(49 days)
MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine Microboun - Bynergios prac - etimicrobial 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 (Enerobution, After inoculation, panels are read on the WalkAway® S/ System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobial Trimethoprim/Sulfamethoxazole on the Synergies plus™ Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing in this panel are:
Escherichia coli Enterobacter spp Klebsiella spp Proteus spo Shigella flexneri Shigella sonnei
The MicroScan® Synergies plus™ Gram-Negative with Trimethoprim/Sulfamethoxazole is not intended for use with:
P. aeruginosa
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 ™ Cram-Negative MIC/Combo Panels are read on the WalkAway 57 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® 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.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device meets the criteria based on the provided document. The document is an FDA 510(k) clearance letter for a medical device and its associated "Indications for Use Statement" and "510(k) Summary".
While it mentions some performance metrics (like "Essential Agreement of 97.5%"), it does not explicitly state the acceptance criteria that were set before the study. It only reports the results of the performance.
Furthermore, the document does not provide the detailed information required for the other points of your request, such as:
- Sample size used for the test set and data provenance: It mentions "fresh and stock Efficacy isolates and stock Challenge strains" but not specific numbers or their origin.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned or described. The analysis compares the device to a reference panel, not human readers with or without AI assistance.
- Standalone performance: The document describes the device's performance against a reference standard, which is essentially a standalone performance, but doesn't explicitly frame it as such for human-in-the-loop comparison.
- Type of ground truth: It states comparison to an "NCCLS frozen Reference Panel" and "Expected Results," but doesn't elaborate on how that ground truth was established (e.g., pathology, outcomes data).
- Sample size for the training set: Not applicable as this device is not described as an AI/ML device that requires a training set in the conventional sense. It's an antimicrobial susceptibility testing device.
- How the ground truth for the training set was established: Not applicable.
Therefore, I cannot extract the specific information you requested from the provided text.
§ 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.”