(29 days)
The BD Vacutainer® Safety-Lok™ Administration Set with Filter is a sterile, single-use wing set intended for the intravenous administration of fluids and may be used for any patic population with consideration given to patient size, appropriateness for the solution being infus and duration of therapy. The BD Vacutainer® Safety-Lok™ Administration Set with Fil minimizes the possibility of needlesticks if manually activated following administration.
The BD Vacutainer® Safety-Lok™ Administration Set with Filter is intended for the infusion of fluids. The wing set contains a safety shield that is manually activated once infusion is complete, helping to prevent accidental needle sticks.
The provided text describes the BD Vacutainer® Safety-Lok™ Administration Set with Filter, but it does not contain specific acceptance criteria or a detailed study report with the information requested in your bullet points.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions "Extensive mechanical and compatibility testing was performed to demonstrate the device's safety and effectiveness," but it does not provide the results of these tests against specific acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
Here's what I can extract based on the limited information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Extensive mechanical and compatibility testing was performed to demonstrate the device's safety and effectiveness." (No specific performance metrics are reported.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no information on expert review or ground truth establishment is provided for testing an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device requiring clinical image/data interpretation.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground truth as typically understood for AI/ML performance evaluation is not relevant here. The evaluation involved "mechanical and compatibility testing," implying engineering and material science evaluations, likely against predefined specification limits.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.