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The NMI PICC II and NMI PICCIV are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft.

This document describes a 510(k) premarket notification for the NMI PICC III and NMI PICC IV devices. It focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study proving device meets acceptance criteria through performance. As such, information regarding a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement is not available in the provided text.

Specifically, the document states:

• "The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft."
• "Biocompatibility testing per ISO 10993-1 demonstrates that the new ink on the proposed device does not affect safety and/or effectiveness."
• "The NMI PICC III and NMI PICC IV are substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests..."

Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating device performance as would be found in a clinical trial or performance study report. The provided text outlines a regulatory submission demonstrating equivalence based on non-clinical testing and similar technological characteristics.

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The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III is a Peripherally Inserted Central Catheter (PICC). It is available in single and multi-lumen configurations in a wide range of sized from 4F to 6F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and maximum power injection flow rate up to 5 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience and demonstrates resistance to blood components (platelet and thrombus) accumulation.

The provided document describes a 510(k) premarket notification for the NMI PICC III device, which is a peripherally inserted central catheter. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study to meet specific acceptance criteria in the context of an AI/ML device. Therefore, many of the requested categories related to AI/ML device performance studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable to this type of regulatory submission.

However, I can extract the information related to the device's technical specifications and the non-clinical tests performed to support its equivalence.

Here's a summary based on the provided text, with "N/A" for sections not applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for an AI/ML device. Instead, it lists technical specifications and performance characteristics that the device is stated to meet, largely by demonstrating equivalence to a predicate device through non-clinical testing.

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

N/A. This is a non-clinical testing submission for a physical medical device, not an AI/ML diagnostic system with a "test set" of data in the common AI/ML sense. The testing involved physical device samples (implicitly, as part of standard medical device testing, but specific numbers are not given). The tests were conducted according to international standards and FDA guidance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth in this context refers to engineering specifications and performance characteristics tested against established standards, not diagnostic data adjudicated by experts.

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

N/A. Not applicable to engineering tests of a physical device.

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

N/A. This is a 510(k) for a physical medical device, not an AI-assisted diagnostic system.

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

N/A. Not applicable to a physical medical device.

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

The "ground truth" for this device's performance is based on engineering specifications, established international standards (EN ISO 10555-1, EN ISO 10555-3), and FDA guidance documents. Performance attributes like flow rates, pressure ratings, and material resistance are measured against these objective criteria.

8. The sample size for the training set

N/A. There is no AI/ML "training set" for this physical medical device.

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

N/A. Not applicable.

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The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The NMI HPICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring.

The proposed device has identical materials, design, components and technological characteristics as the predicate intravascular catheters.

Both the proposed and predicate devices are, in brief,

• . intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling and power injection of contrast media,
• available in single and multi-lumen configurations in a wide range of sized from 3 to 6 . FR outside catheter diameter,
• . rated for maximum power injector settings up to 325 psi,
• rated for maximum power injection flow rate up to 6 ml/second based on model, .
• available kitted with a range of procedural accessories for user convenience; and .
• demonstrative of enhanced resistance to blood component (platelet and thrombus) . accumulation.

The provided text describes a 510(k) summary for medical devices (PICC lines) and focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from the provided document.

Here's an analysis based on the information available:

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

The document does not explicitly state "acceptance criteria" in the traditional sense for a new software or AI/ML device performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily described by the predicate device's characteristics and the non-clinical tests confirming the similarity of the new device.

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

• Sample Size: Not applicable in the context of human data validation or an AI/ML model test set. The "testing" referred to is non-clinical bench testing (biocompatibility, mechanical properties) of the physical device.
• Data Provenance: Not applicable. The "study" is a non-clinical evaluation of the physical device's characteristics and materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of human experts establishing ground truth for a test set in this document, as it pertains to a physical medical device.

4. Adjudication method for the test set:

Not applicable. There is no test set or human adjudication described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This document describes the substantial equivalence of a physical medical device (PICC lines), not an AI/ML system.

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

Not applicable. This is not an algorithm or AI/ML device.

