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For nasogastric oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Nutrifit is a combined system of feeding tubes and extension sets. The feeding tubes are available in several configurations: Not made with DEHP PVC and Polyurethane (PUR). The PUR versions are available without stylet. All tubes include centimeter numerical markings from 5 to 35 cm for the 40, 50 and 75 cm feeding tubes and markings from 5 to 70 cm for the 90, 125 and 160 cm feeding tubes.

The Nutrifit devices are single-use, disposable devices intention in adults and children. Nutrifit PVC feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 5 days. Nutrifit PUR feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 29 days.

The Nutrifit accessories for this submission sets, which enable longer connections for the feeding tubes. They allow greater freedom of movement and greater flexibility and are available with or without a pinch clamp.

Nutrift is ENFit compliant, meeting requirements for design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories as detailed in ISO 80369-3.

The provided text is a 510(k) summary for the Vygon USA Nutrifit device, a gastrointestinal tube and accessories. It asserts the device's substantial equivalence to a predicate device (Nutrisafe 2) based on non-clinical performance bench testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set for any of the bench tests mentioned. It states "Adequate non-clinical performance bench testing was conducted" and "The VYGON's Nutrifit device met all predetermined acceptance criteria."
The data provenance is from non-clinical performance bench testing conducted by Vygon; the country of origin is not explicitly stated but implied to be internal testing by the manufacturer. The data is prospective for this device's evaluation.

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

This information is not provided in the document. The tests performed are engineering/performance-based bench tests, not clinical evaluations requiring expert interpretation of ground truth in the traditional sense (e.g., medical image interpretation). The "ground truth" for these tests would be the established specifications and standards (e.g., ISO 80369-3).

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective, performance-based bench tests against defined specifications, not subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Bench Testing was conducted in order to support this submission." There is no mention of human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. The Nutrifit is a medical device (tubing and accessories), not an AI algorithm or software. The testing focuses on its physical performance and safety characteristics.

7. The Type of Ground Truth Used

The ground truth used for the performance testing cited is based on established engineering specifications, international standards (ISO 80369-3), and FDA guidance protocols (e.g., "Gravity Flow Rate Testing in Enteral Tube"). This falls under objective technical standards rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable as the Nutrifit device is a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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Leaderflex mini and Leaderflex nano are indicated for:
•Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure, or
· Arterial catheterization

Leaderflex Mini and Leaderflex Nano are a radiopaque biostable polyurethane catheters suitable for peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure. Leaderflex Mini and Leaderflex Nano catheters are inserted via Seldinger technique, same as the predicate device. The Leaderflex mini and Leaderflex nano catheters are intended to be used by clinicians such as nurses at in- and out-patient locations. The primary requirement for environment of use is to ensure the environment is appropriate for supporting aseptic technique. These catheters are typically inserted into a peripheral vein on the forearm or leg, with the catheter tip located below the axilla of the arm or below the groin of the leg; however, the catheter is not limited to these anatomical placement locations. This is the same environment of use and anatomical location as the predicate device.
The subject Leaderflex Mini and Leaderflex Nano devices are accompanied by compatible accessories necessary to perform the Seldinger technique; these include: an introducer needle, guidewire, and guidewire insertion aid. The predicate Leaderflex device (K141026) is currently available in 22G configurations with usable lengths of 4cm, 6cm, 8cm and 20cm. The subject device will extend the device configurations to include 24G (Leaderflex Mini) and 26G catheters (Leaderflex Nano) with usable lengths of 2cm, 3cm, and 4cm and will add introducer needle and guidewires.
The subject device also introduces a new guidewire insertion aid for all gauge sizes. The overall device description of the subject and predicate Leaderflex models is the same.

Here's a breakdown of the acceptance criteria and study information for the Leaderflex Mini and Leaderflex Nano devices, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Leaderflex K141026) rather than defining explicit "acceptance criteria" as pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, accuracy). Instead, the acceptance criteria are implicitly met by demonstrating that the new devices (Leaderflex Mini and Nano) are as safe and effective as the predicate device, despite minor design changes. This is primarily shown through adherence to recognized standards and bench testing.

The "reported device performance" is described through the comparison of technological characteristics and compliance with various international standards for medical devices.

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

This submission is for a medical device (intravascular catheter) which primarily relies on non-clinical (bench) testing and comparison to a predicate device for demonstrating substantial equivalence. It does not involve a "test set" in the context of an AI/algorithm-driven device with a dataset of patient cases.

