(187 days)
The DREW D3 Hematology Analyzer is a fully automated (microprocessor controlled) quantitative hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The D3 Hematology Analyzer is a stand-alone benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using the impedance & spectrophotometry techniques.
The D3 Hematology Analyzer is a stand-alone benchtop clinical laboratory instrument that analyzes in-vitro samples of whole blood to provide complete blood count and leukocyte differential count using impedance and spectrophotometry techniques.
The following information regarding the acceptance criteria and the study proving the device meets these criteria is extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list a table of "acceptance criteria" with quantitative values. Instead, it states that "Accuracy, Repeatability, Linearity, Carryover, Sample Stability studies demonstrated acceptable performance per the manufacturers specifications." It also highlights substantial equivalence to the predicate device, DATACELL 18MS (K945678). The key performance aspect is that the device "meets all acceptance criteria and demonstrating that the devices are substantially equivalent to the predicate device."
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Accuracy | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Repeatability | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Linearity | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Carryover | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Sample Stability | Acceptable performance per manufacturer's specifications. | Demonstrated acceptable performance. |
| Electrical Safety | UL 61010-1 standard compliance. | Meets UL 61010-1 standard. |
| EMC | IEC 60601-1-2 standard compliance. | Compliant with IEC 60601-1-2 standard. |
| Substantial Equiv. | Equivalent to predicate device (DATACELL 18MS, K945678) in performance. | Demonstrated substantial equivalence and met all acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "The non-clinical studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. The device is a "D3 Hematology Analyzer," suggesting an automated instrument rather than an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance
The D3 Hematology Analyzer is described as a "fully automated (microprocessor controlled) quantitative hematology analyzer." This indicates that its performance is standalone (algorithm only) without human-in-the-loop directly influencing the output measurements. The performance studies listed (Accuracy, Repeatability, Linearity, Carryover, Sample Stability) describe the standalone performance of the device.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated in the document. For hematology analyzers, ground truth is typically established through reference methods, manual microscopic differentials performed by trained technologists/pathologists, or validated control materials. However, the document does not specify which of these was used.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. Given that the device is a hematology analyzer, and the phrase "training set" is usually associated with AI/machine learning models, it's possible that traditional calibration and validation methods were used rather than an AI-specific training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned, the method for establishing its ground truth is also not detailed.
§ 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.”