Search Results

Ortho-mune OK-COMBO CD3-FITC/CD4-PE is intended for use in identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry. The intended use is the same as the intended use of the predicate device, Simultest CD3/CD4 (Leu-4/3a) commercially distributed by Becton Dickinson Immunocytometry Systems.

Ortho-mune OK-COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) Monoclonal Antibody (Murine) is a blend of the individual purified monoclonal antibodies OKT3 and OKT4A conjugated to the fluorochromes fluorescein isothiocyanate and phycoerythrin respectively.

The provided text describes a 510(k) summary for the Ortho-mune OK-COMBO CD3-FITC/CD4-PE (OKT3/OKT4A) Monoclonal Antibody (Murine) device, which is intended for the identification and enumeration of CD3+ and CD4+ human T lymphocytes in whole blood by flow cytometry. The study aims to demonstrate substantial equivalence to a predicate device, Simultest™ CD3/CD4 Ortho-mune™ OK-COMBO (Leu™-4 / 3a) CD3-FITC/CD4-PE (OKT™3 /OKT4A) Monoclonal Antibody (Murine).

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by achieving a statistically significant correlation between the performance of the new device (Ortho-mune OK-COMBO CD3-FITC/CD4-PE) and the predicate device (Simultest CD3/CD4), as well as between different flow cytometers used with the new device. The benchmark for significance is a p-value (SL) of 0.0001, indicating a very high probability of correlation. The Pearson Product Moment Correlation Coefficient is the metric used to assess this.

Table 1: Acceptance Criteria and Reported Device Performance

Additional Information:

1. Sample size used for the test set and the data provenance:

   • Primary Test Set: 202 normal donors and 86 AIDS/ARC patients.
   • Secondary Test Set (Cytometer Comparison): 17 normal donors.
   • Data Provenance: The text does not explicitly state the country of origin. It indicates "Whole blood specimens" were collected, implying prospective collection for the purpose of the study. It does not mention retrospective data.

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

   • This device is a diagnostic reagent for flow cytometry, which measures cell populations directly. The "ground truth" is established by the flow cytometer itself detecting the stained cells. There is no mention of human experts interpreting images or signals to establish a ground truth; rather, the "truth" is the quantitative measurement of stained cells.

3. Adjudication method for the test set:

   • Not applicable. The study compares the performance of two different monoclonal antibody reagents and two different flow cytometers by measuring the percentage of positive stained cells. This is a direct quantitative comparison, not one that requires adjudication by human readers.

4. 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:

   • No. This is a direct comparison of diagnostic reagents and flow cytometers, not an AI-based system involving human readers interpreting outputs.

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

   • Yes, in essence. The comparison is between the performance of two different reagents in identifying and enumerating cell populations using flow cytometry, which is an automated process of cell counting and characterization. The performance is measured directly by the instrument, without human interpretation of subjective data.

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

   • The ground truth is established by the quantitative measurement of cells positively stained by the predicate device's reagents (Simultest CD3/CD4). The study then evaluates if the new device's reagents produce statistically equivalent measurements. In the cytometer comparison, the ground truth for comparing the CytoronAbsolute to the FACScan is also the measurement performed by the predicate device on the FACScan. The underlying biological "ground truth" is the actual percentage of CD3+ and CD4+ T lymphocytes present in the whole blood samples, as identified by specific antibody binding.

7. The sample size for the training set:

   • Training sets are not mentioned. This type of study validates a specific reagent's performance against a legally marketed predicate device rather than training a machine learning model. The study evaluates the performance of the reagent on a test set (normal donors and AIDS/ARC patients).

8. How the ground truth for the training set was established:

   • Not applicable, as there is no mention of a training set in the context of machine learning. The study focuses on comparing the new device's performance to a predicate device.

Ask a specific question about this device