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The BD Vacutainer® Eclipse™ Blood Collection Needle is a sterile, single-use, medical device specifically intended to be used by healthcare professionals experienced with venipuncture on adults and children in accordance with the instructions for use for the collection of multiple venous blood samples into evacuated blood collection tubes, for the purpose of in vitro diagnostic testing. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture to provide protection from accidental needlesticks.

The BD Vacutainer® Eclipse™ Blood Collection Needle includes a one-piece double-ended needle/cannula fixed to a plastic hub. One end of the cannula is the intravenous (IV) end, and the other is the non-patient (NP) end covered with a sleeve. The whole device is encased in two plastic covers; one at each end of the cannula to protect the device, with a tamper-evident seal placed around the plastic covers. The protective cover/cap is provided to prevent damage and maintain the needle sterility before the point of use. A safety shield is connected to a hinge on a collar attached to the hub. The safety shield is manually activated by locking over the needle after removal from the vein, providing protection from accidental needlestick injuries.

The BD Vacutainer® Eclipse™ BCN consists of:

• Double-ended hollow stainless-steel cannula
• Threaded polystyrene hub
• Polystyrene collar
• Protective needle sleeve that interrupts blood flow between filling multiple tubes
• Safety shield that can be activated to cover the needle immediately after venipuncture to protect against accidental needle sticks during normal handling and disposal
• Pre-attached holder (for user convenience in some models)

The BD Vacutainer® Eclipse™ Blood Collection Needle with Pre-Attached Holder (PAH) consists of a BD Vacutainer® Eclipse™ Blood Collection Needle threaded and bonded to a BD Vacutainer® One Use Holder. The Eclipse™ BCN with PAH allows for the immediate use of the product without the need for assembling the two components. This provides increased convenience to the user and is designed to help minimize the exposure of the user to the non-patient (NP) end of the needle.

The provided FDA 510(k) clearance letter and summary for the BD Vacutainer® Eclipse™ Blood Collection Needle confirm its clearance based on substantial equivalence to a predicate device. However, this document does not contain specific acceptance criteria, reported device performance data, detailed study designs, or ground truth information typical of a clinical performance study for an AI/ML medical device.

The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance testing and biocompatibility testing, rather than clinical trials comparing diagnostic accuracy or AI performance.

Therefore, many of the requested details for an AI/ML device study, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and training set details, are not applicable or not provided in this type of submission.

Here's a breakdown based on the information available in the document, acknowledging the limitations for an AI/ML device context:

Device: BD Vacutainer® Eclipse™ Blood Collection Needle

The submission is for a medical device (blood collection needle) and not an AI/ML driven diagnostic device. Therefore, the detailed breakdowns requested for AI/ML performance studies are largely not applicable. The provided document details non-clinical performance and biocompatibility studies to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document performs non-clinical (engineering and material) tests to demonstrate that the device meets design specifications and relevant standards. The "acceptance criteria" are implied by compliance with these standards and successful completion of the tests.

Specific AI/ML Study Details (Not Applicable for this Device)

As this is a traditional medical device (blood collection needle) and not an AI/ML driven diagnostic device, the following points are not applicable and therefore, no information is provided in the document:

2. Sample sizes used for the test set and the data provenance: Not applicable. Performance was evaluated through non-clinical bench testing and material compatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is based on engineering specifications, material standards, and validated testing protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is for an AI/ML comparative study, which this device is not.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, ground truth is established by engineering specifications, international standards (e.g., ISO, AAMI), material properties, and validated test methods.
8. The sample size for the training set: Not applicable. There is no AI/ML model for this device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document demonstrates the BD Vacutainer® Eclipse™ Blood Collection Needle meets its acceptance criteria through a comprehensive set of non-clinical performance tests and biocompatibility evaluations, ensuring it is safe and effective and substantially equivalent to a predicate device. The information requested regarding AI/ML specific study details is not part of this type of traditional device approval process.

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The BD Vacutainer® Multiple Sample Luer Adapter is a sterile, single-use, non-invasive medical device intended to be connected with BD Vacutainer® brand needle holders, to enable blood collection from venous access devices, such as needles and blood collection sets or catheters with female luer connectors into blood collection tubes or blood culture bottles for the purpose of in vitro diagnostic testing. These devices are intended to be used by healthcare professionals.

