(577 days)
This device is an electromechanical positive displacement fluid compounding device that provides for the compounding of fluids via gravimetric weighing.
The Automix 3 + 3 / AS Compounder System is an electromechanical positive displacement fluid compounding device that provides for the safe, fast, and accurate compounding of a wide variety of fluids via gravimetric weighing. It has the same operational intended use and remains the same in all respects to the currently marketed system, except for the proposed modifications to incorporate a system to aid in the verification of source solution identity and placement.
The Positive Identification Solution Family Monitor, an equipment and software upgrade designed to aid in the verification of the identity of the source solutions being compounded, is a modification and upgrade to the compounding system currently marketed which is found substantially equivalent, for purposes of the Federal Food, Drug and Cosmetic Act only, to the Automix® 3+3 Compounder System under K894827, dated October 6, 1989.
This document, a 510(k) Premarket Notification for the Clintec Automix® 3+3/AS Compounder System, is a submission to the FDA. It declares substantial equivalence to a previously marketed device (K894827). Due to its nature, it does not contain the detailed performance study information typically found in a clinical trial report or a comprehensive validation study.
Therefore, many of the requested criteria cannot be extracted from this document, as it focuses on demonstrating equivalence rather than presenting an exhaustive performance study with acceptance criteria in the way you've described.
Here's an attempt to answer what can be inferred from the provided text, along with explanations for what cannot be:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided 510(k) summary. A 510(k) summary generally states that performance testing was conducted and found acceptable, but it does not typically detail specific acceptance criteria or the raw performance data in a table format.
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 available in the provided 510(k) summary. The document mentions "performance testing" and "verification and validation procedures" 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 is not applicable and not available. This device is an electromechanical fluid compounding system, not a diagnostic device that requires expert interpretation to establish a "ground truth" for a test set in the way a medical imaging AI would. The "ground truth" for this type of device would relate to the accuracy and precision of fluid compounding, which is typically measured by chemical/physical means, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable and not available. Similar to point 3, adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., medical images) to resolve discrepancies. This device is a machine, and its performance is assessed through objective measurements.
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
This is not applicable and not available. MRMC studies are used for diagnostic systems (often AI-powered) where human readers interpret cases. This device is an automated compounding system and does not involve "human readers" in its primary function. Its "Positive Identification Solution Family Monitor" is an aid for verification, not a system that improves human interpretation of cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as an "electromechanical positive displacement fluid compounding device." The "Positive Identification Solution Family Monitor, an equipment and software upgrade designed to aid in the verification of the identity of the source solutions," suggests that the system operates in an automated or semi-automated standalone manner for compounding, with the new feature aiding in verification. However, a formal "standalone" performance study report in the context of an AI algorithm is not detailed or explicitly stated here. The overall device functions as a standalone system for compounding.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" for this device relates to the accurate and precise compounding of fluids. This would typically be established through quantitative physical and chemical measurements (e.g., gravimetric analysis, chemical assays of compounded solutions) to ensure correct ingredient identity, volume, and concentration. The specific methods are not detailed in the provided summary.
8. The sample size for the training set
This is not applicable and not available. The document describes an "electromechanical positive displacement fluid compounding system" that relies on "gravimetric weighing" and an "equipment and software upgrade." This is a traditional engineering system, not a machine learning or AI system that requires a "training set" in the sense of supervised learning. The software aspects likely involve programming logic, control algorithms, and perhaps rule-based systems, but not a data-driven training set like deep learning.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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.