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Applicable to Product Code 2N3383: For the administration of blood components or solutions from a container into the patient's vascular system through a vascular access device.

Applicable to Product Code 2N3385: For the administration of blood components or solutions from a container into the patient's vascular system through a vasular access device. Only for use with Neonates and Pediatios. Not for use in Trauma situations.

Baxter's IV Administration Sets (Blood Administration Sets) are single use, nonpyrogenic, sterile disposable devices intended for the administration of fluids from a container into the patient's vascular system. They can be used to administer solutions, blood, and blood products to patients.

The proposed blood set configuration (Product Code 2N3385) consists of non-DEHP PVC (

The provided text describes a medical device, "Blood Administration Sets," and its substantial equivalence to a predicate device, but it does not contain information relevant to AI/ML device acceptance criteria or studies. The document is a 510(k) premarket notification for a traditional medical device (intravascular administration set), not an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML device from this document.

The document focuses on:

• Device Description: Physical components, materials, and intended use as a blood administration set.
• Technological Characteristics Comparison: A detailed table comparing the proposed device (2N3385) with a predicate device (2N3383), highlighting differences like length, priming volume, and specific components (e.g., spike, blood chamber, dual anti-siphon valve, Clearlink LAV).
• Nonclinical Tests: Bench tests (e.g., Luer tests, tensile strength, leak tests, blood filter tests, spike tests, LAV tests, particulate matter, DEHP claim, blood compatibility, microbial ingress, shelf-life, shipping simulation) to evaluate functional performance and safety.
• Biocompatibility: Assessments per ISO 10993-1.
• Sterility: Validation of gamma radiation sterilization according to ISO 11137-2.
• Shelf-Life: 3-year claim supported by aging testing.
• Microbial Ingress Testing: Evaluations of potential entry points.

All these tests are standard for conventional medical devices and do not involve AI/ML performance evaluation.

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The Blood Administration Sets are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy.

Quest Medical's Q2 Blood Administration Sets are single use, disposable intravenous administration sets used to deliver blood, blood components and IV fluids from a container to a patient's vascular system through the use of a hand pump or through gravity flow. The sets include tubing, bag spike, 200 micron blood filter drip chamber, luer connectors, clamps, hand pump, stopcock and needleless connector.

The provided document is a 510(k) Summary for a medical device called "Q2 Blood Administration Sets." This type of document is for demonstrating substantial equivalence to a predicate device, not for proving the performance of an AI/ML device.

Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML device performance (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document.

This document describes the regulatory approval process for a physical medical device (blood administration sets) and its equivalence to a previously approved device. The "Performance Data" section refers to bench testing (e.g., ISO standards, particulate matter, mechanical hemolysis), biocompatibility testing, and sterility/shelf-life testing for the physical device, not an AI/ML algorithm.

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For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.

The proposed device is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult.

The proposed set consists of non-DEHP PVC (

The provided text describes the regulatory filing for a medical device called a "Blood Administration Set" (K210335) by Baxter Healthcare Corporation. It details the device's indications for use, technological characteristics, and substantial equivalence to a predicate device, as well as a list of nonclinical tests performed to support its safety and effectiveness.

Here's an analysis of the provided information regarding acceptance criteria and study details:

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

Biocompatibility Tests:

Sterility Tests:

Shelf-Life:

2. Sample sizes 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 each of the nonclinical tests. It refers to "risk analyses and design verification tests" and "bench tests" conducted by Baxter Healthcare Corporation. The data provenance is internal to Baxter Healthcare Corporation, indicated by "Baxter Healthcare Corporation conducts risk analyses and design verification tests". There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective, as these are nonclinical bench tests on the device itself.

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 as the studies described are nonclinical (bench) tests on the device's physical and functional properties, not clinical studies involving human patients or expert interpretation of medical data. Therefore, no "ground truth" was established by experts in a healthcare context.

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

This section is not applicable for the same reasons as point 3. Adjudication methods are relevant for clinical studies where human interpretation or expert consensus is required for complex outcomes.

