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Cell cultures to be used as hosts for the isolation and identification of specific viruses. The subject of this 510(k) Notification, the cell lines HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 are susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, CMV, Echovirus, HSV, Poliovirus, Rhinovirus, Vesicular stomatitis (Indiana Strain) virus and VZV; Adenovirus, CMV, Echovirus, HSV, Mumps, Poliovirus, Rhinovirus, VZV; Poliovirus type 1, Enterovirus, Rhinovirus, Myxovirus and Poxvirus groups; HSV, CMV; Vaccinia virus, HSV, Adenovirus, BK polyomavirus, Reoviruses, Measles virus, RSV, some strains of Influenza type A, most Enteroviruses and Rhinoviruses, Parainfluenza and Mumps; Adenovirus, Coxsackie B, HSV, Measles, Mumps, Poliovirus type 3, Rotavirus, Rubella; Adenovirus, CMV, Echovirus, HSV, Influenza, Mumps, Poliovirus, Rhinovirus, RSV, VZV.

FreshCells™ are indicated for use in the isolation of various viruses and Chlamydia from clinical specimens.

The subject device provides HEL, HFF, LLC-MK2, Mv1Lu, NCI H292, Vero and WI-38 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under 510 (k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cells™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

The provided K773414 510(k) summary describes the submission for "FreshCells™," which are cultured cells intended for use as hosts for the isolation and identification of specific viruses. This document establishes substantial equivalence to a predicate device and focuses on the characterization and performance of these cell lines.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of an algorithm or diagnostic model. The evaluation here is for cell cultures. The "testing" refers to the characterization and virus susceptibility studies performed on the subject FreshCells™ lines.

• Sample Size: Not explicitly stated in terms of a numerical count for a test set. This refers to the batches of cells produced and tested during characterization and virus susceptibility studies.
• Data Provenance: The studies were performed by Diagnostic Hybrids, Inc. The data would be prospective in the sense that the characterization and susceptibility testing were performed on newly produced batches of FreshCells™ as part of the validation process. The country of origin is implicitly the United States, where Diagnostic Hybrids, Inc. is located.

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

This information is not applicable to this 510(k) submission. "Ground truth" in this context is established through standard laboratory methods for cell culture characterization and virology testing (e.g., observing cytopathic effect, immunofluorescence, PCR, etc., which are common laboratory techniques). There is no mention of human experts establishing a subjective "ground truth" for a test set in the way one might for image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process as there would be for subjective interpretations (e.g., imaging reads). The results of cell culture characterization and virus susceptibility testing are typically determined by objective laboratory assays.

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 submission is for cultured cells, not an AI-powered diagnostic device or an imaging system that would involve human "readers" or an AI component.

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

Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used

The "ground truth" for this device, which refers to the expected biological behavior and characteristics of the cell lines, is established through:

• Standard Laboratory Assays: This includes macroscopic and microscopic observation of cell growth, morphology, sterility testing, and isoenzyme analysis (to confirm cell line identity).
• Established Virology Protocols: For virus susceptibility, the ground truth is whether a specific cell line reliably supports the replication and identification of a given virus, which is determined by inoculating the cells with known viral strains and observing cytopathic effects or other established detection methods. This is based on decades of virology research and established scientific literature on viral tropism.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI or machine learning device, there is no "training set" in the conventional sense. The development of the FreshCells™ lines relies on established cell culture techniques and knowledge from continuously maintaining and characterizing these cell lines over time.

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

Not applicable, as there is no training set for an algorithm. The "knowledge base" for developing and characterizing these cell lines comes from:

• Scientific Literature and ATCC standards: Established characteristics and maintenance protocols for cell lines obtained from sources like ATCC.
• Internal Quality Control Data: Ongoing in-house testing and characterization of cell batches over their production history to ensure consistency and meet specifications. The submission mentions "non-clinical tests consist of those used to characterize the product such as appearance, growth characteristics, sterility, isoenzyme analysis and virus susceptibility," which collectively form the basis of the "ground truth" for these cell lines.

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Cell cultures to be used for specific virus isolation and identification. The subject of this 510(k) Notification, the cell line, HEp-2, is susceptible to and can be used in the isolation and confirmation of the following viruses from clinical samples: Adenovirus, HSV, Coxsackie B, Measles, Parainfluenza, Poliovirus, RSV

The subject device provides HEp-2 cells as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

Here's an analysis of the provided text in the context of acceptance criteria and a study demonstrating device performance.

It's important to note that the provided text is a 510(k) Summary for a cell culture product (FreshCells™), not a diagnostic device or an AI/software as a medical device (SaMD). Therefore, many of the requested categories for AI/SaMD studies are not applicable. I will address each point based on the information available and indicate when a category is not relevant to this type of submission.

Acceptance Criteria and Device Performance Study (K962280 - FreshCells™)

1. A table of acceptance criteria and the reported device performance

Based on the provided 510(k) summary, the "acceptance criteria" are implied by the "Technological Characteristics" compared to the predicate device, and the "reported device performance" is the statement that the subject device meets these characteristics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided in the 510(k) summary for this type of device. Cell culture products typically undergo quality control and characterization tests rather than "test set" evaluations in the manner of diagnostic assays or AI algorithms. The "non-clinical tests" mentioned (appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility) would be performed on batches of the cell product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. Given that this is a cell culture product, there is no "ground truth" established by experts in the context of clinical interpretation, as would be the case for an AI diagnostic device. The "ground truth" for a cell culture would be its biological characteristics verified through standard lab methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not a part of the characterization of a cell culture product.

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 is not applicable. This submission is for a cell culture product, not an AI device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This is not applicable. This submission is for a cell culture product, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this cell culture product, the "ground truth" is established through laboratory characterization and quality control assays. This includes:

• Biological properties: Appearance, growth characteristics (e.g., confluence).
• Sterility testing: Confirmation of absence of contaminants.
• Isoenzyme analysis: To confirm cell line identity and purity.
• Virus susceptibility testing: Direct experimental verification that the cells support the replication of specific viruses listed in the intended use (Adenovirus, HSV, Coxsackie B, Measles, Parainfluenza, Poliovirus, RSV).

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning product requiring a training set.

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

This is not applicable as this is not an AI/machine learning product.

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