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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It is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is for adult use only.

Blood collection tube holders is single use and sterile, it is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. It is sterile and to be used for assisting blood collection. The device consists of a puncture needle hub, puncture needle, rubber boot and holder. It is packaged in a sealed sterility barrier. This is a single-use device and delivered sterile. Sterilization process is validated according to EN ISO 11135. Shelf life is 5 years.

This FDA 510(k) clearance letter is for a Blood Collection Tube Holder, which is a Class II medical device. The information provided heavily focuses on the comparison to a predicate device and nonclinical (bench) testing, rather than AI-specific criteria. This document does not contain any information about an AI/ML powered device, therefore the specific requests for AI-related study details (MRMC studies, standalone algorithm performance, training set details, expert ground truth adjudication) cannot be answered from the provided text.

However, I can extract the relevant information for the device's acceptance criteria and the study that proves it meets them based on the provided document.

Device: Blood Collection Tube Holders
Device Type: Medical Device (Non-AI/ML specific, per the provided document)
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a non-AI/ML physical medical device, the "acceptance criteria" are based on compliance with established international standards and successful performance in specific physical and biological tests.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices) used for each nonclinical performance test (e.g., puncture force, tensile strength). It generally states "Performance testing was conducted."
• Data Provenance: Not explicitly stated for each test, but the manufacturer is Promisemed Hangzhou Meditech Co., Ltd. in China, implying testing was likely conducted in China or by labs serving Chinese manufacturers. The testing itself is nonclinical (bench) testing, not human data. It is inherently "prospective" in the sense that the tests were performed on newly manufactured devices for the submission.

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

• Not applicable. This device is a physical medical device (blood collection tube holder), not an AI/ML system requiring expert interpretation of medical images or data for ground truth. The "ground truth" for this device's performance is established by objective physical and chemical measurements against internationally recognized standards (ISO, ASTM) and internal engineering specifications, not human expert consensus.

4. Adjudication method for the test set

• Not applicable. As above, this is for physical device performance testing, not interpretive data requiring adjudication. Compliance is determined by meeting the specified thresholds or parameters of the relevant standards.

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 document describes a physical medical device (blood collection tube holder), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant.

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

• Not applicable. This document describes a physical medical device, not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is established by objective, measurable criteria defined by international standards (e.g., ISO, ASTM) and engineering specifications. Examples include specific force measurements, material properties, sterility levels, and biological reactivity thresholds. These are derived from established scientific and engineering principles for medical device safety and efficacy.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML model where "training sets" are used.

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

• Not applicable. See point 8.

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The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.

The Navi™ Needle-free Blood Collection Device is a sterile packaged single use product designed to be attached to an already placed peripheral intravascular catheter (PIVC) system. The device is comprised of an inner flow tube with an atraumatic tip attached to a plunger that is advanced and retracted with the use of a slider. The slider extends through the proximal end of the housing and is connected to the plunger. A male cannula is positioned at the distal end of the housing with Luer clips configured to connect to a PIVC system. The inner flow tube is intended to be advanced distally through the PIVC into a patient blood vessel establishing fluid communication between the blood vessel and the collection assembly. The inner flow tube is designed to extend beyond the distal end of the PIVC. A lateral flexible tube with a female Luer connected to the housing provides a connection point for an evacuated tube holder or syringe to obtain a blood sample. Once complete, the inner flow tube is fully retracted back into the housing, and the device is removed from the PIVC system. The device is available in three sizes (20 GA, 22 GA and 24 GA) that are compatible with the corresponding PIVC.

I am sorry, but the provided FDA 510(k) Clearance Letter for the Navi™ Needle-free Blood Collection Device (K244047) does not contain any information regarding acceptance criteria or the study data that proves the device meets specific performance criteria related to the device's efficacy in blood collection (e.g., blood volume, sample quality, success rate, etc.).

