(19 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® S/ System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.
This particular submission is for the antimicrobial Piperacillin/Tazobactam on the Synergies plus" Gram-Negative MIC/Combo Panels.
The Gram-Negative organisms which may be used for Piperacillin/Tazobactam susceptibility testing in this panel are:
Escherichia coli (Piperacillin-resistant, ß-lactamase producing) Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia spp.
The MicroScan® Synergies plus™ Gram-Negative with Piperacillin/Tazobactam is not intended for use with:
Acinetobacter spp. Citrobacter spp. Enterobacter spp
MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in determing MicroScan® rapLDS plus™ Gram-Negative This. Contines grown on solid media of rapidly of rapidly quantiative and facultative anaerobic gram-sacive bacilli. The MicroScan® rapIDS plas™ rapIDS plas™ Gramgrowing aerobic and facultative anaerobic graili-ligative basin. The University of System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).
The antimicrobial susceptibility tests are miniaturizations susceptibility tost that have The antimicrobial susceptibility tests are inninatinations bridging in clinical interest and are been diluted in Mueller-Himon Broun to concentuations of the coulded and rehydrated with a presented in micro-titer wells in arred form. Tapines at 350 in the Walks ways System or equivalent standardized suspension of the organism and included at 35 ° In the was any was and one of the lowest antimicrobial concentration showing inhibition of growth.
Acceptance Criteria and Study Details for MicroScan® Synergies Plus Gram-Negative MIC/Combo Panels with Piperacillin/Tazobactam
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary explicitly states that the device demonstrated "substantially equivalent performance" to the predicate device. The primary metric cited for this equivalence is a "greater than 94% Essential Agreement" with an NCCLS (National Committee for Clinical Laboratory Standards) frozen Reference panel. While specific numerical acceptance criteria for "Essential Agreement" are not explicitly listed in the summary, the statement implies that >94% essential agreement was the target for acceptance.
| Acceptance Criteria (Implied) | Reported Device Performance (Piperacillin/Tazobactam) |
|---|---|
| Essential Agreement > 94% | Greater than 94% Essential Agreement |
| Acceptable Reproducibility | Acceptable reproducibility and precision |
| Acceptable Quality Control | Acceptable Quality Control results |
Note: Essential Agreement is a common metric in antimicrobial susceptibility testing, representing the agreement between a new method and a reference method within a certain range of concentrations (e.g., +/- 1 dilution). The specific NCCLS document referenced (DRAFT document dated March 16, 2000, for Assessment of Antimicrobial Susceptibility Devices) would contain the precise definition and thresholds for Essential Agreement.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary states, "The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact sample size (number of isolates/strains) used for the test set is NOT explicitly provided in the given text.
Data Provenance: The study was an "external evaluation" conducted with "fresh and stock Efficacy isolates and stock Challenge strains." This implies the data was collected for the purpose of the study (prospective or a blend of prospective with pre-existing stock strains). The country of origin of the data is not specified, but given the context of FDA submission, it is likely that the testing was conducted in the United States or by organizations adhering to US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The 510(k) summary states that the comparison was made against an "NCCLS frozen Reference panel." This implies that the ground truth was established by standardized laboratory methods as defined by NCCLS, rather than solely by human expert consensus or individual interpretation.
Therefore, the ground truth was established by a reference method that follows established guidelines, not by individual experts. The summary does not specify the number or qualifications of experts involved in the initial creation or validation of the NCCLS frozen Reference panel itself, as this panel serves as the established "gold standard" for comparison.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1 or 3+1) is typically used when human readers or varying interpretations need to be reconciled. In this study, the device performance was compared against an "NCCLS frozen Reference panel," which serves as the established ground truth.
Therefore, no multi-reader adjudication method was employed as the primary comparison point was a standardized laboratory reference method, not individual human interpretations requiring consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The summary describes a standalone performance evaluation of the device against a reference standard for determining antimicrobial susceptibility. There is no mention of human readers, AI assistance, or comparing human performance with and without AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The study described evaluates the performance of the "MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels" (the device under review) when read on the "WalkAway® S/ System or equivalent" against an "NCCLS frozen Reference panel." This constitutes an evaluation of the device as a system for determining MICs, without human intervention in interpreting the results once the automated system has processed the panel.
7. Type of Ground Truth Used
The type of ground truth used was a "NCCLS frozen Reference panel." This indicates a highly standardized, laboratory-based reference method for determining minimum inhibitory concentrations (MICs) of antimicrobial agents. The NCCLS (now CLSI - Clinical and Laboratory Standards Institute) publishes consensus standards for antimicrobial susceptibility testing, and a "frozen reference panel" would represent a meticulously characterized set of strains with known MICs determined by these standardized methods.
8. Sample Size for the Training Set
The 510(k) summary does NOT provide information regarding the sample size for a training set. Since this is a submission for a microdilution MIC panel (a diagnostic test kit/system) rather than an AI/machine learning algorithm that requires explicit training data, the concept of a "training set" in the context of machine learning is not directly applicable here. The device's performance is based on its chemical and biological reactions, and the "training" for such a system would involve its design, manufacturing controls, and potentially internal validation during development, not a separate data-driven training phase in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As the device is not an AI/machine learning algorithm that undergoes a training phase with a distinct "training set" of data, this question is not applicable in the context of the provided 510(k) summary. The "ground truth" referenced in the summary pertains to the external validation (test set) using the NCCLS reference standard.
§ 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.”