7. The type of ground truth used:

Not applicable. The "ground truth" for this medical device's performance is based on established engineering principles, material science, and performance standards for intravascular catheters, as demonstrated through non-clinical testing.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood and for power injection of contrast media.

The NMI PICC III are flexible radiopaque catheters with suture wing for catheter securement, extension tubes(s) which connect to proximally located luer lock adapter(s) with and without a pressure activated safety valve (PASV), available in single lumen and multi-lumen configurations and a reverse tapered shaft to aid in staunching bleeding at the insertion site.

The lumens are differentiated by proximally located colored extension tube clamps and/or colored luer adaptors, which identify lumen size, if the lumen is rated for power injection the maximum power injection flow rates, and "NO CT" for non-power injectable lumens.

All NMI PICC III models have been designed with the option of being used with power injectors for the administration of contrast media for imaging studies such as Computerized Tomography (CT) scans and Magnetic Resonance Imaging (MRIs). Models with at least one non-valved lumen are also indicated for central venous pressure monitoring. All catheters are available packaged with a variety of procedural accessories as a convenience to suit specific clinician preference that meet of the PICC placement practice at their institution and in standard kit configurations.

Endexo technology has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Preclinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The acceptance criteria for the NMI PICC III device and the studies that demonstrate its performance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with relevant standards through various tests. The 'acceptance criteria' are implicitly defined by successful completion of these tests, which ensure the device meets specified functional and safety requirements. The reported device performance is generally qualitative (e.g., successful passed testing) rather than specific numerical metrics, with the exception of maximum power injection flow rates.

Acceptance Criteria (Implied by successful testing) & Reported Device Performance

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

• Test Set Sample Size: The document does not specify the exact sample sizes (number of devices or animal subjects) used for each individual test (e.g., Luer connection strength, power injection, in-vitro blood loop, in-vivo ovine study). It only states that the testing was "successfully passed."
• Data Provenance: The studies are described as preclinical ("in vitro and in vivo models") and conducted by the sponsor (Navilyst Medical, Inc.) to support the 510(k) submission. The in-vivo study used an "ovine model," indicating animal testing. The country of origin for the data is not specified beyond being generated by the sponsor for a US FDA submission. The studies are prospective in design for the purpose of evaluating the device's performance against pre-defined criteria.

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

• For the technical and performance tests (e.g., Luer connection, power injection, valve integrity, chemical compatibility), the "ground truth" is established by the specified engineering standards (ISO, FDA guidance) and internal product specifications. These usually involve objective measurements and calibrated equipment, rather than expert human interpretation.
• For the in-vitro and in-vivo thrombus reduction studies, the "ground truth" would be the measured thrombus accumulation. The document does not mention the involvement of external experts to establish this ground truth; it is assumed to be determined by the study investigators. No specific number or qualifications of experts are mentioned for establishing ground truth for any of the performance studies.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (like 2+1 or 3+1 consensus) for the test sets. The performance evaluation relies on objective measurements against established standards and internal specifications, along with direct quantitative or comparative outcomes from in-vitro and in-vivo studies.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a medical catheter, not an imaging AI diagnostic tool that would typically involve human readers interpreting images. The studies conducted are focused on the physical and biological performance of the catheter itself.

6. Standalone Performance Study (Algorithm Only)

Not applicable. The NMI PICC III is a physical medical device (catheter), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the loop performance)" does not apply.

7. Type of Ground Truth Used

The ground truth for the performance studies is based on:

• Objective Measurements: For tests like Luer connection strength, power injection flow rates, and central venous pressure monitoring capabilities, the ground truth is obtained through direct instrumental measurements.
• Compliance with Standards: Meeting the requirements of international standards (EN ISO 10555-1, EN ISO 10555-3, ISO 10993-1) and FDA guidance documents.
• In-vitro Quantifiable Data: For thrombus reduction, the ground truth is based on quantitative measurements of thrombus accumulation in in-vitro blood loop models.
• In-vivo Observational Data: For thromboresistance, the ground truth is derived from observations and measurements in an ovine animal model over specified indwelling times.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or artificial intelligence. The device's design and manufacturing processes are developed through engineering and material science principles, not through data-driven training sets.

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

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

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