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The MICROTAINER® Brand Chemistry tubes with MICROGARD™ Closure are intended to collect, transport, and store skin puncture blood specimens for chemistry determinations requiring serum or heparinized plasma.

The modified MICROTAINER® Brand Chemistry Tubes with MICROGARD™ Closure are non-sterile, single use microcollection tubes. They consist of a polypropylene reservoir with an integral blood collector component, a skirted polyethylene closure with a recessed plug that reduces user exposure to blood.

This 510(k) summary describes a device, the MICROTAINER® Brand Chemistry Tubes with MICROGARD™ Closure, which is a blood collection tube. The study presented is a comparison to a predicate device, not an AI/algorithm-driven device, so many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device is being compared to a predicate device, and the acceptance criteria are implicitly that the new device performs "equivalent or better" in terms of hemolysis and clotting, and demonstrates "equivalent results" for chemistry analytes, with any biases not being "clinically significant."

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

• Sample Size for Test Set: Not explicitly stated. The summary refers to "Clinical testing" and "the study" but does not quantify the number of patients or samples involved.
• Data Provenance: Not explicitly stated, but clinical testing implies human samples. The country of origin is not specified, but the submission is to the US FDA, so US-based data is plausible. The study design sounds prospective as it involved comparing a new device against a predicate.

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

Not applicable. This is a medical device (blood collection tube) comparison study, not an AI diagnostic study requiring expert ground truth establishment in the traditional sense. The 'performance' relates to physical and chemical properties of blood samples.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring human adjudication of diagnostic findings. Performance was likely assessed through laboratory analysis (e.g., spectrophotometry for hemolysis, visual inspection for clotting, automated chemistry analyzers for analytes).

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 not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI/algorithm-driven device.

7. The Type of Ground Truth Used

The "ground truth" here is the direct measurement of clinical performance outcomes related to blood collection:

• Presence/absence and degree of hemolysis
• Presence/absence of clotting
• Measurements of various chemistry analytes in plasma using a device like the Johnson and Johnson Vitros 250 Chemistry Analyzer.

The comparison is against a legally marketed predicate device, effectively using its established performance as a benchmark for "equivalence."

8. The Sample Size for the Training Set

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

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

Not applicable.

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The VACUTAINER® Brand Luer Adapter is a sterile, non-invasive device used to connect venous access devices such as needles, blood collection sets, and infusion sets to blood collection tubes. They are also used in connection with non-needle devices for collection of blood from catheters. The VACUTAINER® Brand Luer Adapter is sold by itself and as a component of other VACUTAINER Brand devices.

The VACUTAINER® Brand Multiple Sample Luer Adapter consists of a male luer-slip fitting which mates with the female connector of other medical devices, and a non-patient (NP) cannula which punctures the stopper of an evacuated tube. The luer hub is injection molded polystyrene to which the stainless steel NP cannula is assembled with epoxy. The hub is threaded at the NP end to allow assembly to a VACUTAINER Brand Needle Holder.

The NP cannula of the multi-sample luer adapter is covered by a sleeve that recovers over the cannula to stop blood flow during collection of multiple tubes. In the principal device, this sleeve is manufactured of latex-free synthetic isoprene rubber.

The provided text is a 510(k) summary for a medical device (VACUTAINER® Brand Multiple Sample Luer Adapter), which details its description, intended use, and a comparison to predicate devices for substantial equivalence. It does not contain information about acceptance criteria, detailed study designs, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices. The document predates common AI/ML regulations and evaluation methods.

Therefore, I cannot extract the requested information about acceptance criteria or a study that proves the device meets those criteria from the provided text in the format you've requested for AI/ML devices. The text describes a traditional medical device's regulatory submission based on substantial equivalence to existing predicate devices, not an AI-powered diagnostic or treatment device with performance metrics like sensitivity, specificity, or AUC against a defined ground truth.

