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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 SportPort™ is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion of drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.

When used with a power injectable needle infusion set, the SportPort™ 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 and 2 ml/s with a 22-gauge non-coring power injectable needle.

The devices are to be used by or on the order of a physician. The SportPort™ line of ports has a body/septum retainer made of either commercially pure grade 2 titanium or medical grade polysulfone and has a body/septum chamber with a silicone rubber septum designed for repeated needle puncturing. The SportPort™ comes in a standard design to enable regular use as an infusion/withdrawal port and has high-pressure injection capability to aid to the delivery of large volumes or special fluids such as contrast media. The shape of the base plate of the port body is triangular and is compatible with most imaging systems. The top of the port (septum retainer) has a raised triangle to secure the septum in place during high-pressure use and to enable palpable or image system identification. The port has six (6) elongated holes for suture fixation to the deep fascia tissue during implantation. The fixation is required to prevent migration or flipping of the port. A catheter comes with the port and is inserted into the vascular system. The catheter is assembled to the port and fed into a venous vessel and fed down into the vascular system. The catheter is radiopaque to enable visualization for proper placement. The kit provided to aid in insertion of the catheter and placement of the port may include items like needles, sheaths, vein picks, guidewires, straighteners, and dilators. Likewise, the cut down kit for port placement may contain most infusion sets with Lucent Non-Coring needles, straight pointed Huber needles, blunt needles, and syringes along with the port and catheter.

The Norfolk Medical SportPort™ family of ports provides a simple method for the delivery of volumes of medications, fluids and special fluids like chemotherapy agents via a chamber leading to a catheter and opening into a large vessel in the body. The catheter is inserted into a large vessel that ideally terminates in the superior vena cava/high right atrial junction. The port is surgically implanted subcutaneously in the soft tissue near the clavicle on the patient's right upper chest wall. Medications, fluids, nutritional liquids or chemotherapy agents can then be administered as necessary. The ports are intended for long-term placement.

The Norfolk Medical SportPort™ family of Vascular Access Devices is a group of ports and catheter sets with infusion and withdrawal capabilities via a port and an access catheter to the large vessels in the vascular system. These ports must be properly attached to a catheter during a procedure.

When used with a legally marketed power capable needle infusion set, the SportPort™ 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 19 or 20 gauge needle and 2ml/sec with a 22 gauge needle set.

The provided text describes a 510(k) premarket notification for the SportPort™ medical device, which is an implanted port and catheter system. The submission focuses on demonstrating substantial equivalence to a predicate device (NorPort CT-PC Port - K111101) rather than presenting a detailed study with acceptance criteria and performance data in the format typically seen for novel AI/diagnostic devices.

Based on the information provided, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical "acceptance criteria" in the typical sense (e.g., sensitivity, specificity, accuracy targets) because it's for a physical medical device (implantable port) and focuses on mechanical and material equivalence to a predicate. Instead, the "performance" is demonstrated through various mechanical tests to show the device functions as intended and is comparable to the predicate.

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

The document does not specify a "test set" in the context of patient data or clinical studies. The "testing" appears to be entirely bench testing (mechanical testing) of the device prototypes. Therefore, there is no information on:

• Sample size used for a test set (as it relates to patients/data).
• Data provenance (country of origin, retrospective/prospective), as no patient data was used.

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

Not applicable. The ground truth for mechanical performance is established through engineering standards and testing protocols, not by expert medical review of a test set.

4. Adjudication Method for the Test Set

Not applicable, as no human adjudication for a test set (e.g., imaging review) is mentioned.

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

No. This type of study is specifically relevant for diagnostic devices where human readers interpret data (e.g., images), often with and without AI assistance, to assess the AI's impact on human performance. The SportPort™ is a physical medical device, not a diagnostic or AI-powered system, so an MRMC study is not relevant or mentioned.

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

Not applicable. The SportPort™ is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth for the device's performance is established by engineering specifications, material science, and mechanical testing standards. The success of the tests (e.g., no leaks, ability to withstand burst pressure, appropriate tensile strength) serves as the ground truth for validating the device's physical and functional integrity.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI or machine learning device. The development process for the SportPort™ relies on engineering design, material selection, and iterative mechanical testing rather than data-driven training.

