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Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult.

Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.

An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.

The provided document is a 510(k) Premarket Notification from Teleflex Incorporated to the FDA regarding their Rusch Endotracheal Tubes. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, this document does NOT describe a study that involves AI or machine learning, human readers, or image-based diagnostics. The "device" in question is an endotracheal tube, a physical medical device, not a software or AI-driven diagnostic tool.

Therefore, many of the requested criteria related to AI/ML model performance, such as sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.

The "acceptance criteria" and "device performance" in this context refer to the physical and biological characteristics of the endotracheal tube, verified through standard bench testing and biocompatibility assessments, rather than diagnostic accuracy or reader improvement.

Here's an attempt to fill in the relevant information based on the provided text, while clearly stating when information is Not Applicable (N/A) due to the nature of the device:

Acceptance Criteria and Device Performance Study for Rusch Endotracheal Tubes

This submission focuses on establishing substantial equivalence for physical medical devices (endotracheal tubes), not software or AI-driven diagnostic tools. Therefore, many standard AI/ML study components are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion of the described bench testing and biocompatibility assessments, demonstrating that the device performs as intended and is safe for its indicated use. The "reported device performance" is the successful fulfillment of these tests, confirming substantial equivalence to the predicate devices.

| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance (as implied by acceptance) |
|------------------------------|----------------------------------------------------------------+|--------------------------------------------------------|
| Physical Performance | Visual inspection | Acceptable |
| | Dimensional testing | Within specifications |
| | Bonding strength (main tube to side arm, inflation tube, connector) | Acceptable |
| | Tube curvature | Acceptable |
| | Cuff restrained burst | Acceptable |
| | Bevel angle | Acceptable |
| | Cuff inflation | Acceptable |
| | Kink resistance | Acceptable |
| | Cuff herniation | Acceptable |
| | Cuff diameter | Acceptable |
| | Tube collapse | Acceptable |
| | Tracheal seal testing | Acceptable |
| Biocompatibility | Cytotoxicity (ISO 10993) | Pass |
| | Sensitization (ISO 10993) | Pass |
| | Irritation (ISO 10993) | Pass |
| | Acute Systemic Toxicity (ISO 10993) | Pass |
| | Material Mediated Pyrogenicity (ISO 10993) | Pass |
| | Implantation (ISO 10993) | Pass |
| | Subacute Systemic Toxicity (ISO 10993) | Pass |
| | Genotoxicity (ISO 10993) | Pass |
| | Chemical Characterization (Exhaustive & Simulated Use) | Pass (Toxicological Risk Assessment Related to Extractables and Leachables) |
| | Particulates and VOC | Pass (Toxicological Risks Related to Inhalation of VOCs and Particulates) |

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of tubes) used for each bench test or biocompatibility test. It indicates that "testing performed verifies that the performance of the subject device is substantially equivalent." For biocompatibility, it states "Materials have been tested per ISO 10993-1" and lists the tests performed, implying standard sample sizes as per the ISO standard.
• Data Provenance: The data provenance is from internal testing conducted by Teleflex Medical, Inc. (the manufacturer). The type of data is physical testing and chemical/biological analysis of device materials. It is implicitly "prospective" in the sense that the testing was performed on newly manufactured devices for the purpose of this submission. Country of origin not specified, but likely where Teleflex manufactures or tests its products, or where the testing labs are located.

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

• Not Applicable (N/A): For a physical device like an endotracheal tube, "ground truth" is established through standardized engineering specifications, material science, and regulatory standards (e.g., ISO standards). It does not involve expert readers reviewing output in the same way an AI diagnostic tool would. The experts involved would be engineers, material scientists, and toxicologists conducting the testing and interpreting the results against established physical and biological acceptance criteria.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): As there is no human interpretation or subjective assessment of "ground truth" images or data points (as in an AI diagnostic study), there is no adjudication method in the context of multiple expert readers. Compliance is determined by objective measurements against predefined engineering and biological limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No: This is a physical medical device; an MRMC study is not relevant.

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

• Not Applicable (N/A): This submission is for a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Standardized Test Results: The "ground truth" for this medical device is based on established engineering specifications for physical characteristics (e.g., dimensions, bond strength, kink resistance, cuff performance) and adherence to recognized international standards for biocompatibility (ISO 10993 series). The device's performance is measured against these objective criteria rather than expert consensus on a diagnostic outcome.

8. The Sample Size for the Training Set

• Not Applicable (N/A): This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

• Not Applicable (N/A): As there is no training set, this question is not applicable.

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The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4 Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec.

The catheters will be packaged sterile in kits that will include components to facilitate insertion.

The provided text is a 510(k) summary for a medical device (Arrow® Pressure Injectable Midline Catheter) and does not describe acceptance criteria for an AI/ML powered device or a study proving that an AI/ML device meets said criteria. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility testing, and sterilization/packaging testing.

Therefore, most of the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this document.

However, I can extract the information that is present about the device's characteristics and the types of non-clinical tests performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria (e.g., "Pass if flow rate >= X mL/s") or specific reported performance values resulting from the tests. Instead, it indicates that "Non-clinical testing related to the device changes has been completed to support the substantial equivalence." This implies that the device met the internal and standard-based requirements for these tests to demonstrate equivalence, but the precise thresholds and results are not detailed.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical engineering and biological performance testing, not AI/ML model testing with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/ML models is not relevant here. The "ground truth" for these tests would be defined by the technical specifications of the standards (e.g., a specific pressure, flow rate, or biological response).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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.

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.): Not applicable to an AI/ML device. For this device, the "ground truth" for testing is established by recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) and internal company test methods, which define acceptable parameters for physical and chemical properties, functionality, and biocompatibility.

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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