(201 days)
The basic Power Express is an automated sample handling system which processes sample tubes from the precentrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Express can be configured with optional software to allow processing of sample tubes on Generic Connection Instruments. The Power Express performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.
The UniCel DxI 800 Access Immunoasav System with laboratory automation is a microcomputer-controlled. random and continuous access analyzer that includes an external computer stores the system user interface (UI) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 800 System uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for determination of various analytes, such as Vitamin B12. Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depent used to induce the enzyme immunoassay reaction. The UniCel Dxl 800 System is an in vitro diagnostic device for use in the clinical laboratory.
The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
The Access HYPER sensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption.
The Power Express is Beckman Coulter's Power Processor Sample Processing System with the modifications noted in this premarket submission. The Power Express and the Power Processor Sample Processing System are scalable laboratory automation systems (LAS) designed to streamline peri-analytical processes in the clinical laboratory.
The Power Express is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting steps to presentation of centrifuged and decapped samples into racks for chemistry, immunoassay, hematology, and coagulation systems. The Power Express is designed to free laboratory personnel from biohazard exposure and routine sample preparation.
The Power Express software can be configured with optional hardware to allow processing of sample tubes on physically connected analyzers using common communication protocols (Generic Connection Instruments). The Power Express performs pre-analytical sample tube preparation then sorts the sample tubes directly to the optional hardware interface between the LAS and analyzer (Generic Connection Module) where the samples are pipetted by the analyzer for testing. After the samples are pipetted, the tubes can be routed to other instruments for additional testing or to Outlet Racks.
A basic Power Express System is comprised of a Line Control Computer, a system console with Cennexus software, Inlet Module, Centrifugation Module, Decapper Module, track transport system and Outlet Module. Additional modules may be added for aliquot capability, sample capping, and ambient or refrigerated storage.
Here's an analysis of the provided text, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the efficacy of new clinical features from scratch. This influences the nature of the "acceptance criteria" and "study" described. The document largely asserts that the modifications to the Power Processor system did not introduce new risks to the performance of the integrated assays, and therefore formal V&V testing was sufficient rather than full clinical studies.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the traditional sense of numerical thresholds for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the statement that "all software design, development and verification activities have been completed and passed to supports equivalency of Power Express to the Power Processor V5.0 Sample Processing System." The performance reported is that the device "functions as intended, meeting the requirements of the design specifications."
Let's infer acceptance criteria based on the modifications and the intent of substantial equivalence:
| Acceptance Criterion (Inferred) | Reported Device Performance (Implied) |
|---|---|
| Functional Equivalence of Software: All new and modified software features (Sample Management, Data Management, Set-up, Analyzer Connections, Host Interface Communications, Communication with Line Control Software, Sample Routing Logic, Sample Storage, Error Recovery) perform their intended functions as safely and effectively as the predicate's software. | "Software design testing of: Sample Management, Data Management, Set-up, Analyzer Connections, Host Interface Communications, Communication with Line Control Software, Sample Routing Logic, Sample Storage, Error Recovery" completed and passed. This implies the software functions as intended and supports the system's overall operation for sample processing and immunoassay integration. |
| System Operations: The overall system, including new hardware components (e.g., increased throughput, new control panel, more modules), processes samples reliably and correctly. | "System verification and validation testing of: System Functions, System operations, Maintenance, Error conditions, Error codes, Problem description and solution in the system instructions for use" completed and passed. This indicates that the integrated system operates as designed, handles various operational scenarios, and maintains user guidance for errors. The comparison table confirms improved throughput (1200 tubes/hour vs. 450 tubes/hour) and enhanced features (e.g., touch screen, improved cybersecurity, mixed tube sizes, dual aliquots, more centrifuges). |
| Assay Performance Maintenance: The performance of the integrated Access Immunoassays (Ferritin, Folate, HYPERsensitive hTSH, Vitamin B12) is not adversely affected by the Power Express system. | The document states, "Based on the risk analysis, the modifications to the Power Processor did not introduce any new risks to the performance of the assays through the chemistry analyzer connections; therefore there was no requirement for Verification and Validation Testing." This implies that the prior proven performance of these assays when run on the predicate system is maintained, and no new studies were deemed necessary to re-verify assay performance due to the nature of the system modifications. The device "functions as intended, meeting the requirements of the design specifications." |
| Safety and Effectiveness: The Power Express is as safe and effective as the predicate device. | "Performance testing of the device demonstrates that the device functions as intended... The changes to the device do not constitute a new intended use and any differences in technological characteristics have been tested to demonstrate that the device is as safe and effective as the predicate and do not raise different questions of safety and effectiveness." |
2. Sample sized 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 sample sizes for test sets in the context of clinical or performance data for the assays themselves. The testing described is primarily software and system verification and validation (V&V). These are typically internal engineering tests rather than studies involving patient samples in a clinical setting with formal sample sizes as understood in clinical trials.
- Sample Size for Test Set: Not specified, as the testing was primarily V&V of the automated system's components and software.
- Data Provenance: Not applicable in the context of system V&V. This would typically be relevant for clinical studies involving patient data. This was internal Beckman Coulter testing.
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)
This is not applicable to the type of V&V testing described. "Ground truth" in this context would likely refer to expected system behaviors, software outputs, or known operational parameters, which would be established by the device's design specifications and engineering teams, rather than by external clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert opinions on diagnosis or outcome. For system V&V, "adjudication" would be a matter of comparing test results against predefined functional requirements and expected outputs, often automated or reviewed by a single test engineer or a team.
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. An MRMC study is relevant for imaging devices or diagnostic tools where human interpretation is involved. The Power Express is an automated sample processing system and immunoassay platform; its function is to prepare samples and run assays, not to assist human interpretation of complex data in the way AI assistance might.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described is effectively "standalone" for the automated system. The Power Express system, as an automated sample handling and processing system, operates without direct human intervention in its core tasks (centrifugation, decapping, sorting, routing, pipetting, running assays on connected instruments). The performance data mentioned refers to the verification and validation of this automated system's functionality and software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the verification and validation (V&V) described would be the design specifications and functional requirements of the Power Express system. This includes:
- Expected software behaviors and outputs.
- Correct execution of mechanical tasks (e.g., decapping, sorting, pipetting).
- Correct communication protocols with connected instruments and the LIS.
- Adherence to performance metrics like throughput.
- The known performance characteristics of the integrated commercial assays (Ferritin, Folate, hTSH, Vitamin B12) which were previously established and not re-evaluated.
8. The sample size for the training set
Not applicable. The Power Express is an automated sample processing system, not an AI or machine learning model that requires a "training set" of data. The software within the system is likely rule-based or deterministic, rather than learned.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.