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The VersaTREK® MYCO PZA KIT is used as a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA). The VersaTREK® MYCO PZA KIT is used with the ESP Culture System II (ESP) and the VersaTREK® Microbial Detection System (VTI).

The VersaTREK® MYCO PZA susceptibility testing kit is used with the VersaTREK MYCO culture bottle and performed on the ESP Culture System II and on the VersaTREK® Microbial Detection System. The MYCO bottles are supplemented with Myco Growth Supplement and VersaTREK® MYCO PZA reagent and prepared with the appropriate dilution of pyrazinamide as the mechanism for performing the susceptibility test.

The VersaTREK® MYCO PZA susceptibility test utilizes a 3 to 15 day testing protocol. A standard suspension of Mycobacterium tuberculosis growth is prepared from a liquid (seed inoculum). 0.5 mL is inoculated into a Growth Control bottle (drug-free), and a bottle containing PZA (both bottles are referred to as an AST set). The test determination is based upon growth of the M. tuberculosis isolate in the Growth Control Bottle compared to the growth in the drug-containing bottle.

At the completion of the PZA susceptibility testing protocol, the determination of susceptible or resistant is performed manually by the user, by comparing the time to detection of the Growth Control Bottle to the PZA test bottle.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. A table of acceptance criteria and the reported device performance: (Provided above)

2. Sample size used for the test set and the data provenance:

   • Analytical Studies:
     • Critical Drug Concentration: 6 susceptible wild strains and 4 resistant strains of M. tuberculosis.
     • Lot Reproducibility: 4 well-characterized M. tuberculosis strains (2 ATCC, 2 CDC).
     • CDC Challenge Panel Testing: 10 strains of Mycobacterium tuberculosis obtained from the Centers for Disease Control (CDC).
   • Clinical Studies:
     • Lot Reproducibility: 2 well-characterized M. tuberculosis strains from CDC.
     • Challenge Testing: 30 organisms from a CDC challenge set, resulting in 77 valid test points.
     • Clinical Isolate Testing: A total of 96 tests from seed bottle inoculum.
   • Data Provenance: The strains used were from known sources like ATCC and CDC, indicating well-characterized, reference strains. Clinical isolates were collected from 5 geographically diverse clinical sites, including regional reference centers, university- and community-based laboratories, suggesting real-world clinical samples. The study appears to be prospective in nature for the clinical isolate testing as it refers to performing tests on samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It refers to "expected results" and comparisons to the predicate device (BACTEC 460TB PZA Kit) and CDC-provided challenge sets, implying that the ground truth for these reference strains and challenge sets was pre-established and widely accepted in the field.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: The document does not specify an adjudication method. For the "Challenge Testing" in clinical studies, the "expected results" were used as the ground truth.

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: Not applicable. This device is an in-vitro diagnostic (IVD) kit for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. The "user manipulation for reading" is mentioned as "Yes" for the predicate and "No" for the new device in the comparison table, but this refers to the automation of the reading process, not human interpretation improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself performs the susceptibility testing. The interpretation of the test "is performed manually by the user, by comparing the time to detection of the Growth Control Bottle to the PZA test bottle." This indicates a manual interpretation step. However, the device determines the growth automatically (via pressure sensor). Therefore, while the final call is human-derived, the core measurement is automated, but it's not a standalone "algorithm only" in the sense of a fully automated diagnostic decision.

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

   • For analytical studies and challenge sets, the ground truth was based on known characteristics of reference strains (ATCC, CDC) and comparisons to the established predicate device (BACTEC 460TB PZA Kit), which implicitly relies on previous expert consensus or established laboratory methods.
   • For clinical isolate testing, the 'expected results' would likely be derived from a reference method or expert consensus interpretation of growth patterns.

8. The sample size for the training set: Not applicable. This document describes performance studies for an IVD kit, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established: Not applicable, as there is no "training set" in the context of device performance studies described here.

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Blood Culture System (K921637/A): VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.

Myco Detection (K972756): VersaTREK Myco, with VersaTrek Myco GS, and Either VersaTREK as or PVNA added is a selective growth medium for use with either VersaTREK or ESP II Culture system II for the culture recovery of mycobacteria from sterile body specimens and from digested-decontaminated clinical specimens.

Myco modification-Organism Identification (KK972772): Organism identification may be determined using nucleic acid probes (AccuProbe®) .

Mvcobacterium tuberculosis susceptibility testing (K972772): The VersaTREK Myco Susceptibility Kit is intended for qualitative in vitro susceptibility testing of isolated colonies of Mycobacterium tuberculosis with Rifampin, Ethambutol, and Isoniazid on the VersaTREK instrument. Appropriate inoculum sources are prepared from growth on solid agar, such as Middlebrook 7H10 or Lowenstein-Jensen slants, or Middlebrook 7H9 broth.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the VERSATREK device does not contain the specific information you are requesting about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The letter primarily focuses on:

• Substantial Equivalence Determination: Stating that the VERSATREK is substantially equivalent to legally marketed predicate devices.
• Regulatory Classification: Identifying the device as Class I and its product code (MDB).
• General Controls: Listing the general regulatory requirements for the device.
• Indications for Use: Detailing the intended purposes of the VERSATREK instrument and its associated components (Blood Culture System, Myco Detection, Myco modification-Organism Identification, Mycobacterium tuberculosis susceptibility testing).

To answer your questions, I would need to analyze a different document, such as the full 510(k) submission, the study report, or a publication detailing the device's validation. This clearance letter is a regulatory approval, not a scientific study report.

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