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The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.

BD Vacutainer® Citrate Blood Collection Tubes (BD Citrate Tubes) are available in plastic configurations and contain a liquid additive. Tubes include a color-coded BD Hemogard™ Closure and are comprised of an inner and outer tube to maintain the draw volume and liquid additive. Refer to Table 1 for unique product configurations. Tube stoppers are lubricated with silicone to facilitate stopper insertion. The buffered sodium citrate solution provides an anticoagulated specimen when used in accordance with the instructions for use. The tubes are compatible with the BD Vacutainer® Blood Collection Needles, Blood Collection Sets, Transfer Devices. Holders and Adaptors.

The information provided in the document describes the substantial equivalence of the "BD Vacutainer Citrate Blood Collection Tubes" to a predicate device, focusing on physical and chemical characteristics, rather than the performance of an AI or software device. As such, many of the requested categories for AI/software device evaluation (e.g., sample size of test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, how ground truth for training set was established) are not applicable to this submission.

However, I can extract information related to the device's performance testing and acceptance criteria as described for the medical device itself.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Non-Clinical Performance Testing Results" in Table 3, which can be interpreted as demonstrating the device's adherence to its design specifications or performance criteria. The acceptance criteria themselves are not explicitly detailed in the provided text (e.g., what constitutes a "Pass" for "Draw Volume" or "Resistance to Breakage"). However, the results consistently report "Pass."

Clinical Performance Studies and Acceptance Criteria (as described):

The clinical studies aimed to demonstrate "Clinical Equivalence" and evaluated specific parameters. The acceptance criteria for these (e.g., non-inferiority margins) are not explicitly stated but are implied by the "demonstrated clinical equivalence" and "passed non-inferiority criterion" statements.

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

The document does not explicitly state the sample sizes for the clinical test sets. It mentions "whole blood collected," but the number of subjects or samples is not specified.

Data Provenance: "Clinical testing was conducted on whole blood collected in the subject device, BD Citrate Tubes, and a similar comparator tube." This implies the data were collected from human subjects, likely in a clinical setting. The country of origin is not specified, and it's a prospective collection for these studies as they were performed to demonstrate equivalence.

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

This information is not applicable. The device is a blood collection tube, not an AI diagnostic system requiring expert interpretation of primary data (like medical images). The "ground truth" for clinical performance likely refers to the analytical results obtained from the blood samples, which are objectively measured by laboratory instruments.

4. Adjudication Method for the Test Set

This information is not applicable for a device of this nature. Adjudication methods are typically relevant for subjective interpretations (e.g., by human readers in medical imaging studies).

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

This is not applicable as the device is a blood collection tube, not an AI or software device that assists human readers.

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

This is not applicable as the device is a blood collection tube, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" refers to the analytical measurements of coagulation parameters (Prothrombin Time [PT], Activated Partial Thromboplastin Time [aPTT], International Normalized Ratio [INR], D-Dimer, Anti-Factor Xa) obtained from the blood plasma after collection and processing. These are objective laboratory measurements, not expert consensus, pathology, or outcomes data in the typical sense for AI devices.

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI/machine learning device that requires a training set.

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

This is not applicable as the device is not an AI/machine learning device that requires a training set.

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The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ Hemoglobin & Hematocrit (H&H) Capillary Blood Collection Tube with K2EDTA is used to collect, anticoagulate, transport, and store capillary whole blood samples from individuals 18 years and older. The System is comprised of a capillary blood collection tube and a BD MiniDraw™ Finger Sleeve that are intended for use by a trained healthcare worker.

BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™™ H&H Capillary Blood Collection Tube is intended for sample collection used in the measurement of Hemoglobin (HgB) & Hematocrit (HCT), when analyzed on Sysmex XN - Series™ systems.

The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is not intended for use with other parameters.

The MiniDraw™ H&H System is designed to collect, anticoagulate, transport, and store capillary blood samples from adults 18 years and older for measurement of hemoglobin and hematocrit requiring whole blood and is clinically equivalent to capillary and venous comparator tubes for both analytes. The system is comprised of a capillary blood collection tube and a Finger Sleeve that is intended for use by trained healthcare workers in ancillary healthcare facilities (e.g., retail pharmacies, clinical and laboratory use environments. It is intended to be used with Sysmex XN - Series™ Analyzers.