The document primarily focuses on:

• Regulatory classification and equivalence: Comparing the Navi™ device to a predicate device (PIVO™ Pro Needle-free Blood Collection Device, K230865) based on indications for use, intended use, and technological characteristics.
• Safety and basic performance testing: Listing applicable standards and types of tests performed (e.g., pressure leak, vacuum leak, kink resistance, biocompatibility, sterilization, packaging integrity) to demonstrate that the differences from the predicate device do not raise new questions of safety or effectiveness.
• Design and material comparisons: Highlighting similarities and differences in components, dimensions, and materials between the subject and predicate devices.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or to provide details on:

• Sample sizes used for a test set proving efficacy/performance, or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth establishment.
• Whether MRMC or standalone (algorithm-only) studies were done, or their effect sizes.
• The type of ground truth used for performance validation.
• Sample size for the training set or how its ground truth was established, as this device is a physical medical device, not an AI/ML-based diagnostic or imaging device that typically has "training sets" and "test sets" in the context of data-driven performance validation.

The document states that "The Navi™ Needle-free Blood Collection Device was tested to demonstrate all product requirements and user needs were met." and "The test data obtained demonstrate that the Navi™ Needle-free Blood Collection Device meets requirements and user needs, and the device is substantially equivalent to the predicate device cleared under K230865." However, it does not explicitly report the quantitative results of these tests against specific numerical acceptance criteria for a "device performance" in the way you've framed the request (e.g., a specific success rate for difficult IV access, or a quantifiable improvement in blood collection efficiency). The tests mentioned (e.g., pressure leak, flow rate, hemolysis) are more fundamental engineering and safety performance tests rather than a clinical efficacy study with acceptance criteria often seen for diagnostic devices.

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The Sol-Guard™ XtraThin Wall Safety Pull button blood collection set is a sterile, multi-sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male Luer adaptor, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and should remain under the direct supervision of a clinician.

The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.

Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term (up to 2 hours) infusion of intravenous fluids. The device is offered with butterfly needle set which has either 21-, 23- or 25-gauge needle with integral butterfly wings, offered in two different flexible tubing lengths of 178mm and 305mm, and a safety tube with tubing leading to a female luer connector. The female luer connector is optionally attached to a luer adapter, or luer adapter plus a tube holder.

The device is designed with spring retractable needle technology that allows needle retraction after use to prevent needle stick injury and blood exposure. When the Button on the body of the butterfly is pulled back, the spring is released, and the needle is retracted into the clear plastic safety tube. In the activated position, the needle is completely enclosed within the clear plastic safety tube which guards against accidental needlesticks during normal handling and disposal.

While the provided FDA 510(k) clearance letter and summary meticulously detail the substantial equivalence of the "Sol-Guard™ XtraThin Safety Pull-Button Blood Collection Set" to its predicate device, it does not contain information related to software, artificial intelligence (AI), diagnostic accuracy, or human reader performance.

The document describes a physical medical device (a blood collection set) and its mechanical and material properties. The term "acceptance criteria" in this context refers to the bench and performance testing standards (e.g., ISO and ASTM standards) the device must meet to demonstrate its safety and effectiveness, particularly concerning the change in needle inner diameter.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria for diagnostic performance or AI.
• Sample sizes for a "test set" in an AI/diagnostic context.
• Data provenance, expert qualifications, or adjudication methods for ground truth.
• MRMC comparative effectiveness studies or effect sizes for human readers with AI assistance.
• Standalone algorithm performance.
• Ground truth types like expert consensus, pathology, or outcomes data.
• Training set sample size or how its ground truth was established.

The document is entirely focused on the physical characteristics and performance of a blood collection device, not on any kind of diagnostic or AI-driven system.

If you are looking for information regarding acceptance criteria and studies for AI-powered medical devices, you would need a 510(k) submission or clearance letter for such a device. This document is for a conventional, non-AI medical device.

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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 PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube, blood culture bottle, or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. For blood culture, the device can be used at initial placement of the peripheral IV catheter.

