) evaluation of the surgical sites and animal health outcomes.

7. The sample size for the training set

   • Not applicable. This is a traditional mechanical medical device, not a machine learning or AI-based system that requires a "training set." The design and manufacturing processes are refined through engineering, prototyping, and iterative testing, not through data-driven training algorithms.

8. How the ground truth for the training set was established

   • Not applicable, as there is no "training set" in the context of an AI/ML device. The "ground truth" for the device's design and engineering is established through established engineering principles, material science, and prior knowledge from predicate devices and surgical practice.

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The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.

The MicroCutter XCHANGE™ 30 is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The staple (blue; 3.5mm) is compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

Here's an analysis of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to predicate devices and meeting design specifications through various tests. The primary acceptance criterion highlighted in the provided text for clinical performance is non-inferiority related to adverse events.

Additional Performance Data (Non-Clinical/Bench Testing - not explicitly "acceptance criteria" but included to show general compliance)

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Test Set): 160 subjects were enrolled, and 423 deployments were performed. 153 patients were included in the primary endpoint calculation.
• Data Provenance: The study was a "prospective, open label, multi-center study" meaning the data was collected specifically for this study in real-time or as events occurred. While the document does not explicitly state the country of origin, the FDA 510(k) submission context implies it would be relevant to US regulatory standards, and the manufacturer is based in Redwood City, California. The "MicroCutter European Trial I (METI)" mentioned under clinical performance suggests an international origin, but it specifically states "The Cardica MicroCutter in Surgical Stapling" for METI, and the results are cited as "Non-inferior to composite historical control." The main clinical study described appears to be for this specific submission and is referenced as "clinical study information" without explicit geographic limitation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish a ground truth for the clinical adverse events. The adverse event rate was compared to a "composite severe adverse event rate... derived from a comprehensive analysis of the medical literature," implying a benchmark from existing published data rather than a newly established expert consensus on the test set.

For the non-clinical and bench tests, it's reasonable to infer that qualified engineers and technicians performed the tests against established design specifications and industry standards, but specific expert qualifications for "ground truth" are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1) for the clinical adverse events. The events were "reported," and it states that "One (1) composite severe adverse event... related to the MicroCutter XCHANGE 30 System was reported." This suggests a direct reporting and classification of events rather than an independent adjudication process among multiple reviewers for the study itself, though standard clinical trial practices would involve physician assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The clinical study performed was a direct assessment of the device's performance against a historical control for adverse event rates, not a comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a surgical stapler, not an AI algorithm. Therefore, the concept of a "standalone algorithm only" performance study is not applicable. The performance studies evaluate the physical device's function.

7. Type of Ground Truth Used

• Clinical Study: The "ground truth" for the clinical study's primary endpoint regarding adverse events was a composite historical control derived from a comprehensive analysis of the medical literature for comparable open and laparoscopic procedures.
• Non-Clinical/Bench Testing: The ground truth for these tests would be based on established design specifications, industry standards (e.g., ASTM, ISO), and performance criteria for surgical staplers.

8. Sample Size for the Training Set

This product is a mechanical surgical stapler, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The design specifications and manufacturing processes are developed through engineering and material science principles.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no "training set" for this type of device. The "ground truth" for the device's design and manufacturing would be established through engineering design principles, material science, regulatory requirements, and established industry best practices for medical device development.

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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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The Cardica® PAS-Port® Proximal Anastomosis System is intended to create the aortic anastomosis of aortic autologous vein grafts.

The Cardica® PAS-Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS-Port® Proximal Anastomosis System consists of a connector and a delivery system.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. This is a 510(k) summary for a medical device (PAS-Port® Proximal Anastomosis System) seeking substantial equivalence to a predicate device.

The document focuses on:

• Device identification and categorization: Trade name, common name, classification, regulation number.
• Predicate device: K081225.
• Device description: How it works for aortic vein graft anastomosis.
• Indications for Use: To create the aortic anastomosis of aortic autologous vein grafts.
• Comparison to predicate device: Stating substantial equivalence and similarity in indications for use and technological characteristics.
• Device Testing Results and Conclusion: A general statement that in vitro and in vivo testing was performed to ensure substantial equivalence, safety, and effectiveness. However, specific acceptance criteria, study designs, or actual performance metrics are not detailed.
• FDA Clearance Letter: Confirming substantial equivalence based on the provided information.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, or training set information. These details are typically part of a more extensive submission package to the FDA, not usually included in the public 510(k) summary.