The MiniDraw™ H&H System is intended to collect a whole blood specimen from a finger and deliver an anticoagulated sample for measurement of hemoglobin and hematocrit. The BD MiniDraw™ H&H Capillary Blood Collection Tube (MiniDraw™ H&H Tube) contains K2EDTA for anticoagulation of whole blood samples. The tube has a unique barcode that links the tube with the patient.

The MiniDraw™ H&H Tube is designed to be used in combination with the BD MiniDraw™M Finger Sleeve (available in four sizes), the BD Microtainer® Contact-Activated Lancet (clearance K223243) and three accessories; BD MiniDraw™ Finger Sizing Tool, BD MiniDraw™ Capillary Tube Adapter H&H, and BD MiniDraw™ Cap Removal Tool.

The provided text is a 510(k) summary for the BD MiniDraw Capillary Blood Collection System, a medical device for collecting blood samples. It discusses the device's intended use, comparison to a predicate device, and performance testing. However, it does not include information about AI/ML models, image analysis, or expert consensus/adjudication for establishing ground truth, which are typically found in the context of AI/ML-driven medical device submissions.

Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance (especially those related to AI/ML, ground truth establishment by experts, and MRMC studies) cannot be extracted from this document.

The document focuses on the physical and chemical performance of a blood collection device, primarily comparing its ability to collect, transport, and preserve blood samples for Hemoglobin (HgB) and Hematocrit (HCT) analysis, and ensuring its stability, compatibility with existing lab equipment (Sysmex XN-Series™ analyzers), and user-friendliness.

Here's what can be extracted and what cannot:

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

The document primarily lists non-clinical (bench) tests with a "Pass" outcome, indicating that the device met the established acceptance criteria for these physical and mechanical properties. For clinical performance, it states that "clinical equivalence" and "non-inferiority" criteria were met, but does not provide quantitative acceptance limits or exact reported values for these.

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

• Test Set Sample Size: Not explicitly stated with a specific number of subjects/samples for each clinical study (Method Comparison, Lot-to-Lot, etc.). It only mentions that studies were performed internally at BD's Franklin Lakes laboratory, or externally at Babson Diagnostics' laboratory, externally at Research Management, Inc. (RMI), or some combination.
• Data Provenance: The locations mentioned (Franklin Lakes, Babson Diagnostics, RMI) suggest US-based data. The studies are described as prospective clinical performance evaluations ("performed to demonstrate that blood specimens collected... produced test results that are clinically equivalent...").

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

• Not applicable/Not mentioned. This is not an AI/ML device relying on image interpretation or diagnostic accuracy where expert consensus would establish ground truth. The "ground truth" here is the result obtained from a reference blood collection tube and analysis on a Sysmex XN-Series™ system, which is a quantitative laboratory measurement.

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

• Not applicable/Not mentioned. No human review or adjudication process is described for establishing ground truth for this type of device. The comparison is against established laboratory methods.

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 device is a blood collection system, not an AI/ML diagnostic tool that assists human readers.

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

• Not applicable. This is not an AI/ML algorithm. The performance evaluated is that of the physical blood collection device in comparison to other blood collection devices, when analyzed by a lab instrument.

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

• The "ground truth" or reference for comparison were clinical laboratory results obtained from established, legally marketed predicate (BD Microtainer® MAP EDTA) and venous comparator (Greiner Vacuette® Blood Collection Tube with K2EDTA) devices, analyzed on Sysmex XN-Series™ systems. The criteria for equivalence/non-inferiority are based on "Clinical Acceptance Limits (CALs)" and the "associated Statistical Analysis Plan."

8. The sample size for the training set:

• Not applicable/Not mentioned. This is not an AI/ML model that requires training data.

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

• Not applicable/Not mentioned. This is not an AI/ML model.

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BD Vacutainer® EDTA Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and transport of human venous blood specimens used for in vitro diagnostic testing.

BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes are used for testing in hematology including white blood cells (WBC), red blood cells (RBC), red blood cell distribution width (RDW), hemoglobin (HgB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, and 5-part white blood cell (WBC) differential counts (neutrophils, lymphocytes, monocytes, eosinophils, basophils).

BD Vacutainer® K2EDTA Blood Collection Tubes and BD Vacutainer® K3EDTA Blood Collection Tubes are for collecting, transporting and centrifuging blood in a closed tube. The blood collection tube consists of closure assembly, a glass tube and EDTA additive.

