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MDx-Chex™ for BC-GN is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of Gram-Negative bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GN Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive Control: Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Pseudomonas aeruginosa, Species: Acinetobacter spe., Citrobacter spp., Enterobacter spp., Proteus spp.; antimicrobial resistance genes: CTX-M, IMP, KPC, NDM, OXA and VIM. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.

MDx-Chex™ for BC-GN is a quality control kit consisting of positive and negative controls for the Luminex VERIGENE® Gram-Negative Blood Culture Test (BC-GN). The MDx-Chex™ for BC-GN Positive Control is positive for pathogens and resistance mechanisms in the VERIGENE BC-GN test (See Table 1). The MDx-Chex™ for BC-GN Negative Control is negative for pathogens and resistance mechanisms in the VERIGENE BC-GN test. Each control mix also controls for blood and blood culture media components that have been identified is inhibitors to DNA hybridization assays, namely hemoglobin, leukocyte DNA, and anticoagulants.

The MDx-Chex™ for BC-GN quality control kit contains stabilized blood components, blood culture media components, and inactivated, intact microorganisms resulting in a full-process, cellular-based control for the Luminex VERIGENE BC-GN panel. Use of full-process cellular controls are necessary to evaluate the entire analytical process, including sample lysis, nucleic acid isolation, DNA hybridization detection, and analysis, as well as the impact of inhibitors present in blood culture samples and preanalytical variables. Routine use of full process quality controls can help identify variations in the test system that can lead to incorrect results.

The provided document describes the performance of the MDx-Chex™ for BC-GN device, a quality control material, rather than an AI/ML medical device for diagnosis or prediction. Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC comparative effectiveness, standalone performance, training set details) are not applicable to this type of device and study.

However, I can extract the acceptance criteria and reported device performance from the provided text for the relevant studies.

Acceptance Criteria and Device Performance

The general acceptance criterion for all studies (Multi-Site Precision, Single-Site Precision, Lot-to-Lot Reproducibility, Closed-Vial Stability, and Shipping Stability) was ≥ 90% agreement with expected results. For Matrix Effect studies, the acceptance criteria was also ≥ 90% agreement for positive detection of analyte for positive controls and ≥ 90% agreement for negative detection of analyte for negative controls.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Multi-Site Precision:

  • Sample Size: 10 positive control samples and 10 negative control samples for each of 3 MDx-Chex™ for BC-GN lots, tested across 3 sites, for a total of 30 samples per control type per lot. This resulted in 90 runs per control type (positive/negative) and 180 total runs for data analysis.
  • Data Provenance: Not explicitly stated, but implies a prospective study design conducted by the manufacturer (Streck) for regulatory submission.

• Single-Site Precision (Repeatability):

  • Sample Size: 20 samples per control type (positive and negative) for each of 3 MDx-Chex™ for BC-GN lots, tested over 20 days. This resulted in 120 runs (20 runs per control type per lot) for data analysis.
  • Data Provenance: Not explicitly stated, but implies a prospective study design conducted by the manufacturer (Streck).

• Lot-to-Lot Reproducibility:

  • Sample Size: 10 positive and 10 negative control tubes per MDx-Chex™ for BC-GN lot (3 lots), resulting in 30 data points per control type (60 total data points).
  • Data Provenance: Not explicitly stated, but implies a prospective study design conducted by the manufacturer (Streck).

• Within-Run Precision:

  • Sample Size: 10 tests for each positive and negative control tube from one MDx-Chex™ for BC-GN lot (total of 20 tests).
  • Data Provenance: This data was sourced from the Day 60 (2C) closed-vial stability data.

• Closed-Vial Stability and Shipping Stability:

  • Sample Size: 20 positive and 20 negative control samples per MDx-Chex™ for BC-GN lot (3 lots), collected at different timepoints and stored at different temperatures. For shipping: one lot (RPL #22355) with 20 samples per control type for each simulated shipping profile.
  • Data Provenance: Not explicitly stated, but implies a prospective study design conducted by the manufacturer (Streck).

• Matrix Effect:

  • Sample Size: Simulated positive MDx-Chex™ for BC-GN matrix (triplicate), simulated positive clinical sample (triplicate), simulated negative MDx-Chex™ for BC-GN matrix (triplicate), simulated negative clinical sample (triplicate). Total of 12 tests.
  • Data Provenance: Not explicitly stated, but implies a prospective study design conducted by the manufacturer (Streck).

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

Not applicable. This device is a quality control material for an in vitro diagnostic test. The "ground truth" is defined by the expected performance of the control material (i.e., whether it should be detected as positive or negative for specific pathogens/genes by the Luminex VERIGENE® BC-GN system). This "ground truth" is inherent to the control material's formulation and its intended reactivity with the target diagnostic system, not established by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As a quality control material, the "ground truth" is binary (positive/negative for specific targets) and is determined by the composition of the control and the design of the diagnostic test it monitors. There is no human adjudication process involved.

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. This is not an AI/ML diagnostic device, nor does it involve human readers or cases. It is a quality control material for an automated molecular diagnostic test.

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

The performance detailed is that of the quality control material when used "standalone" with the Luminex VERIGENE® Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) on Luminex VERIGENE® systems. The "algorithm" in this context refers to the Luminex VERIGENE® system itself, and the studies assess how well the control material performs within that system as expected. The control itself does not have an "algorithm."

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

The "ground truth" for these studies is the expected reactivity of the quality control material with the Luminex VERIGENE® BC-GN system.

