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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.

Device Description

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.

AI/ML Overview

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.

Test Method Description	Acceptance Criteria (Not explicitly quantified, but generally "Pass")	Reported Device Performance
Cap Lid Closure Force	Pass	Pass
Accidental Drop Seal	Pass	Pass
Transit Vibration Seal	Pass	Pass
Cap / Container Pull-Off	Pass	Pass
Tube to Collector Pull-Off Force	Pass	Pass
Latch Press Force	Pass	Pass
Tube to Collector Axial Removal Force	Pass	Pass
Pivot Attachment Force	Pass	Pass
Collector to Finger Cuff Snap De-Latch	Pass	Pass
Friction Retention	Pass	Pass
EDTA Adapter Retention Force	Pass	Pass
Sysmex Barcode Scan	Pass	Pass
Barcode Label Sutherland Rub Test	Pass	Pass
Clinical Performance:	(Not explicitly quantified, implied to be within Medical Decision Levels / CALs)	Clinically Equivalent / Non-Inferior
Method Comparison (Capillary)	Clinically Equivalent to BD MAP EDTA for HgB & HCT	Performance considered clinically equivalent
Method Comparison (Venous)	Clinically Equivalent to Greiner Vacuette EDTA for HgB & HCT	Performance considered clinically equivalent
Lot to Lot Variability (Capillary)	Non-inferiority to BD MAP EDTA for HgB & HCT	Passed non-inferiority criterion
Lot to Lot Variability (Venous)	Non-inferiority to Greiner Vacuette EDTA for HgB & HCT	Passed non-inferiority criterion
Within-Tube Type Stability	Stability up to 4 hours RT and 48 hours refrigerated for all analytes	Demonstrated stability
Operator Variability (Capillary)	Non-inferiority to BD MAP EDTA for HgB & HCT	Passed non-inferiority criterion
Operator Variability (Venous)	Non-inferiority to Greiner Vacuette EDTA for HgB & HCT	Passed non-inferiority criterion
Shelf-Life (9 months)	Clinically equivalent performance newly manufactured vs. aged tubes for HgB & HCT	Demonstrated clinically equivalent performance

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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