Search Results

The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc™ safety infusion set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

The subject Titanium PowerPort™ isp device with 6 Fr ChronoFlex® polyurethane catheter is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a titanium port and ChronoFlex® polyurethane catheter that is attached to the port with a cathlock compression fitting. The subject device is distinguishable as a member of BAS's power injectable port series by the triangular body shape, unique purple coloring, and three palpation bumps on the septum. PowerPort™ implanted ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort™ ports must be accessed with a Bard PowerLoc™ safety infusion set to create a power injectable system.

The provided text from K072549 predominantly describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria for device performance, the study design, or specific performance metrics typically found in validation studies for AI/algorithm-based medical devices.

Therefore, I cannot populate the requested table with acceptance criteria and reported device performance, nor can I answer questions about sample size for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.

The document states:

• "No performance standards have been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act."
• "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for this device. However, design verification testing was performed according to protocols based on the recommendations/requirements of applicable FDA guidance and FDA recognized international standards. Verification testing, determined to be applicable to the safety and efficacy of the device, was shown to meet predetermined acceptance criteria listed therein."

This indicates that internal acceptance criteria were used for design verification testing, but the document does not specify these criteria or the results against them. The device is a physical implanted port and catheter, not an AI/algorithm.

Conclusion: The provided text does not contain the necessary information to answer your questions regarding acceptance criteria and performance studies for an AI/algorithm-based device. The document is a 510(k) summary for a physical medical device (an implanted port and catheter) and focuses on its substantial equivalence to existing predicate devices, rather than the validation of an AI algorithm.

Ask a specific question about this device

The PowerPort™ implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medication, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a PowerLoc™ safety infusion set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

The subject Titanium PowerPort™ isp device is a member of the PowerPort™ series of power injectable implanted ports. The subject device consists of a titanium port and 8 Fr ChronoFlex® polyurethane catheter that is attached to the port with a cathlock (compression fitting). The subject Titanium PowerPort™ isp device is distinguishable as a member of Bard Access Systems's power injectable port series by the triangular body shape, unique purple coloring, and three palpation bumps on the septum. PowerPort™ implanted ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort™ ports must be accessed with a Bard PowerLoc™ safety infusion set to create a power injectable system.

The provided text describes a medical device submission (K072215) for the Titanium PowerPort™ isp Implanted Port with 8 Fr ChronoFlex® Polyurethane Catheter. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical acceptance criteria in a comparative study.

Therefore, the requested information for a comprehensive study including acceptance criteria, sample sizes, expert involvement, and comparative effectiveness (MRMC) cannot be fully extracted from this document, as it is a premarket notification for a medical device seeking substantial equivalence, not a clinical trial report.

However, I can extract information regarding overall safety and performance testing and the ground truth used for that testing, as well as general statements about acceptance criteria.

Acceptance Criteria and Device Performance (as described for non-clinical testing for substantial equivalence)

Study Details from the Provided Text:

1. Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The document describes "design verification testing" and a "failure modes and effects analysis (FMEA)". These are typically laboratory-based tests on device samples, not human subjects data. The provenance of these internal tests is Bard Access Systems, Inc.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in this context, refers to the established standards or internal protocols used for design verification and FMEA. These are defined by engineering and quality control teams within the manufacturer, and by regulatory standards like ISO 14971:2000. It doesn't involve clinical experts establishing ground truth for a diagnostic output.
3. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus-building amongst human readers for image interpretation or clinical outcomes. This document describes device performance testing against engineering and safety standards.
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, an MRMC study was not done. This device is an implanted port and catheter, not an AI software or diagnostic imaging device that would typically undergo such a study.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
6. The type of ground truth used:
   • For design verification testing: Protocols based on FDA guidance and FDA recognized international standards.
   • For risk management (FMEA): An internal protocol based on ISO 14971:2000, Medical Devices - Risk Management for Medical Devices.
7. The sample size for the training set: Not applicable. This refers to a manufactured medical device, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable. This is not a machine learning model.

Summary of the Document's Focus:

This 510(k) summary is for a medical device seeking clearance based on substantial equivalence to previously cleared predicate devices. The "study" mentioned refers to design verification testing and risk management (FMEA) which are internal engineering and quality assurance processes, not clinical trials or studies involving human subjects or AI performance. The document explicitly states: "No performance standards have been established by FDA under section 514 of the Federal Food, Drug and Cosmetic Act. However, design verification testing was performed according to protocols based on the recommendations/requirements of applicable FDA guidance and FDA recognized international standards. Verification testing, determined to be applicable to the safety and efficacy of the device, was shown to meet predetermined acceptance criteria listed therein."

Ask a specific question about this device