• Positive Controls: Expected to be "Detected" for specific Gram-negative bacteria and antimicrobial resistance genes.
• Negative Controls: Expected to be "Not Detected" (buffered solution only).
  This ground truth is based on the known composition of the MDx-Chex™ for BC-GN control material.

8. The sample size for the training set

Not applicable. This device is a quality control material, not an AI/ML model that requires training data.

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

Not applicable. See point 8.

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MDx-Chex™ for BC-GP is intended for use as an external positive assayed control to monitor the performance of the qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes, by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE® systems. The MDx-Chex™ for BC-GP Positive and Negative Controls are composed of a buffered solution with stabilized erythrocytes and leukocytes in a matrix of blood culture media components. Positive bacteria: Staphylococcus aureus, Staphylococus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococus pyogenes, Enterococcus faecium, Streptococus faecium, Streptococus anginosus group; Species: Staphylococcus spp., Streptococcus spp.; antimicrobial resistance genes: mecA, vanA and vanB. Negative Control: buffered solution only. This product is not intended to replace manufacturer controls provided with the device.

MDx-Chex™ for BC-GP is a quality control kit consisting of positive and negative controls for the Luminex VERIGENE® Gram-Positive Blood Culture Test (BC-GP). The MDx-Chex™ for BC-GP Positive Control is positive for pathogens and resistance mechanisms in the VERIGENE BC-GP test (See Table 1). The MDx-Chex™ for BC-GP Negative Control is negative for pathogens and resistance mechanisms in the VERIGENE BC-GP test. Each control mix also controls for blood and blood culture media components that have been identified is inhibitors to DNA hybridization assays, namely hemoglobin, leukocyte DNA, and anticoagulants.

The MDx-Chex™ for BC-GP quality control kit contains stabilized blood components, blood culture media components, and inactivated, intact microorganisms resulting in a full-process, cellular-based control for the Luminex VERIGENE BC-GP panel.

Here's a breakdown of the acceptance criteria and the study used to prove the device meets these criteria, based on the provided text:

Device: MDx-Chex™ for BC-GP (Assayed Quality Control Material For Clinical Microbiology Assays)

Intended Use: To monitor the performance of qualitative detection of Gram-positive bacteria and associated antimicrobial resistance genes by the Luminex VERIGENE® Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on Luminex VERIGENE® systems.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for all performance studies is ≥ 90% agreement with expected results.

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

• Multi-Site Precision (Reproducibility):
  • Sample Size: 30 positive control samples and 30 negative control samples per lot (for each site, making a total of 90 positive and 90 negative samples across 3 sites for 1 lot, and 180 total runs per control type for all lots). The study used 3 lots, so effectively 30 positive and 30 negative tests per lot across 3 sites.
  • Provenanc: Not explicitly stated, but implies a prospective study conducted at 3 different sites as part of device validation.
• Single-Site Precision (Repeatability):
  • Sample Size: 20 samples per control type (positive and negative control tubes), 40 samples per MDx-Chex™ for BC-GP lot. Across 3 lots, this accumulated to 120 runs (20 runs per control type per lot across 3 lots).
  • Provenance: Not explicitly stated, but implies a prospective study conducted at a single site as part of device validation.
• Lot-to-Lot Reproducibility:
  • Sample Size: For the Lot-to-lot study, data from 10 positive and 10 negative control tubes per lot (30 data points per control type across 3 lots, totaling 60 data points). For the within-run precision, 10 tests for each positive and negative control tube from one lot (total of 20 tests).
  • Provenance: Not explicitly stated, but implies a prospective study.
• Closed-Vial Stability and Shipping Stability:
  • Sample Size: 20 positive and 20 negative control samples per MDx-Chex lot, collected at different data collection timepoints and stored at room (25°C) and refrigerated (2°C) temperatures. With 3 lots, this amounts to 60 positive and 60 negative total samples tested for each storage condition and time point. For shipping stability, one lot with 20 samples per control type for each simulated shipping profile.
  • Provenance: Not explicitly stated, but implies a prospective study.
• Matrix Effect:
  • Sample Size: Simulated positive MDx-Chex™ for BC-GP matrix and simulated positive clinical sample were tested in triplicate (3 samples each). Similarly, non-spiked simulated samples (negative controls) were tested in triplicate.
  • Provenance: Not explicitly stated, but implies a prospective study.

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

This device is an assayed quality control material for in vitro diagnostic tests. The ground truth (i.e., whether a control is 'positive' or 'negative' for specific pathogens/resistance genes) is inherent to the control material's design and formulation, not established by human experts interpreting results. The controls contain "inactivated, intact microorganisms" and specific resistance genes, and are designed to elicit a known positive or negative result on the target diagnostic system.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for studies where human interpretation or consensus is required to establish ground truth (e.g., image interpretation). For an in vitro diagnostic quality control material like MDx-Chex™ for BC-GP, the "ground truth" of what the control should detect is pre-defined by its composition. There is no human adjudication process described or expected. The results from the Luminex VERIGENE® system are compared directly to the expected outcome of the quality control material.

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 relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and assessing how AI assistance might improve human performance. MDx-Chex™ for BC-GP is a quality control material for an automated molecular diagnostic test (Luminex VERIGENE® BC-GP) and does not involve human interpretation in the same way. The studies focus on the performance and stability of the control material itself.

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

Yes, implicitly, the studies evaluate the "standalone" performance of the MDx-Chex™ controls when processed by the Luminex VERIGENE® System. Since the device is a quality control material, its "performance" is its ability to consistently produce the expected positive or negative results on the target instrument. The data presented demonstrates the consistency of these expected results. There's no "human-in-the-loop" component for the performance of the control material, other than operators performing the assay.

