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The AMSafe® NeuFloTM Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.

The provided text is a 510(k) summary for the AMSafe® NeuFlo™ Needleless Connector. This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the provided text does not describe a study involving an AI/Machine Learning device, nor does it detail a study that proves a device meets acceptance criteria in the context of AI/ML performance metrics like sensitivity, specificity, or reader studies.

Instead, it details the acceptance criteria and results for a physical medical device. The criteria are based on compliance with established ISO standards and other tests to confirm physical, chemical, and biological performance. The "performance" described refers to the functionality and safety of the needleless connector itself, not AI model performance.

Therefore, I cannot fulfill the request as it pertains to AI/Machine Learning evaluation criteria, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or training set ground truth establishment in the context of an AI/ML device.

The document speaks to the following for the physical medical device:

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

The document provides a table under "g) Summary of Non-clinical testing (Bench)" listing tests, methods, acceptance criteria, and conclusions (Pass/Fail).

For the other points (2-9), as explained, the document pertains to a physical medical device and its compliance with standards, not an AI/ML device performance study. Thus, no information is available regarding:

• Sample size used for the test set and data provenance (in an AI/ML context).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc. for an AI/ML model).
• Sample size for the training set.
• How the ground truth for the training set was established.

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The AMSafe® Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap.

This document describes the premarket notification (510(k)) for the AMSafe® Pre-Filled Normal Saline Flush Syringe. The information provided outlines the device's technical characteristics, intended use, and comparison to a legally marketed predicate device (K183473). The study performed is a non-clinical bench testing study, not an AI/ML-based clinical study, therefore, many of the requested elements for an AI/ML study (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are detailed in "Table 5-2" on page 6 of the document.

Additionally, shelf life was evaluated:

• Test: Shelf life
• Method: ASTM F1980-16
• Acceptance Criteria/Conclusion: Verify that the device will remain within specification during the prescribed shelf life when stored under labeled conditions. (Implied Pass, as per overall conclusion).

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

The document describes non-clinical bench testing of manufacturing characteristics and chemical composition, not an AI/ML-based study with a "test set" composed of patient data. Therefore, the concept of sample size for a test set (e.g., number of images, patient records) and data provenance (country of origin, retrospective/prospective) as typically understood for AI/ML studies are not applicable. The tests were performed on samples of the device itself. The specific number of units tested for each criterion is not provided, but it would typically be a predetermined number based on the statistical requirements of the specific test methods (e.g., ISO, ASTM, USP standards).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This was a bench study, not an AI/ML study requiring expert labeling of data. The "ground truth" for these tests are the established physical, chemical, and biological standards and methodologies outlined in the referenced ISO, ASTM, and USP documents.

4. Adjudication Method for the Test Set

Not Applicable. This was a bench study; there was no human-in-the-loop expert adjudication process as would be typical for AI/ML algorithm evaluation.

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

No, an MRMC study was not done. This is a review of a physical medical device (pre-filled syringe), not an AI/ML diagnostic or assistive tool where human reader performance would be a relevant metric.

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

Not Applicable. This document describes the performance of a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established industry standards and pharmacopeial specifications. This includes:

• Physical Properties: Standards like ISO7886-1, ISO80369-7, ASTM F2338-09.
• Chemical Composition: United States Pharmacopeia (USP) monographs such as USP<791>, USP<191>, USP6-466, USP6-471, USP<241>, USP<643>, USP<233>, USP<232>.
• Biocompatibility: ISO10993 series (ISO10993-11, ISO10993-10, ISO10993-5) and ASTM F756-17.
• Sterility Assurance: The mention of 10-6 SAL (Sterility Assurance Level) indicates adherence to established sterilization standards.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As there is no training set for a physical device, there is no ground truth establishment process in that context.

