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The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the 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 PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.

The provided FDA 510(k) clearance letter and summary discuss the substantial equivalence of the PowerPort™ Implantable Ports to predicate devices. It does not present a study with acceptance criteria and reported device performance in the context of a diagnostic or AI-assisted system performance.

The document is a premarket notification for a medical device (implantable ports) and focuses on demonstrating that the new device is substantially equivalent to existing legally marketed predicate devices. This is a regulatory pathway for devices that do not require clinical trials of the same rigor as novel devices or those with significant changes in technology.

Therefore, many of the requested elements, such as "test set," "ground truth," "MRMC study," "effect size of human readers," and "training set," are not applicable to this type of submission for a physical medical device. The "acceptance criteria" discussed are related to physical performance and material equivalence, not diagnostic accuracy.

However, I can extract the information that is available from the document regarding the device's assessment.

Acceptance Criteria and Device Performance (for physical device modifications)

The study performed is primarily design verification testing to ensure the modifications (dimensional changes, shelf-life extension, alternative locking solutions) do not negatively impact the device's safety and effectiveness compared to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance specifications that were verified. The "Reported Device Performance" column essentially states that the device "performed as intended by meeting product performance specifications." The precise numerical acceptance criteria and specific reported values are not fully detailed in this summary but are implied to have been met.

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

The document does not specify a discrete "test set sample size" or "data provenance" in the typical sense of a clinical or image-based AI study. The evaluation consists of design verification testing on manufactured units of the device and its components. This testing is conducted on physical samples of the device undergoing mechanical, material, and functional assessments. The provenance is internal to the manufacturer (Bard Access Systems, Inc.). The testing involved simulating aging, exposure to ethylene oxide sterilization, and simulated shipping.

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

This concept is not applicable to this type of device submission. Ground truth, in the context of diagnostic accuracy, is not directly relevant for the physical performance testing of an implantable port. The "truth" is determined by established engineering standards and test methods.

4. Adjudication method for the test set

This concept is not applicable as it relates to expert review of diagnostic findings, which is not part of this device's evaluation. Performance is assessed against quantitative engineering specifications.

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, an MRMC comparative effectiveness study was not done. This is a physical medical device (implantable port), not a diagnostic imaging or AI assistance system.

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

No, this is not an algorithm-based device. It is a physical implantable medical device.

7. The type of ground truth used

For the aspects of the device that are being verified (physical performance, material compatibility, and fluid dynamics), the "ground truth" is established through:

• Established engineering standards and test methods (e.g., NF S 94-370, ISO 10555-3, ASTM D412).
• Internal test methods developed by Bard Access Systems, Inc.
• Compliance with FDA guidance for implanted infusion ports.
• Referenced industry standards like "Infusion Therapy Standards of Practice, 9th Edition (2024)" for locking solutions.

8. The sample size for the training set

This concept is not applicable as this is a physical medical device submission, not an AI/algorithm-based device that would require training data.

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

This concept is not applicable for the same reasons as above.

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The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I. V. Iluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ Implantable Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.

The PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.

The provided text describes a 510(k) premarket notification for the PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by internal product performance specifications and meeting acceptable risk levels, as demonstrated through verification testing. The document states that "Design verification testing was conducted to evaluate device performance over the proposed 2-year shelf life of the to-be-marketed configurations for all models of the subject device." It also mentions that "Verification testing demonstrated that the device performed as intended by meeting product performance specifications and controlling risks to an acceptable level..."

Specific quantitative acceptance criteria and their corresponding reported device performance are not explicitly detailed in a comparative table format within the provided text. Instead, the document lists various verification/validation methods and standards applied, implying that the device was tested against these methods and passed their respective criteria.

However, based on the narrative and the types of tests listed, a conceptual table can be constructed, acknowledging that specific numerical values for criteria and performance are not given:

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

The document does not explicitly state the numerical sample size used for each specific test in the verification activities. It generally refers to "the to-be-marketed configurations for all models of the subject device."

Regarding data provenance:

• The tests were conducted by Bard Access Systems, Inc. ("BAS Internal Test-Method").
• The data appears to be prospective as it involves "design verification testing... over the proposed 2-year shelf life," implying new testing for this submission.
• The country of origin for the data is implicitly the United States, as the submission is to the U.S. FDA.

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

This information is not provided in the document. The tests performed are engineering and performance-based, not clinical studies requiring expert ground truth for interpretation (e.g., radiology reads). The "ground truth" here is determined by direct measurement against engineering specifications and industry standards. The document does mention "Material experts at BAS have confirmed the proposed locking solutions will not impact BAS catheters," indicating internal expertise in materials science informed certain aspects of the design verification.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the verification tests described are objective, quantitative engineering tests, not subjective assessments requiring adjudication by multiple readers or 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

This information is not applicable. The device (PowerPort™ ClearVUE™ Slim Implantable Ports) is a physical medical device, specifically an implantable port and catheter system. It is not an AI-enabled diagnostic or therapeutic device. Therefore, an MRMC study related to AI assistance would not be relevant to this submission.

