(160 days)
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobial Ceftazidime on the Synergies plus™ Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Ceftazidime susceptibility testing in this panel are:
Citrobacter spp Escherichia coli Enterobacter spp (excluding Enterobacter cloacae) Klebsiella spp Proteus spo Pseudomonas spp Serratia spp
The MicroScan® Synergies plus™ Gram-Negative Ceftazidime is not intended for use with:
Enterobacter cloacae
MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. The MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are read on the WalkAway SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus™ panels are inoculated and rehydrated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® S7 System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.
This document describes the 510(k) premarket notification for the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Ceftazidime (1-16 µg/ml) (originally named MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels in the initial 510(k) summary).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the proposed device demonstrated substantially equivalent performance to an NCCLS frozen Reference Panel, as defined in the "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices," dated March 8, 2000. Specifically, the criterion mentioned is "Essential Agreement of greater than 96%."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Essential Agreement (EA) > 96% with reference method | Overall Essential Agreement > 96% for Ceftazidime |
| Acceptable Reproducibility and Precision | Demonstrated acceptable reproducibility and precision |
| Acceptable Quality Control results | Demonstrated acceptable results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated with a specific number for organisms or isolates. The document mentions "fresh and stock Efficacy isolates and stock Challenge strains." However, no precise count is provided.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using "stock Efficacy isolates and stock Challenge strains" alongside "fresh" isolates. It's an external evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth was established by an NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) frozen Reference Panel, not by human experts adjudicating individual cases.
4. Adjudication Method for the Test Set
Not applicable. The comparison was made against a standardized reference panel, not requiring adjudication of human-interpreted results.
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 device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was done. The device (MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel with Ceftazidime) was evaluated by comparing its results directly with an NCCLS frozen Reference Panel. The "WalkAway® SI System or equivalent" reads the panels and determines MICs, which is an automated process without direct human interpretation of the MIC determination itself. The study focused on the performance of the device itself against a reference standard.
7. The Type of Ground Truth Used
NCCLS frozen Reference Panel. This is a standardized, recognized method for determining antimicrobial susceptibility, serving as the gold standard for comparison in this type of device submission.
8. The Sample Size for the Training Set
Not applicable. This document describes a 510(k) for an updated version of an existing device (MicroScan® rapID/S plus™), not a de novo submission of a novel algorithmic device that would typically involve a distinct "training set" in the context of machine learning. The "training" in this context would likely refer to the initial development and validation of the broader MicroScan system and panel technology. The current submission focuses on the performance of a specific antimicrobial (Ceftazidime) on the panel.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons mentioned above. The "ground truth" for the overall system development would have been established through extensive laboratory testing and validation against recognized reference methods (like NCCLS/CLSI standards) during the initial development of the MicroScan technology.
§ 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.”