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510(k) Data Aggregation
(164 days)
MoFi is a liquid culture medium intended for human ex vivo tissue and cell culture processing applications.
MoFi is a basal medium based on Iscove's Modified Dulbecco's Medium (IMDM) and cell-degradabe polysaccharide, made of water, carbohydrate, amino acid and salt. It can be mixed with various serums or additional additives to form a complete medium, which can be used to culture suspension/adherent primary cultured cells or cell lines. MoFi provides cells with energy to maintain survival and promote growth.
The provided document describes the FDA 510(k) premarket notification for "MoFi" Cell Culture Basal Medium. This K-submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing details on a study performed by the applicant (DuoGenic StemCells Corporation) to prove performance against specific acceptance criteria for an AI/ML powered device. The document describes a biologically-based product (cell culture medium), not an AI/ML-powered medical device.
Therefore, the requested information regarding acceptance criteria, AI/ML study design (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance), and training set details for an AI/ML device cannot be extracted from this document as it does not pertain to such a device.
The document discusses the following performance characteristics for the MoFi Cell Culture Basal Medium:
1. Acceptance Criteria and Reported Device Performance (for a cell culture medium, not an AI/ML device):
| Acceptance Criteria (for MoFi Medium) | Reported Device Performance (for MoFi Medium) |
|---|---|
| Appearance: Transparent yellowish liquid | Met (as implied by successful testing) |
| pH: 7.0-8.0 | Met (as implied by successful testing) |
| Cell viability: Good cell viability | Good cell viability of four kinds of cells (suspension primary culture cells, suspension cell lines, adherent primary culture cells, and adherent cell lines) |
| Sterility: Negative or not detected | Negative or not detected |
| Endotoxin: < 1 EU/mL | < 1 EU/mL (well controlled) |
| Mycoplasma: Negative or not detected | Negative or not detected |
| Residues of plasticizers, heavy metals and particles | Not detected or can be safely ignored |
| Product Performance: Good cell viability and normal cell morphology of four kinds of cells | Good cell viability and normal cell morphology of four kinds of cells (suspension primary culture cells, suspension cell lines, adherent primary culture cells and adherent cell lines) |
2. Sample Size and Data Provenance (for evaluating cell culture medium, not an AI/ML device):
- The document states "All batches tested met the acceptance criteria of performance testing." It does not specify the exact number of batches or the sample size (e.g., number of cell cultures) per test.
- Data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective, but it is implied to be internal testing conducted by DuoGenic StemCells Corporation for regulatory submission.
3. Number of Experts and Qualifications:
- This information is not applicable as the evaluation is for a cell culture medium's biological performance, not an AI/ML algorithm requiring expert interpretation.
4. Adjudication Method:
- Not applicable for this type of product evaluation.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
- Not applicable as this is not an AI/ML-powered device.
6. Standalone Performance (Algorithm Only):
- Not applicable as this is not an AI/ML algorithm.
7. Type of Ground Truth Used:
- For the cell culture medium, the "ground truth" for performance is based on established biological and chemical assays, such as pH measurement, sterility testing, endotoxin detection, and direct observation of cell viability and morphology compared to established controls and the predicate device.
8. Sample Size for Training Set:
- Not applicable as this is not an AI/ML device requiring a training set.
9. How Ground Truth for Training Set Was Established:
- Not applicable as this is not an AI/ML device.
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