Here's a breakdown of why each requested point cannot be answered:

• 1. Table of acceptance criteria and reported device performance: Not present. The document states "Functional and Mechanical testing was done to compare the performance..." and "Results of the testing demonstrated that the modified... performed as well or better than both the currently manufactured... and the TERUMO® Brand VENOJECT™ Lucr Adapter." However, specific numerical acceptance criteria (e.g., "tensile strength > X N") and corresponding quantitative performance metrics values are not provided.
• 2. Sample size for test set and data provenance: No sample size is mentioned for the functional and mechanical testing. Data provenance is not applicable as this is a physical device, not an AI model trained on data.
• 3. Number of experts and qualifications: Not applicable. This is not an AI/ML study involving expert ground truth labeling.
• 4. Adjudication method: Not applicable. This is not an AI/ML study involving expert ground truth labeling.
• 5. MRMC comparative effectiveness study: No. This is a physical device, not an AI system.
• 6. Standalone performance: "Functional and Mechanical testing" was performed on the device itself, but specific performance metrics are not detailed in this summary.
• 7. Type of ground truth: Not applicable in the context of AI/ML. For a physical device, performance is typically assessed against engineering specifications and functional requirements.
• 8. Sample size for the training set: Not applicable. This is not an AI/ML model.
• 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML model.

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The VACUTAINER® Brand CTAD Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. The CTAD additive, a combination of a buffered sodium citrate, theophylline, adenosine and dipyridamole, provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays.

The VACUTAINER® Brand CTAD Tubes are sterile, glass, evacuated blood collection tubes. The tubes contain 0.109M Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. In addition to citrate, the CTAD tube contains theophylline, adenosine and dipyridamole (inhibitors of platelet activation). The specimen is centrifuged and the plasma portion is analyzed for coagulation parameters to detect clotting time disorders and to monitor patients undergoing anticoagulation therapy.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a comparison study rather than setting explicit numerical acceptance criteria for a new device. The "performance" is reported as demonstrating clinical equivalence or superior performance in specific contexts.

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

• Sample Size: Not explicitly stated. The document refers to "Normal Donors," "Warfarin Donors," and "Heparin Donors," implying multiple participants in each group, but the exact count is not provided.
• Data Provenance: Not explicitly stated. There is no mention of the countries of origin for the data or whether it was prospective or retrospective.

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

This information is not provided in the document. The study compares two blood collection tubes; the "ground truth" here would likely be the actual coagulation parameters measured, rather than interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of comparing laboratory results from blood samples, an adjudication method in the traditional sense (e.g., for image interpretation) is unlikely to be applicable.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a blood collection tube, not an AI-powered diagnostic tool, so "human readers" and "AI assistance" are not applicable.

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

A standalone performance study was not done in the context of an algorithm. This device is a medical device (blood collection tube) that is used by humans to collect samples for laboratory analysis.

7. The Type of Ground Truth Used

The ground truth used was laboratory analysis of coagulation parameters. The document mentions "coagulation parameters," "aPTT," "Heparin Xa," and "Platelet Factor 4 results," which are objective measures obtained from blood samples.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set.

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

This information is not applicable/not provided. As above, this device does not involve a training set or AI model.

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The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. The needle is designed with an attached safety shield, which can be activated to cover the needle immediately after venipuncture salery only accidental needle sticks needle sticks.

The VACUTAINER® Brand ECLIPSE™ Blood Collection Needle is a sterile, multiple sample, single-use device for blood collection. 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 needle sticks.

The provided text describes the Becton Dickinson VACUTAINER® Brand ECLIPSE™ Blood Collection Needle, a sterile, multiple sample, single-use device for blood collection with an attached safety shield.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for the test set: A panel of twenty healthcare professionals was used for Simulated Use Testing. The specific number of individual tests or cases performed by these professionals is not detailed.
• Data provenance: Prospective, as it involved "Simulated Use Testing by a panel of twenty healthcare professionals." The country of origin of the data is not explicitly stated, but given the submission is to the FDA, it is likely US-based or for the US market.

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

• Number of experts: Twenty healthcare professionals.
• Qualifications of those experts: Not explicitly detailed beyond "healthcare professionals." Their specific roles (e.g., phlebotomists, nurses) or years of experience are not mentioned.

4. Adjudication method for the test set

• The text does not specify a formal adjudication method (like 2+1 or 3+1). The "Simulated Use Testing" implies a direct observation and evaluation by the healthcare professionals themselves, who served as the de facto evaluators of reliable activation and ease of use.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the context of comparing human readers' performance with and without AI assistance. This device is a physical medical device, not an AI diagnostic tool.

