Search Results

Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, A549, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, HSV, Influenza, Measles, Mumps, Parainfluenza, Poliovirus, RSV, Rotavirus.

The subject device provides frozen A549 cells in measured quantities allowing the user to simply thaw and dilute the cells to a prescribed volume, plant prescribed volumes in appropriate containers and after a few days, the cell monolayers will be confluent and ready to use for virus isolation and identification.

This 510(k) summary describes a cell culture product (FreshFrozenCells™) for virus isolation and identification, not a medical device in the typical sense that would have performance metrics like sensitivity or specificity. Therefore, the standard acceptance criteria, study design, and performance reporting format as
requested in the prompt do not directly apply to this type of submission.

However, I can interpret the provided information to answer the closest equivalents to your questions within the context of this product.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a cell culture product, "performance" relates to its suitability for supporting virus growth and identification. The closest equivalent to "acceptance criteria" are the characterization tests performed to ensure the cells are viable and suitable for their intended use.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "non-clinical tests" which would involve evaluations of batches of FreshFrozenCells™. The number of batches or individual cell preparations tested is not specified.
• Data Provenance: The tests were conducted internally by Diagnostic Hybrids, Inc. This would typically be considered prospective for the specific batches manufactured for the submission, as the tests are part of the product's characterization and quality control process. The country of origin is implicitly the USA, where Diagnostic Hybrids, Inc. is located.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept doesn't directly apply here. "Ground truth" for a cell culture product like this primarily comes from established laboratory standards and methods for cell characterization and virus culture.

• For Sterility, the "ground truth" is typically defined by standard microbiological culture techniques (e.g., no growth observed).
• For Isoenzyme Analysis, the "ground truth" is a reference isoenzyme profile for the A549 cell line.
• For Virus Susceptibility, the "ground truth" is the known ability of A549 cells to support the replication of specific viruses, confirmed by standard virological assays (e.g., cytopathic effect observation, immunofluorescence).
• No "experts" in the sense of clinical reviewers (e.g., radiologists) were involved in establishing ground truth for this type of product. Rather, it relies on qualified laboratory personnel following validated protocols.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert opinions on clinical cases (e.g., image interpretation). This is a laboratory product relying on objective measurements and established protocols, not subjective expert interpretation of complex data.

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 a cell culture product, not an AI-powered diagnostic device or an assistive technology for human readers. Therefore, an MRMC study and effects on human reader performance are irrelevant.

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

Not applicable. This is a biological reagent for laboratory use, not an algorithm.

7. The type of ground truth used

The "ground truth" for this product's characterization is based on:

• Laboratory Standards: Established protocols for cell culture, sterility testing, isoenzyme analysis.
• Known Biological Properties: The inherent and well-documented susceptibility of the A549 cell line to specific viruses. This is based on decades of scientific research and virological principles.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML algorithm for this product. The manufacturing and quality control for cell lines are based on established biological processes and laboratory standards, not machine learning model training.

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

Not applicable, as there is no training set for this product.

Ask a specific question about this device