(192 days)
The Medonic CA620/530 is a fully automated hematology analyzer used for in vitro diagnostic testing of whole blood specimens. Automated differential cell counters are used to identify and classify one or more populations of formed elements in whole blood specimens
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This document does not contain the detailed study information required to fill out the table and answer all questions about acceptance criteria and device performance studies. The provided text is a 510(k) clearance letter from the FDA for the Medonic CA620/530 Analyzer, which confirms substantial equivalence to a predicate device.
The letter does not include:
- A table of specific acceptance criteria.
- Reported device performance data against those criteria.
- Details about sample sizes for test or training sets.
- Data provenance, expert qualifications, or adjudication methods for ground truth.
- Information about MRMC or standalone studies.
- The type of ground truth used.
Therefore, many of the requested fields cannot be filled from the given text.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Differential Cell Count Accuracy (e.g., specific cell types like Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils) | (Not specified in document) | (Not specified in document) |
| Precision/Reproducibility | (Not specified in document) | (Not specified in document) |
| Carryover | (Not specified in document) | (Not specified in document) |
| Linearity | (Not specified in document) | (Not specified in document) |
| Interfering Substances | (Not specified in document) | (Not specified in document) |
| Throughput | (Not specified in document) | (Not specified in document) |
| Substantial Equivalence (Overall Conclusion) | The device must be "substantially equivalent" to a legally marketed predicate device. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document.
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)
- Not specified in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified in the document.
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/Not specified. This device is an automated differential cell counter, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is described as a "fully automated hematology analyzer." This implies it operates in a standalone manner for producing results without human intervention in the analysis process. However, specific performance data from such a study is not provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified in the document. For an automated differential cell counter, ground truth for performance studies would typically involve manual microscopic differentials performed by trained laboratorians or hematologists (often considered the "gold standard" for comparison).
8. The sample size for the training set
- Not applicable/Not specified. This document is for a traditional device clearance, not an AI/ML algorithm that typically requires a distinct training set. The "development" of the device would involve calibration and internal testing, but the term "training set" in the context of machine learning is not directly relevant here.
9. How the ground truth for the training set was established
- Not applicable/Not specified for the reasons above.
§ 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.”