(34 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Gatifloxacin in the dilution range of 0.002 - 8 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The approved primary "Indications for Use" and clinical significance of Gatifloxacin is for: Streptococcus pneumoniae (penicillin-susceptible strains only) In vitro data, without clinical correlation is provided for: Streptococcus pneumoniae (penicillin- resistant strains)
Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.
Here's an analysis of the provided text regarding the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, focusing on the acceptance criteria and the study proving device performance:
Summary of Acceptance Criteria and Device Performance:
The document describes the addition of Gatifloxacin to an existing device, the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. The acceptance criteria for this modification appear to be based on demonstrating substantial equivalence to pre-existing devices, with specific performance targets for agreement between the new Gatifloxacin testing and a reference method. The primary focus is on the accuracy of Gatifloxacin MIC (Minimum Inhibitory Concentration) results.
- Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Essential Agreement (EA) | ≤ 90% (based on typical FDA criteria for susceptibility testing, though not explicitly stated with a numerical value in this excerpt) | Haemophilus influenzae: |
| Essential Agreement: 98.7% | ||
| Agreement: 100% within one doubling dilution and 100% within two doubling dilutions. |
Streptococcus pneumoniae:
Essential Agreement: 95.8%
Agreement: 99.4% within one doubling dilution and 100% within two doubling dilutions. |
| Category Agreement (CA) | Not explicitly stated in the provided text as a numerical acceptance criterion, but implied as critical for clinical interpretation. | Haemophilus influenzae:
Category Agreement: 98.7%
Major Discrepancies: 1.3% (Susceptible to Resistant)
Minor Discrepancies: 0%
Very Major Discrepancies: 0%
Streptococcus pneumoniae:
Category Agreement: 98.8%
Major Discrepancies: 1.2% (Susceptible to Resistant)
Minor Discrepancies: 0%
Very Major Discrepancies: 0% |
| Valid Isolates | Not explicitly stated as a numerical criterion but implied that a sufficient number of valid isolates should be tested. | Haemophilus influenzae: 157 isolates
Streptococcus pneumoniae: 250 isolates |
| Clinical Significance | Gatifloxacin is indicated for Streptococcus pneumoniae (penicillin-susceptible strains only) with clinical correlation. In vitro data provided for Streptococcus pneumoniae (penicillin-resistant strains). | The device's performance demonstrates high agreement with the reference method, supporting its use for the specified indications. |
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Sample Size Used for the Test Set and Data Provenance:
- Haemophilus influenzae: 157 isolates
- Streptococcus pneumoniae: 250 isolates
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the context of bacterial susceptibility testing for FDA clearance, it is highly likely to be a prospective study using clinical isolates.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not specify the number of experts or their qualifications for establishing the ground truth. In microbiology susceptibility testing, the "ground truth" is typically established by a reference method (e.g., broth microdilution, agar dilution) performed in a CLIA-certified or equivalent laboratory, often by experienced microbiologists following established protocols (e.g., CLSI guidelines). The expertise is embedded in the standardized methodology rather than individual expert review of each case.
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Adjudication Method for the Test Set:
- The document does not describe an adjudication method in the context of expert review. The performance is assessed by direct comparison of the device's MIC results and categorical interpretations against those of the reference method. Discrepancies (major, minor, very major) are calculated based on these direct comparisons.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices (e.g., imaging AI) where human readers interpret results with and without AI assistance. This device is an automated in vitro diagnostic susceptibility plate, and its performance is evaluated against a quantitative reference standard, not against human interpretation per se.
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Standalone (Algorithm Only) Performance:
- Yes, the primary study conducted is a standalone performance study. The document reports the device's accuracy in determining MICs and categorical results directly, independent of human interpretation other than setting up the test and reading the final result (which is also automated or standardized). The "algorithm" here is the chemical reactions and interpretive breakpoints built into the Sensititre plate and its associated reading system.
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Type of Ground Truth Used:
- The ground truth used is a reference method for antimicrobial susceptibility testing. While not explicitly named in this excerpt, for MIC susceptibility plates, this is typically a gold standard broth microdilution or agar dilution method (e.g., as defined by the Clinical and Laboratory Standards Institute - CLSI). This method provides highly accurate quantitative MIC values against which the device's results are compared.
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Sample Size for the Training Set:
- The document does not provide information on a training set sample size. For in vitro diagnostic devices like this, the "training" analogous to machine learning often happens during the device's initial development and validation by the manufacturer, where optimal reagent concentrations and reading parameters are established. The presented data represents the validation or test set used for regulatory submission.
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How the Ground Truth for the Training Set Was Established:
- As with point 8, the document does not specify how a training set's ground truth was established. If a "training set" were implicitly used during development, its ground truth would also have been established using similar reference methods (e.g., CLSI-compliant broth microdilution) to develop and optimize the device's performance characteristics before its final validation.
§ 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).