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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 administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. May be used with TPN solutions containing lipid emulsions.

The Solution Set with 1.2 Micron Air Eliminating Filter product line consists of single use disposable device for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. The filter consists of a 1.2 micron filter consisting of polysulfone solution membrane and a Teflon air vent media enclosed in an acrylic housing and may be used with TPN solutions containing lipid emulsions. The 1.2 micron filter has a maximum pressure of 45 psi (2241 kPa). The Solution Set with 1.2 Micron Air Eliminating Filter was previously cleared under 510(k) premarket notification K952074 (cleared July 27, 1995).

The basis for this premarket notification is modifications to the Solution Set with 1.2 Micron Air Eliminating Filter product line. The modifications consists of the use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer to provide an alternate to the current Non-DEHP PVC tubing material, conversion to sterile packaging, addition of an expiration date, and updates to the labeling.

The provided document is a 510(k) premarket notification from Baxter Healthcare Corporation to the FDA for a "Solution Set with 1.2 Micron Air Eliminating Filter." This document is not about an AI/ML medical device. It concerns a physical medical device (an intravenous administration set) and its modifications.

Therefore, many of the requested categories related to AI/ML device studies (such as the number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this document. The document describes traditional medical device performance testing and biocompatibility assessments.

However, I can extract the acceptance criteria and performance results for the physical device as described in the document.

Here's an analysis of the provided document focusing on the acceptance criteria and study that proves the device meets them, adapted to the context of a physical medical device.

Device Name: Solution Set with 1.2 Micron Air Eliminating Filter

Purpose of the Submission:
The basis for this premarket notification is modifications to an existing device (previously cleared under K952074). The modifications include:

• Use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer.
• Conversion to sterile packaging.
• Addition of an expiration date.
• Updates to the labeling.

The submission aims to demonstrate that these modifications do not impact the intended use or the fundamental technology of the devices and that the modified devices are substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists performance tests conducted to evaluate the effect of using the proposed Non-DEHP PVC tubing material. The acceptance criterion for all these tests is "Per Baxter Test Method." The document explicitly states the overall performance: "All tests met the acceptance criteria."

Biocompatibility Tests:

Sterility & Shelf Life:

• Sterilization Method: Radiation (Method No. 1 as described in ISO 11137-2).
• Sterility Assessment: Minimum Sterilizing Dose (MSD) established and validated to provide a 10⁻⁶ Sterility Assurance Level (SAL).
• Package Verification: Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak. ("These products are labeled 'Sterile, Nonpyrogenic.'")
• Shelf Life: Twenty-four (24) months, supported by aging testing.

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

• Sample Size for performance tests: Not explicitly stated in terms of a numerical count for each test. The document states, "All evaluations were performed on the product code set configuration (Code: 2R8486) that is using the proposed Non-DEHP PVC tubing material." This implies that samples of this specific configuration were used for all listed tests.
• Data Provenance: The studies were conducted by Baxter Healthcare Corporation. No specific country of origin for the data is mentioned, but the company is based in the US (Deerfield, Illinois). The studies are "bench tests" and "design verification tests," which implies a prospective testing approach conducted in a laboratory setting rather than retrospective analysis of clinical data.

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

• Not Applicable. This is a physical medical device. Ground truth, in the context of AI/ML, refers to clinically relevant labels from human annotators for image or signal data. For this device, "ground truth" is typically defined by engineering specifications, industrial standards (e.g., ISO, ASTM, USP), and established test methods, verified by objective measurements. These are not established by "experts" in the clinical sense (e.g., radiologists) for performance testing.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a physical medical device undergoing bench and biocompatibility testing, there is no need for human expert adjudication of results in the way it's done for AI/ML diagnostic tools. The results are quantitative measurements against predefined criteria/standards.

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 is a physical medical device, not an AI-assisted diagnostic tool or an AI/ML algorithm.

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 AI or algorithm. The performance tests ("bench tests") can be considered analogous to "standalone" performance for a physical device, as they assess the device's function directly without human intervention in its operation (beyond setting up the test).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• For Performance Data: The "ground truth" is based on the device meeting the "Per Baxter Test Method" criteria and "ISO Standard 594." These are engineering and performance specifications.
• For Biocompatibility Data: The "ground truth" is based on meeting the requirements of various ISO 10993 standards (e.g., ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11) and USP . These are international and national standards for biological evaluation of medical devices.
• For Sterility: The "ground truth" is based on meeting ISO 11137-2 for achieving a 10⁻⁶ Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Not Applicable. This is not an AI/ML device; therefore, there is no "training set" or ground truth establishment relevant to AI/ML.

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