(98 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 Cefdinir in the dilution range of 0.016 - 4 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Cefdinir is for: Haemophilus Influenzae (including B-lactamase production strains)
Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefdinir 0.016-4 ug/ml
The provided text describes a 510(k) premarket notification for a medical device called "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefdinir 0.016-4 ug/ml." This device is an in vitro diagnostic product used for clinical susceptibility testing of certain bacteria to the antibiotic Cefdinir. The document confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain the detailed study information required to answer all parts of your request. Specifically, it lacks information about:
- Acceptance criteria and detailed reported device performance in a table format.
- Sample sizes used for test and training sets.
- Data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Whether MRMC or standalone studies were done, or their results/effect sizes.
- Type of ground truth used (beyond implying it's related to susceptibility testing which would typically involve laboratory reference methods).
- How ground truth for the training set was established.
The document primarily focuses on FDA's substantial equivalence determination for regulatory clearance based on the device's indications for use.
Based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a performance table. For in vitro diagnostic (IVD) devices like this, acceptance criteria typically involve demonstrating acceptable agreement (e.g., categorical agreement, essential agreement) with a predicate device or a gold standard method. The document only confirms the device's substantial equivalence to a predicate device, implying these criteria were met during the submission process.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For antimicrobial susceptibility testing, "ground truth" is typically established by laboratory reference methods (e.g., broth microdilution or agar dilution as per CLSI guidelines), not by expert human readers/adjudicators in the same way an imaging AI would use radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. Adjudication methods as described (2+1, 3+1) are typically relevant for human interpretation of data, often in imaging or pathology, where human expert disagreement needs resolution. For an IVD like this, the 'ground truth' is usually an objective laboratory reference method, so human adjudication in this sense is not applicable.
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
An MRMC study is not applicable to this device. This device is an in vitro diagnostic test for antimicrobial susceptibility, not an AI or imaging device where human readers interact with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone diagnostic test (a susceptibility plate). It is not an algorithm with human-in-the-loop performance. Its "performance" would be its ability to correctly determine the susceptibility or resistance of bacteria to Cefdinir. The document states it is an "in vitro diagnostic product for clinical susceptibility testing," meaning it operates independently to provide a result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for antimicrobial susceptibility testing is typically established by reference laboratory methods, such as broth microdilution or agar dilution as defined by clinical and laboratory standards (e.g., CLSI guidelines). The document does not explicitly state which specific reference method was used, but this is the standard practice for such devices.
8. The sample size for the training set
This information is not provided in the document. IVD devices like this are not typically "trained" in the way AI algorithms are. They are developed based on known chemical reactions and bacterial physiology, and validated through extensive testing against reference methods.
9. How the ground truth for the training set was established
This information is not provided in the document, and the concept of a "training set" with ground truth in the AI sense is generally not applicable to this type of traditional IVD device. The development and validation involve testing against established microbiological reference methods.
§ 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).