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The PowerPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. The maximum infusion flow rate is 5mL/second for power injection of contral venous pressure monitoring, it is recommended that a catheter lumen of 20gauge or larger be used.

A family of peripherally inserted central catheters made from specially formulated and processed medical grade materials. Each PowerPICC® catheter has a kink resistant, reverse tapered design. Catheters are packaged in a tray with accessories for reliable long (greater than 30 days) or short (less than 30 days) term vascular access.

The provided document is a 510(k) summary for the PowerPICC Catheter. It focuses on demonstrating substantial equivalence to a predicate device through various performance tests, rather than providing details of a study with acceptance criteria for an AI/ML powered device. Therefore, much of the requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the listed tests, indicating that the device performed as expected under the specified conditions. The document states that the performance tests were conducted "in determining substantial equivalence" and that "the subject PowerPICC Family Catheters have been demonstrated to be substantially equivalent to the cited predicate and reference devices." This implies that the device met the acceptance criteria derived from these tests.

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for each test. It refers to "testing" in general. The data provenance is not mentioned, as these are in vitro and in vivo performance tests on the device itself, rather than studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are physical and biological performance tests, not clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is for physical and biological performance testing, not interpretation of data by experts.

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/ML device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for these tests are the established scientific and engineering principles, material properties, and regulatory standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F640-12, ISO 10555-3, FDA Guidance on Premarket Notification for Intravascular Catheters, ISO 80369-7, USP 788). The device's performance is measured against these defined benchmarks.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

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The PowerMidline™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The PowerMidline™ Catheters are suitable for use with power injectors.

Bard Access Systems, Inc.'s (BAS) PowerMidline™ catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each PowerMidline™ catheter is designed with kink-resistant, reverse taper design. The PowerMidline™ catheters are offered in a 3 F Single Lumen (SL) and 4 F Single Lumen (SL) configuration for reliable short term (less than 30 days) vascular access. These catheters are offered in 20 cm trimmable lengths. The PowerMidline™ catheters are suitable for use with power injectors.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study that proves the device meets them.

Specifically, the text does not directly state:

• A table of acceptance criteria and the reported device performance: While it lists performance tests, it does not provide the specific quantitative acceptance criteria or the results achieved.
• Sample sized used for the test set and the data provenance: The document mentions performance tests were completed but does not specify the sample sizes used for these tests or the origin of any data (e.g., country, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present as the studies described are primarily engineering performance tests of the catheter itself, not clinical studies involving expert evaluation of outcomes or data.
• Adjudication method: Not applicable to the type of performance tests described.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: The document does not describe any MRMC studies.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
• The type of ground truth used: For the performance tests, the "ground truth" would be established by the test specifications and standards themselves (e.g., ISO, ASTM standards, BAS internal protocols), but not in the sense of clinical ground truth like pathology or expert consensus.
• The sample size for the training set: Not applicable, as this is a physical medical device.
• How the ground truth for the training set was established: Not applicable, as this is a physical medical device.

What the document does provide regarding performance:

The document states that "The subject device met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared to the cited predicate and reference devices."

It lists the following Performance Tests that were completed on the subject device, along with the standards utilized:

• Device Dimensional Characterization
• Catheter Assembly Tensile (ISO 10555-1: 2013)
• Catheter Assembly Leak
• Burst Pressure Without Power Injection
• Burst Pressure Post Power Injection Gravity Flow (ISO 10555-1: 2013)
• Tensile, Modulus and Elongation Requirements (FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995)
• Priming Volume (FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995)
• Catheter Radiopacity (BAS Internal Protocols/Procedures, ASTM F640-79 (reapproved 2000))
• Power Injection Testing (ISO 10555-1: 2013)
• Tip Displacement During Power Injection (BAS Internal Protocols/Procedures)
• Catheter Cyclic Kink (BAS Internal Protocols/Procedures)

Additionally, the following sterilization and biological tests were performed:

• Sterilant Residual Testing (ISO 10993-7: 2008)
• Cytotoxicity (ISO 10993-5: 2009)
• Sensitization/Irritation (ISO 10993-10: 2010)

The document concludes that the device met these criteria and demonstrated substantially equivalent performance to predicate and reference devices. However, the specific quantitative values for the acceptance criteria and the device's performance are not detailed in this summary.

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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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