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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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The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The VACUETTE® Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle 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. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions.

The VACUETTE® Safety Blood Collection Set is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with a female luer adapter. The Winged needle is designed with a safety shield, which can be activated to cover the noodle in houleve inmediately following venipuncture to aid in the protection against accreental in accordance with these instructions. The safety feature is easily operated through the release of a latch mechanism whereby the The Salely leature is easily operator and it is removed from the patient. Once the user slides a wingsu ocatety cover locks in place. This mechanism is substantially needie is covered, the oulony ject® Angel Wing Blood Collection Set. The VACUETTE® Safety Blood Collection Set will be available in 80 configurations to include needle gauge (10 gauge sizes), needle length (2 lengths) and tubing length (4 lengths). The devices are packaged as sterile and are labeled for single use only. There is no ability The devices are pookegoe as ses. The results of biocompatibility data support the to clean and rease theose and include sterility, pyrogenicity and systemic injection testing.

The provided text describes a medical device, the VACUETTE® Safety Blood Collection Set, and its 510(k) summary for FDA approval. However, the document does not contain information regarding acceptance criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy), nor does it describe a study to prove the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Sherwood Medical Angel Wing™ Safety Blood Collection Set, K912563) based on materials, biocompatibility, and overall performance characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving performance as it is not present in the provided text. The document primarily addresses regulatory aspects of device approval rather than detailed performance study results against specific metrics.

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