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Extension Sets are intended to be used with a vascular access device for direction, intermittent infusion, continuous infusion or aspiration. The Extension Sets may be used with power injector procedures to a maximum pressure of 200 kPa (2 bar).

The subject device, Extension sets are single use, sterile, non-pyrogenic, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. The device is to connect the infusion device through the luer lock connector to add length and provide clamping capacities, or added to an intravascular catheter hub as a conduit for flow to and from the catheter. It is available in various lengths and tube dimensions, and may be comprised of various generic components such as connectors, clamps, flow regulators, filters, check valves and needleless injection ports. It can be used for gravity infusion and pressure infusion with pressure up to a maximum of 200 kPa (2 bar).

The provided text is a 510(k) Summary for a medical device called "Extension Set." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and biocompatibility assessments, rather than presenting a performance study with acceptance criteria in the context of an AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance with AI) are not applicable to this document.

However, I can extract information related to the device's performance based on the non-clinical tests performed to ensure its safety and effectiveness.

Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests)

The document lists numerous non-clinical tests performed to demonstrate that the device meets its design input requirements and applicable standards. The "reported device performance" in this context refers to the affirmation that the device met the requirements of these tests. Specific quantitative acceptance criteria are generally not explicitly stated in this summary but are implied by adherence to the referenced standards and guidance documents (e.g., ISO, ASTM, FDA guidance).

Here's the relevant information based on your numbered questions, with explanations for why some information is not present:

1. A table of acceptance criteria and the reported device performance: See the table above. The acceptance criteria are implicitly defined by the referenced international standards (e.g., ISO 8536 series, ISO 80369-7, ASTM F838-20) and FDA guidance documents, which specify performance requirements (e.g., maximum leakage, tensile strength thresholds, bacterial retention rates). The "reported device performance" is a blanket statement that the device met the requirements of these standards for all tests performed.

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

   • Sample Size for Test Set: Not explicitly stated in the summary document. For medical device bench testing, sample sizes are typically determined by statistical methods for quality control or standard requirements, but these details are not provided here.
   • Data Provenance: The tests were conducted by MEDCAPTAIN LIFE SCIENCE CO., LTD. which is based in Shenzhen, Guangdong, China. The document does not specify if external labs were used or the specific origin of materials if different. Tests are non-clinical (bench tests).

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. This device is a physical medical device (Extension Set), not an AI diagnostic tool. Ground truth for its performance is established through adherence to engineering specifications and performance standards via bench testing, not through expert consensus on medical images or diagnoses.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (often of images) where there can be disagreement, typically in AI/diagnostic studies. Bench testing of a physical device is a direct measurement against defined specifications, not subject to subjective adjudication.

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. MRMC studies are specific to evaluating diagnostic systems, especially those involving AI and human readers. This document concerns a physical "Extension Set" device.

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

   • Not applicable. There is no algorithm or AI component in this medical device.

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

   • The "ground truth" for the device's performance is established by the specifications defined in international standards (e.g., ISO, ASTM) and FDA guidance documents. These standards dictate acceptable ranges for physical, chemical, and biological properties (e.g., acceptable leakage rate, minimum tensile strength, non-cytotoxicity). The device's performance is measured directly against these pre-defined, objective criteria.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable, as there is no training set.

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The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to patient through a cannula placed in the vein or artery.

The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory of an intravascular infusion device to connect a cannula placed in a vein or artery to infuse patients, including adults and pediatrics. The Needle Free Connector can be divided into two versions according to whether it has a protective cap or not. The Needle free connector with protective cap is composed of Body, Core, Polyester Shell or ABS Shell, and Protective Cap. The Needle free connector without protective cap is composed of Body, Core, Polyester Shell, or ABS Shell, or PC shell. The body is made from polycarbonate, the core made from silicone, the protective cap made from ABS. The PC shell of the device is clear with visible liquid pathway. The device is sterilized by EO gas and the sterilization process is validated. It is a luer activated device that eliminates the risk of needle-stick injuries and can be used for a maximum of 7 days following initial connection and 600 activations. It may be used with power injection procedure to a maximum pressure of 350psi.