The BD Vacutainer® Multiple Sample Luer Adapter consists of a luer-slip fitting (male) which mates with the female Luer connector of venous access devices, and an NP (non-patient) cannula, which punctures the stopper of the evacuated tube(s), or the septum of a blood culture bottle(s) to collect blood.

The NP cannula of the device is lubricated and has a sleeve that recovers over the cannula to prevent leakage during blood collection in-between tubes and/or bottles.

Each end of the device is enclosed in a plastic shield, which join together to fully protect the device. A tamper evident label secures the two shields together and allows identification of whether the sterile barrier has been compromised.

The device consists of the following components:

• Non-patient (NP) Cannula
• Sleeve
• Luer Hub
• NP Shield
• IV Shield
• Epoxy

Note: the IV Shield is intended for maintaining sterility of the luer-slip of the device; there is no IV needle component.

This document is a 510(k) premarket notification for a medical device, the BD Vacutainer® Multiple Sample Luer Adapter (K243649). It details the device's characteristics, intended use, and a comparison to a predicate device (K991088) to establish substantial equivalence.

Based on the provided text, the device in question is a physical medical device (a luer adapter) used for blood collection, not an AI/software-based medical device that would typically involve acceptance criteria related to algorithmic performance metrics like sensitivity, specificity, or image analysis. Therefore, much of the requested information (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this type of device submission.

Instead, the "acceptance criteria" for a physical device like this are met through a series of non-clinical performance tests, biocompatibility testing, and sterilization validation. The "study that proves the device meets the acceptance criteria" refers to the entire battery of these tests.

Here's a breakdown of the applicable information:

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

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values for each test. Instead, it states that the tests were conducted to "verify that the subject device met all design specifications and performance standards" and "demonstrates acceptable performance." The acceptance criteria are implicitly defined by the relevant standards and internal design specifications, and the "reported device performance" is summarized as having met these.

However, we can list the types of tests performed, which serve as the basis for the performance evaluation:

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

The document does not explicitly state the sample sizes used for each of the non-clinical performance tests. These types of tests often follow specific ISO or ASTM standards that prescribe minimum sample sizes for statistical confidence, but the exact numbers are not detailed in this summary.

• Data Provenance: The tests were conducted internally by Becton Dickinson and Company. The provenance would be the manufacturer's own testing facilities. No information regarding country of origin of data or retrospective/prospective status is relevant, as this concerns bench testing of physical prototypes/production samples, not patient data.

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

This question is not applicable as the device is a physical, mechanical medical device. "Ground truth" in this context is established through engineering and scientific measurements and adherence to recognized performance standards (e.g., ISO, EN standards), not through expert consensus on interpretation of data like medical images.

4. Adjudication method for the test set

This question is not applicable for the same reasons as point 3. No adjudication of expert opinions or subjective interpretations is 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

This question is not applicable. The device is a physical blood collection adapter, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical blood collection adapter, not an algorithm.

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

For a physical device, the "ground truth" is based on:

• Engineering specifications and tolerances: The physical dimensions, material properties, and functional capabilities must meet predefined engineering standards.
• Regulatory standards: Adherence to international standards (e.g., ISO, EN) for medical devices, manufacturing quality, biocompatibility, and sterilization.
• Predicate device performance: The new device must perform comparably to the predicate device in relevant tests.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is a physical device, not an AI algorithm that undergoes machine learning training.

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

This question is not applicable for the same reasons as point 8.

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The BD Vacutainer® One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer® brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer® blood collection tube(s). This device may also be used with a BD Vacutainer® blood collection set with a luer adapter to obtain blood samples into a BD BACTEC™ blood culture bottle.

The BD Vacutainer® One Use Holder is a non-sterile, single-use plastic device used during the blood collection process. It consists of a one piece plastic barrel with a female threaded connector at one end into which the non-patient end of the hub of a BD Vacutainer® blood collection device is screwed. The other end is open for the insertion of a BD Vacutainer® evacuated blood collection tube or BD BACTECTM Blood Culture Bottle This end also has flanges, which are intended to assist tube insertion. BD Vacutainer® One Use Holder is used to attach and hold a BD Vacutainer® Brand venous access device such as a blood collection needle, blood collection set or Multiple Sample Luer Adapter during venipuncture and to connect the subject device to a BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle.

The provided document is a 510(k) Summary for the BD Vacutainer® One Use Holder, a blood specimen collection device. It describes the device, its intended use, and compares it to a predicate device (Greiner Vacuette® Blood Culture Holder).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

This document does not contain information about acceptance criteria and studies that prove a device meets those criteria in the context of an AI/ML medical device. This is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically a blood specimen collection holder.

