(50 days)
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.
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | Reported Device Performance (VACUETTE® EDTA K2 Tubes) |
|---|---|
| Similar sensitivity and recovery at lower detection limits for HIV PCR. | Demonstrated similar sensitivity and recovery at the lower detection limits for HIV quantitation. |
| Similar sensitivity and recovery at lower detection limits for HCV PCR. | Demonstrated similar sensitivity and recovery at the lower detection limits for HCV quantitation. |
| Substantially equivalent results in HIV quantitation. | Demonstrated substantially equivalent results in HIV quantitation. |
| Substantially equivalent results in HCV quantitation. | Demonstrated substantially equivalent results in HCV quantitation. |
| No significant effect on HIV results when plasma is separated from blood cells within 24 hours. | No effect was seen when plasma collected from the Greiner tube was separated from blood cells within 24 hours for HIV. |
| No significant effect on HCV results when plasma is separated from blood cells within 2 hours. | No effect was seen when plasma collected from the Greiner tube was separated from blood cells within 2 hours for HCV. |
| No difference in HIV results for fresh vs. once frozen samples. | No difference in HIV results within or between the two tube types for fresh versus once frozen samples. |
| No difference in HIV results when plasma samples are exposed to 5 freeze/thaw cycles. | No difference in HIV results when plasma samples were exposed to 5 freeze/thaw cycles. |
| No difference in HCV results for fresh vs. once frozen samples. | No difference in HCV results within or between the two tube types for fresh versus once frozen samples. |
| No difference in HCV results when plasma samples are exposed to 5 freeze/thaw cycles. | No difference in HCV results when plasma samples were exposed to 5 freeze/thaw cycles. |
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.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.