(86 days)
The CADD™ Medication Cassette reservoirs are intended for the delivery of medications and fluids for subcutaneous, intramuscular, intravenous, intra-arterial, intraperitoneal, or intraspinal infusion.
The CADD™ Medication Cassette Reservoir with Flow Stop feature is a modification to the current CADD™ Medication Cassette Reservoir with Flow Stop. The modification incorporates a 250 mL reservoir and a two-part housing assembly. It is provided with a medication bag and pump tube, extension tube, pressure plate with Flow Stop feature, rear housing, clamp and leur assembled with the cover set into the rear housing assembly but not snapped together. This two-part housing design is intended to allow manipulation of the medication bag for removal of air bubbles prior to permanently snapping the housing together.
The provided text describes a 510(k) premarket notification for a medical device called the CADD™ Medication Cassette Reservoir. This document outlines general information about the device, its intended use, and a summary of studies performed. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving those criteria.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states that the device "meets the acceptance criteria for the safety and performance requirements set by the CADD™ Medication Cassette Reservoir with Flow Stop specifications." However, it does not list specific acceptance criteria (e.g., maximum flow rate deviation, burst pressure, material compatibility thresholds).
- Reported Device Performance: Similarly, while it states "All tests performed demonstrate that the CADD™ Medication Cassette Reservoir with Flow Stop meets the acceptance criteria," it does not provide specific performance data or values for any of these tests.
Therefore, a table cannot be constructed with the information provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "Functional Testing," but it does not specify the sample size for any tests conducted.
- Data Provenance: This information is not available in the provided text.
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)
- Since there were no human clinical studies (see point 5 and 6), there was no ground truth established by experts in the context of the device's functional performance. The "ground truth" here would be the engineering specifications against which the device was tested.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This is not applicable as there were no clinical studies 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
- No MRMC study was done. The document explicitly states: "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD™ Medication Cassette Reservoir with Flow Stop."
- AI assistance is not relevant for this type of medical device (a medication cassette reservoir).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical medical reservoir, not an algorithm or AI system. The "Functional Testing" described would be considered a standalone performance evaluation of the device itself against its specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" used for this device would be its engineering specifications and design requirements. The functional tests were conducted to ensure the device performs according to these pre-defined (but not enumerated in the document) criteria. This is implicitly stated as "meets the acceptance criteria for the safety and performance requirements set by the CADD™ Medication Cassette Reservoir with Flow Stop specifications."
8. The sample size for the training set
- This question is not applicable as the device is a physical medical component, not a learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
Summary of available information regarding acceptance criteria and studies:
The document states that the CADD™ Medication Cassette Reservoir with Flow Stop was subjected to functional testing to demonstrate compliance with its internal specifications.
- Acceptance Criteria: Not explicitly listed but referred to as "safety and performance requirements set by the CADD™ Medication Cassette Reservoir with Flow Stop specifications."
- Study Type: Functional Testing (engineering/bench testing).
- Outcomes: "All tests performed demonstrate that the CADD™ Medication Cassette Reservoir with Flow Stop meets the acceptance criteria..."
- Clinical Studies: Deemed "not necessary."
- Predominant Ground Truth: Engineering and design specifications.
§ 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.