• Sample Size for Test Set: Not applicable in the context of a dataset of patient cases. Performance testing was conducted on samples of the physical devices.
• Data Provenance: The data provenance for non-clinical testing refers to the standards (e.g., ISO, AAMI, ASTM) that govern the methodologies. The document does not specify a country of origin for the test data, as it's typically bench testing performed by the manufacturer or accredited labs. The testing is prospective in the sense that the tests were performed on the new device designs to demonstrate compliance, but not in the clinical trial sense.

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

Not applicable. This is a physical medical device, not an AI/software device requiring expert-labeled ground truth for a test set of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There's no "ground truth" to adjudicate in the typical sense of a diagnostic software. Device compliance is determined by meeting the specified requirements of the various ISO and ASTM standards.

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 an intravascular catheter; it is 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 not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by the requirements of recognized international and national standards (e.g., ISO 10555-1 for intravascular catheters, ISO 10993-1 for biocompatibility). Device performance is measured against these established engineering and biological criteria through bench testing.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no training set as would be used for machine learning.

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

Not applicable. There is no training set.

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

The Vygon Midline Catheters are EO sterilized, single-use, polyurethane, reverse taper, short-term, peripheral venous system access catheters. They include materials containing barium sulfate for radiopacity.

The provided text is a 510(k) Summary for the Vygon Midline Catheters. It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI/Machine Learning device.

Therefore, I cannot extract information regarding:

• Sample sizes for test or training sets
• Data provenance (country of origin, retrospective/prospective)
• Number of experts or their qualifications for ground truth establishment
• Adjudication methods
• MRMC comparative effectiveness studies or effect sizes
• Standalone algorithm performance
• Type of ground truth (expert consensus, pathology, outcomes)
• How ground truth for the training set was established

The document explicitly states under "Clinical Testing": "No Clinical Testing was performed." This further confirms that the type of study you are asking about (related to AI performance, human reader improvement, and ground truth establishment) was not conducted for this medical device.

The study described is primarily bench testing and biocompatibility testing to demonstrate that the Vygon Midline Catheters are substantially equivalent to a previously cleared predicate device.

Here's the relevant information that can be extracted, pertaining to acceptance criteria and performance for this non-AI medical device:

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

The document lists various bench tests and biocompatibility tests along with their results. The "Acceptance Criteria" are implied by the "Result" column consistently stating "Passed" or specific equivalent findings.

Table of Acceptance Criteria (Implied) and Reported Device Performance

2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes (number of devices tested) for each bench or biocompatibility test, nor does it specify data provenance as this is not a study involving human data or image data as typically seen with AI devices. The testing is laboratory-based "bench testing" of the physical devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a physical medical device clearance, not an AI/ML device where expert ground truth is established. Performance is determined by standardized laboratory tests adhering to ISO standards and internal requirements.

4. Adjudication method
Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, this type of study was not performed. The document explicitly states "No Clinical Testing was performed."

6. 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.

7. The type of ground truth used
Not applicable for the reasons stated above. The "ground truth" for this device's performance is compliance with international and national standards for medical devices (e.g., ISO, ASTM, FDA guidance) and internal requirements, demonstrated through bench and biocompatibility testing.

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

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 catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/section of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The Vygon PICCs are sterile, single-use, polyurethane PICCs with the same intended use, indications for use, similar design, similar sizes, similar or the same materials, and similar properties as the predicate device.

The provided document details the Vygon PICCs device, its intended use, and substantial equivalence to a predicate device, focusing on various performance and safety tests. However, the document does not describe an algorithm or AI-driven device, nor does it present acceptance criteria and performance data in the context of such a device.

Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission, as it pertains to a physical medical device (Vygon PICCs) and not a software or AI-based diagnostic/screening tool.

The document primarily focuses on bench testing, sterilization testing, and biocompatibility testing to demonstrate that the Vygon PICCs are substantially equivalent to the predicate device (5 Fr DL PowerPICC® Catheter).

Here's an attempt to extract the relevant information based on the provided document, addressing the prompt's categories where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like a PICC, the "acceptance criteria" are typically the satisfactory completion of standardized tests and meeting the requirements outlined in those standards. The "reported device performance" is whether the device "Passed" each test.

2. Sample sized used for the test set and the data provenance:
For a physical device, "sample size" refers to the number of units tested. The document does not explicitly state the sample sizes for each bench, sterilization, or biocompatibility test. The data provenance is internal testing performed by Vygon USA (the submitter). The context implies these are prospective tests conducted on the final device. No country of origin for the data is specified beyond the submitter's location (Lansdale, PA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is subjected to standardized physical and chemical tests, not an assessment requiring expert "ground truth" derived from clinical cases or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or image interpretations. The tests performed are objective, pass/fail criteria based on adherence to international standards and internal requirements.

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-driven device or study.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device is compliance with established engineering and biological standards and specifications.

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

9. How the ground truth for the training set was established:
Not applicable. There is no training set.

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