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The AMSafe® 0.9% Sodium Chloride Pre-Filled Normal Saline Flush Syringe, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

AMSafe® Pre-Filled Normal Saline Flush Syringe is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene cap. The device will be terminally sterilized by gamma radiation sterilization. The device will be marketed as a 12mL syringe with a 3mL, 5mL, or 10mL fill volume, and a 20mL syringe with 20mL fill volume. The products are in two different packages, one is poly blister package and the entire packaged device are gamma radiation sterilized for sterile delivery to a sterile field; another is PP wrapper as a dust cover for non-sterile field. The solution is sterile normal saline for injection and meets the requirements of USP<40>.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the AMSafe® Pre-Filled Normal Saline Flush Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of an AI-powered diagnostic device. Therefore, much of the requested information regarding acceptance criteria and study design for an AI device is not applicable to this document.

However, I can extract information related to the device's acceptance criteria for performance (bench testing) and the testing done to prove it meets those criteria.

Here's an attempt to answer your questions based only on the provided text, recognizing its limitations for an "AI-powered diagnostic device":

Device: AMSafe® Pre-Filled Normal Saline Flush Syringe

Type of Device: Prefilled plastic piston syringe with 0.9% sodium chloride for injection, USP, intended for flushing intravenous administration sets and indwelling intravenous access devices. This is a medical device, not an AI-powered diagnostic device.

Study Type: Non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. No clinical study with human subjects, AI assistance, or MRMC design was conducted.

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

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document describes "non-clinical testing" and lists various tests, each presumably with its own sample size of syringes or solution, but these specific sample sizes are not detailed in the provided text.
• Data Provenance: The tests are standard industry bench tests (e.g., ISO, USP, ASTM standards). The country of origin for the data is not explicitly stated within the context of the testing, but the company is Amsino International Inc., based in Pomona, CA, USA, suggesting testing likely occurred in or for a US regulatory submission. The data is from prospective bench testing, not retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This device is not an AI diagnostic, so there is no concept of "ground truth" derived from expert consensus of images/data in the way it applies to AI devices. The "ground truth" for the performance tests (e.g., pH, chemical content, sterility) is established by the specified reference standards (USP, ISO, ASTM) and the inherent measurable properties of the device and its contents. The results are objective, quantitative measurements following validated methods, not subjective interpretations by experts.

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

• Not applicable as this is not an AI diagnostic device requiring human expert adjudication of diagnostic outcomes. The results are objective measurements against pre-defined criteria.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a pre-filled saline syringe, not an AI-powered diagnostic. This type of study is irrelevant to its purpose and regulatory pathway.

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. The tests performed are standalone bench tests of the physical and chemical properties of the syringe and its contents.

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

• The "ground truth" for these tests is based on established scientific and engineering standards and methods (e.g., USP monographs for chemical purity and content, ISO standards for device properties, ASTM for packaging). It is a direct measurement against defined physical, chemical, and biological specifications, not a diagnostic ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device; therefore, there is no concept of a "training set."

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

• Not applicable. As there is no training set for this type of device, no ground truth needed to be established for it.

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The AMSafe® Sure-Lok™ Needle-Free Connector is an accessory to an Intra-vascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.

The AMSafe® Sure-Lok™ Needle-Free Connector is a Needle-Free connector intended for single patient use, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids used as an accessory to an Intravascular administration set without the use of a needle, thus eliminating the risk of needlestick injuries. The AMSafe® Sure-Lok™ Needle-Free Connector is a closed, Luer activated device that allows for negative fluid displacement. The AMSafe® Sure-Lok™ Needle-Free Connector individually packaged is supplied as a sterile, non-pyrogenic, single use, disposable device.

The provided text is a 510(k) Summary for the AMSafe® Sure-Lok™ Needle-Free Connector, a medical device. This document describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness in comparison to a predicate device.

Here's an analysis of the acceptance criteria and study information, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that "Bench testing of the proposed devices is performed," and tests were conducted according to various ISO and ASTM standards. However, the specific sample sizes used for each individual test or for a comprehensive "test set" are not mentioned. The document does not specify data provenance (country of origin) or if the data was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.

