(109 days)
The "Sensititre® 18 - 24 hour MIC or Breakpoint Susceptibility System" is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms.
This 510(k) is for addition of Doxycycline in the dilution range of 0.03 - 16μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Doxycycline is for:
Aerobic and facultative Gram-negative and Gram-positive microorganisms:
Escherichia coli Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Streptococcus pyogenes Enterococcus spp. (faecalis and faecium) Staphylococcus aureus*
*Doxycycline is not the drug of choice in the treatment of any type of staphylococcal infection.
Not Found
The provided text is a 510(k) premarket notification approval letter for the "Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System Doxycycline (0.03 -16 µg/mL) - Gram Negative and Gram Positive." This document approves the device for marketing and lists its indications for use. However, it does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in the 510(k) summary or the actual study report submitted to the FDA during the review process.
Therefore, many of the requested details cannot be extracted from this document.
Here's what can be inferred or stated based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot be extracted. This document is the approval letter, not the study report itself. It does not contain the specific acceptance criteria (e.g., performance metrics, thresholds) or the detailed performance results of the device.
2. Sample size used for the test set and the data provenance:
- Cannot be extracted. The document does not specify the sample size of the test set or the provenance of the data (country of origin, retrospective/prospective).
- Likely Context: For an Antimicrobial Susceptibility Test (AST) device, the "test set" would consist of a collection of bacterial isolates tested against Doxycycline. Data provenance would typically involve controlled laboratory studies, often performed in multiple sites to ensure generalizability.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be extracted. This information is not present in the provided text.
- Likely Context: For AST devices, the "ground truth" (or reference method) is typically established using a standardized, often manually intensive, reference method suchest as broth microdilution or agar dilution as defined by clinical standards organizations (e.g., CLSI in the US). This is not typically an "expert consensus" process in the way it might be for image-based diagnostics. The "experts" would be skilled microbiologists performing the reference method.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be extracted. This document does not mention an adjudication method.
- Likely Context: Adjudication methods (like 2+1) are typically used for subjective diagnostic interpretations (e.g., reading images). For AST devices, the reference method provides a more objective "ground truth," so a separate adjudication process as described is usually not applicable. Discrepancies between the device and the reference method would be analyzed, but not typically "adjudicated" by multiple readers in this manner.
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 Antimicrobial Susceptibility Testing system, not an AI-assisted diagnostic tool that aids human readers in interpreting results. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Partially applicable/inferred. The Sensititre® system determines MIC or breakpoint suscpetibility, which is essentially a "standalone" algorithmic or automated measurement process (without a human interpreting an image or complex patterns). The performance validation for such a system is, by nature, a "standalone" evaluation against a reference method. The document does not explicitly state "standalone study," but the nature of the device implies its performance is evaluated in this manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred: For an Antimicrobial Susceptibility Test (AST) device, the ground truth is established by a standardized reference method, typically a microbiological reference method like broth microdilution as defined by organizations like CLSI (Clinical and Laboratory Standards Institute). This is considered the definitive method for determining the Minimum Inhibitory Concentration (MIC) or susceptibility.
8. The sample size for the training set:
- Cannot be extracted. The document does not mention training sets.
- Likely Context: For an AST device, while there might be internal development and optimization using various isolates, the concept of a distinct "training set" in the machine learning sense is not explicitly used. The device's underlying principles are based on established microbiological methods and reagents, rather than a machine learning model trained on a large dataset in the way an AI diagnostic would be.
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 with specific ground truth establishment like in AI is generally not relevant for this type of device. The "ground truth" for evaluating the Sensititre system's performance would be the reference method results.
§ 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).