The standard closure assembly is a basic rubber stopper. The tube is also available with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are either pink or lavender to indicate the presence of the EDTA additive.

The provided text describes the regulatory submission for BD Vacutainer® K2EDTA and K3EDTA Blood Collection Tubes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI/human reader device with acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Therefore, many of the requested details about acceptance criteria, study design for AI/human reader performance, sample sizes for training/test sets in machine learning, expert adjudication, MRMC studies, standalone performance, and ground truth establishment in the context of AI are not applicable (N/A) to this document. This submission is for blood collection tubes, not a diagnostic algorithm.

However, I can extract information related to the performance testing of the blood collection tubes themselves.

Here's a breakdown of the relevant information from the document, with an emphasis on why certain requested fields are N/A:

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

Since this is for a medical device (blood collection tubes) and not an AI algorithm, the "acceptance criteria" are related to mechanical and physical performance, and clinical equivalence for blood parameters.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify the exact number of samples or subjects for the clinical studies. It mentions "low medically relevant points were insufficient to adequately power the analysis" for Hgb, PLT, and WBC in the method comparison, suggesting a limitation in that specific subgroup analysis.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies involved "testing performed internally and externally," and "clinical samples." There is no mention of prospective or retrospective design, but clinical equivalence and stability studies typically involve prospective collection or use of fresh samples to assess performance over time/conditions.

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)

• N/A. This device does not rely on expert interpretation for "ground truth" in the way an AI algorithm for image analysis would. The "truth" for blood parameters is established by laboratory analyzers.

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

• N/A. Not relevant. This is not an image interpretation or diagnostic decision-making study that would require adjudication.

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

• N/A. Not an AI-assisted human reader study.

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

• N/A. Not an algorithm.

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

• The "ground truth" for this device's performance would be the analytical results obtained from established, calibrated laboratory instruments (e.g., hematology analyzers) using the collected blood samples. Clinical equivalence was demonstrated against "legally marketed comparator tubes," implying that the comparator's performance on these instruments serves as the reference.

8. The sample size for the training set

• N/A. This is not an AI/machine learning device. There are no training sets.

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

• N/A. Not an AI/machine learning device.

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TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells by flow cytometry. Recovery of lymphocyte subset markers of the HIV panel can be accomplished over a 14-day period following collection. TVTs are in-vitro diagnostic medical devices.

TransFix®/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of white blood cells (WBC, leukocytes) by flow cytometry up to 14-days following collection; the TVTs preserve the qualitative and quantitative leukocyte subset characteristics. Flow cytometry is used to identify subsets of leukocytes that can be distinguished on the basis of cell surface antigens using fluorescent antibodies.

The TransFix®/EDTA Vacuum Blood Collection Tubes (TVTs) consist of purple-capped polyethylene terephthalate blood collection tubes containing the paraformaldehyde based preservative, TransFix, and K2EDTA at the correct volume to simultaneously stabilize and anticoagulate human whole blood at the time of collection. TVTs hold 3mL (final draw volume) with a tube dimension of 13 x 75mm. TVTs are sterilized by gamma radiation. Further, the vacuum contained within the TVT ensures that the TransFix/EDTA reagent is administered at the correct ratio of 1 part TransFix/EDTA to 5 parts whole blood.

The provided text describes the performance of a medical device, the TransFix®/EDTA Vacuum Blood Collection Tubes (TVTs), and presents data to support its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a diagnostic test performance study (e.g., sensitivity, specificity thresholds).

Instead, the documentation focuses on reproducibility (precision) and equivalence (method comparison) to a reference method and a predicate device. The "acceptance criteria" are implied by statements regarding "sufficiently precise" and the comparison tables to accepted methods.

Here's an attempt to extract and present the information given available:

Acceptance Criteria and Device Performance

Implied Acceptance Criteria:

Based on the text, the device aims to demonstrate:

• Reproducibility (Precision): Individual and total %CVs (Coefficient of Variation) are "less than 10% and 15%, respectively" for absolute cell counts of specific lymphocyte biomarkers (CD3, CD8, CD45, CD16/CD56, CD19). This is the key performance metric measured.
• Equivalence: The absolute counts of lymphocyte subsets (CD3, CD4, CD8, CD16/56, CD19, and CD45) in TVT tubes should be comparable to those obtained from the predicate device (Cyto-Chex® BCT) and a gold standard (BD EDTA tubes) over a 14-day storage period. This is assessed via Passing-Bablok regression with slopes and intercepts within an acceptable range, and high R-values indicating strong correlation. The exact thresholds for acceptable slope/intercept/R are not explicitly stated as "acceptance criteria" but are implied by the presentation of the data for a substantial equivalence claim.
• Non-Interference: The performance of the TVTs should not be significantly affected by common interfering substances (bilirubin, hemoglobin, triglycerides).

