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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 C-Port™ "Power Injectable" Port (family of products) will be used as a subcutaneously implanted device where repeated access to the vascular system is the therapy of choice for delivery of medications, fluids, special fluids such as contrast enhancement fluids or for withdrawal of blood.

When used with a power injectable needle infusion set, the C-Port™ "Power Injectable" Port is indicated for power injection of contrast media using an 8.0Fr or 9.6Fr catheter. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle or 2 ml/s with a 22 gauge non-coring power injectable needle.

For CT diagnostic procedures, it is recommended that the number of CT "power injections" be limited to a maximum number of ten (10) accesses over the life of the device.

The device has a port that is a titanium chamber with a silicone membrane for insertion. The port comes in a standard size to enable use with adult patients. A standard profile is preferable so the chamber enable use with adult pationis. Treatment to a catheter that is long enough to insert into the vena cava for positioning to enable fluid infusion into the heart and insert into the rena catheter is fixed to the port with a catheter lock during a larger vossels. The catheter has a senes of radiopaque marks procodire to ith determination when the catheter is inserted into the vena cava. to enable depth dolorhination whole can be cant insertion, and port implantation for A kit is provided to all hirea "sterile, single use". For product supplied as OEM bulk, non-sterile, the product is vacuum-packaged in a double bag format and built, non blonio, the prelabeler to kit and sterilize). Items such as syringes, vein introducers, trocars, guide wires, sheaths, fixation hubs, Huber needles, and infusion sets may be part of a total kit intended for sterilization.

The provided text describes a 510(k) premarket notification for a medical device, the PHS Medical GmbH C-PortHP "Power Injectable" Port. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not explicitly present in this type of regulatory document. The 510(k) summary primarily outlines the device description, indications for use, and a claim of substantial equivalence.

However, I can extract information related to the device's functional specifications and safety, which serve as an indirect form of "acceptance criteria" through the lens of equivalence to predicate devices, and the general "study" or testing approach implied by such submissions.

Here's a breakdown of the available information and an explanation of why other requested details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or reader improvement are not typically reported in this summary. Instead, the "performance" for a 510(k) is primarily demonstrating that the device functions as intended and is safe, similar to legally marketed predicate devices.

The "acceptance criteria" here are implied by the performance specifications for power injection:

Study Details:

The 510(k) summary does not describe a specific clinical study with a defined test set, ground truth, or statistical analysis of performance in the way a clinical trial for a novel device would. Instead, the "study" for a 510(k) involves demonstrating equivalence through:

• Comparison to Predicate Devices: The primary "study" is a comparison to existing, legally marketed devices (C-Port #K030636, Bard Access Systems PowerPort #K060812, MEDCOMP ProFUSET #K070003). This usually involves non-clinical testing (e.g., in-vitro bench testing for flow rates, pressure limits, material compatibility) and sometimes a review of literature or existing data for the predicate devices.
• Engineering and Bench Testing: The claims of "power injectability" at specific rates imply that rigorous bench testing was performed to validate these flow rates and pressure tolerances for the device and its compatibility with specified needle gauges and catheter sizes. These tests would demonstrate the device's ability to withstand the forces associated with power injection.
• Material Compatibility: The use of materials like titanium and silicone membrane implies biocompatibility testing or documentation was performed, likely citing existing data for these common medical device materials.
• Sterilization Validation: The summary mentions that "Sterilization details for validation, verification, bioburden, by can be found in the section on Risk Assessment (7.0) and Sterilization (8.0)". This indicates a comprehensive process for ensuring the device is sterile.

Missing Information (and why):

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a 510(k) of this nature. No "test set" of patient data is described. Performance is primarily established through non-clinical bench testing and comparison to predicates.
• 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): Not applicable. This device does not involve image interpretation or diagnostic performance in a way that would require expert ground truth.
• 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. This is not an AI/diagnostic imaging device.
• 6. 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.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the traditional sense. The "ground truth" for a power-injectable port involves objective physical measurements (flow rates, pressure limits, material properties, sterility) obtained through engineering and laboratory testing, rather than clinical outcomes or expert diagnoses.
• 8. The sample size for the training set: Not applicable. This isn't a machine learning model.
• 9. How the ground truth for the training set was established: Not applicable.

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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 A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader (HyTek-205) is intended for the quantitative determination of total homocysteine (tHCY) in human plasma or serum. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia. The A/C Enzymatic Homocysteine Assay is for in vitro diagnostic use.

The A/C Portable Enzymatic Homocysteine Assay is calibrated with A/C Enzymatic Homocysteine Assay Calibrators. A/C Enzymatic Homocysteine Assay Controls are assayed for the verification of the accuracy and precision of the A/C Portable Enzymatic Homocysteine Assay.

