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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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The Medcomp® Gen III Power Injectable Port is 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.

When used with a power injectable needle, the power injectable infusion 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 Medcomp® Gen III Power Injectable Port includes the Dignity® Mini. Low Profile and Pro-Fuse® Low Profile and Standard are subcutaneously implantable single fluid reservoir port offered with a choice of a silicone or polyurethane cather either pre-attached by the manufacturer or attachable for application by the inserting physician. The Pro-Fuse® product line offers a round base while the Dignity® product line offers a shovel nose concaved sides and smooth contours. The Dignity® product line is offered in Midsize. which has a smaller base than the predicate, K070003. The Dignity® product line is offered in Low Profile, which is a smaller base than the Midsize therefore is smaller than predicate, K070003. The Dignity® product line is offered in Mini, it is the smallest offered profile.

Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catherer lock provides securement of the catheter to the port stem. The port is accessed by inserting needle through the skin into the self-sealing septum.

The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-coming needle at a maximum recommended infusion rate of 5 ml/s.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion.

The provided text describes the Medcomp® Gen III Power Injectable Port and its 510(k) submission (K132177). This document focuses on demonstrating substantial equivalence to a predicate device (K070003) rather than a standalone study proving device performance against specific novel acceptance criteria.

The acceptance criteria are implicitly defined by the safety and performance requirements for implantable infusion ports and are primarily demonstrated through comparison to the predicate and established international standards (ISO 10555-1, ISO 10993).

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding performance results for each criterion. Instead, it lists various "Bench / Performance Data" tests performed and states that the "results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003."

Essentially, the acceptance criterion for each test is that the new device's performance is equivalent to, or meets the established safety and performance characteristics of, the predicate device and relevant ISO standards.

• Power Injection Simulation
• Elongation & Tensile
• Priming Volume
• Gravity Flow
• Stem Break Force
• Cap/Base Bond Integrity
• Catheter Lock Integrity
• Clearance Volume
• Needle Insertion/Extraction Force
• Reservoir Pressure
• Static Burst Pressure | "In vitro testing was performed on the Power Injectable. Implantable Infusion Port to assure reliable design and performance in accordance with the FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990."
  "Verification testing and performance testing performed according to the referenced standards as well as in accordance with in-house protocols."
  "The following testing was performed on all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini. in accordance with requirements of ISO 10555-1 for all configurations listed in pursuant of this application to market."
  "The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate device. K070003."
  No specific numerical performance values are provided, only an assertion of equivalence. |
  | Biocompatibility in accordance with ISO 10993 | "Testing for all materials used for the Power Iniectable Infusion Port has been submitted in previously cleared Medcomp device predicate K070003. All biocompaibility testing demonstrals used meet the requirements of ISO 10993." |
  | Substantial Equivalence to Predicate K070003 | "The proposed devices meet the performance criteria of design verification as specified by ISO standards, guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices." |

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

The document does not explicitly state the sample sizes (number of units or batches tested) for the "Bench / Performance Data" tests. It mentions "all configurations Pro-Fuse Standard and Low Profile, Dignity Low Profile, Midsize and Mini" were tested, indicating multiple product variants were included.

The data provenance is implied to be from in vitro testing performed by the manufacturer (Medcomp®) in the US, as it's a submission to the FDA. It is prospective for the Gen III device, as these tests were conducted on the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this type of submission. This is a premarket notification for a medical device (implantable port) based on substantial equivalence and bench testing, not an algorithmic diagnostic device requiring expert interpretation of clinical images for ground truth establishment.

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

This is not applicable. Adjudication methods are typically used in studies involving human interpretation or performance, often for diagnostic accuracy, which is not the nature of this submission. The "ground truth" for the performance tests would be the measured physical properties of the device against engineering requirements or established standards.

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 is not applicable. An MRMC comparative effectiveness study is specific to diagnostic imaging devices or AI algorithms where human reader performance is a key metric. This submission is for an implantable infusion port.

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

This is not applicable as this is a physical medical device, not an algorithm or AI system. The "standalone" performance here relates to the device's physical and mechanical properties, which were tested in a "standalone" manner (i.e., the device itself was subjected to bench tests).

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

The "ground truth" for the bench tests are:

• Engineering specifications and measurements: For parameters like priming volume, burst pressure, tensile strength, etc.
• Compliance with international standards: ISO 10555-1 for performance and ISO 10993 for biocompatibility.
• Performance of the predicate device (K070003): The new device's performance is shown to be equivalent to the previously cleared predicate.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as above.