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

This section is not applicable as the described studies are bench tests (physical and chemical testing of the device) rather than clinical studies requiring expert interpretation or ground truth establishment based on clinical observations or diagnoses.

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as point 3. Bench testing adherence to standards usually relies on measurement and observation against pre-defined criteria, not expert adjudication of subjective findings.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing and biocompatibility assessments, not comparative effectiveness studies with human readers or clinical outcomes. The goal was to demonstrate substantial equivalence to a predicate device through engineering and biological testing.

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

This question is not applicable as the device is a physical medical connector, not an AI algorithm.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" is defined by the specific requirements and limits set forth in the referenced international standards (ISO, ASTM) and the manufacturer's own internal criteria. For example, for a leakage test, the ground truth is "no leakage" or leakage within a specified limit according to the standard. For biocompatibility tests, the ground truth is a lack of cytotoxic, sensitizing, or toxic effects as defined by the respective ISO standards.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

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

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Pre-filled Syringe for Balloon Inflation with Sterile Water is intended to be used in inflating foley catheter balloon.

The AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is a 3cc, 5cc, 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover. The shelf life of AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water is 3 years.

The provided document describes the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water, which is a pre-filled syringe intended for inflating foley catheter balloons. The document is a 510(k) Premarket Notification, which aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute safety and effectiveness through extensive clinical trials.

Therefore, the information regarding acceptance criteria and study details is presented in the context of demonstrating substantial equivalence rather than a detailed clinical effectiveness study of a novel AI device.

Here's the information as requested, based on the provided text:

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

The document states that the AMSure® Pre-filled Syringe for Balloon Inflation with Sterile Water underwent performance testing to establish substantial equivalence. It does not provide specific quantitative acceptance criteria or detailed performance metrics in the way a clinical study report for an AI device might. Instead, it refers to conformity with established standards.

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

The document does not specify the sample size used for the performance tests, nor does it provide details on the data provenance (country of origin, retrospective/prospective). The tests mentioned are laboratory/bench tests, not typically clinical studies involving patient data.

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)

This type of information is not applicable to this 510(k) submission. The "ground truth" for this device's evaluation is based on established engineering specifications, material science, and regulatory standards for medical devices, not expert human interpretation of medical data.

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

Not applicable. The evaluation relies on standardized test methods and conformity to norms, not on expert adjudication of medical findings.

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 pre-filled syringe, not an AI or diagnostic imaging device that would typically undergo an MRMC study.

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

Not applicable. This is a physical medical device, not a software algorithm.

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

The "ground truth" for evaluating this device's performance is based on established engineering specifications, material standards, and regulatory requirements (e.g., ISO, USP standards) for syringe functionality, sterility, and biocompatibility.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

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The AMSure® Enteral Feeding Syringe with ENFit Tip is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians in adults only.

The AMSure® Enteral Feeding Syringes with ENFit Tip are standard piston style syringes consisting of a syringe barrel with ENFit syringe nozzle, syringe plunger, syringe stopper and protective cap. The devices are made with polypropylene and polyisoprene rubber. The plunger can be linearly pulled and pushed along the inside wall of the barrel, allowing the syringe to take in and expel fluid through the nozzle at the front end of the barrel. The integral syringe nozzle has a female ENFit connector designed to be compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids. The Enteral Feeding Syringes with ENFit Tip have a capacity of 60mL for single-use. The devices are provided either sterilized by EtO or non-sterile.

The provided document is a 510(k) premarket notification for a medical device, specifically an "AMSure® Enteral Feeding Syringe with ENFit Tip." This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing studies and acceptance criteria for a novel AI/software device.

Therefore, the specific information requested, such as acceptance criteria table with reported device performance for an algorithm, sample sizes for test/training sets for an AI model, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training sets, are not applicable to this type of medical device submission.

The "studies" and "acceptance criteria" discussed in this document refer to traditional medical device testing, primarily non-clinical, to ensure the physical and biological safety and performance of the syringe itself.