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

• This question is not applicable as the device is a physical blood collection needle with a safety mechanism, not an algorithm. The "standalone" performance refers to the mechanical function of the safety shield and its activation, which was evaluated through "Mechanical Testing" and "Simulated Use Testing."

7. The type of ground truth used

• The ground truth for the mechanical aspects (forces, lock engagement, defeat conditions) was established through objective mechanical measurements and evaluations.
• For the simulated use aspects (reliable activation, blood splatter observation, ease of activation, technique, handedness, single-handed operation), the ground truth was based on the direct observation and feedback/assessment of the twenty healthcare professionals during the simulated use scenarios. This falls under expert judgment/assessment in a practical use setting.

8. The sample size for the training set

• The concept of a "training set" is not applicable here as the device is a physical medical device, not an AI model requiring a dataset for training. The device's design is stated to use "components that are identical to the conventional VACUTAINER® Brand Blood Collection Needle," implying its functional basis is derived from an established design.

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

• Not applicable, as there is no "training set" in the context of an AI algorithm. The device's performance is based on its mechanical design and human-factors testing for safety and ease of use.

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The VACUTAINER Brand Blood Collection Syringe is intended to collect whole blood specimens for diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium and magnesium), metabolytes, co-oximetry, and other tests.

The VACUTAINER® Brand Blood Collection Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The syringe contains dry calcium-balanced lithium heparin (approximately 50 IU per mL of whole blood) derived from porcine intestinal mucosa, as the anticoagulant. Calcium chloride has been added to the formulation to provide a calcium-balanced lithium heparin solution, specifically allowing the measurement of ionized calcium and magnesium. The calcium chloride solution binds to the heparin prior to blood collection allowing electrolytes such as ionized calcium and magnesium in the blood to be measured without interference from the heparin (calcium-balanced).

VACUTAINER Brand A-LINE Kit: Contains a specifically designed syringe only for aspiration of blood samples from arterial lines.

VACUTAINER Brand PRESET™ Kit: Contains a specifically designed syringe (may include needle) that can be preset to a desired volume, but permits aspiration when necessary. Includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling.

VACUTAINER Brand DRIHEP® PLUS Kit: Contains a specifically designed syringe (may include needle) with a self-venting membrane, (which seals automatically upon blood contact), and low plunger resistance which permits preset, aspiration, and natural fill sampling. Plunger auto-stop avoids overfill and leakage.

Please Note: The needle component may be one of two configurations. The needle may be a single lumen hypodermic needle or a SafetyGlide™ Needle, a single lumen hypodermic needle with a hinge safety mechanism.

The provided text describes the 510(k) summary for the VACUTAINER® Brand Blood Collection Syringe. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device conformance. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific performance metrics against defined acceptance criteria.

Therefore, I cannot provide a complete answer to all your questions from the given text. I will extract what information is available and note where specific details are missing.

Here's the breakdown of the available information:

Acceptance Criteria and Device Performance

The document states that "Three separate performance studies (anticoagulant & hemolysis, analytical, and clinical) were done to show the performance and equivalence of the principal device with the new calcium-balanced lithium heparin anticoagulant to the predicate devices currently marketed in the United States." It concludes that "All results from the three studies show equivalence between the principal device and the predicate device."

Missing Information:

• Specific quantitative acceptance criteria (e.g., "pH measurement should be within X units of the reference method").
• Reported device performance values for these criteria.
• The actual results of the "anticoagulant & hemolysis, analytical, and clinical" studies. The document only reports "equivalence" without detailing the specific findings.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document.

Study Details

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only indicates the studies were conducted to show equivalence to predicate devices marketed in the United States.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: Not applicable. This device is a blood collection syringe, not an AI-assisted diagnostic tool involving human readers.

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

• Standalone Performance: Not applicable. This device is a medical device (syringe), not an algorithm.

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

• Ground Truth Type: Not explicitly stated. The studies focused on demonstrating "equivalence" in anticoagulant & hemolysis, analytical, and clinical performance, implying comparisons to established reference methods or predicate device performance. For example, "analytical studies" would likely compare measured values (pH, blood gases, electrolytes) to a gold standard analytical instrument.

The sample size for the training set:

• Sample Size: Not applicable. This device is a physical product (syringe), not an algorithm that requires a training set.

How the ground truth for the training set was established:

• Ground Truth Establishment: Not applicable.