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The Medcomp® T3 T catheter is a triple lumen catheter indicated for use in attaining short-term vascular access for hemodialysis, apheresis. The third internal lumen is intended for infusion, power injection of contrast media and central venous pressure monitoring.

The catheter is intended to be inserted in the jugular, femoral or subclavian vein as required. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media.

The T3 CT is a triple lumen catheter with a designated lumen for power injection, infusion or pressure monitoring. Each catheter lumen terminates through an extension to a female luer- lock connector. Each extension has an in-line clamp to control fluid flow and the clamp I.D. Ring is marked with the priming volume plus power injection rate is printed on the center clamp. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size, lumen length and both the company and catheter design name. The outer extensions are clear and marked with "Do Not Power Inject" and the center extension is a translucent purple pigment printed with "Power Injectable". The catheter is available with either straight or curved out extensions.

The catheter lumen is composed of a soft, thermo-sensitive, polyurethane material with barium sulfate for radiopacity. At bodv temperature the catherer lumen becomes softer to reduce the risk of vessel trauma.

The catheter hub and extensions are molded from soft pliable polyurethane to increase patient comfort. The suture wing is flexible with suture holes for catheter securement.

The provided document does not contain a study demonstrating acceptance criteria or device performance in the way typically expected for a medical device efficacy or performance study. This document is a 510(k) summary for a hemodialysis catheter (T3 CT).

Instead of a clinical study or performance data against specific acceptance criteria, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that instead of proving the device meets certain performance metrics through a new study, the applicant argues that the new device is as safe and effective as devices already on the market because it has the same intended use, materials, anatomical location, basic design, performance, labeling, manufacturing process, and method of sterilization.

Here's an analysis based on the information provided, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there is no explicit table of acceptance criteria and reported device performance from a specific study presented in this 510(k) summary. The submission asserts that the device "meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." However, the details of these criteria or the test results are not included.

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

Not applicable. No new clinical or performance test set (as in a study to evaluate efficacy or performance against specific metrics) is described. The submission relies on equivalence to predicate devices and adherence to design verification standards (ISO, guidance documents, test protocols), but details of these tests are not provided.

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

Not applicable. No ground truth establishment for a test set is described as part of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring an adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device 510(k) summary for a catheter, not an AI software or imaging device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This is a medical device 510(k) summary for a catheter, not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable in the context of a new efficacy/performance study. The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the identified predicate devices, based on their prior clearance and market history.

8. Sample Size for the Training Set

Not applicable. This is a medical device 510(k) summary for a catheter. The concept of a "training set" is relevant for machine learning algorithms, which is not what this submission is about.

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

Not applicable. See point 8.

Summary of the Acceptance Criteria and "Study":

The "acceptance criteria" for the Medcomp® T3 CT catheter, as presented in this 510(k) summary, are primarily based on:

• Substantial Equivalence: The device is considered substantially equivalent to legally marketed predicate devices (K033570, K083675, K102605 as primary, and several others as secondary). This is the core "study" or justification for its market clearance. The argument is that "there are no differences that raise new issues of safety and effectiveness."
• Design Verification: The submission states that the "proposed device meets the performance criteria of design verification as specified by ISO standards, guidance documents and test protocols." While the specific tests and their results are not detailed, this implies that the device underwent engineering and materials testing to ensure it meets established specifications for medical catheters (e.g., strength, flow rates, material compatibility, etc.).
• Biocompatibility: The materials used meet the requirements of ISO 10993, and all materials have been cleared under past approved 510(k)s. This demonstrates the materials are biologically safe.

Conclusion:

The Medcomp® T3 CT 510(k) submission (K123292) for a hemodialysis catheter does not describe a clinical study to prove device performance against specific efficacy or performance acceptance criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices and adherence to established design verification standards and biocompatibility requirements. This is a common pathway for medical device clearance, especially for devices that are modifications or improvements upon existing technologies rather than entirely novel ones.

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The PRO-PICC m C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The PRO-PICC m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection. Injectable CVC. The PRO-PICC m ™ catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion. The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Medcomp® PRO-PICC ™ CT Peripherally Inserted Central Catheter

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "in vitro testing was performed" without specifying the number of units tested.
• Data Provenance: In vitro testing was performed. The country of origin for the testing is not specified, but the submitter is based in Harleysville, PA, USA. The testing is not retrospective or prospective in the clinical sense, as it was lab-based in vitro testing.

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

• No human experts were used to establish ground truth for this in vitro test set. The acceptance criteria are based on engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols, which are objective, measurable performance parameters.

