(255 days)
This submission is for Etest® Telavancin for MIC determinations across 0.002-32 µg/mL and 0.016-256 µg/mL with Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecalis (vancomycin-susceptible isolates only), Streptococcus agalactiae and Streptococcus anginosus group.
Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacterias, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.
The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/mL of different antimicrobial agents against microorganisms as tested on agar using overnight incubation.
Here's an analysis of the acceptance criteria and study details based on the provided document. Unfortunately, the provided document is a 510(k) clearance letter and an "Indications For Use" statement. It does not contain the detailed study information required to fully answer all parts of your request, such as specific acceptance criteria thresholds, reported performance metrics, sample sizes for test and training sets, details on expert ground truth, or MRMC studies.
Therefore, I will extract what is available and note where information is missing.
Extracted Information:
The document describes the clearance of "Etest® Telavancin for Antimicrobial Susceptibility Testing." The device determines the Minimum Inhibitory Concentration (MIC) for Telavancin against specific bacteria.
Acceptance Criteria and Study Overview
Due to the nature of the provided document (510(k) clearance letter), specific numerical acceptance criteria (e.g., % agreement with a predicate device) and detailed study results are not present. However, the clearance implies that the device met the FDA's requirements for substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Implied by 510(k) Clearance Process):
For an Antimicrobial Susceptibility Test (AST) device seeking 510(k) clearance, the primary acceptance criteria revolve around substantial equivalence to a legally marketed predicate device. This typically involves demonstrating acceptable agreement (e.g., Categorical Agreement (CA), Essential Agreement (EA)) between the new device and the predicate device, or a reference method, for MIC determination.
Reported Device Performance:
- Device Name: Etest® Telavancin - Antimicrobial Susceptibility Test
- MIC Range: 0.002-32 µg/mL and 0.016-256 µg/mL
- Tested Organisms:
- Staphylococcus aureus (including methicillin-resistant isolates)
- Enterococcus faecalis (vancomycin-susceptible isolates only)
- Streptococcus agalactiae
- Streptococcus anginosus group
Specific numerical performance data (e.g., % Categorical Agreement, % Essential Agreement, resolution of discordant results) are NOT provided in this document.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: NOT PROVIDED in this document.
- Data Provenance: NOT PROVIDED in this document (e.g., country of origin, retrospective/prospective). Studies for AST devices typically involve testing a diverse collection of bacterial isolates, usually prospectively collected or from well-characterized strain collections.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: NOT PROVIDED in this document.
- Qualifications of Experts: NOT PROVIDED in this document. For AST devices, ground truth (reference method results) is typically established by trained microbiologists following standardized laboratory procedures.
4. Adjudication Method for the Test Set
- Adjudication Method: NOT PROVIDED in this document. For AST, adjudication methods aren't typically described as 2+1/3+1 in the same way as imaging studies. Discordant results (e.g., between the test device and the reference method) would usually be retested or investigated by a senior microbiologist to determine the definitive result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: NOT APPLICABLE/NOT DONE. MRMC studies are primarily for devices that assist human readers in interpreting clinical images (e.g., AI for radiology). This device is an in vitro diagnostic for antimicrobial susceptibility testing, which provides a direct MIC output, not an interpretation assistance for a human reader of complex data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: YES, inherently. The Etest® Telavancin system is a standalone diagnostic test. It functions by itself to determine the MIC. The performance described (though not explicitly detailed in this document) would be its standalone accuracy compared to a reference method. It's not an AI algorithm, but a phenotypic assay.
7. The Type of Ground Truth Used
- Ground Truth Type: For antimicrobial susceptibility testing, the ground truth is typically established by a reference phenotypic method, such as broth microdilution or agar dilution, performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. This is considered the "gold standard" for MIC determination.
8. The Sample Size for the Training Set
- Training Set Sample Size: NOT APPLICABLE/NOT PROVIDED. Etest® is a phenotypic method, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its performance relies on the biochemical interactions on the strip and agar, rather than a learned model from data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: NOT APPLICABLE. As noted above, this device does not use a training set in the machine learning sense.
§ 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).