7. The Type of Ground Truth Used

The ground truth is pre-defined by the engineered composition of the quality control material.

• For the Positive Control, the ground truth is "Detected" for specific Gram-positive bacteria (e.g., Staphylococcus aureus, Enterococcus faecalis, Streptococcus pneumoniae) and antimicrobial resistance genes (mecA, vanA, vanB) that are intentionally included in the control.
• For the Negative Control, the ground truth is "Not Detected" because it is a buffered solution only, without the target microorganisms or resistance genes.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material, not an AI/machine learning algorithm that requires a training set. Its purpose is to monitor the performance of another diagnostic assay (Luminex VERIGENE® BC-GP), not to make diagnostic predictions itself.

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

Not applicable, as there is no training set for this device.

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MDx-Chex for BCID2 is intended for use as an external positive and negative assayed control to monitor the performance of the qualitative detection of yeast, Gram positive and Gram negative bacteria, as vell as snciated antimicrobial resistance genes, by the BioFire FilmArray Blood Culture Identification 2 (BCID2) Panel on FilmArray systems. Control 1 - GN: Gram negative bacteria: Acinetobacter colcacer in complex, Baceronides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella oxytoca, Klebsiella pneumats Jray, Proteus spp., Salmonella spp., Serratia marcescens, Heisseria vivoca, Neisseria meningitides, Poeudnonas aeruginosa, Stenotrophomonas matophilia; antimicrobial resistance genes: KPC, CTX-M, IMP, NDM, OXA-Ike, VIM, mcr- 1. Control 2 - GPY: Gram positive bacteria: Enterococcus face: 11, 27712-10, nr., iUDM, U.Steria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdumsis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes; yeast: Candida dhicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gatit; animicrobial resistance genes mecA/C and MREJ, vanA/B. This product is not intended to replace manufacturer controls provided with the device.

MDx-Chex for BCID2 Control 1 - GN is positive for certain pathogens and antimicrobial resistance genes in the FilmArray BCID 2 panel and negative for those contained in MDx-Chex for BCID2 Control 2 - GPY. MDx-Chex for BCID2 Control 2 - GPY is positive for the remaining pathogen and antimicrobial resistance genes and negative for those present in MDx-Chex for BCID2 Control 1 - GN (see Table 1 below). Each control mix also contains and controls for blood and blood culture media components that have been identified as PCR inhibitors namely hemoglobin, leukocyte DNA, and anticoagulants. MDx-Chex for BCID2 is a quality control containing stabilized blood components, blood culture media components, and inactivated microorganisms resulting in a full-process, cellular-based control for the BioFire BCID2 Panel. Use of full-process cellular controls are necessary to evaluate the entire analytical process, including sample lysis, nucleic acid isolation and purification, amplification, detection, and analysis, as well as the impact of PCR inhibitors and preanalytical variables. Routine use of full process quality controls can help identify variations in the test system that can lead to incorrect results.

This document describes the performance of a quality control material (MDx-Chex for BCID2) for a qualitative detection assay (BioFire FilmArray Blood Culture Identification 2 (BCID2) Panel). Therefore, the "acceptance criteria" and "device performance" are related to the ability of this quality control material to consistently produce expected positive and negative results when tested with the BCID2 panel, along with its stability under various conditions.

The provided document describes a series of performance studies for the MDx-Chex for BCID2 device. Since this is a quality control material and not a diagnostic device that interprets clinical images or data, many of the typical acceptance criteria and study design elements of AI/ML-based diagnostic devices (e.g., number of experts, adjudication methods, MRMC studies) are not applicable here.

Here's an analysis based on the information provided, focusing on the relevant criteria for a quality control material:

1. Table of Acceptance Criteria and the Reported Device Performance:

The acceptance criterion across all relevant studies (Multi-Site Precision, Single-Site Precision, Lot-to-Lot Reproducibility, Closed-Vial Stability, Open-Vial Stability, Shipping Stability) is "overall positive and negative percent agreement of ≥ 95%" (except for Lot-to-Lot Reproducibility which states "≥ 90%").

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

• Multi-Site Precision (Reproducibility):
  • Sample Size: 10 samples per control level (20 samples total per lot) were tested over 10 days at each of 4 sites. Three lots were used, totaling 240 expected results for positive agreement (4 sites * 20 samples/lot * 3 lots). The narrative indicates "230/240" for observed positive results and "239/240" for negative results (which means 240 expected negative results reported).
  • Data Provenance: Prospective. Collected internally at Streck (La Vista, NE) and externally at UNMC (Omaha, NE), Children's Hospital and Medical Center (Omaha, NE), and Mary Lanning Healthcare (Hastings, NE). All locations are in the USA.
• Single-Site Precision (Repeatability):
  • Sample Size: 20 samples per lot per level were tested by four operators over 20 non-consecutive days. Three lots were used. This totals 120 expected results for positive agreement (20 samples/lot/level * 2 levels * 3 lots, if pooling levels/lots for the single site precision table, or 2023 = 120 positive AND 120 negative). The table shows 114/120 for positive and 120/120 for negative.
  • Data Provenance: Prospective. Collected at Streck (La Vista, NE), USA.
• Lot-to-Lot Reproducibility:
  • Sample Size: 6 samples per control lot and level (12 total samples per lot). Three lots were tested. A total of 36 complete runs were generated. The tables show 12 expected results per lot for positive and negative agreements (12 expected positive results + 12 expected negative results, repeated for 3 lots).
  • Data Provenance: Prospective. Likely collected at Streck (La Vista, NE), USA, as it states "Data from the first 6 timepoints in the repeatability study above were also used".
• Closed-Vial Stability:
  • Sample Size: 10 samples per control lot and level. Three lots. Tested at Day 0 (baseline) and at least Day 61. For Day 0, 120 tubes were completed. For Day 61+, 60 tubes per storage condition (2-8°C and 20-25°C) across the three lots were tested.
  • Data Provenance: Prospective. Likely collected at Streck (La Vista, NE), USA.
• Open-Vial Stability:
  • Sample Size: Same as Closed-Vial Stability, 10 samples per lot per level, three lots, same time points.
  • Data Provenance: Prospective. Likely collected at Streck (La Vista, NE), USA.
• Matrix Effect:
  • Sample Size: Triplicate tests (3/3) for each matrix type (MDx-Chex positive, Clinical positive, MDx-Chex negative, Clinical negative).
  • Data Provenance: Prospective. Likely collected at Streck (La Vista, NE), USA.
• Shipping Stability:
  • Sample Size: Two sets of samples from one control lot were used. Ten samples of Control 1 and Control 2 were tested for each temperature profile (Summer, Winter). This results in 20 expected positive results and 20 expected negative results per temperature profile.
  • Data Provenance: Prospective. Likely collected at Streck (La Vista, NE), USA.