This document is a 510(k) Pre-market Notification for a medical device called a "Needle Free Connector." It details the device's characteristics and compares them to a legally marketed predicate device to demonstrate substantial equivalence, rather than establishing acceptance criteria for an AI/ML powered device and proving those criteria were met through a study.

Therefore, the provided document does not contain the information required to answer the questions. The document describes the characteristics of a physical medical device (Needle Free Connector) and its substantial equivalence to a predicate device, focusing on mechanical, biological, and sterility performance rather than the performance of an AI/ML algorithm.

The questions in the prompt are specific to the study and acceptance criteria of an AI/ML-powered device, which is not what this FDA submission describes.

To reiterate which questions cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists characteristics and performance metrics, but these are for a physical connector, not an AI/ML device. There are no specific AI/ML acceptance criteria defined.
2. Sample sized used for the test set and the data provenance: Not applicable, as this is not an AI/ML study involving test sets of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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KardiFlexTM NC Coronary Dilatation Catheter is indicated for:
• balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

• · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
• · in-stent restenosis.
• · post-delivery expansion of balloon expandable coronary stents.

The KardiFlex™ NC Coronary Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 5.0mm and lengths from 6mm to 30mm. The balloon material is made of a minimally Nylon material and balloons have a rated burst pressure of 22 atmospheres. The minimally material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.

The KardiFlex™ NC Coronary Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-5.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube).

The KardiFlex™ NC Coronary Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.

This document describes the regulatory submission for the KardiFlex™ NC Coronary Dilatation Catheter (K202578). This is a physical device, not an AI/ML powered device, so many of the requested fields are not applicable.

Here's a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "Pass test" for each specified performance test. The reported device performance for all listed tests is "Pass test," indicating that the device met these criteria.

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

The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "the subject device, KardiFlex™ NC Coronary Dilatation Catheter, was subjected to the following applicable testing." This implies that a sufficient number of device units (the "test set") were used for each test to demonstrate compliance with the relevant standards.

The data provenance is from bench testing and biocompatibility testing conducted by the manufacturer, Medcaptain Life Science Co., Ltd., based in Shenzhen, Guangdong, China. This is prospective testing, as it's performed on the device prototypes to demonstrate compliance before marketing.

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

This is not applicable as the evaluation involves physical device performance against established engineering and biological standards, not human interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed are objective, quantitative technical assessments (e.g., measuring burst pressure, inflation time, etc.) against pre-defined thresholds from regulatory standards (ISO, FDA guidance). There is no "adjudication method" in the sense of reconciling differing expert opinions.

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

This is not applicable. The KardiFlex™ NC Coronary Dilatation Catheter is a physical medical device (balloon catheter), not an AI/ML diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study with or without AI assistance is not relevant.

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

This is not applicable. The device is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" used for these tests are the established performance specifications and safety requirements outlined in international standards (e.g., ISO 10993, ISO 10555) and FDA guidance documents. These are objective, quantifiable criteria that the device's physical properties and behavior must meet.

8. The Sample Size for the Training Set

This is not applicable. As a physical device, there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing process are refined through engineering development and quality control, not by training on a dataset.

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

This is not applicable as there is no "training set" for a physical device.

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KardiFlex™ PTCA Balloon Dilatation Catheter is indicated for:
-balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
-balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.

The KardiFlex™ PTCA Balloon Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 4.0mm and lengths from 6mm to 30mm. The balloon material is made of compliant material and balloons have a rated burst pressure of 16 atmospheres. The compliant material allows high pressure dilatation while maintaining precise control of the balloon diameter and length.
The KardiFlex™ PTCA Balloon Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-4.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube).
The KardiFlex "10 PTCA Balloon Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.

The acceptance criteria for the KardiFlex™ PTCA Balloon Dilatation Catheter are based on a comprehensive set of performance tests, as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010). These tests ensure the device's reliable design, performance, and suitability for its intended use.

Here's a breakdown of the acceptance criteria and reported device performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The reported device performance consistently states "Pass test" or "Performed, implied compliant" for all listed tests, indicating that the KardiFlex™ PTCA Balloon Dilatation Catheter met the specified acceptance criteria for each test according to the FDA guidance and ISO standards.