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

This information is not applicable. As stated above, this device is a physical medical product, not an algorithm or software-only device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the verification studies is established by engineering specifications, industry standards (e.g., ISO 10555-3, NF S 94-370, ASTM D412), and FDA guidance documents ("FDA Implanted Infusion Port Guidance"). It is based on objective, measurable performance characteristics rather than clinical "ground truth" derived from patient data or expert interpretation.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical device and does not involve machine learning algorithms that require a "training set."

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

This information is not applicable for the same reason as point 8.

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The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with the 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 PowerPort™ implantable ports, including ECG Enabled Implantable Ports, are implantable access devices designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ implantable port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ implantable ports can be identified subcutaneously by feeling the top of the septum which includes three palpation bumps arranged in a triangle and by palpating the sides of the port, which is also triangular. Radiopaque identifiers for the PowerPort™ devices aid in identification as a BD power injectable port.

The ECG Enabled Implantable Ports function identically to other PowerPort™ power-injectable ports with the option to use ECG instead of fluoroscopy during the implantation procedure for catheter advancement and tip location confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS). ECG technology provides real-time catheter tip location information and is indicated for use as an alternative method to chest X-ray and fluoroscopy for central venous access device (CVAD) tip placement confirmation. When used with the BD Sherlock 3CG+™ TCS, the Sherlock 3CG™ TPS stylet also provides the placer real-time feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection. The Sherlock 3CG™ Tip Confirmation System (TCS) product and accessories are sold separately (refer to K180560, cleared 6/18/2018, for information on Sherlock 3CG+™ product and accessories).

The provided document is a 510(k) premarket notification summary from the FDA, and it does not contain the detailed acceptance criteria and study data typically found in a clinical trial report or a comprehensive performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and functional testing rather than clinical performance for an AI/ML component.

Therefore, for aspects related to an AI/ML device's performance, human reader studies, and AI-specific ground truth establishment, the information is not present in this document. This document describes a medical device (implantable port) with an enabling technology (ECG for tip positioning), but it doesn't describe an AI/ML-driven diagnostic or prognostic device that would require the typical performance metrics associated with AI.

However, I can extract information related to the performance testing that was conducted to support the substantial equivalence claim for the overall device, particularly for the new ECG-enabled feature.

Here's an attempt to answer your questions based on the provided text, highlighting where the requested information is absent or not applicable given the nature of the device and submission:

Device: PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port and related models.

Core Technology Change: The addition of ECG enablement for catheter tip placement confirmation using the BD Sherlock 3CG™ Tip Positioning System (TPS) stylet and BD Sherlock 3CG+™ Tip Confirmation System (TCS).

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

The document lists various performance tests conducted to demonstrate substantial equivalence, and states that "All testing passed the predetermined acceptance criteria." However, it does not provide a table with specific quantitative acceptance criteria or the numerical reported device performance for each test. It only lists the types of tests performed.

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

• Sample Size: Not explicitly stated for any of the performance tests. The testing described appears to be laboratory/bench testing of the device components/full device, not human clinical trial data.
• Data Provenance: This is not a clinical study involving human data in the traditional sense for evaluating the device's performance in a patient population (beyond basic "indications for use"). The testing described is pre-market validation conducted by the manufacturer, likely at their facilities or certified labs. Therefore, "country of origin of the data" and "retrospective or prospective" are not applicable in the context of clinical data for an AI/ML model.

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 is a medical implant, not an AI/ML diagnostic or prognostic system that relies on expert consensus to establish ground truth for image interpretation or disease diagnosis. The "ground truth" for its performance is derived from engineering specifications, established medical device testing standards (e.g., ISO, ASTM), and the fundamental physics/physiology of ECG signals for tip placement.

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

• Not Applicable: As this is not a study requiring expert readers or interpretation, there is no adjudication method.

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 filing is for an implantable port device, not an AI-based diagnostic tool that would typically undergo an MRMC study. The "ECG Enabled" feature is an alternative method for real-time tip placement (vs. fluoroscopy/X-ray), not an AI assisting human interpretation of images. The BD Sherlock 3CG+™ TCS (the system responsible for interpreting the ECG signals) has its own separate 510(k) and likely its own performance data (K180560 is referenced).

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

• Not Applicable: The device itself (the port) does not have a standalone "algorithm only" performance. The ECG enablement relies on the separate BD Sherlock system. The performance tests evaluate the physical and electrical properties of the port that allow it to be used with the ECG system.

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

• Engineering/Physical Standards & Reference Data: The ground truth for the performance tests includes:
  • Pre-determined acceptance criteria based on industry standards (e.g., ISO 11607-1, ASTM D4332, ASTM D4169, ISO 10555, NF S 94-370).
  • Internal Risk Assessment procedures.
  • FDA Guidance documents (e.g., "Guidance on 510(k) Submissions for Implanted Infusion Ports," "Applying Human Factors and Usability Engineering to Medical Devices").
  • Functionality requirements (e.g., accurate reproduction of source ECG signals, no air leaks, appropriate flow rates).