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

Not applicable. This is a quality control material where the "ground truth" is the expected positive or negative result for the specific analytes contained or not contained within the control sample, based on its formulation. The performance is assessed by how consistently the QC material produces these known results when run on the target diagnostic system (BioFire FilmArray BCID2 Panel).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As noted above, the "ground truth" is inherent to the formulation of the quality control material itself (i.e., it is designed to be positive for certain targets and negative for others). Where initial false results occurred, the "correct results upon a single retest" are noted, which implies a re-run of the test and confirms the expected outcome for the control. This is a standard practice in QC testing to ensure an isolated error vs. a systemic issue.

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. This is not an AI/ML diagnostic device for human interpretation. It's a quality control material for an automated molecular diagnostic assay.

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

The device (MDx-Chex for BCID2) is a physical control material. Its "standalone" performance is assessed by how accurately the BioFire FilmArray BCID2 Panel (the primary device it controls) identifies the known positive and negative components within the MDx-Chex material. The studies listed demonstrate this "standalone" performance of the control material with the primary diagnostic system. There is no "algorithm" per se being evaluated in terms of its diagnostic accuracy on clinical cases.

7. The type of ground truth used:

• Formulation-based Ground Truth: The ground truth for this quality control material is established by its known composition. The MDx-Chex for BCID2 Controls are manufactured to contain specific inactivated microorganisms and antimicrobial resistance genes (for positive results) or to be free of certain targets (for negative results), as detailed in Table 1 (pages 4-5).
• For the "Matrix Effect" study, "inactivated Streptococcus pneumoniae was spiked into the control matrix" and "into a BD BACTEC Plus Aerobic/F culture bottle with negative whole blood to simulate a clinical samples". The expected results are thus inherently known based on the spiking.

8. The sample size for the training set:

Not applicable in the conventional sense of training an AI/ML model for diagnostic purposes. This is a manufactured chemical/biological control product. Its "training" equivalent would be the R&D and manufacturing processes to ensure its consistent composition and stability. However, if looking for manufacturing lots/batches rather than a statistical training set: Most studies used three separately manufactured lots of the control material (Lot 20363, Lot 20366, Lot 21129) to demonstrate reproducibility and stability.

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

Not applicable as it's not an AI/ML model with a discrete training set. The "ground truth" for the characteristics of the product itself would be established through its design specifications, formulation, and in-house characterization during manufacturing.

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Cell-Free DNA BCT is a direct-draw venous whole blood collection device intended for the collection, and transport of venous whole blood samples for use in conjunction with cell-free DNA next-generation sequencing liquid biopsy assays that have been cleared or approved for use with samples collected in the Cell-Free DNA BCT device.

Cell-Free DNA BCT is a sterile, single use, direct-draw blood collection tube comprised of 3 components (i.e. glass tube with rubber stopper, anticoagulant, and cell preservatives). The blood collection tube manufactured with USP Type III glass containing cerium oxide (to prevent color change associated with gamma irradiation). Each tube includes 200 uL ± 10% of liquid reagent composition includes an anticoagulant K3EDTAand a preservative.

The device is intended to be placed inside a tube holder or an adaptor that contains a needle designed to pierce the tube closure and allow blood to flow into the tube. Once the vein has been penetrated blood collection needle or a blood collection set), the tube is pushed into the holder, and the blood enters the tube. Once a tube has drawn the appropriate amount of blood (10 mL), it is disengaged from the holder and inverted 10 times to mix the blood. The specimen is then transported to the lab for plasma isolation and extraction of cfDNA.

This response describes the acceptance criteria and study details for the Cell-Free DNA BCT device, as outlined in the provided text.

Acceptance Criteria and Device Performance

The provided document does not explicitly present a consolidated table of acceptance criteria with corresponding reported device performance for all studies. Instead, acceptance is implied through successful outcomes of various analytical performance studies. The core acceptance criteria revolve around the ability of the Cell-Free DNA BCT to preserve cfDNA concentration, size, and integrity, and to maintain variant call concordance (Positive Percent Agreement - PPA and Negative Percent Agreement - NPA) in comparison to a reference or within defined variations. Specific numerical acceptance thresholds are often redacted (marked as "(b) (4)") in the provided text.

Here’s a table summarizing the reported device performance based on the described studies, with acceptance implied by the positive conclusions of the FDA.