In summary, the provided 510(k) summary (K981922) for the VACUTAINER® Brand Blood Collection Syringe mainly focuses on establishing substantial equivalence to existing predicate devices based on the description of the device, its intended use, and general statements about performance studies ("anticoagulant & hemolysis, analytical, and clinical") showing equivalence. It does not provide the detailed quantitative data, sample sizes, or specifics about ground truth establishment that would typically be found in a comprehensive study report for certain types of medical devices, especially AI/ML-based ones.

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

Blood collected in PLUS EDTA and PLUS Serum tubes can be used for immunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.

The VACUTAINER® Brand PLUS Tube with EDTA and the VACUTAINER PLUS Serum Tube are evacuated plastic blood collection tubes for collecting, transporting and processing blood in a closed plastic tube. The VACUTAINER® Brand PLUS Tube with EDTA consists of closure assembly, a plastic tube and EDTA coating (dipotassium). The VACUTAINER PLUS Serum Tube consists of closure assembly, a plastic tube and silica clot activator.

The standard closure assembly is a basic rubber stopper. The tubes are also available with the VACUTAINER® Hemogard Closure Assembly, which consists of a rubber stopper and protective plastic shield to reduce user exposure to blood. The Hemogard closure assembly, intended to reduce user exposure to blood, was described in 510(k) Premarket Notification K945952 that received FDA clearance on January 18, 1995. All stopper/closures are color coded to reflect additive type (see the chart VACUTAINER® Tube Stopper/Closure Color Code Cross Reference located in the Product Insert, Attachment D)

Here's a breakdown of the acceptance criteria and study information for the VACUTAINER® Brand PLUS Tube with EDTA Anticoagulant and VACUTAINER® Brand PLUS Serum Tube, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily focuses on establishing "substantial equivalence" to predicate devices. For the stated expanded indications (immunohematology testing), the acceptance criterion is implicitly "equivalent results" compared to the predicate glass tubes. Specific quantitative thresholds for equivalence (e.g., within certain percentage difference for specific analytes, or perfect concordance in typing) are not detailed in this summary.

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

• Sample Size: Not explicitly stated in the provided text for the clinical evaluation. The document only mentions "Clinical testing to evaluate the effectiveness of the additional Indications for Use... was performed."
• Data Provenance: Not explicitly stated. There's no mention of the country of origin of the data, nor is it explicitly stated whether the study was retrospective or prospective. Given it's a premarket notification for a new indication, a prospective study design is more likely for safety and effectiveness, but this is not confirmed.

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

• This information is not provided in the summary. The document states "Clinical testing... demonstrates equivalent performance," but it does not detail how individual results were evaluated or if "ground truth" was established by experts.

4. Adjudication Method for the Test Set

• This information is not provided in the summary. There is no mention of any adjudication process for the clinical test results.

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

• No, an MRMC comparative effectiveness study was not done. The study's aim was to demonstrate equivalent performance of the new plastic tubes compared to existing glass tubes for specific immunohematology tests. It was a comparison of device performance, not primarily a study on human reader improvement with or without AI assistance.

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

• Not applicable. This device is a blood collection tube, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

• The ground truth (or reference standard) for the clinical evaluation was implicitly the results obtained from the predicate VACUTAINER® Brand (glass) Serum and EDTA tubes. The study aimed to show "equivalent results" using the new plastic tubes.
  • For ABO Grouping, Rh typing, and antibody screening, the "ground truth" would be the established immunological reactions and interpretations obtained using standard methods with the predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set.

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

• Not applicable. See point 8.

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The VACUTAINER® Brand PPT™ Plasma Preparation Tube with HDTA anticoagulant and a gel barrier material are evacuated blood collection which provide a means of collecting, processing and transporting blood in a closed plastic tube. When the Tube is .. used together with VACUPAINER® Brand needles and holders, it is a closed system for the collection of venous blood with the same indications identified here.

Blood collected in a tube containing HDTA anticoagulant and gel barrier material can be primarily used to provide undiluted plasma for use in molecular diagnostic test methods; including but not limited to Polymerase Chain Reaction (PCR) and branched-DNA (bDNA). The specimen may also be used for other testing that requires an undiluted plasma sample as determined by the laboratory.