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The Cardica® C-Port® XATM 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® xATM PLUSTM Distal Anastomosis System is a sterile, single use device for creation of a reliably patent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in the conduit loading and a device that completes the anastomosis with stainless steel clips. Once the conduit has been loaded onto the device and the device positioned against the target vessel, the anastomosis is created by pushing the actuation button.

The provided text describes a 510(k) submission for the C-Port® xA PLUS™ Distal Anastomosis System, which is a sterile, single-use device intended for creating end-to-side anastomoses between a conduit and a small vessel, specifically for coronary artery bypass grafting procedures.

It's important to note that this document is a 510(k) Summary for a Special 510(k) for Device Modification. This means the device is being compared to a previously cleared predicate device (Cardica® C-Port® xA™ Distal Anastomosis System, K063644). The clearance is based on demonstrating "substantial equivalence" rather than a full, de novo clinical trial proving effectiveness against specific acceptance criteria in the same way a PMA device might. Therefore, the information regarding specific acceptance criteria and detailed study outcomes will be limited compared to a novel device submission.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria (e.g., performance metrics with numerical thresholds) or reported device performance against those criteria for this specific modified device in a clinical setting.

Instead, the submission relies on the concept of substantial equivalence to a predicate device (K063644). The "acceptance criteria" are implied to be that the modified device's performance, as demonstrated through various testing, is not significantly different from, and is as safe and effective as, the legally marketed predicate device.

The study that proves the device meets the acceptance criteria (of substantial equivalence) is described as:

• Device Testing Results and Conclusion: "All necessary in vitro and in vivo testing has been performed on the C-Port® XATM PLUS™ Distal Anastomosis System to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device."

Without access to the full 510(k) submission, the specifics of these in vitro and in vivo tests and their individual results against defined performance parameters are not provided in this summary.

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

The summary states "All necessary in vitro and in vivo testing has been performed." However, it does not provide details on the sample size for any test sets (neither for in vitro nor in vivo studies). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of any animal or human data if such was collected beyond basic engineering tests). Given it's a Special 510(k) for modification and not a de novo clearance, extensive human clinical data might not have been required or provided in this summary.

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

This information is not provided in the summary. Since the submission relies on demonstrating substantial equivalence through in vitro and in vivo testing (likely mechanical, functional, and possibly animal studies), the concept of "experts establishing ground truth" in the context of clinical accuracy or diagnosis (e.g., for AI/imaging devices) does not directly apply here. The "ground truth" would be established by the performance metrics of the tests themselves (e.g., burst pressure, clip retention, patency in animal models).

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

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving human interpretation of data where consensus among experts is needed (e.g., radiologists reviewing images). This device is a surgical instrument, and its performance would be assessed through objective measurements from engineering tests or animal studies, not human adjudication of subjective data.

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 MRMC comparative effectiveness study was done or is mentioned. This type of study is relevant for diagnostic devices, particularly AI-powered image analysis tools, where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a surgical instrument, not a diagnostic or AI-assisted diagnostic tool.

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

Not Applicable/Not done. This device is a mechanical surgical instrument. The concept of "standalone algorithm performance" without human-in-the-loop is specific to AI/software devices and does not apply to the C-Port® xA PLUS™ Distal Anastomosis System.

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

For the in vitro and in vivo testing mentioned, the "ground truth" would likely be derived from:

• Physical and mechanical measurements: For in vitro tests (e.g., clip retention strength, burst pressure of an anastomosis, leakage rates).
• Physiological and anatomical observations: For in vivo animal studies (e.g., patency of anastomosis, histological assessment of tissue healing, absence of foreign body reaction, functional outcomes).

The summary does not specify the exact types of ground truth used for each test.

