(143 days)
The VACUTAINER® Brand Sodium Citrate Pediatric Tube is an evacuated blood collection tube which provides a means of collecting, transporting and processing blood in a closed tube. Blood collected in a tube containing Sodium Citrate anticoagulant is used primarily for clinical laboratory coagulation assays.
The VACUTAINER® Brand Sodium Citrate Pediatric Tubes are sterile, glass, evacuated blood collection tubes. The tube contains Sodium Citrate as an anticoagulant intended to prevent whole blood from clotting prior to analysis. The specimen is centrifuged and the plasma portion is analyzed for the coagulation parameters to detect clotting time disorders and/or monitor patients undergoing anticoagulation therapy.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the requested information for a device like an AI-powered diagnostic tool. Instead, the document is a 510(k) summary for a VACUTAINER® Brand Sodium Citrate Pediatric Tube, which is a blood collection tube. The summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria using complex metrics like those for AI models.
Therefore, many of the requested fields are not applicable or cannot be extracted from this document, as it describes a physical medical device (a blood collection tube) and not an AI/ML-based diagnostic system.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The document describes the VACUTAINER® Brand Sodium Citrate Pediatric Tube, a sterile, glass, evacuated blood collection tube containing Sodium Citrate as an anticoagulant. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device, specifically addressing a material modification to the rubber stopper. The "acceptance criteria" in this context are implicitly the analytical and statistical equivalence to the predicate device's performance for its intended use, which is for clinical laboratory coagulation assays.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Does not affect the performance or effectiveness for intended use. | "The modified VACUTAINER® Brand Sodium Citrate Pediatric Tube demonstrated analytically and statistically equivalent results." |
| Substantial equivalence to predicate device. | "Based on comparison of the device features, materials, and intended use, the VACUTAINER® Brand Sodium Citrate Pediatric Tube can be shown to be substantially equivalent to the commercially available predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "Clinical evaluations were performed," but it does not specify the sample size used for these evaluations.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable to this type of device and study. The "ground truth" for a blood collection tube would relate to its ability to preserve blood components for accurate coagulation testing, which is assessed through laboratory methods comparing results to a predicate, not through expert consensus on diagnostic images or pathology.
4. Adjudication Method for the Test Set
- This concept is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, typically involving human readers and interpretations, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems assisting human readers in diagnostic tasks, which is not the nature of this medical device.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study in the context of an algorithm or AI was not done. The device is a physical blood collection tube, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is established by analytical and statistical equivalence of coagulation test results (e.g., clotting times, other coagulation parameters) obtained using the modified tube compared to the predicate device. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic devices. The performance of the collected blood for "clinical laboratory coagulation assays" is the measure of effectiveness.
8. The Sample Size for the Training Set
- This concept is not applicable. The device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
- This concept is not applicable as there is no training set for this type of device.
§ 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.