(19 days)
To determine antimicrobial agent susceptibility
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 play® 40 growing actions and faculture and on the WalkAway SV System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have The allinited 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® S/ System or equivalent standardized suspension of the organism and securition (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.
The provided text describes the 510(k) summary for the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels with Gentamicin. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The text primarily focuses on the "Essential Agreement" metric, which is a common performance criterion for antimicrobial susceptibility devices. While specific numerical acceptance criteria (e.g., "should be > X%") are not explicitly stated, the reported performance is given.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Essential Agreement (compared to NCCLS frozen Reference Panel) | Undefined but implied to be high for acceptance. | Greater than 96% for Gentamicin |
| Reproducibility for Gentamicin (with Turbidity inoculum preparation and WalkAway® SI System) | Acceptable | Acceptable |
| Quality Control testing for Gentamicin | Acceptable | Acceptable |
2. Sample Size Used for the Test Set and Data Provenance
The text states: "The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, no specific sample size (number of isolates/strains) is provided for the test set.
The data provenance is not explicitly stated in terms of country of origin. The study appears to be retrospective (using "fresh and stock isolates") rather than prospective, as it's an evaluation of an existing methodology against a reference.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The ground truth for the test set was established against an "NCCLS frozen Reference Panel" and "Expected Results" for Challenge strains, but the process of how these reference results were generated or by whom is not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document. The comparison was made against a "NCCLS frozen Reference Panel" and "Expected Results," implying a direct comparison without a separate adjudication process among multiple readers/evaluators of the device's results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study described is a standalone performance evaluation against a reference standard. The device determines antimicrobial susceptibility automatically, so the concept of "human readers improve with AI vs without AI assistance" does not directly apply here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The described evaluation assesses the performance of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel (the device itself) in determining antimicrobial susceptibility. The device interprets the results to determine the Minimum Inhibitory Concentration (MIC) for the test organism without human intervention during the reading process. The text states: "The MIC for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth."
7. Type of Ground Truth Used
The ground truth used was a reference standard. Specifically:
- An NCCLS frozen Reference Panel was used for comparison of the rapID/S plus™ Gram-Negative Panel.
- "Expected Results" were used for Challenge strains.
8. Sample Size for the Training Set
This information is not provided in the document. The text describes an evaluation study, but details about the development or training of the device's underlying algorithms (if any complex algorithms are involved beyond direct measurement) are not included.
9. How the Ground Truth for the Training Set Was Established
Since the sample size for the training set is not provided, and the document focuses on the evaluation, how the ground truth for any potential training set was established is not detailed.
§ 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.”