(98 days)
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
Staphytect Plus, and Dryspot Staphytect Plus are latex agglutination tests.
Since the provided text is a 510(k) clearance letter for the Staphytect Plus/Dryspot Staphytect Plus device, it primarily focuses on the FDA's determination of substantial equivalence to a predicate device. This type of regulatory document does not typically contain detailed information about the acceptance criteria, specific study design, or performance metrics in the way that would be found in a clinical study report or a premarket approval (PMA) application.
Therefore, many of the requested details cannot be extracted directly from this document. However, I can provide what can be inferred or directly stated based on the nature of a 510(k) submission.
Here's an attempt to answer your questions based on the provided text, with clear indications where information is not available:
Device Name: Staphytect Plus / Dryspot Staphytect Plus
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Substantial Equivalence | Device found to be "substantially equivalent" to predicate devices. | This is the primary regulatory "acceptance criterion" for a 510(k) submission. The letter indicates the device meets this. Specific performance metrics (e.g., sensitivity, specificity, accuracy) that led to this determination are not detailed in this clearance letter. |
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: Not available in this document.
- Data Provenance: Not available in this document. A 510(k) submission would typically include a summary of data, but the clearance letter itself doesn't contain these specifics. The manufacturer (Oxoid Limited) is based in England, which might suggest data could originate from there or other regions where the company conducted testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not available in this document.
- Qualifications of Experts: Not available in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not available in this document.
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
- MRMC Study Done: Not applicable. This device is a latex agglutination test for bacterial differentiation, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, human readers or AI assistance in that context are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a laboratory reagent-based test. Its performance is inherent to the chemical/biological reaction, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated in the letter. For a bacterial differentiation test, the ground truth would typically be established by:
- Culture and definitive identification methods: Such as biochemical tests, molecular methods (e.g., PCR), or mass spectrometry (e.g., MALDI-TOF MS) to confirm the presence of Staphylococcus species and the specific factors (clumping factor, Protein A, certain capsular polysaccharides).
- Reference laboratory standards: Comparison to established methods or results from validated reference laboratories.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not available. This is a traditional in vitro diagnostic test, not a machine learning/AI model that typically uses a training set. The development of such a test involves extensive R&D and optimization, but not in the "training set" sense of AI.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As noted above, typical AI/ML training concepts do not apply to this type of device. The development process would establish optimal reagent concentrations and reaction conditions based on known positive and negative controls and clinical isolates, but this is a different paradigm than "training" an algorithm.
Summary of what is known from the document regarding regulatory acceptance:
- Regulatory Class: I
- Product Code: JWX
- FDA Determination: Substantially equivalent to devices marketed prior to May 28, 1976.
- Indication for Use: Latex agglutination tests for the differentiation of Staphylococci which possess clumping factor, Protein A, and certain capsular polysaccharides found in MRSA strains, from those which do not.
- CLIA Complexity: The device may require CLIA complexity categorization (applicant advised to contact CDC).
This document serves as the FDA's clearance notice, confirming that the manufacturer has successfully demonstrated substantial equivalence based on the data submitted in their 510(k) application. It does not provide the detailed scientific and clinical evidence itself.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.