(87 days)
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for Ceftazidime/Avibactam the dilution range of 0.015/4-32/4 ug/ml for testing non-fastidious gram negative organisms on the Sensititre 18 - 24 hour MIC panel. The approved primary "Indications for Use" and clinical significance for non-fastidious Gram negative isolates: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Proteus spp. Pseudomonas aeruginosa
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This document describes the FDA clearance (K152774) for the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam. The information provided is primarily regulatory in nature and does not contain details about specific acceptance criteria or a study proving the device meets those criteria in the format requested.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This equivalence determination process often involves demonstrating that the new device performs as well as, or comparably to, the predicate device. However, the specifics of these performance studies (like acceptance criteria, sample sizes, ground truth establishment, etc.) are not present within this document.
Therefore, I cannot populate the table or answer most of the questions based solely on the provided text.
Here's what information I can infer or state about the absence of information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This device is an in vitro diagnostic product for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool that involves "human readers" in the context of imaging or similar interpretation. Therefore, an MRMC study for AI assistance would not be applicable. The document does not mention any studies of this nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a standalone susceptibility testing system. Its performance is evaluated on its own ability to determine antimicrobial susceptibility. The specifics of this evaluation are not detailed in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For antimicrobial susceptibility testing, the "ground truth" typically involves reference microbiology methods (e.g., broth microdilution or agar dilution performed according to CLSI standards) to determine the true Minimum Inhibitory Concentration (MIC) or susceptibility category. This document does not explicitly state the ground truth method used, but it's universally implied in such device clearances.
8. The sample size for the training set
- Not specified. This clearance is for a medical device that likely follows established chemical/biological principles, rather than a machine learning model that requires a "training set" in the common AI sense. If there are internal 'training' or optimization phases for the system's readings, those details are not provided.
9. How the ground truth for the training set was established
- Not applicable in the AI sense. If any internal optimization or calibration used "ground truth," it would be established via reference microbiology methods, but these details are not provided.
Summary of available information:
The document is a clearance letter from the FDA stating that the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam is substantially equivalent to predicate devices for specific non-fastidious gram-negative organisms. It lists the device name, regulation number, regulatory class, and product codes, along with its intended use as an in vitro diagnostic product for clinical susceptibility testing. However, the detailed acceptance criteria and supporting study data requested are not included in this regulatory clearance letter. Such information would typically be found in the 510(k) submission itself, which is not provided here.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).