4. Adjudication Method for the Test Set

• Not applicable. As the ground truth was established by objective engineering standards and measurements, no human adjudication was required.

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

• No, an MRMC comparative effectiveness study was not done. Clinical studies were explicitly not deemed necessary. The device's safety and effectiveness were demonstrated through in vitro testing and comparison to legally marketed predicate devices.

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

• Not applicable. This device is a physical medical catheter, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this product.

7. The Type of Ground Truth Used

• Objective Engineering Standards and Measurements: The ground truth for the device's performance was established using objective measurements against established international engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols. These standards define the acceptable range for physical and chemical properties (e.g., burst pressure, flow rate, leakage).
• Biocompatibility Standard: For biocompatibility, the ground truth was meeting the requirements of ISO 10993.

8. The Sample Size for the Training Set

• Not applicable. This refers to a physical medical device, not a machine learning algorithm. Therefore, there is no "training set." The design and materials are based on existing, cleared predicate devices and engineering principles.

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

• Not applicable. As there is no "training set" in the context of this device, this question is not relevant. The device's design is informed by established engineering principles and prior validated devices.

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The Jet Port Plus HP Catheter System is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the Jet Port Plus HP Catheter System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G noncoring power injectable needle.

The Jet Port Plus HP Catheter System is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site.

The Jet Port Plus HP Catheter System port is available in various profiles The Jet Port Plus HP II has a polyoxymethylene body with a silicone septum The Tita Jet Light HP has a polyoxymethylene body containing a titanium insert with a silicone septum

The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. These letters can be visualized through a Scout CT. The serial number is laser etched into the base of the port. The port can be anchored with sutures in the port pocket for secure seating. The suture holes may contain clear silicone to prevent tissue in growth to the suture holes.

The Jet Port Plus HP Catheter System is offered with the polyurethane catheter either pre-attached by the manufacturer or attachable for application by the inserting physician. The catheter lock provides securement of the catheter to the port. I Introduction into the implanted port and catheter system is through a non-coring needle.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.

The Jet Port Plus HP Catheter System is packaged with the necessary accessories to facilitate catheter insertion.

The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125. The addition of power injection capability is comparable to the currently marketed Power Injectable Infusion Port cleared under K070003.

Components will be assembled into standard configurations specified by the customer and packaged.

The device includes the following components:

• Implantable Port
• . Click Connector
• Guide Wire ●
• Dilator ●
• Tunneling Needle
• Vein Lifter .
• . Nurses Guide
• Companion Checklist
• Catheter .
• Huber Needle
• . Introducing Needle
• . Peel Away Sheath
• . Syringe
• Instructions for Use ●
• Patient Guide .
• Patient ID Card & Key Ring Card .

The provided text is a 510(k) Summary for the Jet Port Plus HP Catheter System, which is an implantable medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and ground truth analysis as typically seen in AI/ML device submissions.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a clinical study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for training or testing sets.

The relevant information from the document is summarized below based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics for the device (e.g., accuracy, sensitivity, specificity, or device failure rates over time from a clinical study). The acceptance for this 510(k) is based on demonstrating substantial equivalence to predicate devices, particularly regarding power injection capability.
• Reported Device Performance: The document describes the intended function of the device and its specifications for power injection but does not report performance data from a study against specific acceptance criteria.
  • Power Injection: Maximum recommended infusion rate of 5 ml/sec with a 19G or 20G non-coring power injectable needle, or 2 ml/sec with a 22G non-coring power injectable needle. Maximum pressure should not exceed 300 psi.
  • Biocompatibility: Stated that materials are "used in legally marketed devices under comparable conditions of use," implying a regulatory acceptance based on prior use and material safety, not a specific study with performance metrics in this summary.

The following information is NOT available in the provided text:

2. Sample size used for the test set and the data provenance: Not applicable or provided. This is a device requiring substantial equivalence, not a performance study as described for AI/ML.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method 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 device is not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the 510(k) context):

The "study" in this context is the process of demonstrating substantial equivalence to legally marketed predicate devices, rather than a clinical performance study with defined acceptance criteria and statistical analysis.

• Comparison to Predicate Devices: The Jet Port Plus HP Catheter System is compared to:
  • pfm Medical, Inc.'s Jet Port Plus Catheter System (K000125): For the basic port and catheter system components and overall function. The document states, "The port and catheter uses the same components and are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125."
  • MedComp's Power Injectable, Implantable Infusion Port (K070003): Specifically for the added power injection capability. The document states, "The addition of power injection capability is comparable to the currently marketed Power Injectable Infusion Port cleared under K070003."

