(266 days)
BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, in vitro diagnostic medical devices available with Sodium Fluoride/Potassium Oxalate or Sodium Fluoride/Na2EDTA. They are intended to be used by trained healthcare professionals for the collection, containment, preservation, and centrifugation of venous blood specimens as required for in vitro diagnostic testing. Plastic BD Vacutainer® Fluoride Blood Collection Tubes are used to collect whole blood for the generation of plasma samples.
Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium FluoridePotassium Oxalate are used for glucose and lactate determinations. Blood collected in BD Vacutainer® Fluoride Blood Collection Tubes containing Sodium Fluoride/Na2EDTA are used for glucose determinations.
The BD Vacutainer® Fluoride Blood Collection Tubes are evacuated, sterile, single use, Class II in vitro diagnostic medical devices regulated under 21 CFR § 862.1675 for blood specimen collection devices, and product code GIM for tubes, vacuum sample, with anticoagulant. The tubes are intended to be used in settings where venous blood samples would be collected by trained healthcare professionals for the collection, containment, preservation, transportation, and centrifugation of blood in a closed tube.
BD Vacutainer® Fluoride Blood Collection Tubes are available in a plastic configuration containing various additive combinations in a blended powder mixture. The blended powder mixture contains sodium fluoride, which acts as an antiglycolytic agent. The plastic tube configurations also include various additives which provide an anticoagulated specimen when used according to the instructions for use. Tubes include a Gray color-coded BD Hemogard™ Closure indicative of the Fluoride additive. Tube stoppers are lubricated with silicone to facilitate stopper insertion.
The provided text describes the regulatory submission for the BD Vacutainer® Fluoride Blood Collection Tubes, a Class II medical device. The focus of the document is on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific performance criteria through a detailed clinical study with AI.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device are not directly applicable or explicitly stated in this document. This submission is for a blood collection tube, which is a physical device, and the "performance testing" described refers to bench and clinical studies on its ability to collect, preserve, and allow for accurate measurement of analytes (glucose, lactate). It does not involve an AI/ML component.
Based on the provided text, here's an attempt to answer the questions to the extent possible, highlighting where the information is not present due to the nature of the device (a blood collection tube, not an AI/ML system):
1. A table of acceptance criteria and the reported device performance
The document mentions that "Non-clinical performance testing was conducted following defined protocols and with established acceptance criteria" and that "Clinical testing results based on pre-determined acceptance criteria confirmed the functional clinical equivalence and performance." However, the specific numerical acceptance criteria and the quantitative reported device performance values are not provided in this summary. Instead, it states that the device "met all non-clinical testing requirements at time-zero and over the product shelf life" and confirmed "functional clinical equivalence and performance."
Therefore, a table cannot be constructed with the detailed information requested.
2. Sample size used for the test set and the data provenance
The document broadly states "Clinical testing was conducted on blood collected in the subject devices (BD Vacutainer® Fluoride Blood Collection Tubes) and a legally marketed comparator device." It does not specify the sample size for clinical testing or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not provided. The "ground truth" for this device would relate to accurate glucose and lactate measurements, which are established by standard laboratory analytical methods, not by human expert interpretation in the way it would be for an AI diagnostic imaging device.
4. Adjudication method for the test set
Not applicable and not provided. Data from analytical measurements do not typically require adjudication.
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 device, nor does it involve human readers in the context of diagnostic interpretation that would benefit from an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a blood collection tube, not an algorithm.
7. The type of ground truth used
For glucose and lactate determinations, the ground truth would be established by reference analytical methods performed on the blood samples, typically using laboratory analyzers considered the gold standard for those measurements. The document implies this by stating the tubes are used "for glucose and lactate determinations" and that clinical testing confirmed "functional clinical equivalence and performance... in the identification of clinically relevant levels of glucose and lactate."
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this device does not use a "training set" in the AI/ML context.
Summary of what is present in the document relevant to device acceptance/performance (though not in the AI/ML context):
- Device: BD Vacutainer® Fluoride Blood Collection Tubes (physical blood collection device).
- Purpose: Collection, containment, preservation, transportation, and centrifugation of venous blood specimens for in vitro diagnostic testing, specifically for glucose and lactate determinations.
- Performance Testing:
- Non-clinical (Bench): Evaluation of attributes such as Draw Volume, X-Value, Second Stopper Pullout, Stopper/Shield Separation, Stopper Leakage, Breakage Resistance During Centrifugation, and Breakage Resistance During Drop Testing. Also, Ship Testing for packaging.
- Clinical: Comparative testing against a legally marketed comparator device to demonstrate clinical equivalence in glucose and lactate determinations. Also, Within-Tube Stability, Shelf-Life Performance, and Repeatability/Reproducibility.
- Results: All non-clinical and clinical testing requirements were met, demonstrating the device functions as designed and is clinically equivalent.
- Acceptance Criteria Details: Not provided publicly in this summary. The document states "defined protocols and with established acceptance criteria" were used, but the specifics are confidential.
- Ground Truth (for glucose/lactate): Implied to be established by standard laboratory analytical methods for glucose and lactate measurements.
§ 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.