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 section is not applicable as the device is a "Blood Administration Set," a physical medical device, not an AI software/algorithm requiring human reader evaluation. There is no mention of AI or human reading in the context of this device.

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

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

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

For the nonclinical tests, the "ground truth" or reference standards are the specified international and national standards (e.g., ISO 80369-7, ISO 1135-4, USP , USP , USP , ISO 10993 series, ANSI/AAMI/ISO 11137 series) that the device must comply with. These standards define the acceptable performance parameters.

8. The sample size for the training set

This section is not applicable. The context is the regulatory filing for a physical medical device, not a machine learning model. There is no concept of a "training set" for the type of nonclinical tests performed for this device.

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

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

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Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient's vascular system.

Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.

Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets are single use, disposable, sterile fluid path, intravenous administration sets used to deliver fluids, medications, blood and blood products from a container into a patient's vascular system depending on the configuration selected. These sets are available in multiple configurations and may be comprised of various components which are broadly used throughout industry tubing, spike assemblies, drip chambers, check valves, clamps, needleless access connector, injection sites, in-line filters, luer connectors, and a tube frame assembly. The administration sets are intended to administer fluids with gravity flow. The IV Administration sets are configured to ensure the intended use of the device is met. The devices are intended for the general patient population.

The provided text describes the 510(k) premarket notification for Smiths Medical's Intellifuse™ Administration and Intellifuse™ Blood Administration Sets. This document from the FDA clears medical devices based on substantial equivalence to legally marketed predicate devices, rather than through extensive clinical trials for effectiveness like drugs. As such, the information you're requesting regarding acceptance criteria and performance studies in the context of an "AI/algorithm-only" or "human-in-the-loop" device is not applicable to this submission.

This device is an intravascular administration set, which is a physical medical device for delivering fluids. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance data and testing to ensure the device functions as intended and is safe, not a comparative effectiveness study involving human readers or AI.

Therefore, many of the requested points, such as AI performance, human expert adjudication, MRMC studies, and ground truth for AI model training, are not relevant to this type of device clearance.

Here's the relevant information based on the provided text, focused on the device's technical specifications and non-clinical testing:

Acceptance Criteria and Device Performance for Smiths Medical Intellifuse™ Administration Sets

The "acceptance criteria" for this device are primarily met through demonstrating substantial equivalence to a predicate device (Hospira Administration Sets K160870) and by non-clinical performance data demonstrating compliance with relevant ISO standards and internal test methods.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in the format typically seen for AI/algorithm performance. Instead, it relies on demonstrating compliance with established standards and the equivalence of functional characteristics.

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test conducted (e.g., how many sets were tested for priming volume, sterility, etc.). These sizes would typically be determined by statistical methods for validation but are not explicitly stated in this summary.
• Data Provenance: The data is generated from non-clinical laboratory testing performed by Smiths Medical. There is no information about country of origin or whether it's retrospective/prospective data as these terms are usually applicable to clinical studies.

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

This question is not applicable. This device is a physical medical device, not an AI or imaging diagnostic tool that requires human expert interpretation or "ground truth" establishment in the context of diagnostic accuracy. The "ground truth" for this device's performance is established by objective engineering and biological testing standards.

4. Adjudication Method for the Test Set

This question is not applicable. As there is no human interpretation or diagnostic decision involved that requires expert consensus or adjudication. The non-clinical tests have predefined acceptance criteria based on engineering specifications and international standards.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This device is an administration set, and its clearance is based on demonstrating functional equivalence and safety through non-clinical testing.

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

This question is not applicable. This device is a physical, non-AI medical product. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Compliance with international standards (e.g., various ISO standards for infusion and transfusion equipment, luer fittings, biocompatibility, sterilization, packaging).
• Compliance with **USP ** for particulate assessment.
• Results from internal test methods for specific functions like Microbial Ingress, Pinch Clamp, and Needleless Access Connector performance, which would be validated against engineering specifications.
• The fundamental physical and chemical properties of the materials used.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/machine learning product, so there is no "training set" in the computational sense. The "development" of the device involves engineering design, prototyping, and testing of physical units.

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

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

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