Study Details

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

• Repeatability (Within-lot variability): 33 patients with advanced stage solid tumors. Each subject provided blood for 4 Cell-Free DNA BCTs from a single lot. Prospective data collection.
• Reproducibility (Lot-to-lot variability): 30 patients with advanced stage solid tumors. Blood was drawn into Cell-Free DNA BCTs representing 3 different lots. Prospective data collection.
• Shelf-life: 30 healthy subjects. Blood collected into tubes tested at various timepoints (T0, T8.5, T12.5, T18.5, T24.5 months) and pre-collection storage temperatures (2, 22, or 30°C). Prospective data collection.
• Preservative interference: 12 subjects with advanced stage solid tumors. Three venous whole blood specimens collected into candidate devices (reference, 2x Preservative A, 2x Preservative B). Prospective data collection.
• Incomplete Mixing: Patients with advanced stage solid tumors (specific number not given, but likely similar to other studies, potentially 12 from context of preservative study). Three Cell-Free DNA BCTs per subject (10, 5, or 15 inversions). Prospective data collection.
• Short Draw: 15 subjects with advanced stage solid tumors. Three Cell-Free DNA BCTs per subject, reflecting normal, 2x Reagent (5mL blood), or (b)(4) Reagent ((b)(4) blood) fill volumes. Prospective data collection.
• cfDNA Stability (device aged): Patients with advanced stage solid tumors (specific number not given). Four Cell-Free DNA BCTs per patient (two reference from youngest lot, one from 8 months, one from 17 months post-manufacture). Prospective data collection.
• Post-Collection Storage of Venous Whole Blood: 30 healthy subjects. Eight tubes per donor (4 K2EDTA, 4 Cell-Free DNA BCTs) tested under various storage conditions (Day 0 immediate, Day 7 at (b)(4) or (b)(4)). Prospective data collection.
• Pre-collection storage and Post-collection storage impacts on Guardant360 CDx assay performance: Whole blood specimens from patients with advanced stage solid tumors (specific number not given). Cell-Free DNA BCTs manufactured at various time points (T0, T3.2, T7.2, T12.2, T18.2, T24.2 months) and BCTs stored at extreme temperatures before collection. Plasma isolated after 1 or 7 days post-collection. Prospective data collection.
• Cell-Free DNA BCT vs. K2EDTA BCT Concordance: 59 patients (non-small cell lung cancer Stage III or IV, pre-screened for CDx variants). Two K2EDTA BCTs and two Cell-Free DNA BCTs collected per patient. Three tubes were processed for the study (one K2EDTA, two Cell-Free DNA BCTs). Prospective data collection. All data appears to be US (country of origin for Guardant Health) and primarily prospective, involving clinical subjects or healthy donors for specific studies.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth. For studies involving variant call concordance, the "ground truth" for the performance metrics (PPA, NPA, APA, ANA) would be derived from the Guardant360 CDx assay (P200010), which is a cleared/approved next-generation sequencing liquid biopsy assay. The internal analysis of these assay results would be performed by qualified laboratory personnel at Guardant Health, but "experts" in the sense of independent clinical reviewers for ground truth are not mentioned as part of these specific analytical studies. The ground truth is the molecular profile determined by the Guardant360 CDx assay itself.

4. Adjudication Method for the Test Set

Adjudication methods for establishing ground truth from multiple readers/methods are not applicable (N/A) in this context. The "ground truth" for each specific experiment is defined by the results obtained from the reference condition or the established Guardant360 CDx assay. Variant call agreements (PPA, NPA, APA, ANA) are calculated by comparing results from different conditions to each other or to a pre-defined reference condition within the study design, not by external expert adjudication of conflicting results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was described. This device is a blood collection tube, and the studies focus on its analytical performance and impact on downstream assay results, not on human reader interpretation of diagnostic images or data. The impact is assessed on the molecular analysis carried out by the Guardant360 CDx assay.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, all presented performance studies are "standalone" in the sense that they evaluate the analytical performance of the device (Cell-Free DNA BCT) in preserving cfDNA and enabling accurate results from the Guardant360 CDx assay. The performance metrics (PPA, NPA, APA, ANA, cfDNA concentration, integrity) are objective measurements derived from the molecular assay, not contingent on human interpretation in the loop with the device itself. The Guardant360 CDx assay itself is an "algorithm only" type of test in that its result is a molecular profile.

7. Type of Ground Truth Used

The primary type of "ground truth" used across these studies is the molecular profile/variant calls generated by the Guardant360 CDx assay (P200010).

• For repeatability and reproducibility, variant calls from replicate tubes serve as a comparison point.
• For preservative, mixing, and short draw interference studies, variant calls from a reference condition (e.g., normal preservative, 10 inversions, full draw) serve as the ground truth against which experimental conditions are compared using PPA and NPA.
• For shelf-life and cfDNA stability studies, cfDNA concentration, size, integrity, and variant call concordance (PPA/NPA) against a Day 0 or youngest-lot reference are used.
• For method comparison, concordance is established against the K2EDTA BCT, which was used to acquire samples for the clinical studies supporting Guardant360 CDx. This implies K2EDTA's performance is currently accepted, making it a de-facto reference.

8. The Sample Size for the Training Set

The document describes performance evaluation studies and does not mention "training sets" as it would for a typical AI/ML algorithm development. This device is a blood collection tube with specific chemical and physical properties aimed at sample preservation, not a diagnostic algorithm that requires training. Therefore, N/A for training set sample size.

Given that the performance is assessed using the Guardant360 CDx assay, it can be inferred that the assay itself would have its own extensive training and validation datasets, but these are not for the Cell-Free DNA BCT device specifically.

