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The NMI Port and NMI Port II with and without PASV Valve Technology are indicated for patients who require longterm access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. When used with a power injectable needle, the NMI Port II are indicated 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 NMI Port and NMI Port II with and without PASV Valve Technology are a subcutaneous implantable venous access device with one reservoir and is designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing silicone septum covering the reservoir. The NMI Port and NMI Port II are available in plastic or titanium single lumen and valved or nonvalved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue; whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) to identify the port as power injectable. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories. The NMI Port II catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.

This document is a 510(k) premarket notification for a medical device, specifically, the NMI Port and NMI Port II, which are subcutaneous implantable venous access devices. The purpose of this type of submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its clinical effectiveness in AI-assisted diagnosis.

Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, expert qualifications, ground truth establishment for training sets, etc.) is not applicable to this document. This document focuses on the physical and performance characteristics of an implantable medical device.

However, I can extract the acceptance criteria and performance data related to the device's physical and functional properties based on the provided text.

1. Table of acceptance criteria and the reported device performance:

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

• Power Injection and Burst Test: 3 lots of 15 each (45 total).
• Aspiration Strength - Open Ended Test: 3 lots of 75 each (225 total).
• Aspiration Strength - Closed Ended Test: 3 lots of 75 each (225 total).
• CT Ink Durability Test: 3 lots of 75 each (225 total).
• Port body height Test: 3 lots of 75 each (225 total).
• Port Body Break Strength Test: 3 lots of 75 each (225 total).

Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective clinical data. However, given this is an engineering and material performance test for a 510(k) submission, the "data" refers to physical measurements and tests conducted on manufactured device samples, not patient data. These are likely prospective tests conducted on new production lots.

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 document does not describe the use of human experts to establish "ground truth" for a test set in the context of diagnostic performance. The tests are engineering and material performance assessments, likely conducted by qualified testing personnel or automated equipment, following established international standards (EN ISO 10555-1:2013, EN ISO 10555-3:2013) and FDA guidance.

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

Not applicable. This is not a study involving human interpretation or adjudication of diagnostic images or clinical outcomes.

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 document is for an implantable medical device (infusion port), not an AI/ML diagnostic software.

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

Not applicable. This document is for an implantable medical device, not an AI algorithm.

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

The "ground truth" in this context refers to the defined physical and functional specifications and performance standards established for the device. These are objective measurements (e.g., burst pressure, freedom from leaks, physical dimensions, breaking force) and visual inspections (e.g., no flaking/chipping of ink). The "truth" is determined by whether the device's performance meets these pre-established quantitative and qualitative acceptance criteria. It's based on engineering principles and regulatory standards.

8. The sample size for the training set:

Not applicable. There is no AI/ML model training discussed in this document.

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

Not applicable. There is no AI/ML model training discussed in this document.

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The NMI Port II with and without PASV Valve Technology is indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

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

The NMI Port II with and without PASV Valve Technology is a subcutaneous implantable venous access device with one reservoir and is designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing silicone septum covering the reservoir.

NMI Port II is available in plastic or titanium single lumen and valved or non-valved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue; whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) to identify the port as power injectable. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories.

The catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.

Here's an analysis of the acceptance criteria and study information for the NMI Port II, based on the provided text:

Acceptance Criteria and Device Performance for NMI Port II (K131694)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria for each performance test. Instead, it states that the device "successfully passed relevant testing per the above Guidance, standards, and pre-established acceptance criteria." The identified performance tests and the reported outcome are:

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

The 510(k) summary does not provide details on the sample sizes used for any of the performance tests (Internal Product Specification, Power Injection, Valve Integrity, etc.).
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for these tests. Based on the context of a 510(k) submission, these tests would typically be conducted by the manufacturer in a controlled laboratory setting (i.e., prospective engineering and bench testing) rather than involving human subject data from a specific country.

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

The disclosed information does not involve a "test set" in the context of expert-reviewed data (e.g., medical images). The "tests" mentioned are primarily engineering and bench performance evaluations of the device itself. Therefore, the concept of "experts used to establish ground truth" with specific qualifications like radiologists with years of experience is not applicable to the studies described. The ground truth for these engineering tests would be established by the physical and chemical properties of the device and its interaction with test fluids and equipment, according to established industry standards and internal specifications.

4. Adjudication Method for the Test Set

Since the studies described are engineering and bench tests rather than studies involving expert review of data, the concept of an "adjudication method" (like 2+1 or 3+1) is not applicable. The outcome of these tests would be determined by whether the device met the pre-defined engineering specifications and performance metrics.

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 provided document describes bench and engineering tests, not studies involving human readers or comparative effectiveness of AI (or any other technology) with or without human assistance.

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

This question is not applicable as the device is a physical medical device (an implanted port catheter), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to evaluate.

7. The Type of Ground Truth Used

For the performance tests mentioned, the "ground truth" would be established by:

• Engineering Specifications: Internal product specification requirements.
• International Standards: The pass/fail criteria defined within EN ISO 10555-1, EN ISO 10555-3, and ISO 10993-1.
• Regulatory Guidance: The requirements outlined in FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports."
• Bench Test Results: Measurable outcomes from laboratory tests (e.g., pressure resistance during power injection, flow rates, material compatibility, integrity assessments).

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This question is not applicable as there is no training set for a physical medical device.

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The NMI Ports with and without PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics. nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

When used with a power injectable needle, the NMI Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

The NMI Ports are subcutaneous implantable venous access devices with one reservoir and are designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing, silicone septum covering the reservoir.

NMI Ports are available in plastic or titanium single lumen and valved or non-valved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue: whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) as a power injectable port. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories.

The provided text is a 510(k) summary for the NMI Port, an implanted infusion port. As such, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's diagnostic performance or comparative effectiveness against human readers.

Therefore, the information requested in your prompt regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance, and AI-related metrics is not available in the provided document. The device in question is a medical hardware component, not an AI-powered diagnostic tool.

However, I can extract the information related to the performance data and "acceptance criteria" (in this context, meaning successful completion of specified tests for product safety and functionality) as described in the 510(k) submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document refers to "relevant testing" without detailing the number of units tested for each criterion.
• Data Provenance: The tests were conducted according to FDA guidance documents and international standards. The document doesn't specify countries of origin for test data, but typically such testing is performed in accredited labs, often within the manufacturer's region (Marlborough, MA, USA for the sponsor). The nature of these tests (e.g., power injection, valve integrity) suggests laboratory-based, prospective testing of manufactured devices.

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 study involves physical device testing against engineering and biocompatibility standards, not the establishment of ground truth from expert clinical interpretation.

4. Adjudication method for the test set:

• This is not applicable for the type of performance testing described. Adjudication methods are typically relevant for human interpretation of medical images or clinical data.

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. This is an implanted medical device, not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

• Not applicable. This is not an algorithm, but a physical medical device. The "standalone" performance refers to the device's operational characteristics as tested (e.g., flow rates, septum integrity).

7. The type of ground truth used:

• The "ground truth" for this type of device testing consists of established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and performance limits defined by the guidance documents mentioned (e.g., maximum infusion rates, pressure limits). The device either met these predefined, objective criteria or it did not.

8. The sample size for the training set:

• Not applicable. There is no AI model or algorithm being trained described in this document.

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

• Not applicable, as there is no training set for an AI model.

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