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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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