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The PAXgene® Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.

The PAXgene® Blood DNA Tube is a sterile, single use, plastic, evacuated blood collection tube with a BD Hemogard™ closure assembly (comprised of Hemogard™ stopper and shield components) and a measured quantity of K2EDTA additive quantity dispensed into each tube is designed to match the nominal blood draw volume of 2.5 mL. The tube is made of polyethylene terephthalate (PET) plastic which functions to maintain vacuum within the tube, allowing for accurate and consistent blood draw for the shelf life of the tube. A predetermined vacuum is drawn inside the tube that is sealed with a BD Hemogard™ closure which consists of a rubber stopper plus BD Hemogard™ shield.

The PAXgene® Blood DNA Tube is available as a 13 x 75 mm tube with a 2.5 mL nominal blood draw. The referenced first dimension represents the diameter of the tube, and the second dimension represents the length of the tube.

This document is a 510(k) summary for the PAXgene® Blood DNA Tube (K231469), comparing it to a predicate device (K142821). The primary change in the subject device is a revised draw volume specification.

Here's the information regarding acceptance criteria and the supporting study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that all other characteristics (General Description, Indications for Use, Device Design, Device Materials, Packaging and Sterility) are identical between the subject and predicate devices. Therefore, the "acceptance criteria" for these would be identical to the predicate's specifications, and the "reported performance" of the subject device is stated to be identical.

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

The document mentions "clinical evidence" and "shelf-life testing" to support the revised draw volume specification. However:

• Specific sample sizes for the clinical study are NOT provided.
• Data provenance (e.g., country of origin, retrospective or prospective) is NOT provided.

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

• This information is NOT provided in the document. The study appears to be a performance validation of a blood collection tube, not one requiring expert interpretation of diagnostic output.

4. Adjudication Method

• This information is NOT applicable/not provided for this type of device validation study (a blood collection tube). Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation of medical images or diagnostic results.

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

• No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is compared. The PAXgene® Blood DNA Tube is a blood collection device, not an AI diagnostic.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone algorithm-only performance study was NOT done. This is not an AI diagnostic device. The performance validation is for the physical blood collection tube itself.

7. The Type of Ground Truth Used

The ground truth for the performance of the device (specifically regarding the revised draw volume specification) appears to be established through:

• Clinical evidence: Implies direct measurement and analysis of blood DNA collected using the tubes.
• Shelf-life testing: Verifies that the device maintains its performance over its specified shelf life, which includes its ability to draw the specified volume and preserve DNA quality.

8. The Sample Size for the Training Set

• This information is NOT applicable/not provided. The 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. As it's not an AI device, there is no "training set" or ground truth established for training. The "ground truth" (or acceptable performance) for the device's function is established through the physical and chemical properties and laboratory performance testing.

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The PAXgene Blood DNA Tube is intended to collect, anticoagulate, stabilize, transport, and store a venous whole blood sample for preparation of human DNA for use with molecular diagnostic test methods that require DNA.
The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.

The PAXgene® Blood DNA Tube is a sterile, single use, plastic, evacuated blood collection tube with a BD Hemogard™ closure assembly and a measured quantity of K2EDTA additive. The additive quantity dispensed into each tube is designed to match the nominal blood draw volume of 2.5 mL. The tube is made of polyethylene terephthalate (PET) plastic which functions to maintain vacuum within the tube, allowing for accurate and consistent blood draw for the duration of the shelf life of the tube. A predetermined vacuum is drawn inside the tube that is sealed with a BD Hemogard™ closure which consists of a rubber stopper plus BD Hemogard™ shield. The tube is intended to be placed inside a tube holder or an adaptor that contains a needle designed to pierce the tube closure and allow blood to flow into the tube. Once the vein has been penetrated (using either a standard blood collection needle or a blood collection set), the tube is pushed into the holder, and the blood enters the tube. Once a tube has drawn the appropriate amount of blood, it is disengaged from the holder and inverted the recommended number of times (8–10) to mix the additive with the blood. The DNA in whole blood collected in the PAXgene® Blood DNA Tube has been shown to be suitable for molecular diagnostic testing for 14 days at room temperature (18–25°C), 28 days refrigerated (2–8°C), 3 days at 35°C, up to 52 weeks frozen (–20°C), or when subjected to up to three freeze-thaw cycles. The PAXgene® Blood DNA Tube is robust with respect to mishandling including reduced inversions and partial blood draw. The product shelf life is one year from the date of manufacture including limited storage temperature excursions which simulate shipping conditions from –20°C to 45°C. The PAXgene® Blood DNA Tube is available as a 13 x 75 mm tube with a 2.5 mL nominal blood draw. The referenced first dimension represents the diameter of the tube and the second dimension represents the length of the tube.