The A/C Enzymatic Homocysteine Assay measures tHCY. The principle of the assay is that after reduction, tHCY is depleted by Homocysteinase (rHCYase) and produces hydrogen sulfide (H2S), which is determined using N.N-dibutyl phenylene diamine (DBPDA), the combination of which forms a chromophore, the fluorescence is measured by the A/C Diagnostics Reader (HyTek-205).

The A/C Portable Enzymatic Homocysteine Assay is a three-steps reaction, which runs at room temperature. The total assay takes 80 minutes, and the A/C Diagnostics Reader is the only equipment needed.

Here's an analysis of the provided text regarding the A/C Portable Enzymatic Homocysteine Assay, focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. It focuses on demonstrating that the new device performs as well as, or better than, the predicate. Therefore, the "acceptance criteria" are implicitly established by the performance of the predicate device. The study aims to show that the new device's performance aligns closely with that of the predicate.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in this summary. Instead, they are implied by the reported performance of the predicate device, which the new device aims to match or closely approximate. The primary performance metric for comparison is the correlation and mean difference between the new device and the predicate.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 50 plasma samples.
   • Data Provenance: Not explicitly stated regarding country of origin or specific demographics. The samples are referred to as "fifty plasma samples," implying they were clinical samples. The study is retrospective, as it compares the new device's results on these samples against those obtained from an existing, already cleared predicate device (the A/C Automatic Enzymatic HCY Assay on Hitachi 912).

2. 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 a quantitative assay like this is typically established by comparison to a reference method or a substantially equivalent predicate device, not by expert consensus on qualitative interpretation. The predicate device itself (A/C Automatic Enzymatic HCY Assay on Hitachi 912) served as the reference for comparison.

3. Adjudication method for the test set:

   • Not applicable. This is a quantitative assay comparison, not a diagnostic imaging or expert interpretation study requiring adjudication.

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:

   • No MRMC study was done. This is a comparison of two in vitro diagnostic devices, not an AI-assisted diagnostic tool involving human readers.

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

   • This is partially applicable, as the "A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostics Reader" is a standalone system in the sense that it performs the measurement without human subjective interpretation of results, beyond the operator running the test. The study is comparing the performance of this standalone system against another standalone system (the predicate device). The performance metrics (correlation, regression, mean difference, precision) are all "algorithm only" or "device only" metrics.

6. The type of ground truth used:

   • The "ground truth" for this study was the results obtained from the predicate device, the A/C Automatic Enzymatic HCY Assay on Hitachi 912 (K030754). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" in the context of device development or machine learning. For in vitro diagnostic assays, performance characteristics are typically established through analytical studies (e.g., precision, linearity, interference) and clinical comparison studies (like this one) using patient samples, rather than a machine learning training paradigm.

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

   • Not applicable, as a "training set" in the machine learning sense is not described. The predicate device's performance was already established through its prior 510(k) clearance (K030754).

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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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The Cardica® C-Port® Flex-A™ 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® Flex-ATM 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 document is a 510(k) summary for the Cardica® C-Port® Flex-AT™ Distal Anastomosis System. This type of submission is for device modification and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.

Therefore, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria as requested. Instead, it relies on the declaration that performance data was collected and demonstrates substantial equivalence to the predicate device.

Here's a breakdown of why the requested information is absent or cannot be fully provided based solely on the given text:

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

• Not present in the document. The 510(k) summary states, "performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence." This implies that specific acceptance criteria and detailed performance results are not publicly available in this summary.

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

• Not present in the document. The document mentions "All necessary in vitro and in vivo testing has been performed," but does not specify sample sizes, data provenance, or whether the study was retrospective or prospective.

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):

• Not applicable/Not present. Since this is a device for creating anastomoses and not an imaging or diagnostic device requiring expert interpretation for ground truth, this information is not relevant to the type of testing described here.

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

• Not applicable/Not present. As mentioned above, this type of adjudication is typically for diagnostic interpretation, which is not the primary evaluation method for this device.

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/Not present. This device is an anastomosis system, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant to its evaluation.

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

• Not applicable/Not present. This device is a surgical instrument. "Standalone" performance as an algorithm is not relevant.

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

• Not explicitly stated for specific tests. For a device like this, ground truth would likely involve direct measurement of anastomotic integrity, flow, burst pressure, and histological evaluation of healing in in vivo models. However, the document only broadly states "necessary in vitro and in vivo testing."

8. The sample size for the training set:

• Not applicable/Not present. This is not an AI/machine learning device that requires a training set.

