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The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection Kit is a real-time polymerase chain reaction (PCR) test system intended for the qualitative in vitro diagnostic (IVD) detection of target DNA sequences of Francisella tularensis. The system can be used to test human whole blood collected in sodium citrate or sputum collected aseptically from individuals greater than 18 years of age suspected of having tularemia. In addition, positive blood cultures and colonies may be tested. This assay is intended to aid in diagnosis of individuals presenting with signs and symptoms of pneumonic or typhoidal tularemia. It is not intended to aid in the diagnosis of glandular, ulceroglandular, oculoglandular, or oropharyngeal tularemia.

The JBAIDS Tularemia Detection Kit is run on the JBAIDS instrument using the Diagnostic Wizard. Results are for the presumptive identification of F. tularensis, in conjunction with culture and other laboratory tests. The definitive identification of F. tularensis from colony growth, liquid blood culture, blood specimens, or sputum specimens requires additional testing and confirmation procedures in consultation with public health or other authorities for whom reports are required.

The diagnosis of tularemia infection must be made based on history, signs, symptoms, exposure likelihood, and other laboratory evidence, in addition to the identification of the target either from colonies, blood culture, whole blood specimens, or sputum specimens.

The JBAIDS Tularemia Detection Kit is intended for use by trained clinical laboratory personnel who have received specific training on the use of the JBAIDS Tularemia Detection kit. The level of F. tularensis that would be present in blood or sputum of individuals with early systemic or pneumonic infection is unknown. Due to the difficulty in obtaining clinical specimens, the assay was not evaluated with blood or sputum from individuals presenting with signs and symptoms of tularemia and who subsequently developed pneumonic or typhoidal tularemia.

The Joint Biological Agent Identification and Diagnostic System (JBAIDS) Tularemia Detection Kit is a real-time polymerase chain reaction (PCR) reagent kit, which, when used with the JBAIDS instrument and software, allows the qualitative in vitro diagnostic (IVD) detection of a target DNA sequence within the pathogenic bacterium, Francisella tularensis, the causative agent of tularemia. Key components of the kit include oligonucleotide primers and a fluorescent-labeled target assay probe that specifically detects F. tularensis DNA. The kit is designed for use with the JBAIDS instrument, a portable thermocycler and real-time fluorimeter that performs PCR in glass capillaries.
Before testing, samples are purified using Idaho Technology's 1-2-37M Sample Purification Kits (or validated equivalent). The resulting purified sample is added to an Unknown reagent vial and an Inhibition Control reagent vial, along with reconstitution buffer. When the organism is present, a fragment of F. tularensis DNA is amplified. The amplicon is detected by fluorescence using a specific hydrolysis probe. The hydrolysis probe contains a short oligonucleotide that hybridizes to an internal sequence of the amplified fragment during the annealing phase of the PCR cycle. This probe has the 5' and 3' ends labeled with a reporter dye and a quenching dye, respectively. When the probe hybridizes to the specific DNA target, the Taq polymerase enzyme replicating the target-specific DNA hydrolyzes the probe, separating the two fluorophores and allowing the reporter dye to fluoresce.

The JBAIDS instrument measures the level of fluorescence from each unknown sample and control. JBAIDS Software analyzes the fluorescence amplification curves and reports results as positive, negative, inhibited, or uncertain. A failure of the Positive or Negative Control will result in the entire run being called invalid. Failure of the Inhibition Control yields an inhibited result when the associated sample has a negative result for the target assay and requires retesting of that sample.

Here's an analysis of the provided text regarding the acceptance criteria and study for the JBAIDS Tularemia Detection Kit, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Analytical Testing (Inclusivity): 27 isolates of F. tularensis (subtypes and strains).
• Analytical Testing (Exclusivity): 24 organisms (phylogenetically related and unrelated).
• Clinical Specificity Testing:
  • Whole Blood: 132 samples
  • Sputum: 36 samples
• Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It indicates a "multisite clinical trial was conducted," suggesting multiple sites, likely within the United States given it's an FDA submission. The clinical data is retrospective in nature, as it was limited to assessing clinical specificity using samples from individuals suspected of tularemia and for whom culture had been ordered. The submission notes the difficulty in obtaining clinical specimens from individuals with confirmed pneumonic or typhoidal tularemia.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. For the analytical and clinical studies, the reference method (culture for clinical specificity, identification of known organisms for analytical studies) served as the comparator without detailing an adjudication process for discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an in vitro diagnostic (IVD) PCR kit, designed for automated laboratory analysis, not human interpretation of images or other data requiring multiple readers. The study primarily focused on the device's accuracy against a "gold standard" (culture for clinical samples, known strains/organisms for analytical studies).

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

Yes, a standalone performance study was conducted. The JBAIDS Tularemia Detection Kit is an automated PCR system. The JBAIDS Software "analyzes the fluorescence amplification curves and reports results as positive, negative, inhibited, or uncertain." This indicates that the algorithm itself (the software within the JBAIDS instrument) provides the primary result interpretation, making it a standalone system. The stated advantage of the JBAIDS is that "the JBAIDS software automatically interprets the assay results, reducing the opportunity for user error."

7. The Type of Ground Truth Used

• Analytical Studies (Inclusivity & Exclusivity): Known bacterial isolates and purified DNA from various F. tularensis strains and other organisms. The ground truth was established by the identity of these reference strains/samples.
• Clinical Studies (Specificity): Laboratory culture was used as the "gold standard technique" for the clinical specificity assessment.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. As a PCR diagnostic kit, performance characteristics are typically established through analytical validation (inclusivity, exclusivity, precision, etc.) and clinical validation studies, rather than a machine learning training/test set paradigm. Therefore, there's no specified training set for an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Since no specific training set for an AI/ML algorithm is described, this question is not applicable in the context of this 510(k) submission for a PCR kit. Ground truth for the analytical and clinical validation was established as described in section 7.

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