The provided document describes the PAXgene® Blood DNA Tube, a blood collection device, and its performance characteristics as part of a 510(k) premarket notification. The study aims to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study findings based on the provided text, while noting the limitations of the document regarding certain specific study parameters that are often found in AI/ML performance studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a typical table format with pre-defined thresholds. Instead, it presents performance data for DNA yield, concentration, purity, and concordance with FDA-cleared molecular diagnostic assays to demonstrate the device's suitability for its intended use and substantial equivalence to the predicate device.

However, based on the summary results and the nature of this submission, which is for a blood collection tube rather than an AI/ML diagnostic algorithm, the acceptance criteria are implicitly met if the device consistently yields high-quality DNA that produces 100% correct calls in various molecular diagnostic assays, and if its stability and robustness are demonstrated.

Here's a synthesized table based on the various performance summaries:

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

The "test set" here refers to the samples used for performance evaluation, as this is not an AI/ML device in the traditional sense that uses training/test splits.

• DNA Yield, Concentration, and Purity Summary:
  • Magnetic Bead based DNA extraction kit: 581 specimens from approximately 200 consented subjects.
  • Silica Membrane based DNA extraction kit: 540 specimens from 152 consented subjects.
• Molecular Diagnostic Test Methods (Assay Concordance):
  • Individual assays varied: CF Assay (40 samples per site, total 117 after retest); HLA Assay 1 (40 samples per site, total 120 after retest); Thrombophilia Assay (80 samples); HLA Assay 2 (698 samples after retest); HLA Assay 3 (100 samples).
  • Reproducibility studies: 20 donors for site-to-site and lot-to-lot.
• Device Shelf-Life Study: Tested with 24 subjects (12 per time point/group) for 12, 13 months, and with temperature cycling.
• DNA Stability (Whole Blood Storage in Tube): Sample sizes of 12 or 60 for various storage conditions and time points.
• Interference Study: 10 samples per interfering substance for both magnetic bead and silica membrane purification methods.
• Sample Handling (Underfilling and Mixing): 10 subjects for each handling condition.

Data Provenance: The document states that blood was drawn from "consented subjects" and mentions testing at "four (4) external clinical test sites and one (1) internal test site". This strongly indicates prospective data collection from human subjects. The document does not specify the country of origin of the data, but given the FDA submission, it likely includes data from the US or regions compliant with FDA standards.

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

This is not applicable in the context of this device. The ground truth for this device (a blood collection tube) is objectively measured through DNA quantification (yield, concentration, purity) and the concordance of results with established, FDA-cleared molecular diagnostic assays. The "ground truth" for the molecular diagnostic assays themselves would be derived from clinical diagnosis or confirmed genetic status, not expert consensus on image interpretation. No human experts are used for establishing ground truth for device performance in this manner.

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

Not applicable. This is not a study requiring reader adjudication of ambiguous cases, as it measures objective biochemical and molecular assay outcomes.

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/ML medical device, and no human readers are involved in interpreting results that would be enhanced by AI assistance. The performance is assessed on the ability of the tube to collect and preserve DNA for downstream molecular diagnostic tests.