However, I can extract the information that is present concerning the non-clinical testing performed on the AMSure® Enteral Feeding Syringe with ENFit Tip, which serves a similar purpose to demonstrating a device meets its intended performance.

Here's the relevant information based on the provided text, re-interpreting "acceptance criteria" and "study" in the context of a physical medical device submission:

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

The document lists various performance characteristics that were tested. For a 510(k) submission, "acceptance criteria" typically refers to established standards (e.g., ISO standards) or pre-defined thresholds that the device must meet to be considered safe and effective and substantially equivalent to its predicate. The document states a general conclusion that the device "passed all acceptance criteria" without specifying the exact numerical criteria or individual results for each test.

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

This information is not provided in the document for the non-clinical tests. Sample sizes for physical device testing typically refer to the number of physical devices subjected to each test. The provenance would be the manufacturing site (Amsino International Inc. in Pomona, CA). The tests are prospective in nature, as they are performed on new devices to demonstrate compliance.

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)

This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device requiring expert ground truth for image interpretation or similar tasks.

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

This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device requiring expert 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

This is not applicable as the device is a physical enteral feeding syringe, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a physical enteral feeding syringe, not an algorithm.

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

For manufacturing quality and performance testing of a physical device, the "ground truth" is typically defined by established engineering specifications, recognized national/international standards (e.g., ISO, ASTM), and regulatory guidance documents (e.g., FDA guidance). Device performance is measured against these objective criteria.

8. The sample size for the training set

This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device that requires a training set.

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

This is not applicable as the device is a physical enteral feeding syringe, not an AI/software device that requires a training set and associated ground truth.

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The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

The AMSINO® I.V. ADMINISTRATION EXTENSION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. The EXTENSION SET will provide a tubing extension to increase the length of an I.V. set or a syringe. The Extension Set consists of various parts such as: drip chamber, luer adapter/connectors, clamp, tubing, flow controller, Y-site, latex-free injection port, needleless injection port, stopcock, flashbulb, filter and manifold.

Based on the provided text, the device is the AMSINO® I.V. ADMINISTRATION SET AND EXTENSION SET. The document is a 510(k) summary demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets new acceptance criteria. The performance data presented refers to the predicate devices and the current device's compliance with established standards and internal testing.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a structured format. Instead, it refers to the predicate devices meeting "Bench performance testing requirement according to ISO 8536-4 when appropriate and/or AMSINO's testing and acceptance criteria." The listed "performance criteria" are general categories of tests.

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

The document does not specify the sample size used for the performance tests conducted for this submission or those referenced in the predicate devices. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The "Bench performance testing" implies laboratory testing rather than human clinical trials.

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

This information is not provided in the document. The performance data relates to engineering and biological testing, not diagnostic or interpretive tasks requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described does not involve tasks requiring 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

No such study was conducted or mentioned. This device is an I.V. administration set, not an AI-powered diagnostic or interpretive device.

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

Not applicable. This device is a medical device for fluid administration, not an algorithm. The performance testing described is for the physical device itself.

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

For the engineering performance tests (e.g., leakage, flow rate, tensile strength), the "ground truth" would be the measurable physical parameters according to the relevant ISO standards or internal AMSINO specifications. For biocompatibility, it's based on established biological safety testing protocols. For sterility, it's the absence of viable microorganisms according to validated sterilization processes.

8. The sample size for the training set

Not applicable. This device does not involve training data or machine learning algorithms.

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

Not applicable, as there is no training set for this device.

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AMSURE® 3-Way Hydrophilic Latex Foley Catheter is intended to be used for bladder/urinary tract drainage and bladder/urinary tract irrigation for urological use only.

