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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 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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The solution adminstration set will be used to administer fluids to a patient's vascular system from a container through a needle or catheter inserted into a vein. The proposed solution set will be primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration with Baxter Flo-Gard® (6200 and 6300 series) and Colleague" volumetric infusion pumps.

The proposed solution set will be used for the administration of intravenous solutions containing the chemotherapeutic drug paclitaxel. The package insert for paclitaxel recommends that the drug be administered parenterally through a polyethylene-lined set because of the concern with diethyl-2-hexylphthalate (DEHP) leaching from DEHP plasticized polyvinyl chloride (PVC). The proposed set is designed to meet the package insert recommendations in that it contains polyethylene-lined tubing, an in-line 0.22 um filter, and no DEHP plasticized PVC in contact with the solution.

The provided 510(k) Premarket Notification document (K981792) is for a "Solution Administration Set". This type of medical device is a physical product, not an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training set) are not applicable to this submission.

However, based on the non-clinical tests described, here's an attempt to extract relevant information and note the inapplicable sections:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The document refers to "Data regarding the functional performance" being "generated," but does not provide details on the number of units tested.
• Data Provenance: Not explicitly stated, but assumed to be generated from non-clinical laboratory testing performed by Baxter Healthcare Corporation. It is prospective testing of the device itself.

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

• This criterion is not applicable. The device is a physical administration set; its "ground truth" is its physical and chemical properties and functional performance, which are evaluated through direct testing, not expert interpretation of data.

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

• This criterion is not applicable. Adjudication methods are typically used for expert consensus on image interpretation or complex clinical outcomes. The functional testing of a physical device does not involve such methods.

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 criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm. No human reader studies with AI assistance were performed or are relevant.

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

• This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm.

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

• The "ground truth" for this device's performance would be established through direct physical and chemical testing standards and laboratory analyses. For example:
  • Measurement of flow rates.
  • Chemical analysis for DEHP leaching.
  • Filtration efficacy.
  • Material compatibility tests.
  • Sterility validation (implied for an IV set, though not explicitly detailed here).

8. The sample size for the training set

• This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm. "Training sets" are for AI/ML models.

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

• This criterion is not applicable. The device is a physical medical device, not an AI/ML algorithm.

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Baxter solution administration sets with capped luer activated valves are intended for use with a vascular access device for the administration of drugs and solutions. The capped luer activated valve will replace the Y-injection site on the set. The valve can be connected to standard male luer adapters (e.g., syringes or sets), for continuous or intermittent fluid administration or the withdrawal of fluids.

The subject of this submission is a capped luer activated valve which Baxter intends to incorporate into currently marketed solution sets. The capped luer activated valve will replace the Y-injection site on the set for continuous or intermittent fluid administration or the withdrawal of fluids. The normally closed valve is opened by removing the cap and inserting a standard male luer adapter such as on syringes or sets to the female end of the valve automatically closes when the male luer is disconnected. The valve is intended to be capped when not in use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Solution Administration Sets with Capped Luer Activated Valve:

Acceptance Criteria and Study Analysis

The provided 510(k) summary for the "Solution Administration Sets with Capped Luer Activated Valve" describes a device intended to replace a Y-injection site on existing solution administration sets. The submission focuses on demonstrating substantial equivalence to a predicate device, the Abbott I.V. Sets with Capped Reflux Valve Port.

It's important to note: The provided document is a 510(k) summary, not a full study report. As such, detailed information regarding specific acceptance criteria, test methodologies, and data breakdowns is very limited. The document states that "A description of the functional testing along with test results has been provided," implying these details were part of the complete 510(k) submission to the FDA, but they are not present in this public summary.

Therefore, many of the requested fields below cannot be fully populated from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document broadly states that the device was evaluated for "functional performance" and met "all functional requirements." However, it does not specify what those functional requirements were (e.g., specific flow rates, pressure resistance, leakage limits, number of activations without failure, material compatibility, sterilization effectiveness, etc.).

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing would have been conducted by Baxter Healthcare Corporation, likely at their facilities, but no geographic origin or retrospective/prospective nature is mentioned.

