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AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.

AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications. AIM-V® is a serum-free medium developed in 1987 to support adoptive immunotherapy (lymphokine-activated killer (LAK) cells) clinical trials. The formula for AIM-V® has remained the same since it was first manufactured with only slight quantity variations. AIM-V® Medium is prepared from a master formulation of Dulbecco's Modified Eagle Medium, HEPES buffer, human serum albumin.USP, human transferrin, and cholesterol, NF(which help promote growth of the cells and tissue).

This document is a 510(k) summary for the Invitrogen Corporation's AIM-V® Medium, a tissue culture media. It is important to note that this document is for a tissue culture media, not a diagnostic device or an AI/ML-based device that would typically have the requested acceptance criteria and study information.

Therefore, many of the requested sections (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth for AI models) are not applicable to this type of regulatory submission. The submission focuses on demonstrating substantial equivalence to a predicate device (Dulbecco's Modified Eagle Medium - DMEM) based on shared intended use, principles of operation, and technological characteristics.

However, I can extract the relevant information from the provided text regarding acceptance criteria and the justification for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of product (tissue culture media), the "acceptance criteria" are not measured in terms of diagnostic performance metrics like sensitivity or specificity. Instead, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device by showing comparable:

• Intended Use
• Principles of Operation
• Technological Characteristics
• Efficacy (generic cellular growth and maintenance)
• Safety (consistency in chemical content and formulation, biocompatibility with cells, and purity)

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. This is a 510(k) submission for tissue culture media, not a diagnostic device with performance testing against a specific test set of data. The "study" for substantial equivalence is a comparison of product characteristics and established scientific literature.

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. Ground truth, in the context of expert consensus, is not relevant for demonstrating substantial equivalence of tissue culture media. Efficacy is supported by "scientific publications."

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

• Not Applicable. No adjudication method is described or relevant for this type of submission.

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 not an AI/ML-based device.

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

• Not Applicable. This is not an AI/ML-based device.

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

• For "efficacy" (supporting cell growth and maintenance), the ground truth is established through scientific literature and established biological principles of cell culture, rather than a specific "ground truth" derived from expert consensus, pathology, or outcomes data in the context of a diagnostic AI product. The submission states efficacy is "well established in scientific publications included in this submission."

8. The sample size for the training set

• Not Applicable. This is not an AI/ML-based device.

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

• Not Applicable. This is not an AI/ML-based device.

Summary of the Study Proving Acceptance Criteria:

The "study" described in the 510(k) summary is a comparison of characteristics and scientific justification for substantial equivalence to a predicate device (Dulbecco's Modified Eagle Medium - DMEM), rather than a traditional clinical trial or performance study against a ground truth dataset commonly associated with AI/diagnostic devices.

The justification is based on:

• Direct comparison of Intended Use: Both AIM-V® and DMEM are for human ex vivo tissue and cell culture processing.
• Comparison of Principles of Operation and Technological Characteristics: Both provide essential nutrients for cell growth and maintenance. AIM-V®'s specific components (HEPES buffer, HSA, transferrin, cholesterol) are detailed, highlighting its formulation derived from DMEM.
• Reliance on Established Scientific Literature: The efficacy of AIM-V® in supporting cell survival, growth, and maintenance is declared "well established in scientific publications included in this submission." This suggests that previous research and published studies using AIM-V® serve as the evidence base for its performance.
• Compliance with Quality System Regulations (QSR): Both devices are manufactured under QSR and aseptically processed, ensuring safety and consistency.

In essence, the "study" is a regulatory assessment demonstrating that the new device (AIM-V®) is sufficiently similar to a previously approved device (DMEM) in its purpose, composition, and expected biological performance, supported by existing scientific knowledge.

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