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

Yes, in a sense, the primary studies are "standalone" performance evaluations of the device itself (the blood collection tube) to ensure it performs its function of preserving DNA for analysis. The "algorithm" here is the device's mechanism (anticoagulation, stabilization) and the subsequent molecular diagnostic assays. The results presented (DNA metrics and assay concordance) are direct outputs of using the PAXgene Blood DNA Tube in conjunction with standard laboratory procedures and FDA-cleared assays, without human interpretation as part of the 'device's' output.

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

The ground truth used for evaluating the PAXgene Blood DNA Tube's performance is multi-faceted:

• Quantitative DNA metrics: Measured values (yield, concentration, purity) obtained through standard laboratory equipment (e.g., UV absorbance).
• Concordance with FDA-cleared Molecular Diagnostic Assays: The "ground truth" for the assay results themselves is that the assay should correctly identify the genetic markers it is cleared to detect. The study establishes that DNA collected in the PAXgene tube yields results (e.g., genotypes) that are 100% concordant with those obtained from control (predicate or EDTA) tubes, demonstrating that the sample preparation did not alter the diagnostic outcome.

8. The sample size for the training set

Not applicable. This is a blood collection device, not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is used for this device.

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VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® EDTA K3 Tubes are used for testing plasma in molecular diagnostics. The performance characteristics of this device have not been established for molecular diagnostic assays in general. Users must validate use of product for their specific molecular diagnostic assay.

VACUETTE® Tubes, Holders and Needles are used together as a system for the collection of venous blood. VACUETTE® tubes are used to collect, transport and process blood for testing serum, plasma or whole blood in the clinical laboratory. VACUETTE® EDTA K3 Tubes are used for testing whole blood in molecular diagnostics.

The provided document describes the 510(k) summary for the Greiner VACUETTE® EDTA K3 Tubes, which are an evacuated blood collection system. The primary goal of the submission was to demonstrate substantial equivalence to predicate devices (Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube and Glass K3 EDTA Tube) for use in molecular diagnostics.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document mentions "contractually healthy blood donors' and patients' samples," but does not specify the exact number of individuals or samples used in the studies.
• Data Provenance: The document does not explicitly state the country of origin for the data. The study appears to be prospective as it involved collecting samples (from healthy donors and patients) specifically for the purpose of the 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 appears to rely on PCR test results as the "ground truth" for molecular diagnostic performance, rather than expert consensus on an image or clinical assessment.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The study focuses on laboratory test results (HIV-1 and HCV PCR), not subjective clinical assessments 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. This type of study is typically performed for AI-powered diagnostic tools that aid human interpretation, which is not the function of a blood collection tube. The study compared the performance of blood samples collected in different tubes on molecular diagnostic assays.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable in the context of this device. The device itself is a blood collection tube, not an algorithm. The "performance" being evaluated is the chemical and physical compatibility of the tube with subsequent molecular diagnostic tests, essentially ensuring the collected sample remains viable and produces equivalent results to samples collected in predicate devices. The PCR assays themselves are standardized laboratory procedures, not AI algorithms.

7. The Type of Ground Truth Used

The ground truth used was molecular diagnostic assay results (HIV-1 and HCV PCR results). The "truth" was established by the output of these laboratory tests performed on samples collected in both the test device and the predicate device, with the expectation that the results would be "substantially equivalent."

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a physical medical device (blood collection tube), not an AI algorithm that requires a training set. The "studies" mentioned refer to performance validation, not machine learning model training.

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

This information is not applicable. As stated above, there is no training set for this device.

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The S-Monovette® EDTA K2-Gel provides a means for collection, processing and transportation of a plasma specimen in a closed system. Following collection of the blood, the S-Monovette® EDTA K2-Gel is to be centrifuged such that the gel creates a barrier between the plasma and cellular components. The plasma specimen can then be removed for testing or the specimen can be transported for testing at another location without the plasma mixing with the cellular components.

The plasma specimen produced by the S-Monovette® EDTA K2-Gel can be used for Nucleic Acid Testing (NAT) by methods such as PCR - Polymerase Chain Reaction or for other procedures where the laboratory has determined that a plasma specimen is appropriate.

