(162 days)
The Dade Behring LabPro AlertEx Software System is intended for use with the LabPro Data Management System Software, version 3.0 and MicroScan® Instruments (e.g., WalkAway SZ, autoSCAN-4). The Alertex Software notifies the user of unusual conditions, or out-of-range results that may warrant further analysis or action, and/or provides the user with the ability to change organism identifications and/or antibiotic susceptibility test interpretations.
The Dade Behring LabPro AlertEx Software System is a rule-based software application within the LabPro Data Management System Software version 3.0. The initial LabPro software releases (prior to version 3.0) contained Alert functionality that automatically notified the user of unusual conditions or out-of-range results that may warrant further analysis or action. The LabPro Alertex software offers added functionality including the ability to change the organism identification (ID) and/or antimicrobial susceptibility testing (AST) interpretations.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. It mainly focuses on the regulatory submission and approval of the Dade Behring LabPro AlertEx Software System, stating its intended use and substantial equivalence to a predicate device.
Here's an analysis of what information is available and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided documents. The text mentions "The LabPro AlertEx Software Verification and Validation Testing confirmed that the AlertEx software operates in accordance with the intended functional requirements." This implies that there were functional requirements acting as acceptance criteria, but their specific details (e.g., specific accuracy thresholds, alert rates) are not provided.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, alert rates for different scenarios) 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)
- This information is not provided in the given 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)
- This information is not provided in the given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided in the given text.
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 information is not provided. The device is described as a "rule-based software system" that notifies users and allows for changes in interpretations, implying a human-in-the-loop system. However, no comparative effectiveness study on human reader improvement is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The text describes the software's function to "notify the user of unusual conditions" and "provide the user with the ability to change organism identifications and/or antibiotic susceptibility test interpretations." This indicates it is designed to work with a human user, not as a standalone diagnostic tool without human oversight. There is no mention of standalone performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- This information is not provided in the given text.
8. The sample size for the training set
- This information is not provided in the given text. As a "rule-based software system," it might not involve traditional machine learning training sets in the same way a deep learning AI would. Its "rules" would likely be derived from expert knowledge and clinical guidelines.
9. How the ground truth for the training set was established
- This information is not provided in the given text.
Summary of available information regarding the "study" and "acceptance criteria":
- The submission mentions "software development and verification and validation testing processes."
- It states that "The LabPro AlertEx Software Verification and Validation Testing confirmed that the AlertEx software operates in accordance with the intended functional requirements."
- The comparison is primarily focused on substantial equivalence to a predicate device (BDXpert System) as defined in a specific FDA guidance document for AST systems. This implies that the 'acceptance criteria' for regulatory approval were met through demonstrating equivalence based on the guidance document, rather than specific performance metrics reported here.
In conclusion, the provided FDA 510(k) summary and approval letter focus on the regulatory process and substantial equivalence, but do not disclose the detailed technical performance study results, acceptance criteria, or methodological specifics (like sample sizes, expert qualifications, or ground truth establishment) that would typically be found in a detailed device performance study report.
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”