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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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The NMI Intravascular Catheter (IC) is indicated for short or long-term vascular access (including peripheral) 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 IC has an open ended lumen with proximally located luer lock adapters(s), extension tube(s) with clamp(s) and suture wing for catheter securement; available in single and multi-lumen with burnif(s) and the reverse tapered shaft to aid in staunching bleeding at the insertion site. The comingulations, when a revelod with depth indicators along its length. The lumens are differentiated by proximally located colored clamps and luer adapter(s) marked with lumen size. Maximum power injection flow rates are indicated on the clamp(s). The proposed NMI IC will be offered in kits with other legally marketed products.

The provided document is a 510(k) premarket notification for a medical device (NMI Intravascular Catheter). It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and providing detailed study results for a new device's performance.

Therefore, the document does not contain the information requested to describe acceptance criteria and the study that proves the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods for a test set.
• Information on MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Details on ground truth for test and training sets, or training set sample size.

The performance data section (H) only lists the FDA guidance documents and international standards that the NMI IC was assessed in accordance with, such as:

• EN ISO 10555-1:1996, AMD 1: 1999, AMD 2: 2004, Sterile, Single use intravascular catheters - Part 1: General Requirements
• EN ISO 10555-3:1997 COR 2002, Sterile, Single-Use Intravascular Catheters Part 3: Central Venous Catheters
• FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995"
• IEC 60601-2-34:2000-10 - Medical Electrical Equipment Part 2-34: Particular Requirements for Invasive Blood Pressure Monitoring Equipment
• AAMI TIR 9: 1992 - Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
• AAMI/ANSI/ISO 10993-1: 2003, Biological evaluation of medical devices Part 1: Evaluation and testing

These standards outline general requirements and testing methodologies for intravascular catheters and medical devices, but the document does not provide the specific acceptance criteria derived from these standards or the detailed results of the studies conducted to meet them. The conclusion states that the device is "substantially equivalent to the predicate devices" based on responses to FDA's 510(k) Decision Making Tree, implying that its performance is considered acceptable if it is comparable to already approved devices.

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