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

• Not applicable/Not present. This is not an AI/machine learning device that requires a training set.

Summary of available information regarding compliance:

The 510(k) summary states that the device is substantially equivalent to the predicate device Cardica® C-Port® Flex-AT™ Distal Anastomosis System (#K070548). The basis for this equivalence is:

• Same indications for use.
• Same technological characteristics.
• Same device characteristics, method of use, materials, labeling, sterilization method, and biocompatibility.

The document explicitly states that "performance data were not included in the submission, but the declarations provide certification that the data demonstrate equivalence." This means that while internal testing was conducted to prove equivalency, the specifics of these tests, including acceptance criteria and detailed results, are not part of this public summary.

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The Cardica® C-Port® FlexA™ 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 ® FlexA™ Distal Anastomosis System is a sterile, single use device for creation of a compliant end-to-side anastomosis between a graft vessel and target vessel. The product consists of a delivery device that holds the graft and deploys the pre-loaded clips, and the implantable stainless steel clips. Once the graft has been loaded onto the device and the device positioned against the target vessel, the arteriotomy and anastomosis are simultaneously created by pushing the actuation button.

The provided text does not contain detailed acceptance criteria and a study specifically proving the device meets those criteria with statistical measures. Instead, it describes a Special 510(k) submission where the device is compared to a previously cleared predicate device, asserting "substantial equivalence" rather than presenting a de novo study with explicit acceptance criteria.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific bond strengths, leak rates, or success percentages with defined thresholds).
• Reported Device Performance: The document generally states: "All necessary verification testing has been performed on the C-Port ® FlexA™ Distal Anastomosis System to assure substantial equivalence to the predicate device and to assure the safety and effectiveness of the device. Based on the results of risk assessment and verification/validation testing the modifications to the FlexA System raise no new safety or efficacy issues."

This implies that the implicit acceptance criteria are that the new device (Cardica C-Port FlexA™) performs functionally and safely at least as well as the predicate device (Cardica C-Port xA™), and its modifications introduce no new risks related to its intended use in creating anastomoses.

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

• Sample Size: Not specified. The document states "All necessary verification testing has been performed" but does not give specific numbers of tests or samples.
• Data Provenance: Not specified. It's likely internal testing by the manufacturer (Cardica, Inc.), but the location or whether it was retrospective/prospective is not detailed.

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

• Number of Experts: Not applicable/not stated. This type of device (a surgical instrument) does not typically involve human expert interpretation of data to establish ground truth in the same way an AI diagnostic device would. Performance is assessed through engineering and functional tests.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not stated. As mentioned above, ground truth for this device's performance relies on objective physical and functional testing, not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI algorithms where reader performance is a key outcome. The Cardica C-Port FlexA™ is a surgical instrument.

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

• Standalone Performance: Not applicable. This is not an AI algorithm; it is a mechanical surgical device. Performance is inherent to the device's design and function, not an algorithm.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this device would be established through objective engineering and functional testing. This would include tests for:
  • Mechanical strength (e.g., clip integrity, holding power)
  • Leak integrity of the anastomosis created
  • Biocompatibility of implantable materials
  • Sterility
  • Functional operation of the delivery system (e.g., smooth deployment, proper clip formation).
    The document mentions "risk assessment and verification/validation testing," which implies these types of objective measures were used.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not use machine learning, so there is no training set in that context.

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

• Ground Truth for Training Set Establishment: Not applicable. As there's no machine learning, there's no training set or associated ground truth for it.

Summary of the Study (Based on the Provided Text):

The submission is a Special 510(k) for the Cardica® C-Port® FlexA™ Distal Anastomosis System. This means the device is being cleared as a modification to an already legally marketed device (the predicate: Cardica® C-Port® xA™ Distal Anastomosis System, K053524 and K063644).

The "study" involved verification testing to demonstrate that the modified device is substantially equivalent to the predicate device. The key changes were in the deployment device design to include a flexible shaft and remote graft clamp actuators. The manufacturer states that these modifications raise no new safety or efficacy issues when compared to the predicate device.

The study's conclusion is that, based on technical information, intended use, and performance information from the verification testing, the FlexA System is substantially equivalent to the predicate device for its intended use in creating anastomoses in blood vessels and grafts, including coronary artery bypass grafting procedures. No specific quantitative performance metrics from this testing are provided in the summary, relying instead on the established safety and effectiveness of the predicate device and the absence of new risks.