Not Found

This document is a 510(k) premarket notification for a medical device, specifically a "S-Monovette EDTA K2-Gel" blood collection tube. It outlines the FDA's decision regarding substantial equivalence to a predicate device and provides information on the intended use of the device.

However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations of AI/ML-driven or diagnostic/screening devices for which the requested information (e.g., sample size for test set, number of experts, adjudication method, AI vs. human performance) would be relevant.

This document pertains to a blood specimen collection device, which is a Class II medical device. The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness through comparisons of design, materials, performance, labeling, and intended use. Performance testing for a blood collection device would typically involve demonstrating its ability to properly collect, store, and process blood specimens according to its stated indications, and to ensure the blood components (e.g., plasma) are suitable for subsequent laboratory testing. This would involve chemical stability, sterility, and physical integrity studies rather than diagnostic accuracy studies with ground truth.

Therefore, I cannot extract the requested information (Table of acceptance criteria, sample size, expert qualifications, etc.) because it is not present in this type of FDA 510(k) summary for a blood collection device. The information requested is more relevant for diagnostic devices that analyze patient data to make a clinical determination.

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The VACUETTE® EDTA K2 tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume. The VACUETTE® EDTA K2 tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

The VACUETTE® EDTA K2 Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

The provided text describes the 510(k) summary for the VACUETTE® EDTA K2 Tubes. The core of the submission is to demonstrate substantial equivalence to a predicate device, the Becton Dickinson Vacutainer® Brand PPT™ Plasma Preparation Tube, rather than meeting specific acceptance criteria defined by a standalone performance study in the way a diagnostic algorithm might. Therefore, the information typically requested for AI/algorithm performance (e.g., sample sizes for test/training, number of experts for ground truth, MRMC study details) is not directly applicable in its usual sense for this device.

However, I can extract the information related to the studies performed to demonstrate "substantial equivalence," interpreting the "acceptance criteria" as the comparable performance necessary to achieve substantial equivalence.

Here's the breakdown of the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence study for a medical device (blood collection tube) rather than a diagnostic algorithm, the "acceptance criteria" are framed as demonstrating performance comparable to the predicate device in specific applications, particularly molecular diagnostic assays. The "reported device performance" shows that the VACUETTE® EDTA K2 Tube achieved this comparable performance.

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

The document does not explicitly state the specific number of samples or subjects used in these validation studies. It describes the types of studies conducted:

• Limited validation testing on HIV and HCV PCR assays using WHO standards at lower detection limits.
• Comparison of HIV and HCV lower detection limits using both types of tubes.
• Comparison of HIV and HCV recovery using both types of tubes.
• Equivalency studies of Greiner and BD tubes with regard to results of HIV and HCV PCR testing.
• Evaluation of effects of delay in separation of plasma and blood cells on HIV and HCV results.
• Determination of equivalency of HIV and HCV results from fresh and multiple freeze-thaw samples.

The data provenance (country of origin, retrospective/prospective) is not specified in the summary.

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

This information is not applicable and is not provided in the document. The "ground truth" in this context would be the actual concentration or presence of HIV/HCV in the samples, determined by established molecular diagnostic assays, not by expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided. The performance assessment is based on quantitative PCR results, which do not typically involve human adjudication in the described manner.

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 information is not applicable. The device is a blood collection tube, not an AI or imaging diagnostic tool. An MRMC study is therefore not relevant.

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 (blood collection tube) and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these studies was the quantitation of HIV and HCV using PCR assays, likely against established reference standards (e.g., WHO standards for lower detection limits). This is a form of laboratory assay result or reference standard comparison.

8. The Sample Size for the Training Set

This concept is not applicable as this is not an AI/machine learning device. The studies described are validation and equivalence studies, not training of an algorithm.

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

This concept is not applicable for the reason stated above. The "ground truth" (HIV/HCV quantitation) was established by standard laboratory procedures and reference materials.

