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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® 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® 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.

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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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The C-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, nutritional solutions and blood products or withdrawal of blood.

The CliniSurg family of Vascular Access devices is a group of subcutaneously implantable ports with a catheter either pre-attached or attachable for application by physicians in indicated therapies. The device has a port that is a titanium chamber with a silicone membrane designed for repeated needle insertion. The port comes in various sizes to enable use with larger adults or smaller pediatric patients or the more emaciated adult patient. A higher or lower profile device is chosen by patient evaluation. The port is connected to a catheter that is long enough to insert into the vena cava for positioning to enable fluid infusion into larger vessels. The catheter is fixed to the port with a hub either during a procedure to implant the device or it comes pre-assembled (physician choice for use). The catheter has a series of radiopaque marks to enable depth determination when the catheter is inserted into the vena cava. A kit is provided to aid in catheter placement, insertion, and port implantation. Items such as syringes, vein introducers, trocars, guide wires, sheaths, fixation hubs, Huber needles, and infusion sets may be part of a total kit.

Here's an analysis of the provided text regarding the C-Port and Catheter Kits, focusing on acceptance criteria and supporting studies:

Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Based on the provided 510(k) summary (K030636) for the C-Port and Catheter Kits, the device's acceptance criteria and proof of meeting them are established primarily through substantial equivalence to existing legally marketed predicate devices, rather than through new clinical studies demonstrating specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for functional performance paired with reported device performance in the manner typically seen for novel devices.

Instead, the acceptance criteria are implicitly met by demonstrating that the device components and materials are equivalent to, and have been tested to meet the same specifications as, those used in predicate devices. The "reported device performance" is largely an assertion of this equivalence.

However, the document lists "Testing of components" which can be interpreted as demonstrating the device meets established engineering and biological specifications. Here's a table based on that:

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set. The "testing of components" (e.g., septum puncture, leak test) would have involved a sample size of devices, but this information is not detailed in the summary.
• Data Provenance: The justification for substantial equivalence relies on the known performance and safety profiles of predicate devices (Titan Port, Vortex Port) and the established use of the materials in similar medical devices. No new, specific patient data (retrospective or prospective) is presented to prove the device's clinical performance.

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

• This is not applicable as no clinical test set for performance was established. The "ground truth" for the device's safety and effectiveness is largely based on the historical performance and established safety of predicate devices and their materials, as evaluated by the FDA and industry standards.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set with human interpretation requiring adjudication was conducted.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed as part of this 510(K) process as the product is identical to products currently cleared for marketing and can be applied for under the substantial equivalence claim." Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance, as AI is not mentioned as part of this device.

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

• Not applicable. This device is a physical medical device (implantable port and catheter), not an algorithm or AI-driven system.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is primarily:
  • Predicate Device Performance and Safety: The established safety and effectiveness of the Titan Port and Vortex Port (K830000).
  • Material Safety and Biocompatibility Data: Long-standing data and specifications for the medical-grade Titanium, Silicone Rubber, and Polyurethane used in implantable devices.
  • Engineering Specifications and Bench Testing: Data from mechanical and functional tests like connection strength, puncture tests, leak tests, fluid dynamics, tensile strength, and elongation strength.

8. The Sample Size for the Training Set

• Not applicable. There's no AI/algorithm component requiring a training set. If interpreted as "training data" for product design, it refers to the vast body of knowledge and specifications used in the design of similar medical devices over time, rather than a specific, quantifiable set for this submission.

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

• Not applicable due to the absence of a training set for an AI/algorithm. For the physical device, the "ground truth" concerning its design and material suitability was established through decades of medical device manufacturing experience, regulatory standards, and clinical use of similar products, leading to the establishment of industry-standard specifications and successful predicate devices.

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