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

As noted above, there is no "training set" for the Cell-Free DNA BCT device. The performance is based on analytical studies. N/A.

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UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™ Automated Urine Particle Analyzer: Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050 fully-automated integrated urine analyzer: utilizing the Aution sticks 10EA Reagent strips: Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Reading of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips, and the Siemens Clinitest® hCG Pregnancy test.

The list of assayed parameters includes:

Sysmex® UF-1000i™: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals

Arkray AU-4050: RBC(/uL), WBC(/uL), Epithelial (/uL), Cast (/uL), Bacteria (/uL), Crystals

Arkray AU-4050 with Aution sticks 10EA Reagent strips : Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), pH (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Turbidity (As Measured)

Siemens ® Clinitek Atlas with Atlas 10 Reagent Pak: Glucose (mg/dL), Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured), Color (As Measured), Clarity (As Measured)

Siemens Clinitek Status System line with Multistix 10SG Reagent Strips: Glucose (mg/d); Bilirubin (As Measured), Ketones (mg/dL), Specific Gravity (As Measured), Blood (As Mesured), pH (As Measured), Protein (me/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As Measured)

Siemens Multistix 10SG Reagent Strips: Glucose (mg/dL), Bilirubin (As Measured), Specific Gravity (As Measured), Blood (As Measured), pH (As Measured), Protein (mg/dL), Urobilinogen (EU/dL), Nitrite (As Measured), Leukocytes (As measured)

Siemens Clinitest hCG Pregnancy Test Cassette: Pregnancy hCG (As Measured)

Manual Confirmatory Testing: Refractive Index (nD)

UA-Cellular® Complete is a three-level, in-vitro diasis control that contains the following: stabilized mammalian red blood cells and white blood cells, stabilized bacteria, and simulative medium. Analyte levels are adjusted with appropriate chenicals. The product is packaged in a 4 oz. amber plastic bottle with a foil-lined flip-top cap. The product must be stored at 2-10°C.

The provided text describes the UA-Cellular® Complete device, a quality control material for urinalysis instruments, and studies performed to demonstrate its performance and stability.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for each specific parameter (e.g., RBC count, glucose level). Instead, it describes acceptance as:

• Cellular study: "acceptable if the mean of each run was within the acceptable range of control."
• Chemistry study: "considered acceptable if it was in agreement with the assigned range/concentration."

The reported device performance is broadly stated as:

• "All data collected fell within the acceptance criteria established for each instrument."
• "Study results show UA-Cellular Complete to be consistently equivalent to the predicate products, and stable for the entire product dating."
• "UA-Cellular Complete is a safe and effective product, which fulfills its intended use when used as instructed in the Instructions for Use."

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

The studies primarily focus on precision and stability testing of the quality control material itself, rather than a clinical trial with patient samples as a "test set" in the typical sense for a diagnostic device.

Multi-Site Precision Study (Test Set equivalent for evaluating the QC material's performance):

• Cellular Instrument Study (Arkray AU4050): Conducted across 3 instruments at three different sites. A single operator at each site ran each lot and level of control for 5 days, 2 runs per day, and 3 replicates per run.
• Chemistry Instrument Study: Not explicitly stated as a number of samples but implied by the different instruments/methods used. "Each site was instructed to run at minimum one 10-run."
• Data Provenance: Not explicitly stated as country of origin, but described as "Multi-Site," indicating data from multiple locations, likely within the US, given the FDA submission. The studies are prospective as they were conducted to substantiate the product performance.

Single-Site Precision Study:

• Cellular Instrument Study (UF-1000 and Arkray AU4050): Conducted with three separately manufactured lots of control. The "20x2x2 model" was followed: Two vials of control were used for each testing interval, and each vial of control was run in duplicate. This means 20 days x 2 vials x 2 replicates = 80 measurements per lot/level. Data was collected internally at Streck.
• Chemistry Instruments/Manual Methods Study: Conducted with three separately manufactured lots of control. The "20x2x2 model" was followed as above. Data was collected internally at Streck.
• Data Provenance: Internally collected at Streck. Prospective.

Open-Vial Stability Study:

• Cellular Instrument Study (UF-1000 and Arkray systems): Conducted with three separately manufactured lots of control. One vial of control per level from each lot was analyzed over 30 days plus one additional time point. Four replicates were taken during each testing event. Data was collected internally with one operator.
• Chemistry Instrument Study: Conducted with three separately manufactured lots of control for each representative instrument/method. One vial of control per level from each lot was analyzed over 30 days plus one additional time point. Four replicates were taken during each testing event.
• Data Provenance: Internally collected at Streck. Prospective.

Closed-Vial Stability Study:

• Cellular Instrument Study (UF-1000 and Arkray systems): Conducted with three separately manufactured lots of control. Two vials of control per level from each lot were analyzed in duplicate over 100 days plus one additional time point. Four data points were collected at each testing event. Data was collected internally with one operator.
• Chemistry Instrument Study: Conducted with three separately manufactured for each representative instrument/method. One vial of control per level from each lot was analyzed over 100 days plus an additional time point. Four replicates were taken during each testing event.
• Data Provenance: Internally collected at Streck. Prospective.

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

This device is a quality control material, not a diagnostic device that interprets patient data. Therefore, the concept of "ground truth" established by experts (like radiologists for image interpretation) for a "test set" of patient cases is not directly applicable.

