(426 days)
The Spirit " , is a computerized, enhanced electronic Hematology System designed for clinical applications to allow 16 whole blood parameters to be measured by a small table top computer driven instrument.
The Spirit" Hematology System is a microprocessor based device which is designed to provide identical function as the System 9000 Plus, (Model 9018). This compact device sits on any desktop. It provides a fathful analysis and display of key blood cells parameters by automatic processing and analyzing test results via a structured computer program. Both the System 9000 Plus, (Model 9018) retain an electronically stored data and act on that data using mathematical computations {proprietary algorithm}and computer programming {stored in a Electronic media and PROM}to provide blood parameters.
Here's an analysis of the provided text regarding the Spirit™ Hematology System, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics. Instead, it relies on claiming "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to System 9000 Plus (Model 9018) | "designed to provide identical function as the System 9000 Plus" |
| Measurement of 16 whole blood parameters | "allow 16 whole blood parameters to be measured" |
| Accuracy (conventional accuracy as per predicate) | "analyze whole blood on a repeatable basis with conventional accuracy. as also does the System 9000 Plus" |
| Safety and Efficacy | "This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy." (No specific metrics or details provided.) |
| Throughput of analytical data (compared to predicate) | "Each process yields a higher throughput of analytical data" |
| Ease of Use (compared to predicate) | "resulting in a system easier to use" |
| Cost (compared to predicate) | "lower in cost" |
| Maintenance (compared to predicate) | "easier to maintain in the field" |
| Good Manufacturing Procedures (GMP) conformance | "benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures." |
2. Sample size used for the test set and the data provenance:
The document does not specify a sample size for a test set. The claim of "substantial equivalence" appears to be based on design and functional similarity rather than a dedicated clinical study with a distinct test set. No information is provided regarding data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention a test set, experts, or the establishment of ground truth by experts.
4. Adjudication method for the test set:
Not applicable, as no dedicated test set or adjudication process is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The Spirit™ is an automated electronic hematology system, not an AI-assisted diagnostic tool for human readers. There is no mention of human readers or comparative effectiveness in the context of AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is described as a "computerized, enhanced electronic Hematology System" and operates in an "unattended mode" to provide "automatic processing and analyzing test results." This strongly suggests a standalone performance mode, as it describes the algorithm/system performing the analysis without human intervention during the measurement process. However, specific standalone performance metrics are not given. The document does state that "Neither device has claims or, is offered as, laboratory analysis equipment. Where either device is used, traditional medical practice requires additional analysis for any authentic diagnosis," implying it's a tool for analysis, but not a standalone diagnoser.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used for validating the device's accuracy. Given the claim of "conventional accuracy" and reliance on "tried and proven chemistry," it implies that the comparison is against established laboratory methods or the performance of the predicate device (System 9000 Plus), which itself would have been validated against some form of ground truth (e.g., manual differential counts, other gold-standard hematology analyzers). However, this is inferred, not explicitly stated.
8. The sample size for the training set:
The document does not mention a training set or its sample size. This type of device, described as using "tried and proven chemistry" and "proprietary algorithm" and "computer programming," is likely rule-based or uses algorithms derived from established hematology principles, rather than being a machine learning model that requires a distinct "training set" in the modern sense.
9. How the ground truth for the training set was established:
Not applicable, as no training set is mentioned in the context of typical machine learning model development.
§ 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.”