(124 days)
The MicroScan® rapID/S 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 Cephalothin on the rapID/S plus " Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Cephalothin susceptibility testing in this panel are:
Klebsiella pneumoniae Proteus mirabilis
The MicroScan® rapID/S plus" Gram-Negative Cephalothin is not intended for use with:
Escherichia coli Klebsiella oxytoca Pseudomonas aeruginosa and all Non-Enterobacteriacea
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™ Gran-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® 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 text describes a 510(k) submission for the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel for antimicrobial susceptibility testing of Cephalothin. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Essential Agreement (compared to NCCLS frozen Reference Panel), as defined in FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000. | Greater than 96% Essential Agreement for Cephalothin. |
| Instrument reproducibility for Cephalothin with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent. | Acceptable reproducibility and precision. |
| Quality Control testing for Cephalothin. | Acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The text states the external evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains," but it does not provide a specific number for the sample size.
- Data Provenance: The text does not explicitly state the country of origin. The study appears to be a prospective evaluation comparing the new device against a reference panel. The "fresh and stock Efficacy isolates and stock Challenge strains" suggest a controlled study design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- The information provided does not mention the number of experts used to establish the ground truth or their qualifications. The ground truth for the "Challenge strains" was "Expected Results determined prior to the evaluation," implying a pre-established standard rather than expert consensus on individual cases during the study.
4. Adjudication Method for the Test Set
- The text does not describe any adjudication method like 2+1 or 3+1. The performance was compared against an NCCLS frozen Reference Panel and "Expected Results" for challenge strains, suggesting a direct comparison to a predetermined standard rather than a consensus process involving multiple human readers for each test case.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility testing panel, not an imaging or diagnostic device where human readers would typically interpret results with or without AI assistance. The evaluation focuses on the device's accuracy in determining MIC, not on how it assists human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone study was done. The entire submission describes the performance of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel as a standalone device. The device itself automatically determines the MIC, and its performance was directly compared to a reference standard (NCCLS frozen Reference Panel). The WalkAway® SI System reads the panels, which implies an automated process without human interpretation as the primary output.
7. Type of Ground Truth Used
- The ground truth used was primarily a reference standard: the NCCLS frozen Reference Panel for efficacy isolates and "Expected Results" for challenge strains. This implies a pre-defined and validated standard for antimicrobial susceptibility.
8. Sample Size for the Training Set
- The text does not mention a training set sample size. This type of device (a microdilution panel read by an automated system) does not typically involve machine learning algorithms that require a distinct "training set" in the same way an AI-based diagnostic image analysis system would. The "training" of the WalkAway® SI System or similar platforms would have been part of its original development and validation, not specific to this 510(k) submission for a new panel formulation.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not explicitly mentioned or implied for this type of device in the provided text, there is no information on how its ground truth would have been 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.”