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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 (< 0.1% DEHP) tubing, blood chamber, 200 um Filter, Clearlink Luer Activated Valve (LAV), notch clamp, female Luer lock, dual anti-syphon valve, male Luer lock, and a filter vented cap for a male Luer lock. It can be used to administer solutions, blood, and blood products to the patient.

The blood set (2N3385) will be used for syringe-based infusion. The clinician attaches the blood set to a blood bag and manually draws blood into a syringe. The blood is then delivered into the patient's vascular system through a vascular access device.

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 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 (< 0.1% DEHP) tubing, a notch clamp, a female Luer lock, a non-vented cap for a female Luer lock, a male Luer lock, and a filter vented cap for a male Luer lock.

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 <788>, USP <85>, USP <161>, 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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