(136 days)
The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is 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 Illness 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 presumptive 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 and should not be used as the sole basis for treatment or other patient management decisions.
Use is limited to Laboratory Response Network (LRN) designated laboratories.
With the exception of some reagents, the Non-variola Orthopoxvirus Realtime PCR Primer and Probe Set device description remains unchanged from the original submission (K053469).
The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Assay uses a fluorogenic probe, consisting of an oligonucleotide with a reporter dye (FAM) attached to the 5' end and a quencher dye (BHQ1) attached at or near the 3' end. The probe anneals to a specific target sequence located between the forward and reverse primers. During the extension phase of the PCR cycle, the 5' nuclease activity of the Tag polymerase degrades the probe causing the reporter dye to separate from the quencher dye, thereby generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved from their respective probes and the fluorescence intensity is monitored during the PCR in real-time. The Taq polymerase used in this assay is inactive at room temperature and is activated by incubation at 95°C, thus minimizing the production of nonspecific amplification products.
Each extracted DNA sample is tested using the Non-variola Orthopoxvirus Real-time PCR Primer and Probe set alonq with an internal control primer and probe set(s) to demonstrate adequate DNA extraction and isolation, proper function of common reagents and equipment, and the absence of inhibitory substances.
I apologize, but the provided text from the FDA 510(k) clearance letter and summary for the "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set" does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.
The document primarily focuses on the regulatory clearance of a PCR-based diagnostic kit, which is an in vitro diagnostic device. It's about detecting a specific DNA sequence, not interpreting medical images or assisting human readers in a diagnostic capacity.
Here's a breakdown of why the requested information cannot be extracted from this document, and what the document does discuss:
Why the document doesn't fit your request:
- Type of Device: This is a PCR primer and probe set, a molecular diagnostic tool. Your request is structured around AI-assisted image analysis or diagnostic systems that involve human readers and ground truth established by experts (e.g., radiologists interpreting images). The "device performance" here is about analytical sensitivity and specificity of a molecular test, not the performance of an AI algorithm in a clinical setting with human interaction.
- Study Design: The document refers to "Analytical Limit of Detection (LoD)" and "Analytical Sensitivity and Specificity" studies, and generally mentions "Clinical Performance" but directs inquiries to the CDC. It does not describe the specific methodologies of these studies in detail, particularly not in the context of a "test set" for an AI or human reader study.
- Absence of AI/Human-in-the-loop: There is no mention of an AI component, human readers, expert consensus for imaging interpretation, or MRMC studies.
What the document does provide (but isn't what you asked for):
- Device Name: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- Intended Use: Qualitative presumptive detection of non-variola Orthopoxvirus DNA from human pustular rash specimens and viral cell culture lysates in Laboratory Response Network (LRN) reference laboratories. It specifically states it does not differentiate between certain Orthopoxviruses and does not detect Variola virus.
- Principle of Operation: Real-time PCR using a fluorogenic probe, demonstrating DNA extraction, reagent function, and absence of inhibitors.
- Predicate Device: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K053469)
- Sample Types: Vesicle fluid, skin, crust, "roof", dry/wet swab of lesion, touch prep, fresh biopsy, viral cell culture lysates.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI device using the provided text.
The document simply states that inquiries regarding performance characteristics should be directed to the Centers for Disease Control and Prevention, indicating that the detailed study results are not included in this summary.
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