Here's why the requested information cannot be extracted from the provided text:

• Type of Device: The BD Vacutainer® One Use Holder is a physical, non-sterile, single-use plastic device. It is not an AI/ML-powered software device.
• Study Focus: The "Non-clinical Performance Summary" states that tests were conducted to "verify that the proposed devices met all design specifications and performance standards." This typically refers to mechanical, material, and functional testing for a physical device, not the evaluation of an AI algorithm's performance on a dataset.
• "Clinical Data - Not Applicable": This explicitly indicates that no clinical studies (which would be the source of test sets, ground truth establishment, expert adjudication, etc., for AI/ML devices) were required or performed for this device.
• Absence of AI/ML Specific Terminology: There is no mention of algorithms, machine learning, deep learning, models, training sets, test sets, inference, sensitivity, specificity, AUC, or any other terminology associated with AI/ML device evaluation.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on indications for use, design, materials, and non-clinical performance characteristics relevant to a conventional medical device.

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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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BD Vacutainer® K2 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® K2 EDTA Blood Collection Tubes are used for Hemoglobin A1c (HbA1c) testing.

BD Vacutainer® K2EDTA Blood Collection Tubes are used for collection, containment, preservation, and transport of human venous blood specimens in a closed tube. The evacuated blood collection tube consists of a Vacutainer® Hemogard™ Closure Assembly, a plastic tube and EDTA additive. The EDTA anticoagulant is spray coated in the dipotassium (K2) form. The EDTA additive prevents specimen coagulation.

The plastic tubes are closed with the Vacutainer® Hemogard™ Closure Assembly which consists of a rubber stopper and protective plastic shield. The Hemogard™ Closure Assembly, introduced in 1995, is intended to help reduce user exposure to blood. All stopper/closures are color coded to reflect additive type; the closures included in this submission are lavender to indicate the presence of the EDTA additive.

The plastic tube is manufactured from Polyethylene terephthalate (PET). These plastic tubes were introduced in 1990. Plastic tubes enhance user safety and disposal because of the reduced risk of tube breakage and the availability of incineration as a method of disposal.

This is a 510(k) summary for a medical device (BD Vacutainer® K2 EDTA Blood Collection Tubes), which focuses on demonstrating substantial equivalence to a predicate device rather than providing device performance against specific acceptance criteria for a novel device. Therefore, a direct table of acceptance criteria and reported device performance isn't entirely applicable in the way it would be for a new diagnostic algorithm.

However, based on the provided text, we can infer the types of performance evaluations conducted and their outcomes.

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

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

• Bench Testing: A "minimum of three unique lots of product" was used for testing.
• Clinical Testing: The text mentions "the distribution of subjects selected to be approximately representative of the general US population." No specific number of subjects or samples is provided for the clinical test set.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It is a 510(k) submission to the US FDA, so studies would likely be relevant to or conducted in the US market. The studies are prospective in nature, as they involve collecting blood samples in the subject device and comparing them to a legally marketed comparator, and conducting stability and repeatability tests on these samples.

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

This information is not applicable to this type of device and study. The "ground truth" for a blood collection tube isn't established by experts in the same way as, for example, image interpretation for an AI diagnostic device. Instead, the "ground truth" for a blood collection tube is the accurate and stable measurement of an analyte (like HbA1c) using standard laboratory methods, assuming the comparator device performs correctly. The study aims to demonstrate that the subject device allows for these accurate measurements.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment of results requiring an adjudication method. The outcome measures are quantitative (e.g., HbA1c levels, physical properties).

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

Not applicable. This is a blood collection tube, not an AI diagnostic algorithm or a device requiring human interpretation of results.

6. Standalone Performance

Not applicable. This device is a blood collection tube, not an algorithm. Its "performance" is inherently tied to its physical characteristics and its ability to preserve blood samples for subsequent in vitro diagnostic testing.

7. Type of Ground Truth Used

For the clinical study, the "ground truth" for HbA1c measurements would be the results obtained from established, validated laboratory analyzers using samples collected in the comparator device. The subject device's performance is gauged by showing that the HbA1c measurements from samples collected in it are equivalent to those from the comparator.

For bench testing, the ground truth is based on engineering specifications and validated test methods (e.g., measuring draw volume against a specified volume, testing for leakage against a pass/fail criterion).

