(1 days)
The Non-variola Orthopoxvirus Real-ime PCR Primer and Probe Set is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular rash specimens and viral cell culture lysates submitted to a Laboratory Response Network (LRN) reference laboratory. The assay detects non-variola Orthopoxvirus DNA, including vaccinia, cowpox, monkeypox and ectromelia viruses at varying concentrations. This assay does not differentiate vaccinia virus or monkeypox virus from other orthopoxviruses detected by this assay and does not detect variola virus. Refer to the CDC algorithm, Acute, Generalized Vesicular or Pustular Rash IIIness Testing Protocol in the United States for recommended testing and evaluation algorithms for patients presenting with acute, generalized pustular or vesicular rash illness.
Results of this assay are for the identification of non-variola Orthopoxvirus DNA. These results must be used in conjunction with other diagnostic assays and clinical observations to diagnose Orthopoxvirus infection. The assay should only be used to test specimens with low/moderate risk of smallpox exists, viral culture should not be attempted. Negative results obtained with this device do not prection virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Use is limited to Centers for Disease Control and Prevention designated laboratories.
Unchanged from original submission (K221658).
This document, a 510(k) summary for the "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set" (K221834) from the Centers for Disease Control and Prevention (CDC), does not provide details on acceptance criteria or the specific study proving the device meets those criteria directly within the provided text.
Instead, it refers to a predicate device (K221658) and indicates that the current submission (K221834) is similar, with the main change being labeling. It explicitly states:
- "Unchanged from original submission (K221658)" for Device Description, Principle of Operation, Sample Types, and Instrumentation/Software.
- For "Analytical Limit of Detection (LoD)", "Analytical Sensitivity and Specificity", and "Clinical Performance," it repeatedly states: "Inquiries regarding performance characteristics for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set should be directed to the Centers for Disease Control and Prevention."
Therefore, based solely on the provided text, the specific information requested cannot be fully extracted. However, I can provide a template of what such an answer would look like if the information were available, and address what can be inferred or is explicitly absent.
Unable to fully answer based on provided text. The document refers to a predicate device and directs inquiries for performance characteristics to the CDC, rather than detailing them.
Here's an overview of the requested information based on what is and isn't present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to performance characteristics from a previous submission (K221658) and states inquiries should be directed to the CDC.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. As this is an in vitro diagnostic (PCR test), ground truth would likely be established through a combination of culture, sequencing, or other highly sensitive and specific reference methods, rather than expert interpretation of images/clinical findings.
4. Adjudication Method
This information is not applicable/provided in the context of a PCR assay. Adjudication methods like 2+1 or 3+1 are typically used for subjective evaluations (e.g., image interpretation by radiologists or pathologists).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/provided in the context of this device. An MRMC study is relevant for devices involving human interpretation (e.g., AI for radiology). This device is a molecular diagnostic assay.
6. Standalone Performance Study
Yes, this device is inherently a standalone algorithm/assay without human-in-the-loop performance measurement beyond the technician performing the PCR and interpreting the quantitative PCR cycles. The document implies such a performance study must have been conducted for the predicate device (K221658) when it mentions "Analytical Limit of Detection (LoD)," "Analytical Sensitivity and Specificity," and "Clinical Performance" studies, even though the results are not detailed here.
7. Type of Ground Truth Used
For a PCR assay, the ground truth for performance studies (LoD, analytical sensitivity, clinical performance) would typically be established by:
- Reference Methods: Culture, sequencing, or a validated gold-standard molecular test for the detection of non-variola Orthopoxviruses.
- Well-characterized samples: Use of known positive and negative controls, spiked samples, and clinical samples with confirmed infection status.
This specific detail is not provided in the document, but these are the standard ground truth types for such a device.
8. Sample Size for the Training Set
This information is not provided in the document. For PCR primer and probe design, a "training set" might refer to the genomic sequences used to design the primers and probes. For assay validation, there isn't a "training set" in the machine learning sense; rather, there are analytical and clinical validation samples.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document, and the concept of "ground truth for a training set" is less directly applicable in the same way as it is for machine learning models. For a PCR assay, primer and probe sequences are designed based on conserved regions of target genomes. Validation samples would then have their true status established by highly reliable reference methods.
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