Reported Device Performance:

Reproducibility Studies:

The tables in the document (Tables 1-12) present %CVs for various biomarkers under different conditions (Between-Day, Between-Lot, Between-Tube, Between-Replicate, Between-Site) and indicate that the TVT lots were "sufficiently precise" against the implied criteria of individual and total %CVs being less than 10% and 15% respectively. For example, in Table 1 (CD3+ biomarker), all total %CVs are well below 15% (ranging from 4.7% to 6.2%). Similar observations are made for all other biomarkers across both reproducibility studies.

Equivalence Study (Method Comparisons):

Tables 12 and 14 (for HIV positive subjects and healthy subjects, respectively) show Passing-Bablok regression results comparing TVTs and BCTs against BD EDTA tubes.

• Slopes: Most slopes for TVT (and BCT) are close to 1.0, indicating good agreement with the BD EDTA control. For HIV-positive subjects, TVT slopes are generally between 0.95 and 1.12. For healthy subjects, TVT slopes are generally between 0.90 and 1.10.
• Intercepts: Intercepts are generally small for both TVT and BCT, indicating minimal systematic bias.
• R-values: All R-values are high (0.95-1.00), demonstrating a strong correlation between the TVTs (and BCTs) and the BD EDTA control for the listed markers.
• The text explicitly states: "The TVT tubes were found to be safe and effective for the intended use."

Interference Study:

The study observed "no significant effects from the potential interferents listed" when comparing results from aliquots with added interfering substances to a control aliquot. This indicates the device meets the non-interference aspect of its performance.

Study Details:

1. A table of acceptance criteria and the reported device performance:
   (Combined above based on implicit criteria in the text).

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

   • Reproducibility Study 1 (Intra-lab variability):

     • Sample Size: 5 healthy subjects. For each subject, blood was collected into six TVTs (two tubes from each of three lots). Testing was performed at three time points (0, 12, 15 days post venipuncture) with triplicate determinations on each of the duplicate TVTs from each of the three lots. (N=54 mentioned for each subject for each biomarker calculation, indicating total determinations).
     • Data Provenance: Not explicitly stated, but the context of submitting to FDA suggests a regulated environment. Likely prospective, as it's a specific study design.

   • Reproducibility Study 2 (Inter-site variability):

     • Sample Size: 5 healthy subjects. Blood collected into six TVTs (from the same lot) from each subject. Tested at three clinical flow cytometry laboratories. Testing performed with triplicate determinations on each of the duplicate TVTs. (N=18 mentioned for each donor for each biomarker calculation).
     • Data Provenance: UK (from "three clinical flow cytometry laboratories in the UK"). Likely prospective.

   • Equivalence Study (Method Comparison):

     • Sample Size: 30 HIV positive donors and 12 normal donors.
     • Data Provenance: Not explicitly stated, but the context implies data collected for this registration. Likely prospective.

   • Interference Study:

     • Sample Size: 5 healthy subjects and 5 HIV positive subjects.
     • Data Provenance: Not explicitly stated. Likely prospective.

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

   • This document describes a device for sample collection and preservation rather than a diagnostic algorithm that interprets images or patient data. Therefore, the concept of "experts establishing ground truth" in the way it applies to AI/radiology devices is not directly applicable here. The ground truth for lymphocyte counts is established by flow cytometry using a reference method (BD EDTA tubes) and accepted laboratory procedures. The "experts" would be the trained laboratory personnel performing the flow cytometry and data analysis. Their specific qualifications are not detailed in this summary.

4. Adjudication method for the test set:

   • Not applicable in this context. This is a quantative measurement of cell counts, not an interpretation requiring adjudication.

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, an MRMC study was not done. This device is a blood collection tube, not an AI diagnostic algorithm for human interpretation.

