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MSC SFM is a liquid tissue culture medium product intended for human ex-vivo tissue and cell culture processing applications.

MSC SFM is a serum-free medium specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). MSC SFM contains MSC SFM Basal Medium and MSC SFM supplement, MSC SFM supplement is a growth factor that should be added to the MSC SFM Basal Medium when use. Using MSC SFM, human MSCs can be expanded for multiple passages while maintaining their trilineage mesoderm potential (i.e., ability to differentiate into osteogenic and adipogenic lineages). Each container is aseptically filled.

The provided text is a 510(k) Premarket Notification from the FDA for a device called "MSC SFM" by Yocon Biology Technology Company. This document primarily describes the regulatory review process and establishes substantial equivalence to a predicate device.

Crucially, this document is for a "Tissue Culture Media For Human Ex Vivo Tissue And Cell Culture Processing Applications" (Product Code: NDS). This is a biological reagent, not an AI/ML-driven medical device that analyzes images or patient data to produce diagnostic or prognostic outputs. Therefore, many of the requested elements regarding acceptance criteria and study design for AI/ML devices (e.g., number of experts for ground truth, MRMC study, effect size of human improvement with AI, standalone performance) are not applicable to this type of product and are not found in the provided text.

The acceptance criteria discussed in this document pertain to the performance and safety of the tissue culture media itself, not the performance of an AI algorithm.

However, based on the information provided, here's what can be extracted and inferred, addressing the spirit of the request where applicable to this specific product, and explicitly stating when information is not applicable or not provided in the document for AI/ML-specific criteria.

Device Type: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications (Biological Reagent)

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to performance standards established in the FDA Guidance Document "Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers," issued May 16, 2001. While the specific numerical acceptance criteria for each test are not explicitly detailed in this 510(k) summary, the types of tests performed and the general findings are mentioned.

Note: The FDA 510(k) summary typically summarizes the results of the testing that support substantial equivalence, rather than providing the detailed raw data or specific numerical acceptance ranges for each test (unless failure of a specific range was a critical point to address). The "Special Controls Guidance Document" would contain the full details of the appropriate acceptance criteria.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each test (e.g., how many batches were tested for sterility, how many cells for performance assay). It refers to "non-clinical data" and "Performance Assay."
• Data Provenance: The manufacturing company is YOCON BIOLOGY TECHNOLOGY COMPANY, located in Beijing, China. The testing would have been conducted by the manufacturer, presumably in China. The data would be prospective in the sense that it was generated for the purpose of demonstrating device performance for this FDA submission.

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 biological reagent, not an AI/ML device requiring human expert annotation of data for ground truth. The "ground truth" for this product is based on established laboratory testing methods, chemical properties, and biological assays (e.g., cell viability, proliferation, differentiation markers, endotoxin levels).

4. Adjudication Method for the Test Set

Not Applicable. As there are no human expert readers generating subjective interpretations, there is no need for an adjudication method. Laboratory tests have defined protocols and result interpretations.

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 device meant to assist human readers.

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

Not Applicable. This document describes a tissue culture medium, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this tissue culture media is established through a combination of:

• Laboratory Standard Tests: Such as USP for Endotoxin, pH, Osmolality, Sterility Testing.
• Biological Performance Assays: Demonstrating the medium's ability to "support of tissue and cell growth" and "lack of potential toxicity" for human mesenchymal stem cells (MSCs), including maintaining their "trilineage mesoderm potential."
• Compliance with Standards: Adherence to ISO 10993-1 for biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device with a training set. The "training" for this product would be the research and development involved in formulating the medium to meet the desired performance characteristics.

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

Not Applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" during product development would be empirical lab results guiding formulation optimization, similar to the performance tests listed in section 7.

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StemPro® MSC SFM Medium is a liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.

StemPro® MSC SFM is a serum-free medium (SFM) specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). StemPro® MSC SFM enables human MSC growth and increased consistency compared to classical serum-supplemented medium. In addition, human MSCs can be expanded for multiple passages while maintaining their multipotential phenotype (i.e. ability to differentiate into osteogenic, chondrogenic, adipogenic lineages). StemPro® MSC SFM contains two components: StemPro® MSC SFM Basal Medium and StemPro® MSC SFM Supplement.

This is a 510(k) premarket notification for a tissue culture medium, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's the relevant information based on the provided text:

Device Name: StemPro® MSC SFM Medium

Predicate Device: Knockout™ SR Medium (K100616)

Intended Use: StemPro® MSC SFM Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications. This device is a chemically defined tissue culture media used to support the growth or maintenance of human tissue or cells in culture.

Acceptance Criteria and Reported Device Performance

The device demonstrates substantial equivalence to its predicate by meeting performance standards outlined in a "Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications".

Study Details (Not applicable for AI/ML device)

This is a medical device submission for a tissue culture medium, not an AI/ML enabled device. Therefore, the following AI/ML-specific questions are not applicable:

• Sample size used for the test set and the data provenance: Not applicable. Performance testing involved laboratory assays rather than clinical data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance studies of tissue culture media relies on established laboratory testing methodologies and specifications.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For performance tests like cytotoxicity, LAL, and chemical purity, the ground truth is established by the specified assay results conforming to pre-defined scientific and regulatory standards (e.g., USP monographs, internal specifications). For cell growth, it's the observed ex vivo cell proliferation and maintenance of phenotype.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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