(302 days)
This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.
PBP21 Latex Agglutination Test
The provided text is a 510(k) premarket notification approval letter for the Oxoid PBP2' Latex Agglutination Test. It includes a general description of the device and its intended use, but it does not contain the detailed information necessary to answer all sections of your request. Specifically, it lacks the actual study design, acceptance criteria, reported performance, and ground truth establishment methods.
Based on the information available, here's what can be extracted:
Acceptance Criteria and Device Performance
The document does not explicitly state acceptance criteria or provide a table of reported device performance values such as sensitivity, specificity, or accuracy. It only states the device's indications for use.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance (Not explicitly stated in the document) |
|---|---|
| (e.g., Sensitivity ≥ X%) | (e.g., Sensitivity = Y%) |
| (e.g., Specificity ≥ Z%) | (e.g., Specificity = W%) |
| ... | ... |
Study Information
The document is a regulatory approval letter and does not include the details of the study that underpinned the 510(k) submission. Therefore, much of the requested information regarding the study is not available in this text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the provided text.
- Data provenance: Not specified in the provided text.
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 available in the provided text, as the method for establishing ground truth is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not available in the provided text, as the study design is not described.
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
- This device is a latex agglutination test, which is a laboratory diagnostic assay, not an AI-assisted imaging device or system that would typically involve human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not applicable to this type of device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This device is a standalone diagnostic test kit that provides a direct result for the presence of PBP2'. Its performance is inherently "standalone" in that it produces a result without human interpretation of complex images or data that an algorithm might process. However, the document does not describe the specific performance study that would detail whether "standalone" performance in a clinical laboratory setting was evaluated and how.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The document does not specify the type of ground truth used. For an antimicrobial susceptibility test, ground truth would typically be established by a reference method for detecting PBP2' or by phenotypic susceptibility testing interpreted against clinical breakpoints (e.g., oxacillin or cefoxitin disk diffusion, broth microdilution).
8. The sample size for the training set
- This information is not available in the provided text. As this is a latex agglutination test, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. However, similar to an algorithm, the test would have been developed and optimized using a set of isolates, but the document does not detail this.
9. How the ground truth for the training set was established
- This information is not available in the provided text for the reasons mentioned above.
In summary, the provided document is a regulatory letter of approval and not the detailed technical submission or study report itself. Therefore, much of the specific study design and performance data you requested is absent.
§ 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).