(15 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 Amikacin on the rapID/S plus" Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Amikacin susceptibility testing in this panel are:
Acintobacter spp Citrobacter freundii Escherichia coli Enterobacter spp Klebsiella spp Proteus spp Providencia alcalifaciens Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Pseudomonas spp Serratia spp
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® S7 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℃ in the WalkAway® SI 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.
The provided document describes the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Amikacin (0.25 - 128 µg/ml), which are used to determine antimicrobial agent susceptibility. The information below is extracted from the 510(k) Summary.
Acceptance Criteria and Device Performance
The study aimed to demonstrate substantial equivalence to an NCCLS frozen Reference Panel. The primary performance metric was "Essential Agreement."
| Acceptance Criteria | Reported Device Performance (Amikacin) |
|---|---|
| Essential Agreement | 96.4% |
Note: The document states that the device demonstrated "acceptable performance with an overall Essential Agreement of 96.4% for Amikacin" when compared with the frozen Reference panel, implying that 96.4% Essential Agreement met the acceptance criteria defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices," dated March 8, 2000. Specific numerical acceptance thresholds beyond this general statement are not detailed in the provided text.
Study Information
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." It does not provide specific numbers for these isolates or strains.
- Data Provenance: Not explicitly stated regarding country of origin. The study was an "external evaluation." It utilized "fresh and stock Efficacy isolates" (implying potentially prospective or recently collected retrospective isolates) and "stock Challenge strains" (retrospective, well-characterized strains).
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)
Not applicable. The ground truth for antimicrobial susceptibility testing is typically established by reference methods, not human expert consensus in this context. The reference panel (NCCLS frozen Reference Panel) itself represents the established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication by human experts is not typically used for establishing ground truth in antimicrobial susceptibility testing, which relies on standardized laboratory methods for comparison.
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 system for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this was a standalone performance study. The MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel is an "algorithm only" type of device in the sense that the automated system (WalkAway® SI System or equivalent) reads the results and determines the MIC. The performance was compared directly to a reference panel without explicit "human-in-the-loop" interaction for result interpretation in the context of the performance study itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth was established by an NCCLS frozen Reference Panel. This represents a standardized, laboratory-based reference method for antimicrobial susceptibility testing. "Challenge strains" were also compared to "Expected Results determined prior to the evaluation," which would have been established using similar reference methods.
8. The sample size for the training set
The document does not explicitly state a "training set" or its sample size. This type of 510(k) submission for a diagnostic test often focuses on a verification and validation (V&V) study against a reference method rather than a machine learning model requiring a distinct training phase. If any internal development iterations occurred, the data for those are not described as a "training set."
9. How the ground truth for the training set was established
Not applicable, as a distinct "training set" is not described or implied in the context of this device's development and validation discussed in the provided text. The device's performance was evaluated against an established reference standard (NCCLS frozen Reference Panel).
§ 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.”