(20 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 Tetracycline on the Synergies plus** Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Tetracycline susceptibility testing in this panel are:
Acinetobacter calcoaceticus
Acinetobacter spp
Escherichia coli
Enterobacter aerogenes
Klebsiella oxytoca
Klebsiella ozaenae
Klebsiella pneumoniae
Klebsiella rhinoscleromatis
Klebsiella spp
Shigella flexneri
Shigella sonnei
Shigella spp
MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in eteterming quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing and facultative anaerobic gram-negative bacilli. The MicroScan® rapID/S play® 40 growing aeroon: and faculiative androone grain negative occessed or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have The antimicrobial susceptionity tests are inimations bridging the range of clinical interest and are been unders in micro-titer wells in dried form. rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SI System or equivalent standardized suspension of the organism and measuration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.
The provided text describes the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Tetracycline. This device is an antimicrobial susceptibility testing device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The text explicitly mentions: "The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially The proposed MRTOSCall TaptDib Pras - One Negal Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", DRAPT Uccument Ourlance on Reviow Criceation (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel Tetracycline. ... Essential Agreement of 92.7% for Tetracycline when compared with the frozen Reference panel."
| Performance Metric | Acceptance Criteria (implied from FDA Guidance) | Reported Device Performance |
|---|---|---|
| Essential Agreement | Not explicitly stated in the document, but typically >90% for AST devices | 92.7% for Tetracycline |
| Reproducibility | Acceptable reproducibility | Acceptable |
| Precision | Acceptable precision | Acceptable |
| Quality Control | Acceptable results | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number. The study utilized "fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number of these isolates/strains used in the external evaluation is not provided.
- Data Provenance: Not explicitly stated. The study refers to "external evaluation," but does not specify the country of origin. It also doesn't explicitly state whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The comparison was made against an "NCCLS frozen Reference panel" and "Expected Results," which implies a standardized reference method rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving human experts. The comparison was made against a "frozen Reference panel" and "Expected Results," indicating a comparison to a predefined standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) Study was conducted. This device is an automated antimicrobial susceptibility testing device, not an imaging device that requires human interpretation. The "comparison with the evaluation" mentioned in the text refers to the device's results compared to a reference standard, not human readers improving with or without AI assistance.
6. Standalone Performance
- Yes, standalone performance was evaluated. The study assessed the device's performance ("Essential Agreement of 92.7% for Tetracycline") by comparing its results directly against a "frozen Reference panel" and "Expected Results." This is a standalone evaluation of the algorithm/device itself without human intervention in the result interpretation.
7. Type of Ground Truth Used
The ground truth used was based on an "NCCLS frozen Reference panel" and "Expected Results." This represents a reference standard method rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This is typical for AST devices, where the "training" (calibration/development) might involve optimizing the interpretation rules based on known antimicrobial-organism interactions and then validating against a reference standard.
9. How Ground Truth for the Training Set Was Established
Since no training set information is provided, there is no information on how ground truth for a training set was established.
§ 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.”