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The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, and rinse solutions to that blood smear.

The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The DxH SMS consists of a slidemaking module, a slidestaining module, and a specimen transport module precisely integrated to provide process control, slidemaking and staining, and cassette or single-tube delivery of specimens. The DxH SMS processes patient specimens and sends status data to the System Manager.

The System Manager:

• Controls processes, such as making and staining blood smears, and diagnostic procedures.
• Manages data, such as test ordering, LIS interface, and logging.

The System Manager resides on a Personal Computer (PC) based workstation running system application specific software. The PC is connected to the DxH SMS via an Ethernet connection. The System Manager provides data management and storage, provides test order management, quality control functionality, diagnostics and maintenance procedures. User interaction is provided via touch screen, keyboard and mouse.

The provided document is a 510(k) premarket notification for a design change to the UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System. This submission is a "Design Change Special 510(k) - Corrective Action Being Effected Submission," meaning the primary purpose is to address a field action (a reported fire within a Stainer module).

Therefore, the document explicitly states that performance testing is not required to demonstrate acceptance criteria for its intended use because the design changes do not impact the intended use or performance claims of the DxH SMS (Page 5, "Comparison to Predicate"). The changes are risk control measures.

Given this, much of the requested information regarding acceptance criteria and performance studies is not applicable or not provided in this specific 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test set sample size: Not applicable for performance. Design and software verification testing was performed (Page 5), but details on the "sample size" of units or scenarios tested are not provided in this summary.
• Data provenance: Not explicitly stated, but given it's a field action by Beckman Coulter, Inc. (a US company), and the submission is to the US FDA, the internal testing would likely be performed by the manufacturer. The initial report of fire was from a "customer's instrument" (Page 4), implying real-world data led to the corrective action.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This submission focuses on design and software verification related to a safety issue, not clinical performance requiring expert ground truth.

4. Adjudication method for the test set

• Not applicable. This submission focuses on design and software verification related to a safety issue, not clinical performance comparison.

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. This device is an automated slidemaker stainer, not an AI-assisted diagnostic device for human readers. An MRMC study is not relevant to this device's function or the nature of this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable in the context of clinical performance. The device's function is automated slide preparation and staining. The design changes are focused on mitigating safety risks in its automated operation.

7. The type of ground truth used

• Not applicable for clinical performance. The "ground truth" for this submission was the confirmed report of a fire within the Stainer module, which initiated a root cause analysis and led to design changes to mitigate identified failure modes.

8. The sample size for the training set

• Not applicable. This device does not appear to involve machine learning, and therefore, a "training set" in that context is not relevant.

9. How the ground truth for the training set was established

• Not applicable, as there is no apparent training set for machine learning.

Summary of the Study (as described in the 510(k) summary provided):

This 510(k) submission describes design control activities for a corrective action to the UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System. The study performed was design and software verification testing (Page 5).

• Purpose: To implement additional risk control measures to mitigate potential failure modes associated with a reported fire within the Stainer module of a customer's instrument.
• Methodology: Design control activities based on risk analysis. Acceptance criteria were set to maintain the efficiency and safety of the device. Testing included:
  • Design verification testing
  • Temperature testing
  • Installation testing
• Conclusion: The design changes applied "do not impact the intended use or performance claims of the DxH SMS" (Page 5) and do not alter the device's control mechanism, operating principle, energy type, environmental specifications, ergonomics, dimensional specifications, or packaging (Page 6). The updated device is considered substantially equivalent in terms of safety and effectiveness to the predicate device.

Key takeaway from the document: This 510(k) is about safety improvements and confirming that these changes do not negatively impact the already cleared performance, rather than providing new performance data against clinical acceptance criteria.

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The UniCel® DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

The UniCel® DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types:

Whole Blood (venous and capillary) - WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF

Pre-Diluted Whole Blood (venous and capillary) - WBC, RBC, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV

Body Fluids (cerebrospinal, serous and synovial) - TNC and RBC

The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The DxH 800 and DxH SMS form a family of integrated and interactive modular products that are scalable to meet the specific laboratory workflow and workload needs. Currently these products are offered as stand-alone devices only.