Instead, the "ground truth" for this product is the assigned range/concentration of the analytes within the control material, determined by the manufacturer through rigorous characterization and validation processes not explicitly detailed in this summary (though typically involves reference methods and multiple testing events). The studies described here verify that the device performs within those pre-defined ranges.

4. Adjudication Method for the Test Set

Not applicable in the context of this type of device and study. The studies assess the control material's performance against its own established ranges/concentrations, not an interpretation of patient data requiring adjudication.

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 relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases, and the study aims to show how AI assistance affects their diagnostic performance compared to reading without AI. UA-Cellular® Complete is a quality control material used to assess the performance of laboratory instruments, not for direct human interpretation of patient data or for AI-assisted diagnostic tasks.

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

Yes, the studies described are essentially "standalone" in the sense that they evaluate the performance of the UA-Cellular® Complete material on automated instruments without active human interpretive intervention for each "case." The human role is in performing the tests according to protocols and analyzing the resulting quantitative data.

7. The Type of Ground Truth Used

The ground truth for these studies is the assigned range/concentration for each analyte (e.g., RBC, glucose, pH) within the UA-Cellular® Complete material, established by the manufacturer. The studies then demonstrate that the device, when run on various instruments, consistently produces results that fall within these pre-defined acceptable ranges. This is an intrinsic property of the quality control material itself, rather than an external reference standard like pathology or outcomes data from patients.

8. The Sample Size for the Training Set

This document describes performance and stability studies for a quality control material. It does not mention a "training set" in the context of machine learning or AI models. The device itself (UA-Cellular® Complete) is a physical control material, not an algorithm that requires training data.

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

Not applicable, as there is no "training set" for this device.

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XN CAL is used for the calibration and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. Assayed parameters include:

WBC (10^3/μL), RBC (10^6/μL), HGB (g/dL), HCT (%), PLT (10^3/ μL), and RET (%)

XN CAL contains the following: stabilized red blood cell component(s), stabilized white blood cell component(s), stabilized platelet component(s), and stabilized nucleated red blood cell component(s) in a preservative medium.

The medical device in question is the XN CAL, a calibrator for cell indices used with Sysmex XN series analyzers. The provided text, a 510(k) summary, describes its intended use, comparison to a predicate device, and results of performance testing.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it describes general study objectives and conclusions about reproducibility and stability. The "reported device performance" is given as conclusions derived from tests.

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

The document does not specify the exact sample sizes (number of measurements, number of vials, etc.) used for the multi-site precision, single-site precision, open-vial stability, or closed-vial stability studies.

The data provenance is not explicitly stated regarding country of origin. The studies are described as "Multi-Site" and "Single-Site," suggesting they were conducted at different locations. The studies were likely prospective as they were conducted to substantiate product performance claims for the 510(k) submission.

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

This information is not provided in the document. As XN CAL is a calibrator for automated hematology analyzers, "ground truth" would typically refer to the accurately assigned values for the calibrator, which are then used to calibrate the analyzers. This process usually involves highly controlled laboratory methods rather than expert human interpretation in the way, for example, a radiograph would be interpreted.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of medical images or data is involved and discrepancies need to be resolved. For a calibrator, performance is measured objectively against established reference values or reproducible results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results (e.g., radiology AI), not for a laboratory calibrator.

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

This question is not directly applicable in the context of XN CAL as it is a physical calibrator solution, not an algorithm. Its performance is evaluated based on its measured values and stability when run on the specified analyzers, which are themselves automated devices. The "algorithm" here would be the instrument's measurement algorithm, and the calibrator helps ensure that algorithm produces accurate results.

7. The Type of Ground Truth Used

The concept of "ground truth" for a calibrator usually refers to the assigned or reference values for the parameters (WBC, RBC, HGB, HCT, PLT, RET) within the calibrator. These values are established through rigorous, highly accurate, and often multi-replicate testing using reference methods or predicate devices, ensuring their accuracy. The document implies that the "intended use" and "consistently reproducible" nature suggest these established values serve as the ground truth.

8. The Sample Size for the Training Set

This information is not provided and is not applicable for this device. The XN CAL is a physical calibration material, not a machine learning or AI algorithm that requires a "training set" of data. The performance studies described (precision, stability) are a form of verification/validation, not model training.

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

This information is not applicable as there is no "training set" in the context of this device.

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XN CHECK is used for control and calibration verification of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

RBC(106/μL), HGB(g/dL), HCT(%), MCV(fL), MCH(pg), MCHC(g/dL), PLT(103/μL), PLT-F*(103/μL), RDW-SD(fL), RDW-CV(%), MPV(fL), WBC(103/uL), NEUT(%), LYMPH (%), MONO(%), EO(%), BASO(%), IG(%), NEUT#(103/pL), LYMPH#(103/pL), MONO# (103/pL), BASO#(103/pL), IG#(103/ μL), IPF(%), IPF# (103/pL), RET#(106/μL), RET%, IRF%, RET-HE(pg), NRBC#* (100 WBC)

*Not Available on the XN-L.

XN CHECK™ is a three level hematology control the following: stabilized red blood cell component(s), stabilized white blood cell component(s) stabilized platelet component(s), and stablic on onnonent(s) in a preservative medium. The product is packaged in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided text is a 510(k) Summary for the XN CHECK™ hematology quality control mixture. It details the device's intended use, comparison to a predicate device, and conclusions from tests. However, it does not fully elaborate on the detailed acceptance criteria for each claimed parameter or explicitly describe the "study that proves the device meets the acceptance criteria" in terms of specific statistical analyses, sample sizes for test sets with ground truth, expert qualifications, or multi-reader studies.

