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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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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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To administer fluids with Baxter infusion pumps to a patient's vascular system from a container though a needle or catheter inserted into a vein, primarily used to admining the chemotherapeutic drug paclitaxel, but can also be used for general solution administration.

The Paclitaxel Sets product line consists of single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular device, primarily for solutions containing the chemotherapeutic drug paclitaxel. These devices are the same as the current marketed devices, which were previously cleared under 510(k) premarket notification K981792 (cleared August 17, 1998).

The sets are each comprised of a non-DEHP drip chamber with a spike, 0.2 micron filter, non-DEHP polyvinyl chloride tubing pump segment, polyethylene (PE)-lined trilayer tubing, and a luer lock. On all sets there is a fixtured slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink or Clearlink), and type of spike (vented or non-vented).

The basis for this premarket notification is a change to the PE-lined trilayer tubing and the 0.2 micron filter currently used in this product line. The inner layer material of the trilayer tubing is changing from Low Density Polyethylene to Linear Low Density Polyethylene. The solution membrane material of the 0.2 micron filter is changing from a hydrophilic polyethersulfone (PES) to another equivalent hydrophilic PES. All changes have been previously cleared under 510(k) premarket notifications for other Baxter Intravascular (IV) Administration Sets.

The provided text describes a 510(k) premarket notification for "Paclitaxel Sets" by Baxter Healthcare Corporation. It outlines the changes made to an existing device, its intended use, and the nonclinical tests conducted to demonstrate equivalence to a predicate device.

However, the document does NOT describe the acceptance criteria and the study that proves a device (e.g., an AI algorithm, a diagnostic tool) meets the acceptance criteria in the context of improving human reader performance or a standalone algorithmic performance.

Instead, this document pertains to a resubmission for a physical medical device (intravenous administration sets) with material changes, and the "acceptance criteria" discussed are largely related to bench testing and material compatibility to ensure that the modified physical device performs equivalently to the original predicate device.

Therefore, many of the requested points, such as AI-assisted human reader improvement, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set details, and MRMC studies, are not applicable to this type of device submission.

Here's an attempt to answer the
questions based on the provided text, highlighting what is present and what is absent/not applicable:

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

The document lists various bench tests and their acceptance criteria, which are consistently stated as "Per Baxter test method" or "Equivalence to predicate device." The actual quantitative performance data that verifies these acceptance criteria are not reported in this summary document, only that the tests were conducted and the results met their criteria.

2. Sample sizes used for the test set and the data provenance

• Sample Size: The document does not specify the sample sizes (number of units) used for each of the bench tests.
• Data Provenance: Not applicable in the context of patient data for a diagnostic/AI device. The testing is bench testing of physical units.

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

Not applicable. This is not a study involving human interpretation of data where expert consensus is needed for ground truth (e.g., medical image interpretation). The "ground truth" for this device is its physical and chemical properties and performance, validated through standard engineering and laboratory tests.

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

Not applicable. There's no human interpretation or subjective judgment that would require adjudication for this type of bench testing.

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 an intravenous administration set, not an AI or diagnostic device that would assist human readers.

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 an algorithm.

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

The "ground truth" for this device is based on established engineering standards, validated laboratory tests, and equivalence to a legally marketed predicate device. For drug compatibility, it is based on observed equivalence in concentration, pH, color, and visual inspection to the predicate device. For sterility, it's based on a defined Sterility Assurance Level validated against ISO standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of Device Performance Study:

The studies described are non-clinical bench tests and biocompatibility assessments designed to demonstrate that the changes made to the "Paclitaxel Sets" (specifically, the inner layer material of the trilayer tubing and the solution membrane material of the 0.2 micron filter) do not negatively impact the intended use or fundamental scientific technology of the device. The reported performance is that "All test results meet their acceptance criteria," indicating successful demonstration of equivalence or performance according to internal Baxter test methods and relevant international standards (e.g., ISO-10993, ANSI/AAMI/ISO 11137-2, ASTM standards). The specific quantitative results are not included in this summary document.

