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The All-In-One Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

The All-In-One Container is an empty EVA (Ethylene Vinyl Acetate) container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

The provided text describes a traditional 510(k) premarket notification for an "All-In-One Container" manufactured by Baxter Healthcare Corporation. This submission focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive performance studies with specific statistical acceptance criteria that one might find for a more complex diagnostic or AI-driven device.

Based on the information provided, here's what can be inferred about acceptance criteria and the "study" (nonclinical tests) that proves the device meets them:

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

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, it makes a general statement:

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

The document does not specify the sample size for any test set or the data provenance. It only refers to "risk analyses and design verification tests." These are typically internal tests, and details about sample size or origin are not usually disclosed in a 510(k) summary for this type of device.

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 information is not applicable and not provided. The testing described for this device (an empty container for compounding and storage) would involve engineering and quality control assessments, not expert-adjudicated ground truth like in a medical image analysis study.

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

This information is not applicable and not provided. Adjudication methods are relevant for subjective assessments, typically in clinical trials or diagnostic studies, not for the design verification of a medical container.

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 information is not applicable and not provided. An MRMC study is relevant for evaluating the performance of diagnostic tools (especially AI-powered ones) in conjunction with human readers. This device is a passive medical container, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. A standalone algorithm performance study is relevant for AI-powered devices. This device is an empty container and does not have an algorithm.

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

This information is not applicable in the context of this device. The "ground truth" for a medical container involves meeting established engineering specifications, material properties, sterility, and functional requirements. It would be determined through validated testing methods, not expert consensus or pathology.

8. The sample size for the training set

This information is not applicable and not provided. The "All-In-One Container" is a physical medical device, not an algorithm that requires a training set.

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

This information is not applicable and not provided for the same reasons as above.

Summary of the "Study" (Nonclinical Tests) Mentioned:

The document states:

• "Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses."
• "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use."

This indicates that Baxter performed internal nonclinical testing to ensure the device met its design specifications and safety requirements. These tests are typically related to:

• Material properties: Ensuring the EVA material is suitable for parenteral nutrition solutions (e.g., chemical compatibility, extractables/leachables).
• Physical integrity: Testing the container for leaks, burst strength, and resistance to damage during storage and handling.
• Sterility: Verifying the container can be sterilized and maintains sterility until use.
• Functional aspects: Ensuring the transfer sets (single or three lead) function correctly with the container.

The "acceptance criteria" would be internally defined specifications for these tests (e.g., "no leaks when subjected to X pressure," "material compatible with Y solution for Z duration"). The "study" is the execution of these design verification tests, and the "proof" is that all results met the predetermined acceptance criteria. The 510(k) process in this instance relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K983294), implying that the established testing methods and acceptance criteria for the predicate device would also apply to the new device.

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The All-In-One™ Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient.

The All-In-One™ Container is an empty, EVA container intended for use in the compounding and storage of parenteral nutrition solutions prior to and during intravascular administration to a patient. The container will be marketed in sizes ranging from 150 mL to 4000 mL. The proposed container is similar to Baxter Healthcare Corporation's currently marketed All-In-One™ Container cleared on June 10, 1994 under K932477.

There is one solution contact material in the proposed All-In-One™ Container which is new to Baxter. It is an ethy ene vinyl acetate (EVA) film which is used to fabricate the container body. The other solution materials used in the proposed device were previously tested and used in other Baxter devices for similar IV container applications.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Modified All-In-One™ Container:

No specific acceptance criteria or detailed study results are provided in the given 510(k) summary.

The document predominantly focuses on establishing substantial equivalence to a predicate device (K932477) by highlighting that the new device is nearly identical, with the only change being a new EVA film for the container body. The testing described is primarily for the new material's biological and physicochemical properties and the overall functional performance of the device.

However, based on the information provided, we can infer some general aspects of the testing and its outcomes.

Implied Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Text)

1. Sample Size Used for Test Set and Data Provenance:

   • Sample Size: Not specified. The document states "Data regarding the functional performance... have been generated and submitted" and refers to "biological methods specified in ISO Standard 10993-1 and USP physicochemical tests described in General Chapter ". These standards typically outline testing methodologies which would involve a certain number of samples or replicates, but the exact sample sizes used in this specific submission are not detailed.
   • Data Provenance: Not explicitly stated, but given that Baxter Healthcare Corporation is a U.S. company submitting to the FDA, it is highly likely the studies were conducted in the U.S. and are retrospective analyses of internal testing.

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

   • Not applicable/Not specified. This device is a medical container, and the testing described is material and functional performance testing, not diagnostic performance where "ground truth" is established by human experts. The ground truth (or reference standard) would be defined by the specifications of the materials and the functional design, and evaluated by laboratory instruments and standardized protocols.

3. Adjudication Method for the Test Set:

   • Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or diagnostic performance evaluations where human interpretation is involved. For material and functional testing, the results are objectively measured against pre-defined specifications.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI). The device described is a medical container, not a diagnostic tool requiring human readability or interpretation.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No, this is not relevant for this device. "Standalone" performance refers to the capability of an algorithm without human intervention, which applies to AI/software as a medical device. This is a physical medical container.

6. Type of Ground Truth Used:

   • Material Testing: The ground truth for the biological and chemical reactivity testing would be the standards themselves (ISO 10993-1 and USP 23 General Chapter ) and the pass/fail criteria defined within those standards or Baxter's internal specifications derived from them.
   • Functional Testing: The ground truth for functional performance would be the engineering and design specifications for the container (e.g., leak integrity, tensile strength, clarity, sterility maintenance, compatibility with parenteral nutrition solutions over time).

7. Sample Size for the Training Set:

   • Not applicable/Not specified. This is not an AI/machine learning device, so there is no concept of a "training set" in the context of the device's development or validation.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As above, there is no training set for this type of device.

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