The PIVOTM Pro Needle-free Blood Collection Device is a sterile, single use needle-free collection device that attaches to a peripheral intravascular (IV) catheter system for use to obtain venous blood specimens. The device is comprised of an inner flow tube with a slider, proximal flexible tube with female Luer, outer housing and winged clip on the distal end. The winged clip attaches to the catheter system The female Luer attaches to an evacuated tube holder or syringe. The inner flow tube is then advanced to collect a blood sample. Once complete, the inner flow tube is retracted, and the device is removed from the IV. The device is also suitable for use for blood culture collection at initial placement of peripheral IV catheters. The device is available in three sizes: 20GA, 22GA and 24GA IV compatible. The device is compatible with the corresponding IV gauge and larger IV catheters. The PIVOTM Pro Needle-free Blood Collection Device is compatible with peripheral IV catheters and extension sets with NearPortTM IV Access.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "PIVO™ Pro Needle-free Blood Collection Device." This document details the device's indications for use, technological characteristics, and comparison to a predicate device, along with a summary of performance tests. However, it does not describe an AI/ML powered device or a study involving human experts for ground truth establishment, MRMC studies, or training/test set sample sizes in the context of AI/ML.

The document primarily focuses on establishing substantial equivalence for the device itself (a needle-free blood collection device), specifically for the addition of blood culture collection and an extended shelf life. The performance tests mentioned (e.g., Insertion Test, Blood Leak Test, Package Integrity) are related to the physical and functional aspects of the hardware device, not the performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML powered device, the study proving its performance (in terms of AI metrics), sample sizes for AI test/training sets, expert involvement in ground truth, or MRMC studies, as this information is not present in the provided text.

The text does state:

• "Clinical studies are not required to demonstrate substantial equivalence to the predicate device."
• "Summary of Performance tests completed on the subject devices were limited to those tests required Performance to support a determination of substantial equivalence to the predicate device."
• "Per design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance test, demonstrating substantial equivalence to the predicate device."

This indicates that internal performance tests were conducted against pre-determined acceptance criteria, but these are for the physical device's functionality and safety, not for an AI/ML algorithm's diagnostic or predictive performance.

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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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The VACUETTE® QUICKSHIELD Complete is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. They are for single-use only and should be used by properly trained healthcare professionals only in accordance with these instructions.

The VACUETTE® QUICKSHIELD Complete PLUS is intended to be used only with VACUETTE® Blood Collection Tubes as a system in routine venipuncture procedures. This device is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. VACUETTE® VISIO PLUS Needles are designed for use in the daily blood collection routine when delegated by a qualified practitioner. The flashback window is situated in the transparent part of the cannula hub, which assists the user to recognize successful vein penetration. They are for single- use only and should only be used by adequately trained healthcare personnel in accordance with these instructions.

The sterile VACUETTE®QUICKSHIELD Complete is a single packed VACUETTE®QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® Multiple Use Drawing Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.

The sterile VACUETTE® QUICKSHIELD Complete PLUS is a single packed VACUETTE® QUICKSHIELD Safety Tube Holder with pre-threaded VACUETTE® VISIO PLUS Blood Collection Needle in a blister pack. It is a sterile, single-use plastic tube holder, designed with a safety shield, which can be activated to cover the needle immediately following venipuncture.

This document is an FDA 510(k) Premarket Notification summary for a medical device, not a study describing AI algorithm performance. Therefore, most of the requested information regarding acceptance criteria for AI algorithms, sample size, ground truth expert establishment, MRMC studies, and training set details are not applicable.

However, I can extract the acceptance criteria and performance data for this physical medical device based on the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Requirement" and "Outcome" columns in the "PERFORMANCE DATA" section. The document states that performance testing was conducted to demonstrate substantial equivalency and that the device performs as intended. All listed requirements passed.