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

   • Not applicable. This is not an algorithm.

7. The type of ground truth used:

   • For the equivalence study, the ground truth was established by immediate (Day 0, within 6 hours) analysis of blood samples collected in BD EDTA tubes, considered the reference condition for immunophenotyping. This represents a "reference method" ground truth.

8. The sample size for the training set:

   • Not applicable as this is a physical device (blood collection tube) and not an algorithm requiring a training set in the machine learning sense. The "training" of the tubes is inherent in their manufacturing process and formulation.

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

   • Not applicable (as above).

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Cyto-Chex® BCT™ is intended for collection and storage of blood specimens for immunophenotyping of WBC by flowcytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 14-day period following collection.

Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 75.8ul of sterile KJEDTA anti-coagulant and WBC preservative. It is manufactured with a vacuum to draw 5ml of blood by venipuncture.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The text states "multiple healthy donors" and "samples from HIV positive patients." Specific numerical sample sizes for either group are not provided.
• Data Provenance: Not explicitly stated, but it implies a prospective clinical study where fresh blood samples were collected and then split into different tubes and analyzed over time. The mention of "resource-poor countries" in the conclusion suggests a global relevance, but doesn't specifically state the origin of the study participants. The study tested both healthy and HIV-positive individuals.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. The ground truth was established by laboratory analysis using flow cytometry, a standardized method. The expertise would lie in the technicians performing and interpreting these tests, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This device is a blood collection tube for sample preservation, not an AI diagnostic tool requiring expert adjudication of image interpretations or similar subjective assessments. The "ground truth" was derived from direct laboratory measurements (flow cytometry results of fresh samples).

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

• MRMC Study: No. This is not an imaging or diagnostic device that involves human interpretation of results. Therefore, an MRMC study is not relevant.

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

• Standalone Performance: No. This is a medical device (blood collection tube) that is designed to preserve biological samples. Its performance is assessed by how well it maintains the integrity of the sample, not as an algorithm performing a task autonomously.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth was established by direct laboratory measurement from fresh samples (specifically, flow cytometric data for lymphocyte subset cell-surface markers from K2EDTA blood collection tubes analyzed within 6 hours of draw). This serves as the "reference value" against which the Cyto-Chex BCT preserved samples were compared.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires training. The device's performance is based on its physical properties and chemical composition to preserve blood samples.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor) for the collection and stabilization of 2.5 mL whole blood prior to removal of plasma for total homocysteine measurement by HPLC for the detection of hyperhomocysteinæmia.
prescription use

Plastic, evacuated blood collection tube containing EDTA (anti-coagulant) and 3deazaadenosine (enzyme inhibitor)

The provided text is a 510(k) clearance letter from the FDA for a blood collection tube (DS30 Hcy Blood Collection Tubes). It does not contain information on acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies typically associated with AI/ML-based medical devices or comparative effectiveness studies.

Therefore, I cannot fulfill the request as the provided document focuses on regulatory clearance for a blood specimen collection device and does not detail a study involving the criteria mentioned.

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The VACUTAINER® Brand PLUS (plastic) Tube with EDTA is an evacuated blood collection tube which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein.

Blood collected in a tube containing EDTA Anticoagulant is primarily used for clinical laboratory testing-hematology study using whole blood but may be used for other studies including such studies as testing for lead and FEP analyses, requiring whole blood as determined by the laboratory.

The VACUTAINER® Brand PLUS Tube with EDTA is an evacuated plastic tube for collecting, transmitting and processing blood in a closed plastic tube. The blood collection tube consists of closure assembly, a plastic tube and EDTA coating (dipotassium, K2). The plastic tube is manufactured from PET (Polyethylene terepthalate Plastic and enhances user safety and disposal because of the reduced risk of tube breakage and incineration as a method of disposal. The standard closure assembly is a basic rubber stopper. The tube is also available with VACUTAINER Systems Hemogard™ Closure assembly which is designed to reduce user exposure to blood. The EDTA anticoagulant tube coating is spray coated in a dipotassium (K2) form. The EDTA prevents specimen coagulation.

The provided text describes a 510(k) premarket notification for the VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• For FEP and Blood Lead Analysis: The specific sample size for the clinical evaluation comparing the Plus Tube to the Glass Tube is not explicitly stated.
• For Tube Lead Levels: "Twenty tubes from each of the three lots" were tested, totaling 60 tubes (20 tubes/lot * 3 lots).
• Data Provenance: The document does not specify the country of origin for the clinical evaluation data. It is a prospective comparison study for FEP and Blood Lead, and an analytical/bench study for tube lead levels.

