(63 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 Moxifloxacin in the dilution range of 0.004 - 8 ug/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 Moxilloxacin is for: Streptococcus pneumoniae (penicillin-susceptible strains only) In vitro data, without clinical correlation is provided for: Streptococcus pneumoniae (penicillin- resistant strains)
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The provided text is a 510(k) approval letter and associated documentation for a medical device called "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates," specifically for the addition of Moxifloxacin. It does not contain the detailed information necessary to complete most of the requested fields in the table, as it is a regulatory approval rather than a scientific study report.
Here's a breakdown of what can and cannot be extracted:
- Acceptance Criteria and Reported Device Performance: This information is typically found in the clinical or analytical study section of a 510(k) summary, which is not fully provided here. The document mentions "clinical susceptibility testing" but doesn't detail performance metrics like sensitivity, specificity, accuracy, or specific MIC agreement rates against a reference method (which would be the common acceptance criteria for such a device).
- Sample Size and Data Provenance: Not available in this document.
- Number of Experts and Qualifications: Not available. This primarily applies to diagnostic imaging or interpretation tasks, not usually to automated susceptibility testing.
- Adjudication Method: Not applicable or available.
- MRMC Comparative Effectiveness Study: Not applicable to this type of device (an in vitro diagnostic susceptibility plate). This is relevant for devices providing interpretations for human readers (e.g., AI in radiology).
- Standalone Performance: The general nature of an in vitro diagnostic susceptibility plate is that it's a standalone test. However, specific performance metrics (accuracy, etc.) are not detailed.
- Type of Ground Truth: For antimicrobial susceptibility testing, the ground truth is typically established by a reference method, such as broth microdilution or agar dilution, performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. This document doesn't explicitly state the reference method used.
- Training Set Sample Size and Ground Truth: Not available, as the document describes a device, not an AI/ML algorithm that requires a training set.
Based on the provided text, here is what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (Not explicitly stated in text, typical for AST devices) | Reported Device Performance (Not explicitly stated in text) |
|---|---|---|
| Essential Agreement (EA) | Typically >90-95% for each drug-bug combination | Not provided in the document |
| Category Agreement (CA) | Typically >90-95% for each drug-bug combination | Not provided in the document |
| Major Discrepancies (MD) | Typically |
§ 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).