(49 days)
The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus/Streptococcus pneumoniae.
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms.
This 510(k) is for the addition of Telithromycin in the dilution range of 0.002-16µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcusion pneumoniae and the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance for Telithromycin is for: Streptococcus_pneumoniae (including multi-drug resistant isolates [MDRSP]), Haemophilus influenzae, and Staphylococcus aureus (methicillin and erythromycin susceptible isolates only). In vitro data, without clinical correlation is provided for: Streptococcus pyogenes(erythromycin susceptible isolates only).
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Here's a breakdown of the acceptance criteria and study information for the Sensititre® Haemophilus/Streptococcus pneumoniae (HP) MIC/Susceptibility Plate and Test Panel for Telithromycin 0.002-16μg/ml, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) clearance letter, which indicates the device is substantially equivalent to a legally marketed predicate device. For such submissions, the acceptance criteria are generally based on agreement rates between the new device and a reference method (often a standard broth microdilution method). The specific acceptance criteria (e.g., Categorical Agreement and Essential Agreement percentages) and the reported performance are not explicitly detailed in this clearance letter. However, the letter implies that the device successfully met these benchmarks.
As a typical example for antimicrobial susceptibility tests (ASTs) in 510(k) submissions, the acceptance criteria and performance would look something like this (actual values are usually found in the full 510(k) summary, not just the clearance letter):
| Metric | Acceptance Criteria (Example) | Reported Device Performance (Example) |
|---|---|---|
| Essential Agreement (EA) | ≥ 90.0% | 97.5% |
| Categorical Agreement (CA) | ≥ 90.0% | 98.2% |
| Major Discrepancy (MD) Rate | ≤ 3.0% | 0.8% |
| Very Major Discrepancy (VMD) Rate | ≤ 1.5% | 0.2% |
Note: The document only states that the device was deemed "substantially equivalent." This means that the performance was considered comparable to the predicate device, which inherently means it met the necessary agreement criteria with a reference method. The specific numerical values for acceptance criteria and performance are not present in this clearance letter.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided document.
- Data Provenance: Not explicitly stated. For clinical trials supporting 510(k) submissions for ASTs, data typically comes from clinical laboratories, often across multiple sites, within the US. The document does not specify if it was retrospective or prospective, but clinical test validation data for ASTs is often prospective collection and testing of isolates.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable in the context of an antimicrobial susceptibility test (AST) device.
- For ASTs, the "ground truth" is established by a reference method (e.g., broth microdilution or agar dilution) performed by trained microbiologists following standardized protocols, not by expert interpretation of images or other subjective data. These methods are quantitative and provide the minimum inhibitory concentration (MIC) values directly.
4. Adjudication Method for the Test Set
- This is not applicable for an AST device. The ground truth for ASTs is determined by a quantitative reference method, not by expert consensus or adjudication. Discrepancies are often resolved by re-testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret data (e.g., radiology images) and the AI's role is to assist or replace that interpretation.
- The Sensititre device is an in vitro diagnostic product designed to directly measure antimicrobial susceptibility. Its performance is evaluated against a reference method, not by comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, standalone performance is what is primarily evaluated for this device. The Sensititre plate is designed to provide MIC values automatically or semi-automatically. The "algorithm" here is the system's ability to accurately measure growth inhibition relative to a reference method, without significant human interpretation beyond setting up the test and reading the final result (which is often automated). The performance data cited for substantial equivalence would be the standalone performance of the device against the reference method.
7. The Type of Ground Truth Used
- Expert Consensus: Not used.
- Pathology: Not used.
- Outcomes Data: Not used.
- The ground truth for AST devices is typically established by a recognized reference method, such as CLSI (Clinical and Laboratory Standards Institute) or ISO (International Organization for Standardization) standard broth microdilution or agar dilution methods. These methods provide quantitative Minimum Inhibitory Concentration (MIC) values.
8. The Sample Size for the Training Set
- This information is not explicitly provided in the clearance letter.
- For an AST plate, the concept of a "training set" in the machine learning sense (for training an algorithm) is less direct. Instead, a large bank of characterized bacterial isolates (many of which are historical and well-studied) is used during the development and optimization phase to ensure the test system can accurately detect susceptibility and resistance across a wide range of relevant organisms and resistance mechanisms. The letter doesn't specify the size of this internal development/optimization data.
9. How the Ground Truth for the Training Set Was Established
- Similar to the test set, the "ground truth" for any internal development or optimization of an AST device (analogous to a training set) would be established using standardized reference methods (e.g., CLSI broth microdilution) for each isolate. This involves growing the bacteria in the presence of varying concentrations of the antimicrobial and observing the lowest concentration that inhibits visible growth.
In summary, the provided document is a 510(k) clearance, which confirms substantial equivalence based on prior studies. However, it does not contain the granular details of the specific acceptance criteria, study design parameters (like sample sizes or ground truth establishment methods) that would typically be found in the full 510(k) summary or clinical study reports. The nature of the device (an in vitro diagnostic AST) means many questions related to expert interpretation or AI assistance are not directly applicable.
§ 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).