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

Not applicable, as there is no training set for this device.

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The NorPort Family of Implanted Vascular Access Devices is indicated for use when the patient requires repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.

Our device is composed of a port reservoir with an attachable catheter system. The Port reservoir consists of a titanium (510 (k)# 871192) or polysulfone (510 (k)# 840788) chamber with a silicone septum and an outlet section. The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity. The port comes in two different sizes to accommodate different body frames. The catheter that is attached to the port is long enough to be inserted in the superior vena cava/right atrium junction to allow for fluid infusion into the heart and large blood vessels. The NorPort will also be available as part of an implantable kit. The kit contains all the tools needed to aid in catheter placement, insertion and port implantation.

The Norfolk Medical NorPort is an implanted drug delivery device (port) consisting of a reservoir with an attachable catheter system. The port is intended for repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood.

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

1. Acceptance Criteria and Reported Device Performance

The document states that "The NorPort family of products meets all established acceptance criteria for performance testing and design verification testing" (Page 7). While the specific quantitative acceptance criteria are not explicitly listed in a table, the document indicates that the device's performance was compared to established standards and predicate devices.

Table of Acceptance Criteria and Reported Device Performance (Inferred from Text):

The overarching acceptance criterion is Substantial Equivalence to legally marketed predicate devices, which the study concluded was met.

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

• Sample Size: The document does not specify the exact number of devices or components used for each non-clinical test (catheter to port connection, septum puncture/port leak, patency verification, static burst, tensile strength). The phrasing "data collected from the non-clinical tests" implies a test set was used, but the quantity is not provided.
• Data Provenance: The tests are described as "non-clinical tests" and "design verification testing," suggesting these were conducted in a laboratory setting, likely by the manufacturer, rather than on human or animal subjects. No information is provided about the country of origin or whether it was retrospective or prospective, but as it's non-clinical, these terms are less applicable.

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

• Number of Experts: Not applicable. For non-clinical performance and design verification tests of a medical device like an implantable port, the "ground truth" is typically established by engineering specifications, recognized industry standards (e.g., ISO, FDA guidance), and the performance characteristics of predicate devices. There wouldn't be human experts establishing "ground truth" in the same way as, for example, reading medical images.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would be conducted by qualified engineers and technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where multiple human readers interpret results and discrepancies are resolved by a senior expert. For non-clinical performance testing, the results are objectively measured against defined criteria, standards, or predicate device performance.

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

• MRMC Study Done: No. An MRMC study is designed to assess the performance of a diagnostic device or AI algorithm when used by multiple human readers across multiple cases, often comparing performance with and without AI assistance. This device is an implanted drug delivery port, not a diagnostic tool or an AI-assisted interpretation system. Therefore, such a study would not be relevant or possible for this type of device.
• Effect Size of Human Readers Improvement with AI: Not applicable, as no MRMC study was conducted.

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

• Standalone Study Done: No. This term also typically applies to AI or diagnostic algorithms. For a physical medical device like an implantable port, performance is inherently "standalone" in mechanical and material terms, but it functions as part of a human-in-the-loop system (physician implants, nurse accesses, patient lives with it). The non-clinical tests evaluated the device's inherent physical performance characteristics.

7. Type of Ground Truth Used

The ground truth used for evaluating the NorPort's performance was based on:

• Recognized Industry Standards: FDA Guidance on 510(k) Submissions for Implanted Infusion Ports (October 1990), BS EN ISO 10555-1:2009 (Sterile, single-use intravascular catheters Part 1: General requirements), and ISO 11135-1:2007 (Sterilization of health care products - Ethylene oxide).
• Predicate Device Performance: The NorPort's functionality and performance characteristics were compared to "currently marketed vascular ports" and explicitly to specific predicate devices: Norfolk Medical Vascular Access Port (K830000), PHS C-Port (K091099), Angiodynamics Vortex VX Port Implantable Infusion Port (K081472), and Bard PowerPort Implanted Titanium Port Chronoflex with 8 Fr. Catheter (K060812).

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical medical implant, not an AI algorithm, so there is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative development, prototyping, and testing, but not a formal "training set" for an algorithm.

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. The design specifications and performance objectives are established through engineering design processes, regulatory requirements, and historical data from similar devices.

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