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

• The document describes analytical and statistical equivalence based on laboratory measurements (FEP, Blood Lead, Atomic Absorption for lead). It does not mention the use of human experts to establish "ground truth" in the typical sense of expert consensus for diagnostic interpretation.
• The "ground truth" for FEP and Blood Lead would be the quantitative measurements themselves, and for lead levels, it would be the results from Atomic Absorption.

4. Adjudication Method for the Test Set:

• Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies involving human interpretation of diagnostic images or clinical assessments where there might be inter-reader variability.
• Given the nature of the tests (quantitative analyte measurements and material analysis), no adjudication method was mentioned or appears to be applicable in this context. The determination of equivalence and lead levels relies on direct analytical measurements.

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

• No, an MRMC comparative effectiveness study was not done. The study design involved comparing a new medical device (plastic tube) to an existing device (glass tube) for its ability to preserve sample integrity for specific laboratory tests (FEP and Blood Lead) and for its material properties (lead levels in the tube). This is not equivalent to an MRMC study which typically assesses the impact of AI on human reader performance in diagnostic tasks.

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

• This device is a blood collection tube, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's performance is driven by its material properties and manufacturing, assessed through analytical and clinical laboratory testing.

7. The Type of Ground Truth Used:

• Quantitative Analytical Measurements:
  • For FEP and Blood Lead analyses: The "ground truth" was established by quantitative measurements of FEP and blood lead levels from blood samples collected in both the test (plastic) and predicate (glass) tubes. The comparison was based on the numerical results and their statistical equivalence.
  • For tube lead levels: The "ground truth" was established by Atomic Absorption (AA) measurements of lead levels within the tubes.

8. The Sample Size for the Training Set:

• This device is a physical medical device (blood collection tube), not an AI model that requires a "training set." Therefore, the concept of a training set does not apply to this submission.

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

• As concluded in point 8, there is no training set for this device.

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The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.

The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive. The tube material for the Greiner product is clear plastic.

This document is a 510(k) summary for a blood collection tube, not a medical device involving AI or complex algorithms. Therefore, much of the requested information (e.g., AI performance, expert consensus, training sets, MRMC studies) is not applicable.

Here's the relevant information based on the provided text:

I. Acceptance Criteria and Study Details for Greiner Vacuette® Blood Collection Tube with Sodium Citrate

This submission describes a direct comparison study to establish substantial equivalence for a new medical device (blood collection tube) with an existing predicate device. The acceptance criteria and performance are based on the correlation of results from these two devices for specific laboratory tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria (e.g., correlation coefficient thresholds). Instead, it uses the qualitative term "good correlation."

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

• Sample Size: Not explicitly stated. The study involved "paired samples."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, given the nature of a 510(k) submission for a physical device, it's highly likely to be prospective clinical laboratory testing conducted in a controlled environment.

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

• Not Applicable: For a blood collection tube, "ground truth" is established by the analytical results of standardized laboratory tests. There are no human experts interpreting images or making diagnoses in this context to establish a conventional "ground truth." The "ground truth" is effectively the result obtained from the predicate device which is considered the standard.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods are typically used for subjective diagnostic tasks (e.g., image interpretation). This study involves objective laboratory measurements. The comparison is direct, not interpretive.

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

• No: An MRMC comparative effectiveness study is not applicable as this device is a blood collection tube, not an AI-powered diagnostic tool requiring human interpretation.

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

• Not Applicable: This is a physical blood collection device, not an algorithm, so "standalone performance" in the AI sense is not relevant. The performance is the analytical result generated by the laboratory instrument after blood collection in the tube.

7. The Type of Ground Truth Used

• Comparator Device Results: The "ground truth" or reference standard for comparison was the results obtained from the Becton Dickinson Vacutainer® sodium citrate tube (predicate device). The equivalency was evaluated by comparing test results from the new device against the established predicate.

8. The Sample Size for the Training Set

• Not Applicable: This is a physical medical device, not an AI model. Therefore, there is no "training set."

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

• Not Applicable: As there is no training set for this type of device, this question is irrelevant.

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