(60 days)
The CELL-DYN 3500 and the CELL-DYN 3700 Systems are automated, multi-parameter hematology analyzers intended to classify the following formed elements of EDTA anticoagulated blood including: White Blood Cell Parameters: WBC -- White Blood Cell or Leukocyte Count, NEU -- Neutrophil Absolute Count, %N -- Neutrophil Percent, LYM -- Lymphocyte Absolute Count, %L -- Lymphocyte Percent, MONO -- Monocyte Absolute Count, %M -- Monocyte Percent, EOS -- Eosinophil Absolute Count, %E -- Eosinophil Percent, BASO -- Basophil Absolute Count, %B -- Basophil Percent; Red Blood Cell Parameters: RBC -- Red Blood Cell or Erythrocyte Count, HCT -- Hematocrit, MCV -- Mean Corpuscular Volume, RDW -- Red Cell Distribution Width; Hemoglobin Parameters: HGB -- Hemoglobin Concentration, MCH -- Mean Corpuscular Hemoglobin, MCHC -- Mean Corpuscular Hemoglobin Concentration; Platelet Parameters: PLT -- Platelet Count, MPV -- Mean Platelet Volume, *PDW -- Platelet Distribution Width, *PCT -- Plateletcrit; Reticulocyte Parameters: RETC -- Reticulocyte Concentration, %R -- Reticulocyte Percent of RBC Count, IRF -- Immature Reticulocyte Fraction. * These parameters are provided for laboratory use only and are not reportable in the US.
The CELL-DYN 3500 and the CELL-DYN 3700 Systems have four main modules: 1) the Analyzer, which aspirates, dilutes and analyzes each whole blood specimen 2) the Sample Loader, which automatically identifies, mixes, and presents specimens for processing 3) the Data Station, which controls all system processing and provides the primary operator interface with the system and; 4) the Color Printer, which generates reports automatically or on demand. The analyzer counts, sizes and classifies blood cells by the combination of methods: Laser Optical Light Scatter, Impedance, and Absorption Spectrophotometry. The IRF is derived from the data measured for the Reticulocyte parameters. The CELL-DYN 3500 and the CELL-DYN 3700 Systems use a Helium-Neon laser as the optical light source. The Optical Bench detects light in the form of scatter from blood cell surfaces and internal structures. For the reticulocyte parameters, an off-line dilution of blood and Reticulocyte Reagent is prepared and stained for 15 minutes. The dilution is aspirated and the reticulocytes are counted in the WOC channel. Data are collected for scatter (0°, 10°, and 90°) as each cell passes through the laser beam. The CELL-DYN 3500 and the CELL-DYN 3700 Systems report Reticulocyte % and Absolute Count. The IRF is a fraction of the total reticulocyte absolute count. The CELL-DYN 3500 and the CELL-DYN 3700 Systems are designed to analyze EDTA-anticoagulated whole blood specimens and report the additional Immature Reticulocyte Parameter.
Here's an analysis of the acceptance criteria and study details for the CELL-DYN 3500 and 3700 Systems with Immature Reticulocyte Fraction (IRF), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text states that the study evaluated "background, accuracy, precision, linearity, and carryover" and that the "accuracy, precision, and linearity data shows performance to manufacturer's specifications." However, it does not explicitly list the quantitative acceptance criteria for these aspects, nor does it provide quantitative performance results. It only states that the device met the manufacturer's specifications.
Therefore, a table cannot be fully populated with specific numerical acceptance criteria and performance data from the given document.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a single number. The study was conducted at "two field clinical sites and one internal site," collecting data for "background, accuracy, precision, linearity, and carryover." It's implied that various samples were used to assess these different aspects, but a total sample size for the test set is not provided.
- Data Provenance:
- Country of Origin: United States (Scottsdale, AZ; Phoenix, AZ; Santa Clara, CA).
- Retrospective or Prospective: Not explicitly stated. Given that data was "collected" at clinical and internal sites for the purpose of showing substantial equivalence, it suggests a prospective, controlled study design, but this is an inference.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information provided regarding experts being used to establish ground truth. The study appears to be a comparative effectiveness study against a predicate device (CELL-DYN 4000 System) and against manufacturer's specifications, rather than a study relying on expert human interpretation for ground truth. The devices are automated hematology analyzers, meaning their measurements are compared against other automated methods or predefined analytical standards.
4. Adjudication Method for the Test Set
Not applicable. The study is comparing automated analytical results against a predicate automated device and manufacturer's specifications, not against human interpretation that would require adjudication.
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, an MRMC comparative effectiveness study was not done. This study concerns an automated hematology analyzer, not an AI system assisting human readers. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was done. The CELL-DYN 3500 and 3700 Systems are automated hematology analyzers. The study evaluated the performance of these devices (the "algorithm only") in reporting parameters including the Immature Reticulocyte Fraction (IRF) in comparison to a predicate automated device and manufacturer specifications.
7. The Type of Ground Truth Used
The ground truth for this study was established through:
- Comparison to a Predicate Device: The CELL-DYN 4000 System (510(k) #971152/S1). The study aimed to demonstrate "substantial equivalence" to this predicate device for the IRF parameter.
- Manufacturer's Specifications: The device's "accuracy, precision, and linearity data shows performance to manufacturer's specifications." This implies that the manufacturer had internal analytical standards that the device was evaluated against.
Therefore, the ground truth is analytical accuracy and precision relative to a legally marketed predicate device and internal performance criteria.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a medical device's performance, not the training of a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied in the context of AI/ML. The device's underlying principles are based on established analytical methods (Laser Optical Light Scatter, Impedance, and Absorption Spectrophotometry) rather than learned patterns from a training dataset.
§ 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.”