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device that requires a training set. The device's function is mechanical and electrical, not data-driven learning.

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

• Not Applicable: As there is no training set for an AI/ML model, this question is not relevant to this submission.

In summary, the provided document is a regulatory submission for a physical medical device (an implantable port) that has been modified to be compatible with an existing ECG-based tip positioning system. The "performance data" presented is primarily a list of engineering and functional tests to demonstrate that the new design maintains safety and effectiveness and is substantially equivalent to predicate devices, not data from a clinical study on an AI/ML model.

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The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood, and blood products.

The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximium recommended infusion rate is 5 mL/s.

The TidalPort-AP™ has one port size (Standard) and one catheter size (9.6F Polyurethane). It is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The TidalPort-APTM is available as a standard profile totally implantable, titanium port-based design and is accessed perpendicularly to the skin like a typical, conventional access port. For the purpose of apheresis, high-flow procedures, it is accessed with using the FDA Cleared 16G or 18G high-flow, non-coring needle Tidal High-Flow Non-coring Needle (K151341).

The TidalPort-APTM can also be used for routine vascular access infusion or withdrawal using Huber point needle. For power injection infusion procedures, the subject device can be accessed with a power injection rated needle to create a power-injectable system.

The design of the TidalPort-AP™ utilizes a spherical reservoir and an elongated radius contoured septum to achieve the design purpose of creating a port with a smaller reservoir and less clearance volume. The TidalPort-APTM comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The TidalPort-AP™ and necessary kit components are provided sterile (EtO).

The overall implanted port system consists of three primary components: the titanium port body with a silicone septum, an attachable radiopaque polyurethane catheter, and a catheter lock which secures the catheter to the port body stem. Once implanted, the method of accessing the subject TidalPort-APTM device is the exact same as the predicate TidalPort™ device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped port. Once the port is palpated, providing the location of the septum, the 16G or 18G high-flow needle (K151341) is inserted into the reservoir for apheresis procedure use. After the reservoir floor is reached, the stylet is unlocked and pulled back slightly, and the needle is once again advanced forward until contacting the reservoir floor again. The stylet is then completely removed, leaving the hollow cannula with luer lock fitting in place. After stylet removal, the cannula is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.

The provided text describes a 510(k) premarket notification for the TidalPort-AP™ Implantable Apheresis Vascular Access Port. This document details the device's indications for use, technological characteristics, and non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment in a format typically used for evaluating the performance of AI/ML-driven devices.

The document focuses on engineering and material performance testing of a physical medical device, not a diagnostic or prognostic AI/ML algorithm. Therefore, many of the requested fields are not applicable in this context.

Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:

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

The document lists performance tests but does not explicitly state quantitative "acceptance criteria" and "reported performance" in a structured table for each test. It states that "The TidalPort-AP™ Implantable Apheresis Vascular Access Port has met all predetermined acceptance criteria of design verification evaluations through testing examination." This implies that the device did meet the criteria for each performed test.

Key Performance Tests Mentioned:

• Catheter to Port Connection
• Catheter Tensile Strength
• Radiopacity
• Gravity Flow Rate
• Port System Burst under Power Injection
• Stem Tensile Strength
• Corrosion Resistance
• Septum Puncture / Port Leak (w/both Huber point and 2-part large bore needles)
• Port Clearance Volume
• Power Injection / Multi-Power Injection
• Simulated Apheresis Testing- comparison to predicate (PowerFlow)
• Recirculation, Forward and Reverse Flow- comparison to predicate (PowerFlow)
• Hemolysis, Forward and Reverse Flow- comparison to predicate (PowerFlow)
• MRI Safety Testing
• Packaging Ship Testing
• Pyrogenicity Testing

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

Not applicable. The document describes bench testing and biocompatibility assessments of a physical device, not a test set of medical images or patient data.

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 is not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from a test set of data.

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-assisted diagnostic or prognostic 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 context of AI/ML ground truth. For this physical device, the "ground truth" would be established by validated engineering specifications, accepted international standards (ISO, ASTM), and FDA guidance documents (e.g., FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, standards listed in the document). Performance was evaluated against these predefined physical and functional requirements.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes a "training set."

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

Not applicable.

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The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine.

When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power injectable needles or 2 mL/s with a 22G non-coring power injectable needle.

The SmartPort* device with ENDEXO and Vortex Technology and the SmartPort Plastic device with Vortex Technology are implantable venous access devices designed for repeated access to the vascular system. The SmartPort* and SmartPort Plastic devices are subcutaneous implant devices with one reservoir. The ports are accessed using a Huber needle which is passed through the self-sealing silicone septum covering the reservoir. When used with power injectable needles, the port can be used for power injection of contrast media and contrast enhanced computed tomography (CECT).

