(121 days)
Hospira Burette sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.
The Hospira Burette Sets with Secure Lock are intended for use as gravity sets. Hospira Burette sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly and injection site assembly. Burette sets are configured to ensure the intended use of the device is met. Hospira Burette sets are intended for the delivery of fluids from a container to a patient's vascular system. The sets are disposable devices for single patient use.
The provided document is a 510(k) summary for the Hospira Burette Sets, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study of AI performance.
Therefore, many of the requested elements for describing the acceptance criteria and study proving device meets those criteria, particularly those related to AI effectiveness, human readers, sample sizes for training sets, and expert adjudication, are not applicable to this document. This document describes a medical device, Burette Sets, not an AI or imaging diagnostic device.
However, I can extract and infer some information based on the document's content regarding the device's performance and the testing conducted.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported device performance values in the way you might expect for an AI diagnostic study. Instead, it refers to compliance with international standards and internal testing.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (Material safety) | "All materials of construction for Hospira Burette Sets meet the applicable material test requirements for ISO 10993." |
| Performance (Functional intent) | "New performance data has been generated to ensure the device performs as intended in accordance with ISO 594-1, ISO 594-2, ISO 8536-4. All testing is acceptable." |
| Sterility Assurance Level | "The product Sterility Assurance Level is 10-6." |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample size used for performance or material testing. It states that "new performance data has been generated" and "all testing is acceptable."
- Data Provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by Hospira, Incorporated as part of their 510(k) submission. This would be prospective testing for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device (intravascular administration set), not a diagnostic device requiring expert interpretation or ground truth establishment in the context of medical imaging or AI. Testing would involve engineering and laboratory personnel following established protocols and standards.
4. Adjudication method for the test set
- Not Applicable. As above, this type of testing for a physical device does not typically involve adjudication methods like those used for expert consensus in diagnostic studies. Compliance with standards (e.g., ISO) is the primary method of evaluation.
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 study is not an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. It's for a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI algorithm. It's a medical device. Performance testing for the device would be analogous to "standalone" performance testing for a physical product, demonstrating it meets its specifications independently.
7. The type of ground truth used
The "ground truth" for this device is based on compliance with established international standards for medical devices (ISO 10993 for biocompatibility, ISO 594-1, ISO 594-2, ISO 8536-4 for various performance aspects of injection and infusion equipment) and achieving a specific sterility assurance level (10-6). The performance claims are also against the intended use of the device for fluid delivery.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, this is not an AI model.
In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating an AI diagnostic tool. Therefore, many of the questions related to AI performance, human readers, and ground truth establishment for AI models are not relevant to this context. The "study" proving the device meets the criteria refers to the non-clinical performance testing and material testing conducted to ensure compliance with relevant ISO standards and the stated Sterility Assurance Level.
§ 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.