The AMSURE® 3-WAY Hydrophilic Latex Foley Catheter is a retention type urological catheter made of silicone coated natural latex material modified with the addition of a lubricious/hydrophilic coating to facilitate insertion of the catheter. This device is a Latex tube with three lumens: one lumen for urinary drainage which is to be connected to a urine collecting container; one lumen with two-way valve for inflation/deflation of the foley balloon and one lumen for irrigation of the bladder/urinary tract. The 3-Way Hydrophilic Latex Foley Catheter is coated with a lubricious hydrophilic coating which becomes slippery when wet. On the opposing end of the shaft are a connecting funnel and a luer activated valve. This product is available in a combination of French sizes, balloon capacities and lengths to accommodate adult male and female applications. The device will be offered in French sizes from 14Fr to 26Fr, balloon size of 5 cc and 30cc, The device is disposable, sterile (Ethylene Oxide Sterilization) and for single use only.

The AMSURE® 3-WAY Hydrophilic Latex Foley Catheter was evaluated for substantial equivalence to predicate devices, and its performance was assessed through various tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not specify a distinct "test set" in the context of device performance data from human subjects or image analysis. Instead, the performance testing described is likely in vitro or bench testing. Therefore, information about sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The performance testing appears to be based on engineering and material standards, not expert subjective assessment of medical data.

4. Adjudication Method

Not applicable. The performance testing is based on objective measurements against engineering standards.

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

No. This type of study is typically done for diagnostic or screening devices involving human interpretation of medical images. This 510(k) pertains to a urological catheter, whose performance is evaluated through physical and material properties, not human interpretation.

6. Standalone Performance Study (Algorithm only)

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

7. Type of Ground Truth Used

The "ground truth" for the device's performance is established by engineering standards and material specifications, as well as equivalency to predicate devices. This includes:

• ASTM F-623-99 (Standard Specification for Foley Catheter)
• FDA's Guidance for Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters - February 27, 1997
• ISO 10993 (Biocompatibility)
• ISO 11135-1:2007 (Sterilization)
• The known performance and safety history of the predicate devices based on their materials and manufacturing processes.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models that require a "training set" of data.

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

Not applicable, as no training set is involved.

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The AMSINO® I.V. ADMINISTRATION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

The AMSINO® I.V. ADMINISTRATION SET is a single use, latex-free, Non-DEHP, gravity feed, sterile device sterilized with Ethylene Oxide Gas. It is used to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein. It is comprised of various components such as: bag, spike, drip chamber (vented and non-vented), Y-site, burette, tubing, flow controller, drip selector, clamp, check valve, latex-free injection site, needleless injection site, flashbulb, filter, manifold, stopcock, flash bulb, luer connectors and bag hanger.

This submission is an extension of the original approval (K973107) and covers the following AMSINO Product Line:

AMSINO® STANDARD I.V. ADMINISTRATION SET AMSafe® I.V. ADMINISTRATION SET (identical to the Amsino Standard I.V. Administration set, except it is marketed for Emergency Medical Services group/personnel)

AMSafe3® I.V. ADMINISTRATION SET (identical to AmSafe I.V. Administration Set, with the exception of the drip selector option.)

AMSINO offers both standard and custom sets with tubing of various sizes and lengths with a choice of 10, 15, 20 and 60 drops per ml to meet customer requirements and specifications. Customers may request I.V. Administration sets with varying configuration containing any combination of the parts per the table:

Tubing
Drip Chamber
Needleless injection site
Split Septum Injection Site
Bag Spike
Clamp
Flow Controller
Drip Selector
Filter
Rotating male luer lock
Male or Female luer lock
Check Valve
Bag Hanger
Y-site
stopcock
manifold

The provided document describes a Special 510(k) Premarket Notification for a modification to the AMSINO® I.V. ADMINISTRATION SET. This submission primarily focuses on demonstrating substantial equivalence to a previously cleared device (K973107) rather than a de novo device requiring extensive clinical studies to establish safety and effectiveness.

Therefore, the "study that proves the device meets the acceptance criteria" in the traditional sense of a human clinical trial is not applicable here. Instead, the submission relies on bench performance testing, biocompatibility, and sterilization validations to show that the modified device performs as intended and is as safe and effective as the predicate device.