Available in plastic and titanium port bodies, the SmartPort* device has standard, low profile, and mini Titanium port configurations and low-profile Plastic port configurations. The ports are offered with a 5F, 6F or 8F single lumen BioFlo catheter. The BioFlo catheter with ENDEXO technology is present in the previously cleared NMI Port II (K131694) for improved resistance to thrombus accumulation and/or formation on the catheter. The outlet of the vortex port chamber is set at a tangent rather than perpendicularly.

The SmartPort Plastic device is offered in a low-profile Plastic port body configuration with a 6F or 8F single lumen polyurethane catheter. Both the BioFlo and polyurethane catheters are radiopague.

When used with power injectable needles, the ports are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate setting is 5 ml/s with 19G or 20G non-coring power injectable needles or 2 ml/s with a 22G non-coring power injectable needle.

The ports are available with either silicone filled suture fixation holes. If desired, the suture fixation holes can be used to anchor the port to the subcutaneous tissue. All port configurations have a radiopaque identifier (CT mark) as a power injectable port. The radiopaque catheter is marked at every centimeter and can be cut to the desired length.

The ports are packaged with procedural accessories in a kit to the end user

The provided text does not contain information about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device. Instead, it is a 510(k) premarket notification for implantable infusion ports (SmartPort+ and SmartPort Plastic Implantable Ports), which are physical medical devices, not AI/ML software. Therefore, the requested information regarding acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, and standalone performance studies cannot be extracted from this document.

The document details non-clinical performance testing for the physical device, including:

• Multiple Power Injections
• Port Septum Testing
• Chemical / Vesicant Compatibility
• Nuclear Medicine Compatibility
• Off-Axial Connection
• Power Injection Flow Rate
• Assembly Leak Strength
• Static Burst Strength
• Port Maximum Operating Pressure, Dynamic
• Catheter Kink Resistance
• Catheter Flex Life Strength
• Catheter Freedom from Leakage
• Catheter Burst Strength
• Catheter Peak Tensile Force
• Catheter Radiopacity
• Catheter Distance Marking
• Catheter Print Integrity
• Catheter Tip Dimensions
• Aspiration Strength Open Ended
• Aspiration Strength Closed Ended
• Tunneler to Catheter Compatibility
• 17G Blunt Needle to Catheter Compatibility
• Guidewire to Catheter Compatibility
• Introducer to Catheter Compatibility
• Gravity Flow Rate
• Distribution Simulation
• Surface Finish
• Hyperbaric Chamber Environment

It also includes a biocompatibility assessment and sterilization validation. However, these are for the physical properties and biological interaction of the implantable port, not for an AI/ML algorithm's performance.

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The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, IV fluids, parenteral nutrition solutions, blood and blood products.

The Bard PowerFlow™M Implantable Apheress IV Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

The PowerFlow™ Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex™ Catheter is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The PowerFlow™ Implantable Apheresis IV Port is a low profile totally implantable, angled access titanium port-based design and is accessed through an angled opening which consists of a funnel shaped entrance designed to guide the peripheral intravenous (P.I.V.) access needle and catheter into the subject device. The PowerFlow™ Implantable Apheresis IV Port comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The PowerFlow™ Implantable Apheresis IV Port and necessary kit components are provided sterile (EtO).

The overall implanted system consists of three primary components: the port body with a silicone layered septum, an attachable radiopaque polyurethane catheter lock which secures the catheter to the port body stem. The method of implantation and access of the subject PowerFlow™ Implantable Apheresis IV Port is the exact same as the predicate PowerFlow™ Implantable Apheresis IV Port device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped angled entry funnel. Once the funnel is palpated, providing the location of the introducer needle access path, the 14 or 16Ga introducer needle is inserted into the funnel. After the Introducer Needle Stop is reached, the Introducer Needle is pulled back slightly and the P.I.V. Catheter is advanced forward. The P.I.V. Catheter is then advanced through the silicone layered septum and the Introducer Needle is removed. After needle removal, the P.I.V. Catheter is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.

The PowerFlow™ Implantable Apheresis IV Port can be used for routine vascular access infusion or withdrawal using a BD Insyte™ Autoguard™ Shielded IV Catheter. For power injection infusion procedures, the subject device can be accessed with a power injection rated IV catheter to create a power-injectable system.

This is a 510(k) summary for a medical device and therefore does not include the detailed information typically found in a clinical study report that directly proves the device meets acceptance criteria. The document asserts substantial equivalence to a predicate device based on performance tests and technological comparisons, rather than a prospective clinical study involving human patients.

However, based on the provided text, here's what can be extracted and inferred regarding "acceptance criteria" and "proof":

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

The document states: "The results demonstrate that the subject device met all pre-determined acceptance criteria and that it performs equivalently to the predicate device." However, the specific quantitative acceptance criteria for each test and the precise reported device performance are not explicitly provided in a table format. The tests performed are listed, indicating that for each of these, acceptance criteria existed and were met.

