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The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Groshong™ NXT Peripherally Inserted Central Catheters are made from specially formulated and processed medical grade materials in a tray with accessories for reliable long- (greater than 30 days) or short- (less than 30 days) term vascular access.

Groshong™ Valve Function

The Groshong™ catheter incorporates the patented, 3-position, pressure-sensitive Groshong™ valve. The valve is located near the rounded, closed, radiopaque catheter tip and allows fluid infusion and blood aspiration. When not in use, the valve restricts blood backflow and air embolism by remaining closed.

The Groshong™ valve is designed to remain closed between -7- and 80-mm Hg. Since the normal central venous pressure range in the superior vena cava is 0 to 5 mm Hg, the valve remains closed at normal central venous pressure. Pressure in the superior vena cava must exceed 80 mm Hg to open the valve inward. Also, negative pressure (vacuum) will cause the valve to open inward, allowing blood aspiration.

Positive pressure into the catheter (gravity, pump, syringe) will open the valve outward, allowing fluid infusion. The need for the anticoagulant effect of heparin is eliminated because the closed valve prevents blood from entering the catheter and clotting. If the catheter is aspirated, pulling the valve inward, it must be flushed with normal saline to clear blood from the lumen and allow the valve to return to its normal, closed position.

The provided text is a 510(k) summary for the Groshong™ NXT PICC Catheter. It outlines the device's characteristics, its similarities to a predicate device, and the testing performed to demonstrate substantial equivalence. However, it does not contain detailed acceptance criteria, specific reported device performance values, or information about a study proving the device meets these criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (also named Groshong™ NXT PICC Catheter, K034020), rather than establishing and meeting novel acceptance criteria for the new device and then detailing a study specifically proving the new device's performance against them. The premise is that because the new device is largely similar to the predicate and differences have been evaluated not to raise new safety/effectiveness concerns, its performance is considered substantially equivalent.

Therefore, many of the requested items cannot be extracted from this document, as it's designed for a different purpose (510(k) clearance based on substantial equivalence) than a detailed clinical or performance study report.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided directly from the text. The document lists performance tests and reference standards (e.g., ISO 10555-1, ASTM F640), but it does not specify quantitative acceptance criteria or the reported performance values for the "subject device" against these criteria. It only states that the tests were "conducted per guidance documents, industry standards, and in-house protocols to establish the performance of the device, thereby leading to a conclusion of substantial equivalence."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document mentions "Verification and validation tests" and "Performance tests for Subject Device," but does not specify sample sizes for these tests, the country of origin of the data, or whether the data was retrospective or prospective. These would typically be detailed in a separate test report, not the 510(k) summary.

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 / Cannot be provided. This type of information is relevant for studies involving expert review, such as image analysis for AI devices. The Groshong™ NXT PICC Catheter is an intravascular catheter, and the performance tests mentioned (e.g., biocompatibility, sterility, radiopacity) do not typically involve human expert interpretation in the way an AI diagnostic device would.

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

• Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in studies involving human interpretation or outcome assessment, not for the technical performance testing of a catheter.

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 device is a medical catheter, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a medical catheter, not an algorithm.

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

• Limited information. For the physical and material tests, the "ground truth" would be the established scientific principles and specifications defined by the referenced ISO and ASTM standards. For example, for biocompatibility, the ground truth is adherence to ISO 10993-1. For radiopacity, it's meeting the criteria of ASTM F640. There isn't "expert consensus" or "pathology" in the sense of a diagnostic outcome for this type of device performance testing.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set is involved.

Summary of what is available from the text:

The document describes the Groshong™ NXT PICC Catheter and states that its technological characteristics are substantially equivalent to a predicate device (K034020) with the same name. The key differences evaluated were:

• A change to the inner lumen geometry (from round to rectangular).
• A material and formulation change to the catheter silicone and catheter silicone colorant.

These differences were evaluated through risk assessment and performance tests. The document asserts these changes "do not raise new or different questions of safety or effectiveness."

Performance Tests Conducted (Verification / Validation Method and Reference Standards):

• Performance:
  • ISO 10555-1:2013/Amd 1:2017: Intravascular Catheters - Sterile and Single-Use Intravascular Catheters - Part 1: General Requirements
  • ISO 10555-3:2013: Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
  • ASMT F640-12: Standard Test Methods for Determining Radiopacity for Medical Use
  • ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
  • ASTM F2182: Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
  • ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
  • ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
• Biocompatibility Evaluations:
  • ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process
  • USP: Particulate Matters in Injections (method 1 Light Obscuration Particle Count Test)
• Sterilization:
  • ANSI AAMI ISO 11135:2014C: Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.

In conclusion, while the document confirms tests were done according to established standards to support substantial equivalence, it does not provide the detailed study information or quantitative acceptance criteria and results as typically found in a clinical study report for an AI device.

Ask a specific question about this device

The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term periphcral access to the central venous system for intravenous therapy or blood sampling.

The 4 Fr single lumen silicone Groshong® NXT PICC catheter is a 60 cm, trimmable catheter with depth markings. It has a closed, rounded, atraumatic, radiopaque distal tip with the 3-position, pressure-sensitive Groshong® valve.

It has a 2-piece connection with extension leg and lucr lock connector that is designed to be attached by the clinician after trimming the catheter tube to length. The connector has suture wings that are StatLockcompatible for stability.

The provided document describes the 510(k) summary for the 4 Fr Single Lumen Groshong® NXT PICC Catheter, which is a medical device. This type of device is subject to performance testing against established criteria to demonstrate substantial equivalence to a predicate device, rather than a clinical study measuring diagnostic performance of an AI algorithm.

Therefore, many of the requested categories in your prompt (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, and training set information) are not applicable to this type of device submission.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Testing was performed using the Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 included assessments of" a list of 12 tests, with an additional 9 non-guidance tests. The report indicates that "Performance data gathered in design verification testing demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC."

While the document lists the types of tests performed, it does not explicitly state specific quantitative acceptance criteria or the numerical results for each test. Instead, it concludes that the device "demonstrate[s] equivalence" and is "substantially equivalent" to the predicate device.

Regarding the other points in your request:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: This is a physical medical device. The "test set" refers to physical samples of the catheter that underwent various engineering and mechanical tests (e.g., tensile strength, flow rate). The sample sizes for these specific engineering tests are not provided in this 510(k) summary, nor is data provenance in terms of country of origin or retrospective/prospective.

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: "Ground truth" in the context of diagnostic algorithms and expert consensus is not relevant here. The "ground truth" for a physical device is established by validated engineering standards and test methods. Scientific methods exist for assessing the effects of new characteristics.

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

• Not Applicable: Adjudication methods are for human interpretation differences, typically in diagnostic studies. This is a physical device testing scenario applying established engineering principles.

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: An MRMC study is for evaluating diagnostic performance, often with AI. This document is for a physical medical device (catheter) and its inherent performance, not its use to assist human readers in diagnosis.

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

• Not Applicable: This is not an AI algorithm; it is a physical medical device.

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

• Not Applicable / Inherent: The "ground truth" for the device's performance is based on established engineering and material science principles, against which the physical properties of the catheter (e.g., burst pressure, flow rate, tensile strength) are measured and compared to predefined specifications or performance of a predicate device. The document explicitly states, "Do accepted scientific methods exist for assessing effects of the new characteristics? Yes. Design performance is in compliance with the FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/ 95."

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/machine learning device. The device is manufactured according to specifications, and samples from production are tested for quality control and performance verification.

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

• Not Applicable: No training set or associated ground truth in this context.

Ask a specific question about this device