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BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™ Finger Sleeve that is intended for use by a trained healthcare worker.

BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT), Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total Cholesterol (CHOL), and Triglycerides (TRIG).

BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes.

The BD MiniDraw™ Capillary Blood Collection System family of devices is a capillary blood collection solution designed to collect, separate, transport, and store capillary blood samples from a finger stick that are clinically equivalent to both capillary and venous comparator tubes. The system is designed to standardize the capillary blood collection procedure, thereby allowing users who are trained to use the subject device, but who may not otherwise have been trained in phlebotomy, to collect fingerstick capillary blood samples. The BD MiniDraw™ Capillary Blood Collection System is intended to be used by trained healthcare workers in ancillary healthcare facilities and clinical use environments (e.g., retail pharmacies, clinics).

The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ System) is a subset of components in the BD MiniDraw™ Capillary Blood Collection System. It is intended to collect a whole blood specimen from a finger and deliver a serum sample for measurement of specific analytes listed in the Indication for Use. The BD MiniDraw™ SST™ Capillary Blood Collection Tube (MiniDraw™ SST™ Tube) contains a silica-based clot activator solution and a gel that creates a barrier between serum and cells during centrifugation. The tube has a unique barcode that links the tube with the patient.

The MiniDraw™ SST™ Tube is designed to be used in combination with the BD MiniDraw™ 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 SST™ and BD MiniDraw™ Cap Removal Tool.

The provided text is a 510(k) Premarket Notification from the FDA for a blood specimen collection device. It details the device, its intended use, comparison to a predicate device, and performance testing. However, it does not describe an AI/ML-based medical device. Therefore, the requested information about acceptance criteria, study design for AI models (sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) is not present in the provided document.

The document discusses the clinical performance testing for a physical blood collection device. The "acceptance criteria" referred to are for the physical and chemical performance of the collection tubes, not for an AI model's diagnostic or predictive accuracy.

Therefore, I cannot provide the requested table and details as they pertain to an AI device, which is not the subject of this document.

If you are interested in the acceptance criteria and performance data for this specific device (the BD MiniDraw™ Capillary Blood Collection System), here's what can be extracted from the document:

Study Proving Device Meets Acceptance Criteria (Physical/Chemical Performance)

The study was a series of non-clinical (bench) and clinical performance tests designed to demonstrate that the BD MiniDraw™ SST™ Capillary Blood Collection System performs as intended and is substantially equivalent to predicate devices.

1. Table of acceptance criteria and reported device performance (for the physical device):

The document lists "Acceptance Criteria" being "met" or "Pass" for each test but does not provide the specific quantitative thresholds for these criteria. It states that results were evaluated against "predetermined acceptance criteria" and "Clinical Acceptance Limits (CALs)".

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

• Sample Size: The document does not specify the exact number of samples or subjects included in the clinical performance testing. It mentions "studies were performed at internal and/or external sites."
• Data Provenance: Not explicitly stated, but clinical studies are generally prospective for a 510(k) submission. No country of origin is specified for the clinical data.

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

• Not applicable for this type of device. The "ground truth" here is the accurate measurement of analytes in the blood samples, which would be established by standard laboratory reference methods, not by expert consensus or interpretations. The comparison is between the new device's collection method and existing, cleared collection methods.

4. Adjudication method for the test set:

• Not applicable for this type of device. Adjudication is relevant for subjective interpretations (like medical images). For quantitative measurements of analytes, "adjudication" would involve laboratory quality control and statistical analysis of results against established analytical performance criteria.

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 a blood collection device, not an AI diagnostic tool.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

• Comparator Devices/Reference Methods: For clinical equivalence, the "ground truth" was established by comparing analyte measurements from samples collected using the BD MiniDraw™ SST™ Tube against measurements from samples collected using legally marketed predicate and comparator devices (BD Microtainer® SST™ (capillary) and Greiner Bio-One Vacuette® Serum Tubes (venous)), presumably analyzed using validated laboratory methods. The clinical acceptance limits (CALs) served as the benchmark for equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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