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

• Sample Size: Not specified. The document only lists the types of tests performed.
• Data Provenance: The tests are described as "verification tests" and "non-clinical testing of medical devices," implying they were conducted in a laboratory setting. There is no mention of human subject data, so it is not retrospective or prospective in that sense. The "provenance" refers to the manufacturer's internal testing or contracted lab testing.

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

• Not applicable. This information pertains to studies where human experts establish ground truth, typically in AI/ML performance evaluations or clinical trials. This document describes non-clinical engineering and biocompatibility testing. The "ground truth" for these performance tests is based on established engineering standards, guidance documents, and internal risk assessment procedures.

4. Adjudication method for the test set:

• Not applicable. This applies to expert review processes, which are not relevant for the described non-clinical performance and biocompatibility testing. The "adjudication" is determined by whether the test results meet the pre-defined acceptance criteria based on scientific and engineering principles.

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 a non-AI medical device (an implantable port). MRMC studies are relevant for diagnostic AI tools involving human interpretation.

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

• Not applicable. This device does not involve an algorithm.

7. The type of ground truth used:

• For the performance tests (e.g., radiopacity, corrosion resistance, tensile strength, air leak, valve life, silicone boot retention): The "ground truth" is defined by predetermined acceptance criteria based on engineering standards, guidance documents, and internal risk assessments. This is a form of engineering/technical specification compliance.
• For biocompatibility tests (cytotoxicity, chemical characterization, sensitization, etc.): The "ground truth" is established by scientifically validated methods and endpoints that assess the material's interaction with biological systems according to ISO and ASTM standards and regulatory guidance for biocompatibility. Leveraging data from a component made of the same MIM titanium material suggests that the material properties are the ground truth for biocompatibility conclusions.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML product and does not involve a training set.

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

• Not applicable. As above, no training set for this device.

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The PowerPort® Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anticancer medicines (chemotherapy), 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.

PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Catheters, included with the port, are pre-attached or may be attached to the port by the physician during implantation.

PowerPort® Implantable 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 (SIS) to create a power-injectable system.

The provided text describes specific acceptance criteria and the studies conducted to demonstrate that the Bard Power-Injectable Implantable Ports (PowerPorts®) meet these criteria, primarily focusing on the expansion of their indications for use to explicitly include anti-cancer medicines.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document details performance testing (bench tests) and clinical analysis (literature review and retrospective studies).

• Bench Tests (Test Set): The document does not specify an exact number of devices used for each individual bench test. It states "the devices underwent chemical conditioning" and "the testing also demonstrated that devices were able to further withstand and pass all of the robust physical testing." This implies a representative sample of each device type was used.

  • Data Provenance: This is in-house laboratory testing at Bard Access Systems (C.R. Bard, Inc.). It is prospective in nature as it was designed and performed specifically for this submission.

• Clinical Analysis (Test Set - Retrospective Studies):

  • Study 1 (DiMatteo C, Nishimoto B, Thomas I. 2014): "multicenter, retrospective database review" to determine AE/malfunction rates.
    • Sample Size: "subjects consisted of adult males and females ≥21 years of age who had infusions through a Bard port or any PIV." No specific number is provided in this summary.
    • Data Provenance: Retrospective, multicenter study. The country of origin is not explicitly stated but generally sponsored studies by US companies often involve US data.
  • Study 2 (McDonald M. 2017): "retrospective multicentered study to assess the complication rates of oncology patients accessed with peripheral intravenous lines versus implantable ports."
    • Sample Size: "Patient data was collected from five different clinical sites for patients who were at least 21 years of age, had a Bard® Groshong® Port Catheter, had completed cancer therapy, and had maintenance flushes." No specific number is provided in this summary.
    • Data Provenance: Retrospective, multicenter study from five different clinical sites. Country of origin not explicitly stated.
  • Health Claims Data Analysis: "retrospective analysis of US health care claims data."
    • Sample Size: Not specified beyond "US health care claims data."
    • Data Provenance: Retrospective, US.

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

• Bench Tests: The "ground truth" for the bench tests is defined by established engineering and material science principles, as well as predefined acceptance criteria derived from FDA guidance documents ("FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990" and "FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995") and in-house protocols. No external experts are mentioned for establishing the ground truth of these physical tests; it's based on objective measurement against specifications.

• Clinical Analysis (Retrospective Studies and Literature Review):

  • Literature Review: The ground truth comes from the published clinical literature itself, assessed by the "clinical analysis" team at Bard/C.R. Bard, Inc. The qualifications of these reviewers are not stated.
  • Retrospective Studies: The ground truth for these studies would be derived from the patient medical records/databases used. This medical information is typically established by treating physicians and other healthcare professionals (e.g., nurses administering infusions, radiologists performing imaging, pathologists for cancer diagnoses). The number and specific qualifications of clinicians establishing these initial patient records are not provided, as these are secondary analyses of existing data.