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The Cardica® C-Port® xA 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 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 is a 510(k) summary for the Cardica® C-Port® xA Anastomosis System. It is focused on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a study with an AI component. Therefore, much of the requested information about AI model performance and study details is not present.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify quantitative acceptance criteria or provide detailed performance metrics like sensitivity, specificity, accuracy, or F1-score for the device itself. Instead, the submission states that "All necessary verification testing has been performed on the C-Port xA Anastomosis System with the modified clip to assure substantial equivalence to the predicate device and to assure the safety and effectiveness of the device."

The focus is on demonstrating that the modified device is as safe and effective as the predicate device (Cardica® C-Port® xA Anastomosis System, K053524). This is a common approach for 510(k) submissions where a modification to an already cleared device is being presented.

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

The document does not provide details on the sample size used for any specific test set, nor does it mention data provenance (e.g., country of origin, retrospective or prospective). The testing mentioned is "verification testing" to assure substantial equivalence, rather than a clinical trial with a defined test set for performance.

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

This information is not applicable and therefore not present. The device is a surgical instrument (anastomosis system) and not an AI or diagnostic device that requires expert-established ground truth for image or data interpretation. The "ground truth" for a device like this would relate to its mechanical performance, biocompatibility, and ability to create a functional anastomosis, which would be assessed through engineering tests, animal studies, or potentially human clinical data (though not detailed here).

4. Adjudication Method for the Test Set

This information is not applicable and therefore not present, as there is no diagnostic output that requires adjudication.

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

There is no mention of an MRMC study, AI, or human readers. The device is a surgical instrument.

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

This is not applicable as the device is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The concept of "ground truth" as it applies to an AI or diagnostic device (e.g., pathology, outcomes data) is not directly applicable here. For this surgical device, the "ground truth" would be related to its engineering specifications, successful creation of an anastomosis, and patient outcomes related to the surgical procedure, as determined through various verification and potentially pre-clinical/clinical tests. The document broadly states "All necessary verification testing has been performed," without detailing the specific "ground truth" for each test.

8. The Sample Size for the Training Set

This is not applicable since the device is not an AI system that requires a training set.

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

This is not applicable for the same reason as above.

In summary, this 510(k) submission is for a modification to a mechanical surgical device and primarily focuses on demonstrating substantial equivalence to a predicate device through verification testing. It does not involve AI, image analysis, or diagnostic capabilities, and therefore, most of the requested information regarding AI model performance, expert ground truth, and study designs for such applications is absent.

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The Cardica® C-Port® xA 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® 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.

This submission concerns a medical device, the Cardica® C-Port® xA Anastomosis System, and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device testing (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

The submission is a 510(k) Pre-market Notification for a device intended for surgical anastomosis. The primary method of demonstrating acceptance criteria is by claiming substantial equivalence to a previously cleared predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a substantial equivalence determination based on a comparison to the predicate device (Cardica® C-Port® Anastomosis System, K040832). This is a non-clinical study typically involving engineering analysis, bench testing (in vitro), and potentially animal studies (in vivo) to demonstrate that the new device performs as intended and is as safe and effective as the predicate device.

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

• Sample size: Not explicitly stated in this summary. For a non-clinical 510(k) submission based on substantial equivalence, the "test set" would refer to the samples and conditions used in the in vitro and in vivo studies. The summary only broadly states "All necessary in vitro and in vivo testing has been performed."
• Data provenance: Not explicitly stated. Such testing is typically conducted internally by the manufacturer or by contract research organizations (CROs) in a controlled environment. It is not patient or country-specific data as would be the case for clinical trials.

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

• Not applicable. This relates to clinical data evaluation, which is not the primary basis of this 510(k) submission. The "ground truth" here is the performance and safety established for the predicate device, against which the new device is compared through non-clinical testing.

4. Adjudication method for the test set:

• Not applicable. This applies to clinical study endpoints and data interpretation by multiple readers/experts.

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 is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for this substantial equivalence submission is the established safety and effectiveness profile of the predicate device (Cardica® C-Port® Anastomosis System, K040832). The new device's performance, as measured through in vitro and in vivo testing, is then compared to this established profile to demonstrate equivalent safety and effectiveness.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Cardica® C-Port™ 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™ Anastomosis System is a sterile, single-patient use device. The Cardica® C-Port™ Anastomosis System is designed to create a reliable and consistent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in 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 an actuation button.

The provided text states that "All necessary bench, animal, and clinical testing has been performed on the C-Port™ Anastomosis System and packaging to ensure substantial equivalence to the predicate devices and to ensure the safety and effectiveness of the device." However, no specific details about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, or different types of studies (MRMC, standalone) are provided.

Therefore, I cannot extract the requested information. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a study proving the device meets specific acceptance criteria.

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