(29 days)
FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens. Viruses and Chlamydia are intracellular parasites which can be cultured or grown only in specific cellular hosts. They cause a variety of diseases in man with some virus infections being lethal, particularly if the individual is immunocompromised. With the introduction of several new and specific antiviral drugs over the last several years, the need to determine the identity of the viral agent has become even more important. Culture of viruses in specific cell lines has become the standard for the identification of these viruses.
The subject device provides HEL, HFF, LLC-MK2, MV1Lu, NCI H292, Vero and WI-38 cell lines as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.
The provided text describes a 510(k) submission for "FreshCells™" cell cultures, which are intended for use in the isolation and identification of specific viruses. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel design requiring extensive new performance data against specific acceptance criteria. Therefore, the information typically found in acceptance criteria tables and detailed study descriptions for new devices is not present.
Based on the provided text, here's an analysis of the information requested:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format typically used for a new medical device study. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and intended use.
The "performance" is implied by the similarity to the predicate device and the non-clinical tests performed.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Implied) |
|---|---|---|
| Source of Cell Line | ATCC or another approved supplier (same as predicate) | Same as predicate device |
| Confluence | Provided as nearly confluent monolayers (same as predicate) | Same as predicate device |
| Intended Use | Isolation & Confirmation of specific viruses (same as predicate) | Same as predicate device |
| Appearance | Acceptable appearance | Characterized (implicitly acceptable) |
| Growth | Acceptable growth characteristics | Characterized (implicitly acceptable) |
| Sterility | Sterile | Characterized (implicitly sterile) |
| Isoenzyme Analysis | Consistent with known cell line | Characterized (implicitly consistent) |
| Virus Susceptibility | Susceptible to listed viruses | Characterized (implicitly susceptible) |
2. Sample size used for the test set and the data provenance
The document does not describe a formal "test set" in the context of a clinical performance study with a specific sample size. The non-clinical tests mentioned were for product characterization (appearance, growth, sterility, isoenzyme analysis, virus susceptibility). The document does not specify the number of samples or "cases" used for these characterization tests, nor does it detail the provenance of any data (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes product characterization tests and a comparison to a predicate device, not a performance study requiring ground truth established by experts.
4. Adjudication method for the test set
Not applicable, as no formal test set requiring adjudication is described.
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 device is a cell culture for virus isolation, not an AI-powered diagnostic tool, and therefore no MRMC studies are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
The concept of "ground truth" as typically applied to diagnostic performance studies (e.g., pathology, outcomes data) is not explicitly detailed. For the non-clinical tests mentioned:
- Appearance, growth characteristics, sterility: Likely determined by standard laboratory methods and observations, potentially against internal controls or established specifications.
- Isoenzyme analysis: Used to confirm the identity and purity of the cell lines, with the "ground truth" being the expected isoenzyme profile for that specific cell line.
- Virus susceptibility: Determined by challenging the cell lines with known viruses and observing viral replication, with the "ground truth" being the known susceptibility of that cell line to specific viruses.
8. The sample size for the training set
Not applicable. The device is a cell culture, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 864.2280 Cultured animal and human cells.
(a)
Identification. Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.