4. Adjudication Method for the Test Set

• Bench Tests: No adjudication method is described beyond successful completion of the tests against predetermined acceptance criteria.
• Clinical Analysis (Retrospective Studies and Literature Review): No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the literature review or the retrospective data analysis. The studies are described as reviewing existing data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done & Effect Size

No MRMC comparative effectiveness study is mentioned for this submission. The submission is not for a diagnostic imaging AI device but for an implantable port. Thus, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is an implantable port, not an algorithm or AI system. Its performance is evaluated through physical characteristics, ability to withstand power injection, and clinical utility for drug delivery.

7. The Type of Ground Truth Used

• Bench Tests: Objective physical measurements and functional performance against engineering specifications and regulatory guidance.
• Clinical Analysis (for expanded Indications):
  • Literature Review: Published clinical evidence and scientific consensus from existing randomized controlled trials, prospective registries, and retrospective analyses.
  • Retrospective Studies: Patient medical record data / health care claims data, which reflects real-world clinical outcomes and diagnoses from healthcare professionals.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set." The development of the port itself relies on engineering design principles, material science, and manufacturing processes.

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

Not applicable, as there is no "training set" for a physical device like this implantable port.

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The Bard PowerFlow™ Implantable Apheress IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, I.V. fluids, parenteral nutrition solutions, blood and blood products.

The Bard PowerFlow™M Implantable Apheresis IV Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

The PowerFlow Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex Catheter is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The Bard PowerFlow Apheresis IV Port is a low profile totally implantable, angled access titanium port based design and is accessed through an angled opening which consists of a funnel shaped entrance designed to guide the peripheral intravenous (P.I.V.) access needle and catheter into the subject device. The PowerFlow Apheresis IV Port comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The PowerFlow Apheresis IV Port and necessary kit components are provided sterile (EtO).

The overall implanted system consists of three primary components: the port body with a silicone layered septum, an attachable radiopaque polyurethane catheter lock which secures the catheter to the port body stem. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Once implanted, the method of accessing the subject Bard PowerFlow Apheresis IV Port is the exact same as the predicate Bard CathLink 20 Titanium Port device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped angled entry funnel. Once the funnel is palpated, providing the location of the introducer needle access path, the 14 or 16Ga introducer needle is inserted into the funnel. After the Introducer Needle Stop is reached, the Introducer Needle is pulled back slightly and the P.I.V. Catheter is advanced forward. The P.I.V. Catheter is then advanced through the silicone layered septum and the Introducer Needle is removed. After needle removal, the Peripheral IV Catheter is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.

The PowerFlow Implantable Apheresis IV Port can be used for routine vascular access infusion or withdrawal using a BD Insyte Autoguard Shielded IV Catheter. For power injection infusion procedures, the subject device can be accessed with a power injection rated IV catheter to create a power-injectable system.

This document describes the premarket notification for the "PowerFlow™ Implantable Apheresis IV Port" and its substantial equivalence to a predicate device. Below is an analysis of the acceptance criteria and the studies performed.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table of acceptance criteria with quantitative thresholds for each test, followed by the reported device performance against those specific thresholds. Instead, it lists various performance tests and then states a general conclusion for each section.

However, based on the information provided, we can infer the acceptance criteria was that the device must meet the requirements of the listed standards and guidance documents, and demonstrate performance "substantially equivalent" to the predicate device.

Here's an inferred summary:

• Low complication rates (e.g., thrombotic occlusion rate of 0.16 per 1,000 catheter patient days).
• Median length of continuous port use of 45 months.
• Successful access by apheresis personnel (1.23 ± 0.6 attempts per port).
• Adequate whole blood and plasma flow rates.
• No adverse effects from use and no hospitalizations for plasma exchange. The report concludes that "Significant design similarities... suggest that this clinical data can provide reasonable expectations for the safety and effectiveness of the PowerFlow™ device." |
  | Power Injectability | Meet safety and functionality for power injection. | "The same test methods and acceptance criteria utilized for the Bard Titanium PowerPort ISP Implanted Port cleared through K072215 was used." This implies the PowerFlow device met these criteria, specifically mentioning a maximum recommended infusion rate of 5 mL/s. |
  | Substantial Equivalence | Device is substantially equivalent to the predicate device. | "Based on the indications for use, technological characteristics, performance testing and biocompatibility testing the subject PowerFlow Implantable Apheresis IV Port... demonstrates that the subject device is substantially equivalent to the predicate device." |

