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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Solution Administration Sets. These devices include Basic, Secondary, CONTINU-FLO solution sets, Stand-Alone devices and Chemotherapy devices (see Table 2 for a list of subject device set names per product family). They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

This is a 510(k) premarket notification for "Solution Administration Sets" by Baxter Healthcare Corporation. The document states that the devices are substantially equivalent to a predicate device (K203609 cleared on September 30, 2021).

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance values in the format usually seen for AI/ML devices. Instead, it describes general conformance to recognized standards and the positive outcomes of various tests.

Note: This submission is for a traditional medical device (solution administration sets), not an AI/ML device. Therefore, the questions related to AI/ML specific studies (sample size for test set, data provenance, number of experts for ground truth, adjudication, MRMC study, standalone performance, training set sample size, training set ground truth) are not applicable to this document. The "tests" described are standard engineering, biocompatibility, and sterilization validations for physical medical devices.

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

Not applicable, as this is a traditional medical device, not an AI/ML device. The testing described is bench testing and biocompatibility assessments, not a study involving patient data or a specific test set in the AI/ML context.

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, as this is a traditional medical device, not an AI/ML device. Ground truth as typically defined for AI/ML models is not relevant here.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device. Instead of "ground truth," the device relies on conformance to established international and national standards (ISO, ASTM, USP) and predefined acceptance criteria for various physical, chemical, and biological tests.

8. The sample size for the training set

Not applicable, as this is a traditional medical device, not an AI/ML device.

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

Not applicable, as this is a traditional medical device, not an AI/ML device.

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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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For the administration of fluids from a container into the patient's vascular system through a vascular access device. For use in adult populations only.

The proposed devices are patient controlled analgesia (PCA) syringe sets. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular access device. They are non-pyrogenic, sterile devices that can be directly attached to a syringe.

The PCA syringe sets consist of non-DEHP PVC tubing/bushing, female luer cap, antisiphon valve with female luer, on-off clamp(s), male luer lock, male luer cap, back check valve with female luer (2P3331 and 2P3332 only), and y-connector (2P3331 and 2P3332 only). They are used to administer analgesics from a syringe to the patient IV access device (2P3331 and 2P3332 only) or from a syringe to a primary administration set (2P3333 only); and are also used to administer fluids from a container at the y-type connector (2P3331 and 2P3332 only).

This document describes the acceptance criteria and the studies conducted to prove that Baxter Healthcare Corporation's PCA Syringe Sets meet these criteria, thereby demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the exact sample sizes used for each individual performance test (e.g., number of devices tested for leak, tensile strength, etc.). It generally states that "All tests met the acceptance criteria" and that "Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses."

The data provenance is implied to be from internal laboratory testing conducted by Baxter Healthcare Corporation. No information is provided regarding the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of these tests (bench tests, biocompatibility, sterility, shelf life), they are typically prospective studies performed in a controlled laboratory environment.

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

This information is not applicable. The studies described are primarily engineering performance tests, biocompatibility assessments, and sterility validations, which rely on industry standards (ISO, BS EN, USP) and predefined acceptance criteria rather than expert-established ground truth in the context of clinical interpretation or diagnosis.

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

This information is not applicable. The tests performed are objective measurements and validations against specified standards, not subjective assessments requiring adjudication by multiple experts.

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 (PCA Syringe Sets) is a medical administration set, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to this device.

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 administration set, not an algorithm.

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

The "ground truth" for the performance of the device is established by adherence to recognized national and international engineering and medical device standards, such as ISO 80369-7, BS EN ISO 8536-9, BS ISO 8536-12, BS EN ISO 8536-14, USP Chapters and , USP , ISO 10993 series, and ANSI/AAMI/ISO 11137 series. These standards define the acceptable range of performance for specific physical and biological characteristics of the device.

8. The sample size for the training set:

This is not applicable. The device is a physical product and not an AI/ML algorithm that requires a training set.

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

This is not applicable because there is no training set for this device.

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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of Intravascular Administration Sets. These devices include Basic, Secondary, and CONTINU-FLO solution sets. They are single use disposable, non-pyrogenic, sterile devices intended for the administration of fluids from a container into the patient's vascular system.

The provided text is a 510(k) summary for Baxter Healthcare Corporation's Intravascular Administration Sets (K203609). It details the substantial equivalence determination for this medical device to a predicate device (Solution Administration Sets, K112893).

However, the summary does not contain the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Device Description: What the Intravascular Administration Sets are, their components, and how they function.
• Predicate Device Comparison: A detailed table comparing the technological characteristics of the proposed device to the predicate device, highlighting differences in length, priming volume, dimensions, and material components.
• Discussion of Differences: Explanations for each technological difference and assurance that these differences do not raise new questions of safety or effectiveness.
• Nonclinical Tests: A list of bench tests (Luer tests, particulate matter, non-DEHP claim, solvent bond tests, flow rate tests, pump compatibility), biocompatibility tests (cytotoxicity, sensitization, toxicity, hemolysis), and sterility tests (barrier packaging, fluid path, shelf life, sterilization dose establishment, pyrogen testing, microbial ingress). It states that all test results meet their acceptance criteria.

Therefore, I cannot populate the table or provide detailed answers to questions 1-9 as the necessary information is not present in the provided document. The document states that "All test results meet their acceptance criteria," but it does not define what those criteria are or report specific performance metrics against those criteria. It also does not discuss any studies involving human readers or expert consensus for ground truth.

Here's what I can infer from the document, though it falls short of the requested detail:

• Acceptance Criteria & Reported Performance: The document states, "All test results meet their acceptance criteria." This implies that acceptance criteria were established for each of the listed bench, biocompatibility, and sterility tests. However, the specific quantitative acceptance criteria (e.g., maximum allowable particulate matter, minimum burst pressure, flow rate accuracy range) and the reported device performance (e.g., actual particulate count, measured burst pressure, achieved flow rate accuracy) are not provided.
• Sample Sizes: The document does not specify sample sizes used for any of the tests.
• Data Provenance: The tests are described as "bench tests," "biocompatibility," and "sterility" tests conducted by the manufacturer (Baxter Healthcare Corporation). The data would therefore be prospective, internal testing data. No country of origin for data is specified beyond the manufacturer's location (Round Lake, Illinois).
• Experts for Ground Truth / Adjudication / MRMC Study / Standalone Performance: This section of the prompt is highly relevant for AI/ML device clearances (e.g., software as a medical device). This document describes a traditional Class II medical device (intravascular administration sets). There is no mention of AI/ML components, human readers, expert panels, or comparative effectiveness studies in the context of diagnostic or interpretive performance. Therefore, questions regarding these aspects are not applicable to the content provided.
• Type of Ground Truth: For this type of physical device, "ground truth" would be established by the physical and chemical properties and performance characteristics measured in the listed bench, biocompatibility, and sterility tests, compared against established engineering standards (e.g., ISO, USP, ASTM) and internal specifications. There is no subjective human interpretation or diagnostic outcome data involved.
• Training Set Sample Size / Ground Truth Establishment (for AI/ML): These questions are entirely irrelevant to this device and the provided document, as it is not an AI/ML product. The "training set" here would metaphorically be the design and manufacturing processes refined over time.

In summary, the provided document is a regulatory submission for a physical medical device, not an AI/enabled one. Therefore, many of the questions asked, particularly those related to data sets, expert involvement, and reader studies, are not applicable to the content provided.

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