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The BD FACSTM Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II flow cytometry systems.

Pipetting blood, reagents and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems:

• . BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes
• BD Multitest IMK Kit with or without BD Trucount Tubes .
• BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
• BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes

For in vitro diagnostic use.

The BD FACS Sample Prep Assistant III is a microprocessor-controlled pipetting and diluting system which automatically prepares whole blood samples using the lyse / nowash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCanto flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.

The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

The provided text describes the BD FACS Sample Prep Assistant III (SPA III) device and its performance studies. However, it does not contain detailed acceptance criteria, specific reported device performance metrics with numerical values, sample sizes for test sets, data provenance, information about experts for ground truth, adjudication methods, details of comparative effectiveness studies (MRMC), or specifics about training sets.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (BD FACS Sample Prep Assistant II) through high-level study results.

Here's an attempt to answer the questions based only on the provided text, with clear indications of what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Missing - Not explicitly stated in the document)

The document states that the SPA III demonstrated performance "within specification" or "equivalent performance" in various studies, implying that there were pre-defined acceptance criteria. However, the specific numerical or qualitative criteria themselves are not provided.

Reported Device Performance

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

• Sample Size for Test Set: Not specified. The "Accuracy" study mentions "Using Patient Samples," but the number of samples is not given.
• Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.

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

• Not applicable. This device is an automated sample preparation system for flow cytometry, not an AI/CADe device that interprets images or diagnoses conditions which would typically require expert ground truth.

4. Adjudication Method for the Test Set

• Not applicable for this type of device. The studies relate to the automated preparation process's accuracy, precision, and carryover, not diagnostic interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic aids where human readers interpret cases. The SPA III is a sample preparation accessory.

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

• Yes, the performance studies (Accuracy, Precision, Carryover) evaluated the standalone device (SPA III with the BD FACSCanto system) without explicit human intervention in the preparation process itself. The "human-in-the-loop" concept is not directly applicable here as it's an automated lab instrument, not a diagnostic interpretation tool.

7. The Type of Ground Truth Used

• For the Accuracy study, the ground truth was based on "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, CLSI document EP9-A2." This implies comparison against an established reference method or the predicate device's performance. The specific nature of this "ground truth" (e.g., gold standard manual method, results from the predicate device) is not explicitly detailed beyond citing the CLSI guideline.
• For Precision and Carryover, the ground truth implicitly refers to pre-defined "specifications" for these performance characteristics, as outlined in the cited CLSI and FDA guidelines.

8. The Sample Size for the Training Set

• Not specified. This device is a hardware and software system for automated sample preparation. It is unlikely to involve a "training set" in the machine learning sense for building a diagnostic algorithm. Its function relies on programmed protocols, not learned patterns from data.

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

• Not applicable, as there is no indication of a "training set" for an AI/ML algorithm.

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