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

• Test Set (Bench Testing/Non-Clinical): The document does not specify exact sample sizes for each of the numerous performance and biocompatibility tests. It broadly states that "Final, finished, sterile samples of the subject Bard PowerFlow Implantable Apheresis IV Port assembly were used for all recommended biocompatibility tests." For other tests (e.g., flow rates, tensile strength), standard engineering and quality control practices typically involve specific sample sizes to ensure statistical significance, but these are not enumerated in this summary.
• Data Provenance (Clinical - for Predicate Device):
  • The clinical data presented is for the predicate device, CATHLINK 20, not the subject device (PowerFlow).
  • The studies were retrospective or prospective clinical observations.
  • Country of Origin: Not explicitly stated, but the referenced academic journals often span international research. The institutions involved in the studies (e.g., Pediatry Blood Cancer, J Clin Apher) suggest clinical settings, likely within professional healthcare systems.
  • Study 1 (Raj et al.): 18 CATHLINK 20 ports implanted in 15 patients.
  • Study 2 (Pertine et al.): Six patients.
  • Study 3 (Gonzalez et al.): Four patients.

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

• For Non-Clinical Tests (Performance & Biocompatibility): The "ground truth" for these tests are the established international standards and FDA guidance documents (e.g., ISO 10555-1, ISO 10993-1, ASTM standards, FDA guidances). The experts involved would be the engineers, scientists, and technicians at Bard Access Systems (or independent contract laboratories) who designed, performed, and interpreted these tests according to the specified methodologies. Their qualifications are not individually listed but are implied by their adherence to GLP standards and relevant regulatory frameworks.
• For Clinical Data (Predicate Device): The "ground truth" here is the clinical outcomes reported by the studies. The experts are the medical professionals (e.g., physicians, nurses, apheresis personnel) involved in conducting the studies, implanting the devices, performing procedures, and collecting data. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed in this summary, but they are implied to be clinical specialists in relevant fields (e.g., hematology, neurology, apheresis).

4. Adjudication Method for the Test Set

• For Non-Clinical Tests: Adjudication is not typically performed by external experts in this context. The results are evaluated against predetermined acceptance criteria specified by the standards and internal protocols. Any discrepancies or failures would lead to further investigation and potentially design changes, followed by re-testing.
• For Clinical Data (Predicate Device): The document does not describe adjudication methods for the clinical studies of the predicate device. Clinical studies generally involve independent verification of data and outcomes, but specific adjudication processes (like 2+1 reads for imaging) are not mentioned as these were clinical outcome studies, not diagnostic device studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed for this device. This type of study is primarily relevant for diagnostic imaging devices where different readers evaluate the same cases with and without AI assistance to measure reader performance improvement. The PowerFlow™ Implantable Apheresis IV Port is a medical device for vascular access, and its evaluation centers on physical performance, biocompatibility, and clinical outcomes for the intended use, not diagnostic interpretation.

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

No, a standalone (algorithm-only) performance study was not done. This concept is not applicable to an implantable vascular access port, which is a physical medical device and not an AI algorithm.

7. The Type of Ground Truth Used

• For Performance Tests (Mechanical, Flow Rates, etc.): The ground truth is based on objective measurements against engineering specifications and industry and regulatory standards.
• For Biocompatibility Tests: The ground truth is determined by the biological responses observed in standardized in-vitro and in-vivo tests, evaluated against established toxicity, irritation, and sensitization profiles defined by ISO 10993.
• For Clinical Data (Predicate Device): The ground truth is based on clinical outcomes data (e.g., complication rates, duration of use, successful access attempts, flow rates, patient-reported experiences) observed during the actual use of the predicate device in a patient population.

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and validation of the device rely on engineering principles, materials science, and conformity to established standards and clinical performance of predicate devices.

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

As there is no "training set" in the AI/ML sense for this device, this question is not applicable. The "ground truth" for the device's design and validation is established through:
* Literature review and understanding of clinical needs (for indications).
* Engineering design specifications.
* Compliance with recognized national and international standards (e.g., ISO, ASTM).
* Performance data from similar legally marketed predicate devices.

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The BardPort®, SlimPort®, and X-Port® implanted ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

BardPort®, SlimPort®, and X-Port® Implanted Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. BardPort®, SlimPort®, and X-Port® Implanted Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation. BardPort®, SlimPort®, and X-Port® Implanted Ports can be used for routine vascular access using a non-coring access needle.

The provided text is a 510(k) Pre-Market Notification for BardPort®, SlimPort®, and X-Port® Implanted Ports. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance testing. It does not describe an AI/ML device or its acceptance criteria and study data in the typical sense of diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested elements for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, effect size of human improvement) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (implanted infusion ports).

However, I can extract information related to the performance tests conducted to demonstrate the substantial equivalence of the device, which serves as the "study" proving the device meets its "acceptance criteria" in the context of this 510(k) submission.

Here's the closest interpretation of your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of medical device are typically defined by engineering specifications and recognized standards, which are evaluated through physical performance tests. The "reported device performance" is the successful completion of these tests.