The 510(k) summary explains the device's design, components, and intended use, asserting that its materials and general function are equivalent to K000125, and its power injection capabilities are comparable to K070003. This is the basis for FDA's substantial equivalence determination, not a clinical trial demonstrating performance against specific numerical acceptance criteria.

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The T-Port HP Infusion Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

When used with a power injectable needle, the T-Port HP Infusion Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

The T-Port HP Infusion Port is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site. The T-Port HP Infusion Port is offered with the polyurethane catheter either preattached by the manufacturer or attachable for application by the inserting physician. The port can be anchored with sutures in the port pocket for secure seating. The catheter lock provides securement of the catheter to the port. Introduction of solution into the implanted port and catheter system is through a non-coring needle.

The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. The serial number is laser etched into the base of the suture holes may contain clear silicone to prevent tissue in growth to the suture holes.

Power injection of contrast media, can be safely administered with a 19 or 20 qauqe power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.

The T-Port HP Infusion Port is packaged with the necessary accessories to facilitate catheter insertion.

The port and catheter are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125. The addition of power injection capability is comparable to the currently marketed Power Injectable Implantable Infusion Port cleared under K070003.

Components will be assembled into standard configurations specified by the customer and packaged.

The device includes the following components:

• Implantable Port
• Click Connector
• Guide Wire
• Dilator
• Tunneling Needle
• Vein Lifter
• Nurses Guide
• Companion Checklist
• Catheter
• Huber Needle
• Introducing Needle
• Peel Away Sheath
• Syringe
• Instructions for Use
• Patient Guide
• Patient ID Card & Key Ring Card

The provided 510(k) summary for the T-Port HP Infusion Port does not contain information about acceptance criteria or a study proving its performance against acceptance criteria in the manner typically described for AI/ML-based devices or complex diagnostic tools.

This document describes a medical device, specifically an implantable infusion port, and its substantial equivalence to previously marketed devices. The "performance" discussed relates to its physical characteristics and functionality, not to a diagnostic or predictive algorithm.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

However, I can extract information related to the device's technical specifications and how its "performance" (in terms of physical capabilities) is established through comparison to predicate devices.

Explanation of Missing Information:

• Acceptance Criteria & Reported Device Performance (Table): This type of information is typically for devices that perform a measurement or make a diagnostic determination, where criteria like sensitivity, specificity, accuracy, or specific thresholds for a measurement are set. For an infusion port, "performance" is more about structural integrity, flow rates, and biocompatibility, which are verified through engineering tests and material comparisons, not typically reported in terms of specific "acceptance criteria" and "reported device performance" in a 510(k) summary like this. The document states its capabilities (e.g., maximum infusion rates, pressure) but doesn't frame them as acceptance criteria for a study.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Info: These are all concepts relevant to studies evaluating the performance of algorithms, diagnostic devices, or AI/ML systems. They are not applicable to the clearance of an implantable infusion port which relies on demonstrating substantial equivalence to predicate devices through comparisons of material, design, and intended use, often supported by bench testing and sometimes animal studies (though not detailed here beyond biocompatibility).

What the document does provide regarding "performance" and "studies":

The document primarily focuses on demonstrating substantial equivalence to predicate devices. This is the "study" in this context.

Description of Device Capabilities (which could be considered performance specifications):

• Maximum Recommended Infusion Rate:
  • 19 or 20 gauge non-coring needle: 5 ml/sec
  • 22 gauge non-coring needle: 2 ml/sec
• Maximum Pressure: Not to exceed 300 psi.
• Biocompatibility: Materials are used in legally marketed devices under comparable conditions of use.

Nature of the "Study" (Demonstration of Substantial Equivalence):

The "study" or justification for clearance is based on comparing the T-Port HP Infusion Port to two predicate devices:

1. pfm Medical, Inc Manufacturer: MedComp Name: Jet Port Plus Catheter System (Cleared under K000125) - This is for the basic functionality as an implantable infusion port.
2. Power Injectable Implantable Infusion Port (Cleared under K070003) - This is for the addition of power injection capability.

The document states: "The port and catheter are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125. The addition of power injection capability is comparable to the currently marketed Power Injectable Implantable Infusion Port cleared under K070003."

This implicitly means that the performance specifications (flow rates, pressure limits) for power injection are comparable to the K070003 predicate device, and the general port functionality (repeated access, material, sterilization) is comparable to the K000125 predicate device.

Therefore, I cannot fill out the requested template in full, but can summarize the device capabilities and the basis of its clearance.

Unavailable Information from the Provided Text:

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