Additionally, the following were met:

• Sterility: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ via e-beam irradiation, in accordance with ISO 11137-1 and ISO 11737-1.
• Biocompatibility: Demonstrated compliance with ISO 10993 series standards and FDA guidance for:
  • Cytotoxicity (ISO 10993-5)
  • Sensitization (ISO 10993-10)
  • Irritation (ISO 10993-23)
  • Hemocompatibility (ISO 10993-4)
  • Material mediated pyrogenicity (ISO 10993-11)
  • Acute Systemic Toxicity (ISO 10993-11)

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many devices were tested for "Force to remove shield"). It refers to "Simulated use tests" and "Performance testing" in general.

Data provenance is not specified in terms of country of origin for the testing, and the testing described is prospective for demonstrating compliance with standards for the device being submitted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The document describes the testing of a physical medical device (blood collection system) against engineering and biological performance standards, not an AI algorithm requiring expert ground truth for classification or detection.

4. Adjudication Method for the Test Set

This information is not applicable as the device performance is measured against objective engineering and biological standards, not requiring human adjudication of subjective data.

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

This information is not applicable. MRMC studies are typically performed for imaging diagnostics or AI-assisted diagnostic tools to assess the impact on human reader performance. This document is for a physical blood collection device.

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

This information is not applicable. The device is a physical product, not an algorithm. The performance tests ("Torque to rotate shield," "Puncture force," etc.) are inherent to the device's design and function in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by recognized consensus standards (e.g., ISO 23908, ISO 7864, ISO 9626, ISO 11137-1, ISO 11737-1, ISO 10993 series) and internal specifications. This means that the device was tested to meet predefined physical, mechanical, and biological properties, not a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of an AI study.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI algorithm; there is no training set.

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

This information is not applicable.

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The Safety Sliding Blood Collection Set is intention into a patient's vascular system for blood collection or short term (up to 2 hours) IV administration, by a trained medical professional. It aids in the prevention of accidental needle stick through the use of an active safety feature.

Components of the subject device include: (1) Needle cap, (2) Butterfly wings, (3) Safety shield, (4) Needle, (5) Flexible tube, (6) Female luer (adapter), (7) Male luer hub, (8) Puncture needle, (9) Rubber sleeve, (10) Puncture needle protect cover, (11) Holder, (12) Protective cap.

The subject device has three configurations: with Holder, with Holder, without Male Adapter. Each configuration has all of the (1) - (6) components mentioned above. The difference between the three configurations is that they have only one or more of the (7) – (12) components mentioned above. The proposed device is available various needle size and flexible tube length. The range of needle size is from 25G (0.5mm) to 20G (0.9mm). The range of flexible tube length is from 10cm (4") to 30cm (12").

The subject device has sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature.

The subject device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

The provided document describes the Jiangsu Caina Medical Co., Ltd.'s "Safety Sliding Blood Collection Set" (K232781) and its substantial equivalence to a predicate device (K980414), but it does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria.

The document primarily focuses on:

• Regulatory Clearance: Announcing FDA clearance (510(k)) based on substantial equivalence.
• Indications for Use: Describing the intended purpose of the device.
• Device Description: Outlining the components and configurations.
• Comparison to Predicate Device: Detailing similarities and differences between the subject device and the predicate.
• Non-Clinical Testing: Listing the international standards and specific tests conducted (e.g., biocompatibility, sterility, seal integrity, sharps injury protection) to support the substantial equivalence claim.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving their fulfillment based on this document.

The document explicitly states:

• 10. Clinical Test Conclusion: "Clinical studies are not required to demonstrate substantial equivalence to the predicate device." This indicates that the regulatory clearance was based on non-clinical data and comparison to an existing device, rather than a clinical trial with specific performance acceptance criteria.

The "Non-Clinical Testing" section lists various tests performed (e.g., ISO, ASTM standards, extraction force, simulated clinical study for safety feature, sharps injury protection testing). These tests would have their own internal pass/fail criteria as defined by the respective standards or the manufacturer's internal specifications. However, these specific criteria and the detailed results demonstrating achievement are not provided in this publicly available 510(k) summary.

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