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

• Sample Size for Test Set: The document does not specify the exact number of units/samples tested for each performance test. It only lists the types of tests conducted.
• Data Provenance: Not applicable in the context of a physical device's engineering and performance testing. The "data" comes from in-house 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 as the "ground truth" for a physical device like an implanted port is determined by objective engineering measurements and adherence to specified performance standards, not expert interpretation of diagnostic images or clinical outcomes. The "experts" in this context would be the engineers and quality control personnel performing and evaluating the tests.

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

• Not applicable. Performance tests for physical devices typically rely on objective measurements against pre-defined thresholds, rather than subjective 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

• 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 (expert consensus, pathology, outcomes data, etc.)

• In the context of this device, the "ground truth" is established through objective physical and chemical properties testing against defined engineering specifications and recognized standards. Examples include measurements of tensile strength, burst pressure, leak rates, material composition, and dimensional accuracy, as outlined by standards like ISO 10555-1, ISO 10555-3, and ASTM F2503-13.

8. The sample size for the training set

• Not applicable. There is no AI/ML model being "trained" for this device. The development process for the device involved design controls and risk analysis, with modifications based on prior cleared devices (predicates).

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

• Not applicable. There is no AI/ML model for which a "training set" ground truth would be established. The "ground truth" for the device's design and performance validation relies on established engineering principles, material science, and adherence to medical device standards.

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The Dignity® Dual Port is a power injectable implantable infusion port that is indicated for patient therapies requiring repeated access to the vascular system. The Dignity® Dual Port can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with a power injectable needle, the Dignity® Dual Port is indicated for power injection of contrast media. 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. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

The Dignity® Dual power injectable implantable infusion port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a power injectable needle only. The Dignity® Dual Port device consists of two primary components: an injection port with a self-sealing septa and a radiopaque catheter. The Dignity® Dual Ports can be identified subcutaneously by feeling the top of the septum and the top rim of the port housing. Power Injectable Implantable Infusion Ports can be identified by the letters "CT" under radiographic imaging.

The Dignity® Dual Port will be marketed in four kit configurations, which are listed below:

• 9.5F Standard Port Kit (Catalog number MRDP95ADN)
• 9.5F Port Kit with Micro-Stick (Catalog number MIDP95ADN)
• 9.5F Standard Port Kit with Silicone Filled Suture Holes (Catalog number MRDP95ADS)
• 9.5F Port kit with Silicone Filled Suture Holes and with Micro-Stick (Catalog number MIDP95ADS)

The Dignity® Dual Port is comprised of a polysulfone cap (with silicone filled suture holes, or open suture holes), two silicone septa, and a polysulfone base assembly with a titanium tube that provides a channel from the stem to the distal reservoir. The reservoir is plastic (polysulfone). The Dignity® Dual catheter locking assembly (makrolon/pellethane) locks the chronoflex lumen to the plastic stem of the Dignity® Dual Port.

The provided text describes the "Dignity® Dual Port," a power injectable implantable infusion port. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to pre-existing devices. Therefore, the "study" referred to is a demonstration of equivalence through functional and material comparisons, rather than a traditional clinical study with human patients and outcomes data.

Here's the breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a 510(k) submission, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with a distinct human "test set."

• Test Set: No independent human "test set" in the context of a clinical trial is described. The "testing" involves bench testing, material comparisons, and a comparison matrix against a predicate and reference devices.
• Data Provenance: The data provenance is primarily from bench/performance data and comparison to previously FDA-cleared devices (predicate K090512, reference K070003, K120281). This is not data from human subjects or from a specific country of origin in the way a clinical trial would generate it. All data would be generated in a lab setting by Medcomp® or its contracted testing facilities.

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

• Ground Truth Establishment: Not applicable in the context of this 510(k) summary. The "ground truth" for the current device's acceptability is established by demonstrating its equivalence to predicate devices that have already been determined safe and effective by the FDA. The performance standards are derived from established industry standards (e.g., ISO, ASTM) and the performance characteristics of the predicate device.
• Experts: No external experts are described as establishing "ground truth" for the test set. The submission itself is prepared by Medcomp®'s regulatory associate, Ms. Courtney Nix, and reviewed internally by Medcomp® and externally by the FDA (specifically the Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" of patient data requiring adjudication. The assessment is a comparison of design, materials, and performance data against established standards and predicate device specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret results with and without AI assistance. The Dignity® Dual Port is an implantable infusion port, a physical medical device, not an imaging or diagnostic AI system.

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

• Standalone Performance: Not applicable. The device is a physical implantable infusion port, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the submission is the established safety and effectiveness of the legally marketed predicate device (C.R. Bard PowerPort©, K090512) and reference devices (Medcomp® Pro-Fuse®, K070003; Medcomp® Dignity® Power Injectable Titanium Port, K120281), as interpreted through FDA regulations and consensus standards (ISO, ASTM). The equivalence is demonstrated through comparative analysis of specifications, materials, and bench test results against these established benchmarks.

8. The Sample Size for the Training Set

• Training Set: Not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.

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