DxH 800: The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a Complete Blood Count (CBC), Leukocyte Five-part Differential (Diff), Reticulocyte (RET), Nucleated Red Blood Cell (NRBC) on whole blood, Total Nucleated Count (TNC) and Red Blood Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial)

DxH SMS: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The upgrade of these devices with software v3.0 will allow for these stand-alone devices to be configured into five workcell configurations through physical and virtual connections. Physically, the instruments are connected via hardware and the virtual connection is accomplished by means of the new control system software that provides integrated process control, data consolidation and sample transport to the various instruments in the workcell in order to facilitate and improve laboratory efficiency. This will yield a total of seven product configurations, including:

Stand-alone DxH 800 with software v3.0
Stand-alone DxH SMS with software v3.0
Five customizable workcell configurations comprised of DxH 800 and DxH SMS with software v3.0
DxH 801 - one DxH 800 + one DxH SMS
DxH 1600 two DxH 800
DxH 1601 two DxH 800 + one DxH SMS
DxH 2400 three DxH 800
DxH 2401 three DxH 800 + one DxH SMS

These workcell configurations allow for increased system efficiencies through workload balancing between available instruments within the workcell, and automated pass through processing of selected slide preparation and stain test orders.

This document describes the 510(k) premarket notification for the UniCel DxH 800 and DxH Slidemaker Stainer Coulter Cellular Analysis System, specifically referring to the update to software version 3.0.

Here's an analysis of the acceptance criteria and supporting studies, as per your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance characteristics and testing results rather than explicit "acceptance criteria" in a numerical or categorical format within a single table. It states that the device "meets the performance requirements." Based on the studies summarized, the implied acceptance criterion for each study is that the device demonstrates compliance with the respective performance requirement.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the various performance tests (e.g., for measurement procedure comparison, imprecision, linearity, carryover, slide quality).

The data provenance is not explicitly detailed regarding country of origin or whether it was retrospective or prospective. However, the studies are described as "Verification" or "Evaluation" and refer to "patient samples," implying that the testing was conducted with biological samples in a laboratory setting. The predicate device (v2.0) was manufactured by Beckman Coulter, suggesting the studies would likely be linked to their research and development activities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For the DxH SMS, the reference method is "Manually prepared blood films per the manual wedge-pull film technique as described in CLSI H20-A2," which implies human expert review, but the number and qualifications of these experts are not specified.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. For a device like an automated differential cell counter and slidemaker/stainer, ground truth is typically established against established manual methods and/or expert morphological review, but the specific adjudication process is not detailed.

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

The document describes an automated hematology analyzer and slidemaker/stainer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with AI assistance is not applicable and was not performed or reported. The studies evaluate the device's technical performance against a predicate device or established manual methods.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are for the standalone performance of the UniCel DxH 800 and DxH SMS devices. The document focuses on the device's ability to accurately enumerate and identify blood parameters and prepare quality slides directly, without an explicit human-in-the-loop component being evaluated for its performance metrics. The performance characteristics compare the device's outputs to a predicate device (DxH 800 v2.0) or a manual reference method (for DxH SMS), assessing the algorithm's accuracy in a standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of ground truth used varies by the study:

• For the UniCel DxH 800 (measuring parameters like WBC, RBC, etc.): The ground truth for bias evaluation was established by comparison against a predicate device (UniCel DxH 800 Software 2.0), which itself would have been previously validated against established methods. The guidance documents (CLSI H26-A2, EP9-A3) also imply accepted reference measurement procedures.
• For the UniCel DxH Slidemaker Stainer (DxH SMS): The ground truth for slide quality was established against the manual wedge-pull film technique as described in CLSI H20-A2. This CLSI standard is likely considered the gold standard for manual blood film preparation, implying that the "ground truth" for slide quality aligns with the criteria outlined in that standard, which would typically be assessed by trained laboratory professionals.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. This type of regulatory submission (510(k)) for an automated hematology analyzer typically focuses on verification and validation studies on a test set, demonstrating equivalence to an existing device or method. If machine learning was used in the development of the algorithms, information about the training set might be proprietary or not deemed necessary for this level of regulatory submission, especially if the changes are primarily integration and software.

9. How the Ground Truth for the Training Set was Established

As no information on a specific "training set" is provided, how its ground truth was established is not detailed in this document.

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