8. The sample size for the training set

Not Applicable/Not provided. This device is a mechanical surgical instrument and does not involve AI or machine learning, therefore, there is no "training set."

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

Not Applicable/Not provided. As there is no training set for an AI/ML model, this question does not apply.

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The PAS•Port® System is intended to create the aortic anastomosis of aortic autologous vein grafts.

The Cardica® PAS•Port® Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent and reproducible anastomosis. The PAS•Port® Proximal Anastomosis System consists of a connector and a delivery system.

The provided text is a 510(k) Premarket Notification for the Cardica® PAS•Port® Proximal Anastomosis System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a study proving the device meets such criteria.

The document states:
"All necessary in vitro and in vivo testing has been performed on the PAS-Port™ Proximal Anastomosis System and its packaging to ensure substantial equivalence to the predicate device, and to ensure the safety and effectiveness of the device."

This statement confirms that testing was done, but it does not provide details about:

1. A table of acceptance criteria and reported device performance: No such table is present.
2. Sample size used for the test set and data provenance: Not mentioned.
3. Number of experts and their qualifications for ground truth: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a medical device, not an AI or imaging diagnostic tool.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not applicable (not an AI/ML algorithm).
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device (St. Jude Medical Aortic Connector System). This process typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, often through comparisons of materials, design, and general in vitro/in vivo testing, but it doesn't usually present detailed acceptance criteria and performance data in the way requested for an AI/ML product.

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The Cardica® Cardica® C-PORT® X-CHANGE™ 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® X-CHANGE™ ANASTOMOSIS SYSTEM is a sterile, single use device for creation of a reliably patent end-to-side anastomosis between a conduit and a small vessel. The product delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and a conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis which is functionally equivalent to a hand-sutured, interrupted stitch anastomosis. The system consists of one (1) C-PORT® HANDLE X-CHANGE™ with up to three (3) C-PORT® xA™ X-CHANGE™ subassemblies and one (1) Retractor Mount.

The provided text is a 510(k) summary for the Cardica® C-PORT® X-CHANGE™ Anastomosis System. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with explicit acceptance criteria and performance data for a new device.

Therefore, the information requested regarding acceptance criteria and a study proving a device meets them is largely not applicable in the context of this 510(k) summary. The submission's core argument is that the new device is "substantially equivalent" to an already cleared device, not that it independently meets pre-defined performance thresholds through a separate study.

However, I can extract the information that is present and explain why certain sections cannot be fully addressed based on the provided document.

Acceptance Criteria and Device Performance

Study Details (as far as can be inferred from a 510(k) summary)

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

   • Sample Size: Not specified in the summary.
   • Data Provenance: Not specified in the summary. The testing performed includes "in vitro and in vivo testing," which suggests a mix of laboratory and potentially animal or pre-clinical human studies, but details are not provided.
   • Retrospective or Prospective: Not specified.

2. 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):

   • Not Applicable. This information is typically relevant for studies involving human interpretation (e.g., imaging devices) where "ground truth" is established by expert consensus. For a mechanical medical device, ground truth is typically established through direct physical measurements, functional tests, or histological analysis, not expert interpretation of data.

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

   • Not Applicable. See point 2.

4. 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 surgical instrument, not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant.

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

   • Not Applicable. This device is a surgical instrument, not an algorithm. Performance would be assessed through its mechanical and functional characteristics, not algorithm-only evaluation.

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

   • For this type of device (anastomosis system), "ground truth" would likely be established through:
     • Physical measurements: verifying dimensions, clip deployment accuracy.
     • Mechanical testing: burst pressure, tensile strength of anastomoses.
     • Histological analysis: confirming vessel wall apposition and patency in animal models.
     • In vivo patency and healing studies: assessing long-term success of anastomoses in animal models.
   • The summary generically mentions "in vitro and in vivo testing," implying these types of methods were used to ensure safety, effectiveness, and substantial equivalence to the predicate.

7. The sample size for the training set:

   • Not Applicable. This information is typically relevant for machine learning or AI-based devices. For a mechanical device, there isn't a "training set" in the same sense. Design iterations and verification/validation testing are performed, but not referred to as a "training set."

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

   • Not Applicable. See point 7.

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