Therefore, many of the requested details cannot be extracted directly from this document. The information provided is at a high level, focusing on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "XN CHECK is used for control and calibration verification... and that the product is stable for the entire product dating." It also mentions "reproducible" and "stable" in the conclusions. However, it does not provide specific numerical acceptance criteria (e.g., maximum allowable coefficient of variation for precision, or specific stability limits for each parameter) nor quantified performance data for each of the numerous assayed parameters. It only describes the types of studies conducted.

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XN-L CHECK is used for control and calibration verification of Sysmex XN-L analyzers. It is not, however, intended for actual calibration of this analyzer. Assayed parameters include:

RBC (10^6/uL), HGB (g/dL), HCT (%), MCV (fL), MCH (pg), MCHC (g/dL), PLT (10^3/uL), RDW-SD (fL), RDW-CV (%), MPV (fL), WBC (10^3/uL), NEUT (%), LYMPH (%), MONO (%), EO (%), BASO (%), IG (%), NEUT# (10^3/uL), LYMPH# (10^3/μL), MONO# (10^3/μL), EO# (10^3/μL), BASO# (10^3/μL), IG# (10^3/μL), RET# (10^6/uL), RET%, IRF%, RET-He (pg).

XN-L CHECK™ is an in-vitro diagnostic, three level (Levels 1, 2, and 3) hematology product that contains the following stabilized red blood cell component(s), stabilized white blood cell component(s) in a preservative medium. The product is packaged in polypropylene plastic vias with screw caps with a 3 ml fill. The vials will be pacum formed clamshell container with the Instructions for Use (FU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided document is a 510(k) premarket notification for a medical device called "XN-L CHECK™", a hematology quality control mixture. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, study details, or results in the format requested.

The document broadly states:

• "The resultant data set established that XN-L CHECK is safe and effective for its intended use and that the product is stable for the entire product dating."
• "Study results show XN-L CHECK to be consistently reproducible, substantially equivalent to the predicate products, and stable for the entire product dating."

It mentions the following types of studies were conducted:

• Multi-Site Precision Study
• Single-Site Precision Study
• Open-Vial Stability
• Closed-Vial Stability

However, it does not provide any quantitative acceptance criteria or the reported device performance measurements for these studies. Therefore, I cannot generate the requested table or answer most of the specific questions about sample sizes, ground truth, expert involvement, or MRMC studies.

Based on the information available, here's what can be inferred or explicitly stated:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states that performance data was collected and the device was found safe, effective, and stable, but it does not specify the numerical acceptance criteria (e.g., specific thresholds for precision or stability over time) or the actual reported performance values.

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

• Cannot be provided. The document mentions "Multi-Site Precision Study, Single-Site Precision Study, Open-Vial Stability and Closed-Vial Stability" but does not specify the sample sizes (number of samples, runs, instruments, or sites) used for these studies, nor the provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable / Cannot be provided. This device is a quality control mixture and not an interpretive AI device that would require expert adjudication for a diagnostic ground truth. The "ground truth" for a quality control device typically involves reference methods or established performance specifications of the analyzer it controls. The document does not mention any experts in the context of establishing ground truth for testing.

4. Adjudication method for the test set

• Not applicable / Cannot be provided. As explained in point 3, this is a quality control material, not a diagnostic device requiring expert interpretation and adjudication of results for a reference standard.

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 a hematology quality control mixture, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or mentioned.

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

• Not applicable / Cannot be provided. This is not an algorithm or AI device. It's a physical control material used to assess the performance of a hematology analyzer.

7. The type of ground truth used

• Inferred: For a quality control mixture, the "ground truth" or reference values are typically established through extensive testing against highly accurate reference methods or by comparison to another established quality control material (the predicate device in this case) on the target analyzer. The document doesn't explicitly state the "type of ground truth" but implies it involves demonstrating "consistent reproducibility" and "substantial equivalence to the predicate products."

8. The sample size for the training set

• Not applicable / Cannot be provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable / Cannot be provided. As explained in point 8, there's no training set for this type of device.

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XN CHECK BF is used for control and calibration of Sysmex XN series (XN-10, XN-11, XN-20, XN-21, XN-L) analyzers. It is not, however, intended for actual calibration of these analyzers. Assayed parameters include:

WBC-BF (10^3/μL), RBC-BF (10^6/μL), MN# (10^3/μL), PMN# (10^3/μL), MN%, PMN%, TC-BF# (10^3/uL)

XN CHECK™ BF is an in-vitro diagnostic, two level, control. It contains the following: stabilized red blood cell component(s) and stabilized white blood cell component(s) in a preservative medium in polypropylene plastic vials with screw caps with a 3 mL fill. The vials will be packaged in (4) welled vacuum formed clamshell container with the Instructions for Use (IFU) / assay sheet. Product storage conditions are 2 - 8° C.

The provided document is a 510(k) premarket notification for a medical device called "XN CHECK BF." This device is a hematology quality control mixture, and the submission is for a new iteration of an already marketed product (K141957). The primary change in the new device is the addition of compatibility with the Sysmex XN-L analyzer.

The document does not contain the information requested regarding acceptance criteria for an AI/ML device, the study to prove it meets those criteria, sample sizes, expert involvement, or MRMC studies. This is because XN CHECK BF is a quality control material for laboratory analyzers, not an AI/ML diagnostic or image analysis device.

Therefore, I cannot extract the requested information from the provided text. The document focuses on performance testing relevant to a quality control material, such as precision and stability studies, which are different from the types of studies performed for AI/ML diagnostic tools.

To answer your request, I would need a document describing the regulatory submission for an AI/ML-driven medical device.

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