8. Sample Size for the Training Set

Not applicable. This device is a physical blood collection tube, not an AI or machine learning algorithm that requires a training set.

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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The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is a sterile, single used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain and store serum for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a trained healthcare professional. The BD Vacutainer® Serum Separator (SST™) Blood Collection Tube is used for clinical laboratory testing in chemistry and for the monitoring of certain therapeutic drugs.

BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes are sterile blood collection tubes which use a controlled vacuum to pull a specific volume of blood into the tube. Each BD Vacutainer® Serum Separator (SST™) Blood Collection Tube consists of 1) a plastic tube manufactured from PET (polyethylene terephthalate), 2) a BD Hemogard™ cap assembly or Conventional rubber stopper with lubricant. 3) an inert polymer separator gel, and 4) a clot activator.

The provided text is a 510(k) premarket notification for a medical device, specifically a blood collection tube. It details the device's characteristics, its comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.

However, the questions you've posed (related to acceptance criteria and studies proving the device meets them, particularly pertaining to AI/algorithm performance, expert ground truth, MRMC studies, training/test set sample sizes, etc.) are not covered in this document. This document describes the regulatory submission for a physical medical device (blood collection tube) and focuses on its physical and chemical performance, sterility, shelf-life, and clinical equivalence for its intended use in collecting and processing blood samples for in vitro diagnostic testing.

There is no mention of any AI component, algorithm, or software in this submission. Therefore, it's impossible to extract information about:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
• Sample sizes for AI test sets or data provenance
• Number/qualifications of experts for AI ground truth
• Adjudication methods for AI test sets
• MRMC studies for AI assistance or standalone AI performance
• Type of ground truth for AI (pathology, outcomes data, etc.)
• Training set sample size for AI
• How ground truth for AI training was established

In summary, the provided document does not contain the information required to answer your specific questions, as those questions are relevant to the regulatory clearance of AI/Software as a Medical Device (SaMD), not a physical blood collection tube.

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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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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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BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are plastic, evacuated, sterile, single use, in vitro diagnostic medical devices. They are intended to be used in settings where venous blood specimens are collected by trained healthcare professionals for the collection, transportation, and processing of blood in a closed tube. Blood collected in the BD Vacutainer® Trace Element Serum Tubes and BD Vacutainer® Trace Element K2EDTA Tubes are used for trace element testing (e.g., Arsenic, Cadmium, Chromium, Copper, Lead, Manganese, Mercury, Selenium, and Zinc).

The BD Vacutainer® Trace Element K2EDTA Tube is an evacuated plastic blood collection tube. It consists of closure assembly, a plastic tube, and EDTA coating (dipotassium) and is available in two draw sizes, 6 mL (13 x 100 mm) and 3 mL (13 x 75 mm). The plastic tube is manufactured from PET (polyethylene terephthalate) plastic, which enhances user safety and disposal because of the reduced risk of tube breakage and the use of incineration as a method of disposal compared to glass. The EDTA anticoagulant coating is spray-dried on the walls of the tube in the dipotassium (K2) form.

The BD Vacutainer® Trace Element Serum Tube is also an evacuated plastic blood collection tube consisting of a closure assembly, a plastic tube and contains a silica clot activator additive which is spray-dried on the interior walls of the tube. It is available in one draw size, 6 mL (13 x 100 mm). The plastic tube is manufactured from PET (polyethylene terephthalate) plastic.

All of these plastic tubes are closed with a BD Hemogard™ Closure, which consists of a rubber stopper and protective plastic shield to help reduce user exposure to blood. The stopper/closures are color coded to reflect the intended use (Royal Blue for trace element tubes).

The provided text describes a 510(k) premarket notification for new blood collection tubes, asserting their substantial equivalence to previously cleared predicate devices. It focuses on the device's characteristics and performance testing. However, the information does not describe an AI/ML-based device, nor does it involve the use of experts for ground truth establishment, MRMC studies, or training/test sets in the context of an AI/ML model for clinical diagnosis or prediction.

Therefore, I cannot fulfill your request for information related to Acceptance Criteria and Proof of Device Performance for an AI/ML device based on the provided text. The document is about a physical medical device (blood collection tubes) and its performance related to functionality, sterility, and suitability for trace element testing, not an AI/ML algorithm.

If you have a document describing an AI/ML medical device, please provide it, and I will do my best to extract the requested information.

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