(25 days)
CYTO-STAT tetraCHROME CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of Total CD3+ (T cells), Total CD4+, Total CD8+, Dual CD3+/CD4+, Dual CD3+/CD8+ lymphocyte percentages and absolute counts as well as the CD4/CD8 ratio in whole blood flow cytometry. When used in conjunction with CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5, the total lymphocyte percentage can be obtained. CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 monoclonal antibody reagent is intended "For In Vitro Diagnostic Use", allowing the identification and enumeration of total CD19+ (B cells) and CD3-/CD56+ (NK cells) lymphocyte percentages and absolute counts in whole blood flow cytometry. The total lymphocyte percentage can be obtained as well.
The products are: The CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagent. Each is a combination of four murine monoclonal antibodies, each conjugated to a different fluorochrome and specific for a different cell surface antigen.
The provided document describes the "Summary of Safety and Effectiveness" for the CYTO-STAT® tetraCHROME™ CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 and CYTO-STAT® tetraCHROME™ CD45-FITC/CD56-PE/CD19-ECD/CD3-PC5 Monoclonal Antibody Reagents. This document is a 510(k) premarket notification for a medical device.
Crucially, this document specifies indications for use and details a device modification but it does not, in the provided text, describe specific acceptance criteria or a study proving the device meets those criteria with performance metrics, sample sizes, ground truth establishment, or expert adjudication as typically seen for AI/software devices.
The filing states that the device claims substantial equivalence to a previously cleared device (FDA 510(k) Number: K990172). This means that the review process focused on demonstrating that the modified device performs as safely and effectively as the predicate device, rather than establishing new performance benchmarks from scratch. The modification described is the use of the two monoclonal antibody reagent system components as stand-alone reagents on any equivalent flow cytometer system, allowing manual adjustment of parameters, as opposed to being solely part of the automated tetraONE System.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not typically included in a 510(k) summary for a substantial equivalence claim based on a modification of an existing device when no new clinical claims or significant technological changes are introduced that would necessitate new performance studies against specific acceptance thresholds.
Given the information provided, here's an attempt to answer the questions, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a table of reported device performance metrics against such criteria. The device is cleared based on demonstrating substantial equivalence to a predicate device for its intended use of identifying and enumerating lymphocyte subpopulations.
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 sample size for a test set nor the data provenance (country of origin, retrospective/prospective). Substantial equivalence claims often rely on data from the predicate device or a limited bridge study.
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)
The document does not describe the use of experts to establish ground truth for a test set. This type of expert review is not typically part of a 510(k) submission for a diagnostic reagent claiming substantial equivalence, especially when the modification is primarily about device compatibility and manual operation. The "ground truth" for flow cytometry is generally established by established laboratory methods and controls.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for a test set.
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
No MRMC comparative effectiveness study was done or is described. This device is a monoclonal antibody reagent for flow cytometry, not an AI or software-assisted diagnostic tool for "human readers" in the context of imaging interpretation. The modification allows for manual adjustment of parameters by an operator, which is the opposite of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of an algorithm. This device is not an algorithm. It is a reagent. While it can be used with automated flow cytometer systems that have software, the current filing is about its use as a stand-alone reagent on any equivalent flow cytometer system, allowing manual operation. Therefore, this question is not applicable in the context of this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly describe the type of ground truth used in a formal study. For flow cytometry reagents, the "ground truth" is typically established through well-characterized cellular populations, internal and external controls, and comparisons to established reference methods for identifying specific cell markers. The document implies that the device's ability to identify and enumerate specific lymphocyte percentages and absolute counts is the performance metric, which would be compared against a reliable reference method if a new performance claim were being made. For this substantial equivalence claim, the predicate device's performance established the baseline.
8. The sample size for the training set
The document does not mention a "training set" as would be relevant for machine learning or AI models. This device is a diagnostic reagent.
9. How the ground truth for the training set was established
As there is no mention of a training set, this question is not applicable.
In summary: The provided 510(k) summary is for a monoclonal antibody reagent. Its clearance is based on a claim of "substantial equivalence" to a previously marketed device (K990172) following a modification that allows its use as a standalone reagent on various flow cytometers with manual control. It is not an AI/software device, and therefore the types of studies, criteria, and methodologies typically required for AI/software, as implied by many of the questions, are not present in this regulatory document. The focus of such a submission is to demonstrate that the modified device is as safe and effective as the predicate device for its intended use, rather than presenting a de novo performance study against new, specific acceptance criteria.
§ 864.5220 Automated differential cell counter.
(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”