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The METIC™ – Airway Balloon Catheter is comprised of a single lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A Luer at the proximal end is used for the placement of the stylet and injecting sterile water into the balloon.

AI/ML Overview

The document describes the acceptance criteria and performance of the METIC™ Airway Balloon Catheter, but it does not involve a study based on artificial intelligence or machine learning. Instead, it describes laboratory and bench testing for a physical medical device. Therefore, several sections of your requested output, which are relevant to AI/ML studies, cannot be extracted from this document, as they are not applicable.

Here's the information that can be extracted relevant to the physical device's performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristics	Acceptance Criteria (Specification)	Reported Device Performance
Balloon Length	24 mm and 40 ± 1mm	Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion.
Balloon Diameters	5.00, 7.00, 9.00, 10.00, 12.00, 14.00 & 16.00 mm ± 10% at balloon Nominal pressure	Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion.
Balloon Profile	5.0 X 24mm: 2.60 to 3.00 mm 7.0 X 24mm: 3.10 to 3.70 mm 10.0 X 40mm: 3.80 to 4.50 mm (Other sizes unspecified for profile)	Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion.
Catheter Usable Length	425 ± 10 mm	Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion.
Catheter Overall Length	450 ± 10 mm	Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion.
Balloon Burst Test	Actual Burst Pressure: 5.0 X 24mm: ≥ 22 ATM 7.0 X 24mm: ≥ 22 ATM 9.0 X 24mm: ≥ 22 ATM 10.0 X 40mm: ≥ 15 ATM 12.0 X 40mm: ≥ 15 ATM 14.0 X 40mm: ≥ 15 ATM 16.0 X 40mm: ≥ 15 ATM	"The safety and effectiveness of METIC™ – Airway Balloon Catheter has been evaluated for the following performance and safety requirements: - Visual Inspection - Dimensional Measurement - Balloon Burst and Balloon Compliance - Inflation and Deflation Time - Catheter Bond Strength - Flexibility and Kink - Torquability - Catheter Fatigue - Balloon Hub Measurement - Proximal Luer fitting - Balloon Preparation, Deployment and Retraction" The document then states in the conclusion: "The performance, biocompatibility, sterilization, packaging and shelf life study conducted on METIC™ – Airway Balloon Catheter demonstrated the device is as safe and as effective as the predicate device." Indicating these tests met the criteria.
Balloon Diameter @ Nominal Pressure	5.0 X 24mm: 10 ATM 7.0 X 24mm: 10 ATM 9.0 X 24mm: 10 ATM 10.0 X 40mm: 7 ATM 12.0 X 40mm: 7 ATM 14.0 X 40mm: 7 ATM 16.0 X 40mm: 7 ATM	(See above for general statement on performance evaluation and conclusion)
Balloon Fatigue Test	Catheter shall withstand 10 cycles minimum to Rated Burst Pressure Rated Burst Pressure: 5.0 X 24mm: 17 ATM 7.0 X 24mm: 17 ATM 9.0 X 24mm: 17 ATM 10.0 X 40mm: 10 ATM 12.0 X 40mm: 10 ATM 14.0 X 40mm: 10 ATM 16.0 X 40mm: 10 ATM	(See above for general statement on performance evaluation and conclusion)
Balloon Inflation Time	≤ 25 seconds	(See above for general statement on performance evaluation and conclusion)
Balloon Deflation Time	< 10 seconds	(See above for general statement on performance evaluation and conclusion)
Balloon Refoldability Test	Minimum 3 pleats should appear when looked from the tip after balloon inflation & Deflation up to 10 cycles at Nominal Pressure.	(See above for general statement on performance evaluation and conclusion)
Biocompatibility	Complies with ISO 10993	The document states: "Biological evaluation of Metic™ Airway Balloon Catheter as per Use of International Standard ISO 10993-1..." and the conclusion states "biocompatibility...demonstrated the device is as safe and as effective as the predicate device."
Sterilization	Sterilized by Ethylene Oxide, SAL = 10^-6, EO residuals < 4mg/device, Ethylene Chlorhydrin < 9mg/device	The document states: "Metic™ Airway Balloon Catheter is sterilized by traditional Ethylene Oxide sterilization methods... The Ethylene Oxide sterilization process is validated as per ANSI /AAMI/ ISO 11135-1...SAL = 10^-6", and lists the residual levels. The conclusion states "sterilization...demonstrated the device is as safe and as effective as the predicate device."
Shelf-life	Proposed shelf life of 5 years (supported by accelerated and 2-year real-time study)	"The real time shelf time study for 2 years has been completed. The result of elevated temperature and real-time study has not shown any significant changes in product characteristics." The conclusion states "shelf life study...demonstrated the device is as safe and as effective as the predicate device."

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

The document does not specify exact sample sizes for each mechanical or physical test (e.g., how many balloons were tested for burst pressure). It generally states that "the Guidance for industry & FDA staff class II special control guidance document for certain Percutaneous Transluminal coronary angioplasty (PTCA) catheters, September 8, 2010 was used for test methodology and sampling." This implies that industry-standard sampling methods for medical devices were followed.

Data Provenance: The testing was performed by M/s. Meril Life Sciences Private Limited, located in Vapi, Gujarat, India. This is retrospective data from internal testing of the manufactured device.

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

This question is applicable to studies where human expert judgment is used to label data for an AI/ML system. Since this document describes the testing of a physical medical device (a balloon catheter), not an AI/ML system, this information is not applicable. Ground truth for the device's performance is established by metrological measurements, physical and mechanical tests, and compliance with material and biological standards, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This question is applicable to studies involving human reviewers or evaluators, often in AI/ML performance assessment. Since this document is about the physical testing of a medical device, this information is not applicable. Device performance is measured against predefined specifications and 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

This question is specifically for AI/ML studies assessing changes in human performance with AI assistance. This document describes the physical testing of a medical device, not an AI/ML system. Therefore, this information is not applicable. The device's safety and effectiveness were established through bench testing and comparison to predicate devices, not through a clinical study involving human readers or AI.

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

This question refers to the performance of an AI algorithm without human interaction. Since this document is about the physical testing of a medical device, this information is not applicable. The device itself is a physical tool, not an algorithm.

7. The Type of Ground Truth Used

For the physical device, the "ground truth" for its performance is established by:

Direct measurements: Dimensional measurements, inflation/deflation times.
Physical and mechanical tests: Balloon burst pressure, fatigue resistance, bond strength, flexibility, kink resistance, torquability.
Chemical and biological tests: Biocompatibility (cytotoxicity, irritation, sensitization), ethylene oxide residuals.
Compliance with established standards: ISO and AAMI standards for manufacturing, sterilization, and biocompatibility.

There is no "expert consensus," "pathology," or "outcomes data" specifically used as ground truth for these engineering performance tests.

8. The Sample Size for the Training Set

This question is applicable to AI/ML studies. Since this document describes the physical testing of a medical device, this information is not applicable. There is no "training set" in the context of this device's development and testing.

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

This question is applicable to AI/ML studies. Since this document describes the physical testing of a medical device, this information is not applicable. There is no "training set" or "ground truth for a training set" in the context of this device's development and testing.

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