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The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material. The VACUETTE® EDTA K2 Gel tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

The VACUETTE® EDTA K2 Gel tube provides a means for collection, processing and transportation of an undiluted plasma specimen in a closed evacuated system. The tube contains spray-dried EDTA, yielding a ratio of 1.8mg/mL of blood when the evacuated tube is filled correctly to its fill volume, and a gel barrier material.

The VACUETTE® EDTA K2 Gel Tube is used for plasma preparation and is made of plastic for the collection of venous blood which upon centrifugation separates undiluted plasma for use in molecular diagnostic test methods (such as but not limited to PCR - Polymerase Chain Reaction), or other procedures where an undiluted plasma specimen is required as determined by the laboratory.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Greiner VACUETTE® EDTA K2 Gel Tubes:

This 510(k) summary is for a medical device (blood collection tube) and focuses on demonstrating substantial equivalence to an existing predicate device rather than meeting specific performance criteria against predefined numerical targets. Therefore, the "acceptance criteria" are implied by the performance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size (number of patient samples or replicates) used for the tests. It only mentions "samples from these tubes" which were used in PCR assays.
• Data Provenance: Not explicitly stated, but the mention of "WHO standards" suggests an international or standardized approach. The study was conducted by Greiner Vacuette North America, Inc. It's likely these were prospective studies conducted for the purpose of this submission, but it's not explicitly labeled as "prospective" or "retrospective."
• Country of Origin: Not specified.

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

• Number of Experts: This information is not provided.
• Qualifications of Experts: This information is not provided.
  • Note: Given the nature of a blood collection device study focused on PCR assay performance, ground truth would likely be established by lab technicians/scientists following validated PCR protocols, rather than medical experts in the traditional sense (e.g., radiologists). The "ground truth" here is the accurate quantification of HIV and HCV using established PCR methods.

4. Adjudication Method for the Test Set

• Adjudication Method: This information is not provided. Adjudication as typically understood in image analysis (e.g., 2+1) is not applicable to this type of laboratory-based quantitative comparison. The "adjudication" would be inherent in the standard laboratory protocols and quality control measures for PCR assays.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation (e.g., radiology AI). This device is a blood collection tube, and the "effectiveness" is measured by the performance of subsequent analytical assays (PCR), not human reader performance.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Yes, in essence, the study conducted represents a "standalone" evaluation of the device's impact on the sample. The performance is assessed directly through laboratory assays (PCR) using samples collected in the device, without an "human-in-the-loop" interpretation step that would involve a human user's decision-making in the context of the device's output. The device itself (the tube) doesn't have an "algorithm" in the conventional sense, but its physical and chemical properties are tested in isolation regarding their effect on sample integrity for PCR.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth is the quantification of HIV and HCV RNA/DNA using established PCR assay methods, validated by "WHO standards" at lower detection limits. The "truth" is the accurate and consistent measurement of these viral loads. The comparison is made against the performance of the predicate device under the same conditions.

8. Sample Size for the Training Set

• Sample Size for Training Set: This information is not provided. For a medical device like a blood collection tube, there isn't typically a "training set" in the machine learning sense. The device itself isn't "trained." If any initial development or optimization involved testing, the details are not included in this summary. The studies described are validation studies for the final product.

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

• Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the machine learning context for this device. The rigorous laboratory testing and comparison to WHO standards would serve as the basis for understanding and demonstrating the performance characteristics of the VACUETTE® EDTA K2 Gel Tubes.

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A blood collection kit for D.N.A. is a device intended for medical purposes to collection tubes. A blood collection kit for D.N.A. is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.

A blood collection kit for D.N.A. is a device intended for medical purposes to collection tubes. A blood collection kit for D.N.A. is a device may include blood collection tubes, vials, systems, or vacuum sample tubes.

I apologize, but the provided text describes a 510(k) clearance letter for a DNA Blood Collection Kit and does not contain information about acceptance criteria or a study proving device performance as requested. It is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the input provided.

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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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