(289 days)
Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures containing yeasts observed on Gram stain or other microbiological stains. The test does not distinguish between C. albicans and C. parapsilosis. The test does not distinguish between C. qlabrata and C. krusei.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation between C. albicans and C. parapsilosis, differentiation between C. glabrata and C. krusei, and/or differentiation of mixed growth.
Yeast Traffic Light PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia.
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The provided document is a 510(k) summary for the Yeast Traffic Light PNA FISH device. It describes the device's intended use and includes some information about the studies conducted to support its substantial equivalence. However, it does not contain the detailed information requested in the prompt regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I can only provide information based on what is available in the document. Many of your questions cannot be answered from this text.
Here is what can be inferred or explicitly stated:
Acceptance Criteria and Study for Yeast Traffic Light PNA FISH
The document provides an "Indications for Use" statement, which outlines the device's intended diagnostic performance. While explicit "acceptance criteria" in a quantitative table are not provided in this document, the statement implies the device must accurately identify specific Candida species (or groups of species) from positive blood cultures. The provided text indicates that performance was evaluated against a predicate device for substantial equivalence, implying that the device's diagnostic accuracy for these identifications was deemed acceptable.
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., sensitivity, specificity thresholds) in this document. The implicit criterion is that the device must be able to qualitatively identify the specified Candida species or groups of species (C. albicans/C. parapsilosis, C. tropicalis, and C. glabrata/C. krusei) from positive blood cultures within an acceptable range, demonstrating substantial equivalence to a legally marketed predicate device.
- Reported Device Performance: Not provided in quantitative form (e.g., specific sensitivity or specificity values) within this 510(k) summary letter. The letter only states that the FDA has "determined the device is substantially equivalent... to legally marketed predicate devices." This implies that the performance was found to be sufficient to meet the substantial equivalence standard, but the specific performance metrics are not detailed here.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This information is not provided in the document.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided in the document.
4. Adjudication Method
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This document does not describe an MRMC comparative effectiveness study, nor does it mention human readers or AI assistance. The device is a "qualitative nucleic acid hybridization assay," suggesting it is a lab-based test, not a diagnostic imaging AI system.
6. Standalone Performance Study
- The 510(k) process typically involves studies to demonstrate the device's performance, which in the context of a qualitative assay, would be a form of standalone performance evaluation. However, the specific details of such a study (e.g., sensitivity, specificity, PPV, NPV values against a gold standard) are not included in this document. The letter only confirms substantial equivalence.
7. Type of Ground Truth Used
- While not explicitly stated for the studies supporting this device, for an infectious disease diagnostic like this, the ground truth would typically be established by conventional microbiological methods, such as culture followed by definitive species identification (e.g., biochemical tests, mass spectrometry, or another nucleic acid-based method often considered the "gold standard" at the time). The document indicates the device is used to identify yeast "on smears made from positive blood cultures," implying the "positive blood cultures" themselves are a starting point for evaluation against more definitive methods.
8. Sample Size for the Training Set
- This information is not provided in the document. (Note: For an assay like this, the concept of a "training set" in the AI/machine learning sense is not directly applicable. More likely, studies would involve verification and validation sets).
9. How Ground Truth for the Training Set Was Established
- This information is not provided in the document. (See note for point 8).
Summary Limitations:
The provided text is an FDA 510(k) substantial equivalence letter. This letter confirms that a submission was reviewed and found substantially equivalent to a predicate device, allowing it to be marketed. It typically summarizes findings but does not provide the full technical details of the underlying studies that were submitted to the FDA (which would be found in the 510(k) summary or full submission document, separate from this letter). Therefore, most of the detailed information requested is not present here.
§ 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.