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For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

The Solution Administration Sets with a 0.2 micron filter product line consists of sterile, non-pyrogenic, single use disposable devices used for the administration of fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They are indicated for the retention of microorganisms and removal of air and particulate matter from infusion fluids. The filter consists of a 0.2 micron polyethersulfone (PES) solution membrane and 0.1 micron polyvinylidene fluoride air vent membrane enclosed in a copolyester housing.

The provided text is a 510(k) summary for a medical device (Solution Administration Sets with 0.2 Micron Filter) and, as such, focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance rather than a comprehensive study evaluating device performance against established acceptance criteria in a research context.

This document does not contain the kind of detailed information about a study that would rigorously prove a device meets acceptance criteria in the typical scientific sense (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies). It is a regulatory submission, so the "studies" are verification tests to ensure the modified device is equivalent to the predicate.

However, I can extract the acceptance criteria mentioned and the reported "performance" based on the provided text, while noting the limitations in the depth of information available.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only states that "All tests met the acceptance criteria" without providing the specific numerical or qualitative thresholds for those criteria. It implies that these criteria were pre-established internally by Baxter Healthcare Corporation for their risk analysis and design verification.

Here's why the other requested information is largely not present in this type of regulatory document:

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

• Not explicitly stated. The document is a summary and does not include the detailed protocols, sample sizes, or statistical analysis reports from the bench tests or biocompatibility assessments.
• Data Provenance: The tests were conducted by Baxter Healthcare Corporation. The document doesn't specify the country of origin for the data beyond that. These are typically internal corporate studies (retrospective in the sense that they are conducted on manufactured samples, but prospective in terms of the test design).

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

• Not applicable/Not mentioned. This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical evaluations). For bench tests and biocompatibility tests of a physical device, the "ground truth" is typically defined by scientific principles, international standards (e.g., ISO-10993), and validated test methodologies. There's no "expert ground truth" in the sense of consensus from adjudicators.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. As above, adjudication is not a standard part of these types of engineering and biological safety tests. The results are typically quantitative measurements against defined specifications.

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. This is a completely different type of study, relevant for AI/radiology devices. This document is a 510(k) for an administration set with a filter, not an AI diagnostic tool.

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

• Not applicable. This question pertains to AI algorithms. The device discussed is a physical medical device.

7. The type of ground truth used:

• For Performance Data (e.g., flow rate, bacterial retention): The "ground truth" would be established by the validated test methods themselves, based on physical and microbiological principles, often referenced to international standards or established industry practices for filter performance.
• For Biocompatibility: The "ground truth" is defined by the requirements of international standards like ISO-10993-1 and FDA guidance, which specify the types of biological responses that are considered acceptable or unacceptable.

8. The sample size for the training set:

• Not applicable. This question refers to machine learning models. This device does not involve a "training set" in that context.

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

• Not applicable. As above, no training set for an AI model is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes a series of nonclinical bench tests and biocompatibility assessments conducted by Baxter Healthcare Corporation.

• Objective: To evaluate the effect of a material modification (change in solution membrane material from one hydrophilic polyethersulfone to another hydrophilic polyethersulfone) in the 0.2 micron filter within their Solution Administration Sets. The goal was to establish substantial equivalence to the previously cleared predicate device (K964850).
• Tests Performed:
  • Performance Data: Air diffusion, bubble point, gravity flow rate, flow rate post sterile water conditioning, flow rate post parenteral nutrition conditioning, and bacterial retention.
  • Biocompatibility: Cytotoxicity, Systemic Toxicity, Intracutaneous, Hemolysis, Pyrogen, Sensitization, and USP Physicochemical. These were conducted in accordance with ISO-10993 and FDA guidance.
• Results: The document states that "All tests met the acceptance criteria."
• Conclusion: Based on these tests, Baxter concluded that "The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed for the same intended use."

This is a regulatory study designed to show equivalence, not an independent research study to establish novel performance claims.

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