(61 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 Ceftriaxone on the Synergies plus™ "Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Ceftriaxone susceptibility testing in this panel are:
Acinetobacter calcoaceticus Escherichia coli Enterobacter spp. (except Enterobacter cloacae) Klebsiella pneumoniae Klebsiella oxytoca Morganella morganii Proteus mirabilis Providencia spp. Pseudomonas aeruginosa Serratia marcescens Shigella spp. Salmonella spp.
The MicroScan® Synergies plus™ Gram-Negative with Ceftriaxone is not intended for use with:
Citrobacter son Enterobacter cloacae Proteus vulgaris
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® 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 with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SY 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 Ceftriaxone. It details the device's intended use and provides a summary of the performance study conducted.
Here is an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a tabulated format with specific pass/fail thresholds. However, it does report performance metrics that imply the criteria met for substantial equivalence.
| Performance Metric | Reported Device Performance (Ceftriaxone) | Implicit Acceptance Criteria (based on "acceptable performance") |
|---|---|---|
| Overall Essential Agreement | 95.9% | Likely ≥ 90% or 95% (common for microdilution susceptibility) |
| Overall Categorical Agreement (breakpoint dilutions) | 89.6% | Likely ≥ 90% (common for microdilution susceptibility) |
| Instrument Reproducibility (Turbidity inoculum) | Acceptable | Implies meeting pre-defined precision/variability standards |
| Quality Control Testing | Acceptable | Implies meeting pre-defined QC ranges |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number of isolates/samples used in the test set is not specified.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was an "external evaluation," and given the FDA approval, it's reasonable to assume the study was conducted to meet US regulatory requirements. The study appears to be retrospective, using "fresh and stock Efficacy isolates and stock Challenge strains."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The ground truth was established by an "NCCLS frozen Reference Panel." The document doesn't detail how this reference panel's results were determined or if expert consensus was involved in its creation.
4. Adjudication method for the test set
This information is not provided in the document.
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. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool involving human readers interpreting results. It determines MIC values autonomously.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance study was done. The device (MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels read on the WalkAway® System) was compared against an "NCCLS frozen Reference Panel" without human intervention in the result interpretation from the device itself. The "human-in-the-loop" aspect for this type of device typically involves preparing the inoculum and loading the panels, but the reading and interpretation of MICs are automated.
7. The type of ground truth used
- The ground truth used was an NCCLS frozen Reference Panel. This type of reference standard is typically established through a standardized, highly controlled laboratory method (e.g., broth microdilution or agar dilution) performed by experienced microbiologists, potentially following guidelines set by organizations like the Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS).
8. The sample size for the training set
- The document does not specify a training set size. For an antimicrobial susceptibility device, the "training" aspect is more about assay development and optimization rather than machine learning algorithm training with distinct datasets. The performance evaluation focuses on the test set of isolates.
9. How the ground truth for the training set was established
- As a training set is not explicitly mentioned in the context of typical machine learning, this question is not directly applicable. If "training" refers to the development of the device's reading algorithms, the ground truth for establishing those algorithms would have been based on established phenotypic antimicrobial susceptibility testing methods. However, the document does not detail this developmental process.
§ 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.”