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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, MvlLu, 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.

FreshCella™ 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 Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

The provided 510(k) summary for K973211 describes the "FreshCells™" product, which consists of various cell lines intended for the isolation and identification of specific viruses. However, the document does not present a typical device performance study with quantitative acceptance criteria as might be seen for a diagnostic test with metrics like sensitivity or specificity.

Instead, the acceptance criteria are implicitly defined by a comparison to a predicate device and a demonstration of the cell lines' suitability for their intended use through characterization tests.

Here's a breakdown of the requested information based on the provided text:

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

The acceptance criteria are performance characteristics, and the device performance is stated as being "Same as predicate device" for these characteristics.

Table 1: Cell Line Susceptibility to Viruses (Part of Device Performance demonstrating acceptance of virus susceptibility)

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

The document does not specify a "test set" in terms of clinical samples with a defined sample size. The testing appears to be primarily laboratory-based characterization of the cell lines themselves. Therefore, information on data provenance (country of origin, retrospective/prospective) is not provided and not applicable in the context of this submission.

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 provided in the document. The "ground truth" for cell line characteristics is established through standard laboratory assays and adherence to established cell culture practices (e.g., verifying sterility, growth rates, isoenzyme analysis). The "ground truth" for virus susceptibility is based on the known tropism of viruses for specific cell lines, which is part of general scientific knowledge in virology and cell biology, rather than being established by a panel of experts for a specific test set.

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

Not applicable. There is no mention of a human expert adjudication process for a test set in the context of the device's assessment.

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 biological reagent (cell culture) and not an AI-powered diagnostic system. No MRMC study was conducted or is relevant.

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

Not applicable. This device is a biological reagent (cell culture) and not an algorithm.

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

The "ground truth" for the device's performance, i.e., the proper functionality of the cell lines, is based on:

• Laboratory Characterization: Demonstrating expected appearance, growth characteristics, sterility, and isoenzyme analysis according to established scientific and quality control standards for cell cultures.
• Established Viral Tropism: The susceptibility of the cell lines to specific viruses is based on well-known scientific literature and established laboratory practices in virology.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm.

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FreshCells™ are indicated for use in the isolation of 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, JAC-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.

This document describes a 510(k) submission for "FreshCells™", which are cultured animal and human cells intended for use as hosts for the isolation and identification of specific viruses. The submission is a "Substantially Equivalent" determination, meaning the device's performance does not need to be "proven" in the same way a novel device would. Instead, the submission demonstrates that the new FreshCells™ lines are as safe and effective as a previously marketed predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy against a gold standard) because the submission is for cell lines acting as a medium, not a diagnostic test with a direct output. Instead, the "acceptance criteria" are implied by the comparison to the predicate device and the non-clinical tests performed to characterize the cell lines' capabilities.

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

The document does not describe a traditional "test set" with a sample size for evaluating a diagnostic algorithm's performance against a ground truth. Instead, the "testing" involved characterizing the cell lines themselves. The "non-clinical tests" mentioned (appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility) would have involved a sufficient number of cell cultures/batches to demonstrate their consistency and performance.

• Sample Size: Not specified as a numerical sample size of "cases" or "patients." These are in-vitro studies characterizing batches of cell lines.
• Data Provenance: The document implies these are internal characterization studies ("The non-clinical tests consist of those used to characterize the product..."). There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical samples, as the study is on the cell lines themselves.

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

This information is not applicable to this type of submission. There is no "ground truth" derived from human experts in the context of clinical images or patient data because the device is a cell culture medium, not an interpretative diagnostic device. The "ground truth" for the cell lines themselves would be established by standard cell biology, virology, and quality control methods.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication method described or required for this type of in-vitro diagnostic component.

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 not an AI-powered diagnostic tool, nor is it subject to an MRMC study. It is a biological product (cell cultures) used as a growth medium for viruses.

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

Not applicable. This is not an algorithm, but a physical biological product.

7. The Type of Ground Truth Used

The "ground truth" relevant to this device is established through various scientific and quality control methods:

• Cell Line Identity and Purity: Confirmed by isoenzyme analysis, morphological assessment (appearance), and sterility testing.
• Growth Characteristics: Verified through standard cell culture techniques to ensure they form "nearly confluent monolayers."
• Virus Susceptibility: Confirmed by inoculating the cell lines with known reference viral strains and observing the expected cytopathic effects or viral replication. This is the qualitative "performance" for their intended use.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI for this device.

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

Not applicable, as there is no training set.

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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 cells (in addition to MRC-5, McCOY, BGMK, and CV-1, under S10(k) K936271 and A549 and HEp-2, under 510(k) K962306 which have previously been cleared for marketing under the same name, Fresh Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

The provided text is a 510(k) summary for a medical device (FreshCells™) and does not describe a study that uses acceptance criteria and reports device performance in the way typically expected for an AI or imaging device submission. Instead, it's about the substantial equivalence of cell cultures for virus isolation. Therefore, many of the requested categories are "Not Applicable" or cannot be extracted from the given information.