2. Sample Size for the Test Set and Data Provenance

The provided document details various bench tests and biocompatibility tests. It does not mention clinical trials with human subjects or a "test set" in the context of diagnostic performance (e.g., imaging studies). Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), number of experts, and adjudication methods are not applicable to the type of testing described in this 510(k) summary, which focuses on the physical and biological characteristics of the medical device itself.

The tests are laboratory-based and include:

• Biocompatibility Testing: Performed per ISO 10993-1: 2018 and FDA guidance.
• Bench Testing (Zero Time and Accelerated Aged): Performed per various ISO standards (e.g., ISO 10555-1, ISO 10555-4) and FDA guidance.

The provenance of this data is from the manufacturer's (Medcaptain Life Science Co., Ltd.) internal testing or contracted laboratories, as part of their submission to the FDA. The country of origin for the submitter is China.

3. Number of Experts and Qualifications for Ground Truth

Not applicable, as this is a medical device (catheter) and the "ground truth" refers to the physical and biological properties being tested against established engineering and biocompatibility standards, not diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. The tests are quantitative measurements and qualitative assessments against predefined pass/fail criteria according to international standards and FDA guidance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device (catheter) for interventional procedures, not a diagnostic AI algorithm that would typically undergo MRMC studies to compare human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. There is no AI algorithm being evaluated. The device performance relates to its physical and biological attributes.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on established international standards (ISO, USP, ANSI/AAMI) and FDA guidance documents for physical, mechanical, and biological properties of PTCA catheters. For example, balloon burst pressure is measured against a specified atmosphere (16 atm), and biocompatibility is assessed against the criteria outlined in ISO 10993. These are objective scientific and engineering benchmarks.

8. Sample Size for the Training Set

Not applicable. There is no AI algorithm to be trained.

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

Not applicable.

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Enteral feeding catheter is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route. The target population is adults and pediatrics.

The Enteral Feeding Catheter is composed of a feeding catheter and stylet and can be divided into Funnel type and Enfit type as per the structure of the feeding catheter. For Funnel type, the feeding catheter is composed of tip, body, Y connector. The Y connector has integrated protective cap and strap. For Enfit type, the feeding catheter is composed of tip, body, Y connector, protective cap, and strap. The feeding catheter is made of polyurethane tube with BNF-II-79 hydrophilic coating. The feeding catheter is available in sizes of 6Fr, 8Fr, 10Fr and lengths of 70cm, 100cm, 120cm and 140cm. The length is measured from the distal tip to the proximal hub. The distal end of the feeding catheter features a sideport and is a smooth rounded finish. The proximal end of the feeding catheter features a funnel Y connector that is made of polyurethane or Enfit Y connector that is made of polycarbonate. A stainless-steel stylet with a length corresponding to the feeding catheter is fit inside the feeding catheter. The subject device, Enteral Feeding Catheter, may be introduced directly when there is adequate peristalsis and no gastric outlet obstruction. Alternatively, the feeding catheter may be passed over a stylet. The feeding catheter is intended to be indwelling up to four weeks and is for single-use only.

The provided document is a 510(k) Premarket Notification from the FDA for an "Enteral Feeding Catheter." It is a regulatory submission for a medical device and describes the device, its intended use, and how it compares to a predicate device.

Crucially, this document does not contain the kind of information requested regarding AI device acceptance criteria, study performance, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies. The device discussed here is a physical medical device (a feeding tube), not an AI/ML-based diagnostic or therapeutic device. The "performance data" section refers to standard biocompatibility and bench testing for physical medical devices, not algorithm performance metrics.

Therefore, I cannot extract the requested information from this document because it is irrelevant to the type of device and study requested in the prompt.

The document discusses:

• Device: Enteral Feeding Catheter
• Intended Use: For intermittent or continuous tube feedings via nasogastric or nasoenteric route in adults and pediatrics.
• Predicate Device: Corpark Enteric Feeding Tube W/Guide Tip (K821906)
• Performance Data: Biocompatibility testing (e.g., cytotoxicity, implantation, sensitization) and Bench Testing (e.g., appearance, dimensions, tensile property, flow rate, sterility, shelf life validation) to demonstrate the physical and chemical properties of the feeding catheter.

No information regarding AI/ML efficacy or safety is present.

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