(13 days)
Robertsite* Vial Adapter is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
Robertsite* Vial Adapter is indicated to allow multiple needleless access to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.
Sterile single use device.
The provided text describes a 510(k) premarket notification for a medical device called the "Robertsite* Vial Adapter." The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.
Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" cannot be fully extracted in the way it would for a typical performance study of AI/ML technologies. The document states that the new device has different characteristics (stem and cap configuration, length, split septum configuration) from the predicate device that could affect safety or effectiveness, but asserts that the safety and effectiveness questions are the same for all vial adapter systems.
The "acceptance criteria" referred to in this document are implicitly related to the "Guidance on 510(k) Submissions for Intravascular Administration Sets" and in-house protocols, rather than specific performance thresholds for metrics like accuracy or sensitivity.
Here's an attempt to answer your questions based on the provided text, acknowledging where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. It generally states that "in house test protocols were used to evaluate the device's performance" and "performance data gathered in design verification and validation testing demonstrated that the Robertsite* Vial Adapter is substantially equivalent to the predicate... and for met predetermined acceptance criteria".
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "in house test protocols" and "design verification and validation testing," but does not specify sample sizes or data provenance.
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)
This information is not applicable and therefore not provided. The study is a laboratory-based performance testing of a medical device (vial adapter), not an AI/ML-based diagnostic system that relies on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. This is not a study involving human interpretation or 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/ML-driven device, nor does it involve human readers in an interpretive capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI/ML algorithm. The performance testing was of the physical device itself. The document states "Clinical performance testing was not required," indicating that the evaluation was based on laboratory testing of the device's physical characteristics and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI/ML or diagnostic studies is not directly applicable here. The "ground truth" for this device's performance would be the established scientific and engineering principles for fluid transfer, sterility, material compatibility, and structural integrity as outlined in the "FDA's Draft October 12, 2000 'Guidance on 510(k) Submissions for Intravascular Administration Sets'" and the manufacturer's in-house protocols. These would involve physical measurements, functional tests, and material analyses rather than expert consensus on images or pathology results.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device that requires a training set.
§ 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.