Here's an analysis of the provided information based on your requested categories:

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

The document lists several performance criteria the device meets, primarily referencing ISO standards and/or AMSINO's internal testing criteria. However, specific quantitative acceptance criteria values and corresponding reported device performance values are generally not provided in this summary document. Instead, it makes statements of compliance.

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

The document does not explicitly state the sample sizes for the various bench tests, biocompatibility tests, or microbial ingress tests. It only states that these tests were conducted and the device "meets requirements" or "demonstrates a 4-log reduction." The data provenance is internal to Amsino International, Inc. (Pomona, CA, USA) and the testing would be considered prospective for the purpose of this submission, meaning the tests were conducted specifically to support this application.

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)

This section is not applicable to this type of device and submission. The "ground truth" for the performance criteria is established by recognized international standards (like ISO) and internal engineering/quality specifications, not expert consensus in the medical image interpretation sense. The experts involved would be the engineers and quality assurance personnel at Amsino International responsible for designing, testing, and validating the device and its manufacturing processes. Their qualifications are not detailed.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical data (e.g., images) by multiple readers. This is not applicable to the bench testing, biocompatibility, or sterilization validation performed for this I.V. administration set.

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 is not applicable. The device is an I.V. administration set, not an AI-powered diagnostic tool requiring human readability studies.

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.

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

The "ground truth" for this device's performance is based on established engineering and materials science principles, international standards (e.g., ISO 8536-4, ISO 10993-1, ISO 11135-1), and Amsino's internal product specifications. This would involve:

• Physical/Mechanical Properties: Measured values against predefined tolerance ranges.
• Biocompatibility: Laboratory test results (e.g., cell viability, irritation scores) compared against acceptable limits derived from ISO 10993.
• Sterility: Sterility assurance levels (SAL) achieved through validated processes per ISO 11135-1.
• Microbial Ingress: Measured reduction in microbial count against a defined log reduction target.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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The AMSure ™ PVC Intermittent Catheter is intended for use in the drainage of urine from the bladder.

The AMSure ™ PVC Intermittent Catheter is a sterile, single- use patient device, compromising a PVC tubing and funnel.

This document describes a Special 510(k) Submission for the AMSure™ PVC Intermittent Catheter. This type of submission is for modifications to a previously cleared device, asserting substantial equivalence to its predicate device. As such, the focus of the submission is on demonstrating that the modifications do not raise new questions of safety or effectiveness.

Therefore, the provided text does not contain information about:

• Acceptance criteria in the context of specific performance metrics for a novel device.
• A "study that proves the device meets the acceptance criteria" in terms of clinical performance or diagnostic accuracy.
• Sample sizes for test sets or training sets in the context of algorithm development.
• Data provenance, expert ground truth establishment, or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Instead, the document focuses on:

• Non-Clinical Testing: "Performance and biocompatibility testing has demonstrated the safety and effectiveness of the AMSure™ PVC Intermittent Catheter for its intended use." This is very general and does not provide specific criteria or results.
• Comparison to Predicate: "The AMSure™ PVC Intermittent Catheter is a configuration and label modification of the AMSure™ Urethral Catheterization Tray (K030712) and is intended for the same use." This implies that the device meets the same performance standards as the predicate device by virtue of being a minor modification.

Based on the provided text, the specific information requested in your prompt cannot be extracted because the submission is for a medical device (catheter), not an AI/software device, and thus the acceptance criteria and study designs are fundamentally different.

The document confirms that:

• Device Name: AMSure™ PVC Intermittent Catheter
• Intended Use: For use in the drainage of urine from the bladder.
• Predicate Device: AMSure™ Urethral Catheterization Tray (K030712)
• Changes: Configuration and label modification.
• Testing: Performance and biocompatibility testing was performed to demonstrate safety and effectiveness. (No specific details provided).

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