Here is an attempt to structure the information based on the request, highlighting where information is not available for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The non-clinical tests involved "characterizing the product," which would include testing batches of the cell lines for the listed parameters. The specific number of cell batches or individual cell cultures tested is not provided.
• Data Provenance: Not explicitly stated, but based on the nature of cell culture characterization tests, the data would be generated internally by Diagnostic Hybrids, Inc. It's prospective in the sense that these tests were performed on the manufactured product to demonstrate its characteristics. Country of origin would be the USA (Diagnostic Hybrids, Inc., Athens, OH).

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

• Number of Experts: Not applicable in the context of this device. The "ground truth" for cell culture characterization and virus susceptibility is established through standard laboratory methodologies and accepted scientific benchmarks (e.g., ATCC standards for cell lines, established virology protocols).
• Qualifications of Experts: Not applicable. The work would be performed by qualified laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring expert adjudication of results. The results of the non-clinical tests (e.g., sterility, isoenzyme analysis, growth characteristics, virus susceptibility) are objective laboratory measurements against defined standards.

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

• MRMC Study: No. This device is a cell culture medium, not an AI or imaging device with human readers.
• Effect Size: Not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth is based on established scientific principles and laboratory standards for cell biology and virology.
  • Cell Line Identity: Confirmed through methods like isoenzyme analysis against known ATCC (American Type Culture Collection) standards.
  • Sterility: Absence of microbial growth in standard sterility tests.
  • Growth Characteristics: Expected cell morphology and proliferation rates for the specific cell lines.
  • Virus Susceptibility: Demonstrated ability of the cell line to support replication of specific viruses based on established virological assays.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set. The cell lines themselves are "trained" over passages based on established cell culture techniques, but this is not data-driven training in the AI sense.

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

• Ground Truth for Training Set: Not applicable. (See #8). The "ground truth" for the cell lines' characteristics is inherent in their established biological properties and validated through standard cell culture and molecular biology methods.

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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 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 Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

This document is a 510(k) summary for a medical device called FreshCells™ by Diagnostic Hybrids, Inc. This device provides various cultured cell lines (HEL, HFF, LLC-MK2, MV1Lu, NCI/H292, Vero, and WI-38) to be used as hosts for the isolation and identification of specific viruses.

Here's an breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance:

The document describes the device's characteristics and compares them to a predicate device. The acceptance criteria are implicitly defined by the substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

   Characteristics	Acceptance Criteria (Predicate Device)	Reported Device Performance (Subject Device)
   Source of Cell Line	ATCC or another approved supplier.	Same as predicate device.
   Provided as nearly confluent monolayers	Cells are provided routinely as nearly confluent monolayers.	Same as predicate device.
   Intended Use	Isolation & Confirmation of specific viruses.	Same as predicate device.
   Specific Viruses Susceptibility (Cell Line dependent)	(Not explicitly listed as a single table here but detailed for each predicate cell line in the "Intended Use" section for FreshCells™. The subject device must demonstrate susceptibility to these viruses.)	The subject device cell lines (HEL, HFF, LLC-MK2, MvlLu, NCI H292, Vero, and WI-38) are explicitly stated to be "susceptible to and can be used in the isolation and confirmation of" the respective viruses listed in the Intended Use table.

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

   • The document implies that non-clinical tests were performed to characterize the product (appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility). However, specific sample sizes for these tests are not provided.
   • Data Provenance: Not explicitly stated. The tests are referred to as "non-clinical tests" conducted to characterize the product.

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

   • Not applicable. The provided text does not describe a study involving human readers or experts establishing ground truth for evaluating the device's diagnostic performance against a reference standard in a clinical setting. This device is a tool (cell culture) used by laboratory personnel, not a diagnostic algorithm that analyzes data and requires expert ground truth for its output.

4. Adjudication Method for the Test Set:

   • Not applicable. See point 3.

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 medium, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

   • Not applicable. See point 5. This device is a biological product used in a laboratory process; it is not an algorithm.

7. The Type of Ground Truth Used:

   • For the performance related to virus susceptibility, the "ground truth" would be the demonstrated ability of the cell lines to successfully isolate and confirm the presence of the specified viruses based on established laboratory protocols. This is typically achieved through experimental validation and literature references for viral tropism in specific cell lines.

8. The Sample Size for the Training Set:

   • Not applicable. This device is a biological product used for culturing, not a machine learning model that requires a "training set." The development of the cell lines and characterization would involve various analytical and biological assays, but not in the context of a training set for an algorithm.

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

   • Not applicable. See point 8.

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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, MvlLu, 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:

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, MVILu, 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 Cella™) as nearly confluent monolayers ready for use upon receipt after a short pre-incubation period.

The provided text describes the 510(k) submission for "FreshCells™" cell cultures, intended for the isolation and identification of specific viruses. This submission is for a biological product (cell cultures used in diagnostic tests), not an AI/ML powered device. As such, the requested information regarding acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on:

1. Technological Characteristics Comparison: Showing that the source of the cell line, the format (nearly confluent monolayers), and the intended use are the same as the predicate device.
2. Non-Clinical Tests: Characterizing the product based on appearance, growth characteristics, sterility, isoenzyme analysis, and virus susceptibility.

Essentially, the "device" here is a biological reagent (cell cultures), and the evaluation is about its quality and suitability for its intended biological diagnostic purpose, not about the performance of an algorithm.

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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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