The VACUTAINER® Brand PPT™-Plasma Preparation Tube (blood collection The VACOTAINER® Brand Property is an evacuated plastic tube containing EDTA Antiocagana, processing and transporting blood in a blood obliobiler Rabe for Selleum NER® Brand PPT™ consists of a Closed plastic tube. The VAOS v. ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (dipotassium or tripotassium) and a polymeric gel barrier material.

The provided text describes the 510(k) summary for the VACUTAINER® Brand PPT™-Plasma Preparation Tube, which is a blood specimen collection device. The studies are designed to demonstrate substantial equivalence to existing predicate devices, rather than establishing specific acceptance criteria for performance metrics of a novel device. The primary evaluation is focused on comparisons of HIV and HCV viral load measurements.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in the typical sense (e.g., minimum sensitivity or specificity targets). Instead, the acceptance criterion for the device seems to be "statistically and clinically equivalent results" and "equivalent results" when compared to predicate devices for viral load determinations.

Given this, the table would look like this:

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

• Study I (HIV): 56 HIV-Positive patients.
• Studies III & IV (HIV): 40 HIV-positive subjects.
• Study II (HCV b-DNA): 49 paired samples from 24 HCV negative and 25 HCV positive subjects.
• Studies V & VI (HCV PCR): 65 HCV-positive patients.

Data Provenance: The document does not specify the country of origin of the data. It appears to be prospective as it mentions "paired samples were collected."

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

The ground truth in this context refers to the viral load measurements themselves, as determined by established molecular diagnostic kits (e.g., Roche Amplicor® HIV RT PCR Monitor™ Kit, Chiron Quantiplex HCV RNA Assay). The document does not mention the use of experts to establish a "ground truth" other than the performance of these assays. There is no indication of expert consensus or adjudication in this regard; the assays themselves are the reference.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned. The studies involve direct comparison of viral load measurements obtained from different tubes using standard laboratory assays.

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 a medical device for blood collection and preparation, not an AI-powered diagnostic tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not applicable to this device.

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

This is a physical medical device (blood collection tube) and does not involve an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was established by viral load measurements using commercially available and validated molecular diagnostic kits (e.g., Roche Amplicor® HIV RT PCR Monitor™ Kit, Amplicor® HCV RT PCR Monitor - Test Kit, Chiron Quantiplex HCV RNA Assay) on blood samples. These kits are considered the reference standard for viral load quantification.

8. The Sample Size for the Training Set

The document does not describe a "training set" as it would for a machine learning model. The studies described are clinical evaluations comparing the performance of the device to predicate devices. There is no mention of a separate training phase for the device itself.

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

As there is no "training set" in the context of this physical device's evaluation, this question is not applicable.

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The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device designed to attach and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection Set during venipuncture.

The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device designed to attach and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection set during venipuncture. The holder has a quick release feature which allows the contaminated needle to be disengaged with a simple one handed push-button technique.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Becton Dickinson VACUTAINER® Brand Pronto™ Needle Holder:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "results indicating acceptable product performance" for all three attributes. However, it does not provide specific numerical thresholds for "acceptable product performance" for each attribute, nor does it provide the measured values for these attributes.

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

• Sample Size for Test Set: A total of 30 holders were tested.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given the context of a 510(k) submission to the FDA in the USA for a US-based manufacturer, it is highly probable the testing was conducted in the USA as part of a prospective design verification study.

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

This information is not provided in the document. The study described is a mechanical testing study of the device's physical attributes, not a study requiring expert interpretation of results or clinical outcomes. Therefore, the concept of "ground truth established by experts" as typically applied in clinical or diagnostic studies is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As noted above, this was a mechanical testing study, not a study involving human interpretation of results requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a mechanical testing study of the device itself, not a study involving human readers or assessment of human performance with or without AI assistance.

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

No, a standalone study was not done, and it is not applicable. This device is a mechanical medical instrument (needle holder), not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

The "ground truth" for this study was established by pre-defined engineering specifications and established BDVS procedures for mechanical testing of overtorque, activation force, and spinout. The performance of the devices was measured against these internal specifications to determine "acceptable product performance."

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a mechanical instrument, and the study described is a design verification test, not a study involving a "training set" in the context of machine learning or algorithms.

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

This information is not applicable/not provided as there was no training set for this type of device and study.

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

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

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