(55 days)
Sulopenem SPM 2 μg is an in vitro semi-quantitative method for antimicrobial susceptibility of clinical isolates tested on agar media using overnight incubation.
The Sulopenem SPM 2 μg is intended to determine susceptibility of Enterobacterales to sulopenem, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Sulopenem at concentrations of 2 μg should be interpreted at 16-18 hours of incubation.
The Sulopenem SPM 2 μg demonstrated acceptable performance with the following organisms:
Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii).
Not Found
This FDA 510(k) clearance letter details the clearance of an Antimicrobial Susceptibility Test Disc, not an AI/ML medical device. Therefore, the information typically requested in an AI/ML device acceptance criteria and study section (such as human-in-the-loop performance, expert consensus on ground truth, training set details, or MRMC studies) is not applicable and is not present in the provided text.
The information from the letter describes a Sulopenem SPM 2 µg Antimicrobial Susceptibility Test Disc, a device used in vitro to determine the susceptibility of Enterobacterales to sulopenem. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and validation studies required for such an in vitro diagnostic (IVD) device.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "The Sulopenem SPM 2 µg demonstrated acceptable performance with the following organisms: Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii)."
However, the specific quantitative acceptance criteria (e.g., minimum essential agreement, categorical agreement percentages) and the reported performance values (e.g., actual percentages of agreement achieved) are not detailed in this clearance letter. These would typically be found in the more comprehensive 510(k) submission summary or review memorandum, which is not provided here.
2. Sample sizes used for the test set and the data provenance
The letter does not specify the sample size (number of isolates tested) used for the performance evaluation or the data provenance (e.g., country of origin, retrospective/prospective nature of the isolate collection).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the "ground truth" for an antimicrobial susceptibility test is typically established by a reference method (e.g., broth microdilution or agar dilution) performed by trained laboratory personnel following standardized protocols, not by expert consensus in the way it is for imaging AI.
4. Adjudication method for the test set
Not applicable in the context of an AST device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. MRMC studies are relevant for imaging AI devices that assist human readers. This is an in vitro diagnostic disc.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical disc; its "standalone performance" refers to its accuracy against a reference method. The letter confirms "acceptable performance" but does not detail the specific study methodology.
7. The type of ground truth used
The ground truth for antimicrobial susceptibility testing is typically established by comparing the device's results (zone of inhibition for a disc) to a gold standard reference method, such as broth microdilution or agar dilution, which determine the Minimum Inhibitory Concentration (MIC). The letter references the "FDA Susceptibility Test Interpretive Criteria (STIC)," implying these are the standards used for interpretation against a reference method. The letter also specifies "clinical isolates," indicating the testing was performed on real-world samples.
8. The sample size for the training set
This concept (training set) is typically associated with AI/Machine Learning models, not with a physical antimicrobial susceptibility test disc. Therefore, no "training set" or its size is mentioned.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
In summary, based only on the provided FDA 510(k) clearance letter:
The letter confirms the Sulopenem SPM 2 µg Antimicrobial Susceptibility Test Disc has demonstrated "acceptable performance" for determining susceptibility of specific Enterobacterales (listed in the document) to sulopenem, according to FDA Susceptibility Test Interpretive Criteria (STIC) when interpreted at 16-18 hours of incubation. However, the specific quantitative results of the performance study and the details of the study methodology (like exact sample sizes, and the precise nature of the "acceptable performance" criteria in terms of agreement percentages) are not disclosed in this high-level clearance summary. These details would be contained within the full 510(k) submission.
§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).