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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 Centers for Disease Control and Prevention designated laboratory. The assay detects nonvariola 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 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 (K221834).

The provided text is a 510(k) Summary for the "Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set". This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and some general performance characteristic categories.

However, the document does not include detailed information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Specific types of ground truth used (beyond implying laboratory testing).
• Sample size for training sets.
• How ground truth for training sets was established.

Instead, for performance characteristics, the document 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." It mentions that the Limit of Detection (LOD) was determined through an analytical sensitivity study and broadly references analytical sensitivity and specificity, as well as clinical performance, but without providing the detailed results or methodologies for these studies within this summary.

The document highlights the device's intended use for in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA and the need to use results in conjunction with other diagnostic assays and clinical observations. It also specifies use limitations to "Centers for Disease Control and Prevention designated laboratories."

Therefore, based solely on the provided text, I cannot provide the requested detailed information regarding acceptance criteria and study particulars. The document explicitly directs inquiries about these performance characteristics to the CDC.

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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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The Non-variola Orthopoxvirus Real-time 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 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 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.

The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set uses a fluorogenic probe, consisting of an oliqonucleotide 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 Taq 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, proper function of common reagents and equipment, and the absence of inhibitory substances.

This document is a 510(k) summary for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set, submitted by the Centers for Disease Control and Prevention (CDC). It is a re-submission (K221658) of a previously cleared device (K181205). The document largely states that many aspects of the device are unchanged from the previous submission and directs further inquiries about performance characteristics to the CDC.

Based on the provided text, many of the requested details are not explicitly stated in this FDA summary document. The document refers to an "Original Submission (K181205)" for comparison and states that for most performance characteristics, inquiries should be directed to the CDC. However, based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a tabulated format or provide detailed "reported device performance" in this summary. It mentions an "Analytical Limit of Detection (LoD)" and "Analytical Sensitivity and Specificity" studies were performed. It also indicates "Clinical Performance" studies were conducted, but the results for these are not presented here. Given that this is a re-submission with an "Unchanged" intended use and principle of operation, the acceptance criteria and performance would likely be similar to or supported by the original submission (K181205).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not explicitly provided in the text. It states that inquiries regarding performance characteristics should be directed to the CDC.

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 explicitly provided in the text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not explicitly provided in the text.

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 PCR primer and probe set for detecting viral DNA, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a molecular diagnostic assay. Its performance is inherent to the chemical reactions and detection system, and it operates "stand-alone" in the sense that the test result is directly outputted by the instrumentation without human real-time modification of the analytical process. However, human interpretation of the results and clinical context is required as stated in the Indications for Use: "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."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document refers to "identification of non-variola Orthopoxvirus DNA" as the output. The ground truth for such molecular tests typically involves:

• Validated reference strains/samples: For analytical sensitivity and specificity, the ground truth would be precisely known viral DNA concentrations or the known presence/absence of target and non-target organisms.
• Clinical diagnosis/outcome: For clinical performance, the ground truth would be established through a combination of other diagnostic assays, clinical observations, and potentially follow-up outcomes, as implied by the statement "These results must be used in conjunction with other diagnostic assays and clinical observations to diagnose Orthopoxvirus infection."

Specific details are not provided in this summary.

8. The sample size for the training set

This information is not provided in the text. As a PCR diagnostic kit, there isn't typically a "training set" in the machine learning sense. Instead, development involves assay design, optimization, and then validation studies.

9. How the ground truth for the training set was established

Not applicable as there is no "training set" in the machine learning context for this type of device. Assay optimization and validation (which could be considered analogous to "training" and "testing" in a broad sense for a traditional diagnostic) would rely on well-characterized samples with established viral content.

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Ask a specific question about this device

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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