(63 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic device for antimicrobial susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Moxifloxacin in the dilution range of 0.004 - 3 µgml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC panel for testing Streptococcus pneumoniae and Haemophilus Influenzae isolates.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Moxifloxacin. It confirms the substantial equivalence of the device to legally marketed predicate devices for the specified indications for use.
While the document confirms regulatory clearance based on substantial equivalence, it does not contain the detailed study results, acceptance criteria, or sample sizes related to the device's performance in the way requested. The 510(k) summary (which would include such information) is not provided in this extract.
Therefore, most of the requested information cannot be directly extracted from this document. However, based on the nature of a 510(k) submission for an antimicrobial susceptibility test, we can infer some general aspects and state what is missing.
Here's an attempt to answer the questions based on the provided text and general knowledge of such submissions:
Acceptance Criteria and Device Performance Study Information
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted directly from the provided text. The 510(k) letter confirms substantial equivalence but does not provide the specific performance data or the acceptance criteria used to demonstrate that equivalence. In a typical 510(k) for an AST device, this would involve comparing the device's Minimum Inhibitory Concentration (MIC) results and categorical agreement (Susceptible, Intermediate, Resistant) with a US FDA-approved reference method.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted directly from the provided text. The sample size for the test set (number of isolates tested) and the data provenance (e.g., country of origin, retrospective/prospective nature of the study) are not mentioned in this regulatory letter. This information would typically be detailed in the study report within the 510(k) submission.
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 applicable in this context. For antimicrobial susceptibility testing, the "ground truth" is typically established by comparing the device's results to a recognized reference method (e.g., broth microdilution according to CLSI standards) performed by trained laboratory personnel. It does not typically involve a panel of "experts" in the same way, for example, an imaging study would use radiologists. The accuracy of the reference method itself is the benchmark.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in this context. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are interpreting images or clinical data and there's a need to resolve discrepancies. For AST devices, the "adjudication" is generally based on pre-defined criteria for agreement between the test device and the reference method, and any significant discrepancies would trigger retesting or further investigation.
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
- Not applicable. This device is an in vitro diagnostic susceptibility plate, not an AI-assisted diagnostic tool that involves human readers interpreting results in a comparative effectiveness study. Its performance is assessed on its ability to accurately determine antibiotic susceptibility.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself (the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates) is a standalone system for determining MICs. While a human is involved in performing the test and interpreting the result (e.g., reading the well for growth inhibition), the core performance assessment is of the device and its ability to provide accurate MICs and categorical interpretations (susceptible, intermediate, resistant) compared to a reference method. It's not an "algorithm-only" interpretation in the AI sense, but the device's analytical performance is evaluated independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for antimicrobial susceptibility testing is typically established by a reference method, most commonly the Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method. This method is standardized and validated, and its results are considered the gold standard for determining MIC values.
8. The sample size for the training set
- Cannot be extracted directly from the provided text. The 510(k) letter does not mention a training set. For in vitro diagnostic devices like this, the "training set" concept (as in machine learning) may not apply directly to the development of the susceptibility plate itself, but rather to the internal validation and optimization processes of the manufacturer. The regulatory submission focuses on the performance of the final device, which is evaluated against a test set (clinical isolates).
9. How the ground truth for the training set was established
- Not applicable/Cannot be extracted. As mentioned above, the concept of a "training set" and its ground truth in the machine learning sense is not explicitly addressed in this type of regulatory document for an in vitro diagnostic test. If there were internal development/optimization studies, the ground truth would similarly be established by reference methods or other validated laboratory techniques.
In summary: The provided document is a regulatory clearance letter acknowledging substantial equivalence but does not contain the detailed performance study results that would typically be found in the 510(k) summary or the full submission. Therefore, most of the specific quantitative details about the study design and results are missing.
§ 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).