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CT-STOR is a liquid culture media intended for ex vivo cell and tissue processing applications

CT-STOR is a tissue culture media intended for human ex vivo tissue and cell culture processing applications. AIM-V® is the predicate device and is also a tissue culture media intended for human ex vivo tissue and cell culture processing applications. CT-STOR and AIM-V® are composed of chemically defined nutrient materials in solution (with or without supplements) that are essential for the survival and development of tissue or cells of human or other animal origin. These nutrients are provided in liquid form for use in supporting the growth or maintenance of human tissue and cells.

Here's a breakdown of the acceptance criteria and study information for the CT-STOR device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The table in the document only provides a single acceptance criterion for CT-STOR stability, which is "Seeding Comparison (%)" with an "Acceptable Limit: > 75%". The reported device performance exceeds this limit at both 8 and 128 days aged.)

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

For the non-clinical performance testing of CT-STOR stability:

• Sample Size: The study used "Primary HDFa cells were purchased from American Type Culture Collection (ATCC, PCS-201-012, Primary Dermal Fibroblast; Normal, Human, Adult (HDFa), Manassas, VA)".
  • Specifically, cells were "plated at 10,000 cells per well on a 24-well plate." The exact number of wells or replicates is not explicitly stated, but it implies multiple wells were used for testing and control.
• Data Provenance: The cells were purchased from ATCC, a common biological resource. The study itself appears to be a prospective non-clinical study performed by Energy Delivery Solutions to validate the stability of CT-STOR. The origin of the human dermal fibroblasts (HDFa) is stated as "Normal, Human, Adult."

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

This information is not provided in the document. The study described is a non-clinical, in-vitro stability study using cell culture, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the measured cell proliferation compared against a predefined acceptable limit.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a non-clinical, in-vitro stability study measuring cell proliferation, not a study requiring human interpretation or adjudication.

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. The device, CT-STOR, is a "liquid culture media intended for ex vivo cell and tissue processing applications," not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. As stated above, CT-STOR is a culture medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical stability study was established by quantitative measurement of cell proliferation (seeding comparison percentage) compared against a pre-defined acceptable limit (> 75%). This can be considered an objective, laboratory-based ground truth.

8. The Sample Size for the Training Set

This information is not applicable. CT-STOR is a chemical composition (culture media), not a machine learning algorithm that requires a training set. The "formula for CT-STOR has remained the same since it was first manufactured with only a few minor alterations to composition."

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

This information is not applicable as there is no training set for this type of device. The formulation of CT-STOR is based on established scientific principles regarding essential nutrients for cell and tissue viability, as well as modifications over time based on apparently non-ML-driven optimization. The document mentions that the product's efficacy has been "well established in scientific publications included in this submission," suggesting reliance on existing biological and chemical knowledge.

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