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

• Number of Experts: Not applicable. This device is a mechanical medical device (solution administration set). The "ground truth" for its performance is established through engineering and functional testing, not typically through human expert adjudication as would be the case for diagnostic AI.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. For a mechanical device, testing results are objectively measured against predefined engineering specifications. There is no subjective adjudication process mentioned or typically used for this type of device.

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

• MRMC Study Done? No. This type of study is relevant for diagnostic devices that humans interpret (e.g., radiology AI). This submission is for a mechanical solution administration set, which does not involve human interpretation in its primary function, nor does it involve "AI."
• Effect Size of AI Assistance: Not applicable.

6. Standalone Performance (Algorithm Only)

• Standalone Performance Done? N/A. This device does not have an "algorithm" in the sense of AI or software interpreting data. Its performance is entirely "standalone" in that it functions as a mechanical component.

7. Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications and performance metrics. For example, leakage tests, flow rate measurements, pressure resistance, ability to connect and disconnect luer adapters, durability/number of cycles, material biocompatibility, and sterilization validation would all contribute to the "ground truth" of the device's functional performance. The document only broadly refers to "functional requirements."

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. This submission is for a mechanical medical device, not an AI/ML model that requires a training set. The development of such devices involves design, prototyping, and iterative functional testing, but not a "training set" in the computational sense.

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

• Ground Truth Establishment (Training Set): Not applicable.

Summary of Limitations from the Document:

The provided 510(k) summary is a high-level overview. It confirms that functional testing was performed and that the device met its requirements for substantial equivalence. However, it lacks the detailed technical specifications and study breakdowns that would be present in the full original 510(k) submission to the FDA. Specifically, it does not provide:

• Exact numerical acceptance criteria for any functional test.
• Quantified test results (e.g., "passed 1000 cycles" vs. "meets requirements").
• The number of units tested (sample size).
• Specific test methodologies.
• Any information related to clinical trials or human factors testing, beyond "intended for use with a vascular access device."

The document's primary purpose is to declare substantial equivalence to a predicate device (Abbott I.V. Sets with Capped Reflux Valve Port) based on similar technological characteristics and demonstrated functional performance, allowing the device to be marketed.

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The subject of this submission is the Millipore 0.22 micron filter which Baxter intends to incorporate into various configurations of solution sets for the administration of intravenous solutions. The filter is manufactured by Millipore and has been recently cleared for marketing in Abbott solution administration sets covered by K960466. Baxter will purchase the 0.22 micron filter from Millipore and incorporate it into currently marketed solution administration sets. Baxter is making no changes to the design, components or materials of the Millipore filter.

This 510(k) summary describes a new solution administration set incorporating a 0.22 micron filter manufactured by Millipore, intended for use with intravenous solutions. The submission focuses on the filter itself, as Baxter will be integrating it into their existing solution administration set designs. The predicate devices are Abbott and Baxter solution sets, both incorporating 0.22 micron filters.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The summary mentions "Data regarding the functional performance [...] were generated by Millipore," but does not specify the number of units tested for each criterion.
• Data Provenance: The data was generated by Millipore, the manufacturer of the 0.22 micron filter. It is not specified whether the data is retrospective or prospective, nor the country of origin, though given the context of a US 510(k) submission, it's highly likely to be considered within a US regulatory framework.

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

This information is not applicable to this type of medical device submission. This refers to clinical studies where expert consensus or diagnostic interpretation is required for ground truth. For a filter, the "ground truth" is typically defined by standardized physical, chemical, and microbiological tests.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or diagnostic studies to resolve discrepancies between multiple expert readers. For a filter, objective measurements are taken, and results are compared against predefined acceptance limits.

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. This submission is for a physical medical device (a filter), not an AI-powered diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant here.

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

This is not applicable. As mentioned above, this is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective, quantitative measurements obtained from established test methods for filter performance, biocompatibility, and structural integrity. This includes:

• Physical measurements (e.g., burst strength, flow rates).
• Chemical purity assessments (e.g., bacterial endotoxins, particle counts).
• Microbiological testing (e.g., bioburden evaluation) demonstrating sterile filtration capabilities.
• Drug compatibility studies.

These "ground truths" are derived from validated test procedures and industry standards relevant to medical filters.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not an AI model requiring a training set.

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

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

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