The provided text describes a medical device, the theraPORT® Vascular Access System, and outlines performance testing rather than acceptance criteria and a study to prove meeting those criteria in the context of diagnostic accuracy or clinical outcomes. The device is an implanted system, and the "studies" mentioned focus on engineering performance tests as opposed to clinical trials.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions that performance testing was conducted in accordance with the "Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990." While specific quantitative acceptance criteria are not explicitly stated, the types of tests performed indicate the areas of performance evaluated. The "reported device performance" is summarized as the device "functions properly" and is "substantially equivalent."

Acceptance Criteria (Implied from tests performed)	Reported Device Performance
Catheter-to-port connection strength	Functions properly
Septum puncture durability	Functions properly
Port leakage integrity	Functions properly
Port/catheter clearance	Functions properly

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

The document does not provide the sample sizes for the performance tests conducted. It also does not specify the origin of any data, as the tests described are laboratory-based engineering performance tests, not clinical studies with human subjects or retrospective data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable to the provided document. The ground truth for engineering performance tests is typically defined by engineering specifications and standards, not by expert consensus in a clinical diagnostic sense. No clinical experts were involved in what's described as "performance testing."

4. Adjudication Method for the Test Set

This is not applicable. The tests described are objective engineering performance tests, not subjective interpretations requiring adjudication.

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 done. The document explicitly states: "Clinical studies were not conducted as they were determined to be not necessary due to the similarity in design, performance, materials, function and intended use of the theraPORT® Vascular Access System to other commercially available systems." Therefore, there is no effect size of human readers improving with or without AI assistance.

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

This question is not applicable. The theraPORT® Vascular Access System is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be defined by engineering standards and specifications outlined in the "Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990." For example, a "catheter-to-port connection strength" test would have a specified minimum force it must withstand, which serves as the ground truth for that particular test.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.

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

This question is not applicable for the reasons stated in point 8.

Summary

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K960350

510(k) Summary for the theraPORT® Vascular Access System

APR 1 5 1996

GENERAL INFORMATION:

Common/Usual Names:	Implanted Subcutaneous Intravascular Catheter;Implantable Vascular Access System; ImplantedInfusion Port
Proprietary Name:	theraPORT® Vascular Access System
Applicant:	Biocontrol Technology, Inc.300 Indian Springs RoadIndiana, PA 15701(412)349-1811
Equivalence Device Comparison:	Cook Pacemaker Corporation, VITAL-PORT®Vascular Access Port with Detached Catheter;Pharmacia Deltec, Inc., PORT-A-CATH® Implant-able Access System; and Therex, Inc., A-PORT®Implantable Vascular Access System.

DEVICE DESCRIPTION:

The theraPORT® Vascular Access System is a totally implantable venous access system consisting of a detached catheter and port.

INTENDED USE:

The theraPORT® is intended for use with patients that require repeated venous access for injection or infusion therapy and/or venous blood sampling.

ALTERNATIVE DEVICES:

Alternative devices to the theraPORT® Vascular Access System are other commercially available implantable vascular venous access systems such as the Cook Pacemaker Corporation, VITAL- PORT® Vascular Access Port with Detached Catheter, the Pharmacia Deltec, Inc. PORT-A-CATH® Implantable Access System, and the Therex Corporation, A-PORT® Implantable Vascular Access System.

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POTENTIAL ADVERSE EFFECTS:

The following adverse effects, which are normally associated with the insertion or use of any implanted device or indwelling catheter, may occur when using the theraPORT® Vascular Access System: air embolism, bacteremia, catheter disconnection, catheter fragmentation, cardiac arthythmia, cardiac puncture, cardiac tamponade, catheter occlusion, catheter rupture, catheter shearing, catheter/port erosion through blood vessel/skin, catheter/port migration, drug extravasation, hematoma, hemothorax, implant rejection, laceration or puncture of vessels, pneumothorax, sepsis, thromboembolism, thrombophlebitis, thrombosis.

SUMMARY OF STUDIES:

Performance Testing:

Performance testing of the theraPORT® Vascular Access System was conducted in accordance with the "Guidance on 510(k) Submissions for Implanted Infusion Ports," Center for Devices and Radiological Health, Office of Device Evaluation, Division of Gastroenterology/Urology and General Use Devices, Food and Drug Administration, October 1990. Catheter-to-port connection strength tests, septum puncture durability tests, port leakage integrity tests and port/catheter clearance tests were all performed.

Biocompatibility testing was not conducted since all materials, their processing, and their sterilization are identical to substantially equivalent devices.

Clinical Studies:

Clinical studies were not conducted as they were determined to be not necessary due to the similarity in design, performance, materials, function and intended use of the theraPORT® Vascular Access System to other commercially available systems.

CONCLUSIONS DETERMINED FROM TESTS:

The above described studies demonstrate that the theraPORT® Vascular Access System functions properly and is substantially equivalent to the aforementioned commercially available predicate devices. Therefore, the theraPORT® Vascular Access System is determined to be safe and effective for its intended use.

theraPORT® is a registered trademark of Biocontrol Technology, Inc.

A-Port® is a registered trademark of Therex, Corp.

Port-A-Cath® is a registered trademark of Pharmacia-Deltec, Inc.

Vital-Port® is a registered trademark of Cook Pacemaker Corp.

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.