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The MALDI Biotyper CA System is a mass spectrometer systems using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast infections.

The MBT-CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The system uses a different methodology for organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ≥2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and

Here's a breakdown of the acceptance criteria and the study details for the MALDI Biotyper CA (MBT-CA) System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or overall accuracy. Instead, it presents performance results from various studies (reproducibility, challenge panel, method comparison) and concludes that the device performs acceptably.

However, based on the reported performance in the Method Comparison study, common metrics for identification systems would be:

Note: The "acceptance criteria" presented above are inferred from the strong performance and conclusions drawn in the document, rather than explicitly stated numerical targets prior to testing.

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

• Method Comparison Study (Overall Isolate Performance):

  • Sample Size: 2091 fresh and stored organisms.
  • Data Provenance: Organisms were tested at four (4) US clinical test sites and an in-house laboratory. Isolates were sub-cultured and sent to an interim reference laboratory and then to a sequencing reference laboratory for ground truth determination. This indicates prospective and retrospective data collection with a US origin.

• Reproducibility Study:

  • Sample Size: 9 unique organisms (REPRO-02 excluded). Each organism tested in duplicate, 5 days, 2 runs/day, 3 sites (9 organisms x 2 replicates x 5 days x 2 runs x 3 sites = 540 measurements). Total MBT-CA IDs for summary = 179/180 per site.
  • Data Provenance: Conducted at three (3) clinical study sites (US, likely, given the FDA submission context). The organisms were "well-characterized," suggesting they might be reference strains or previously identified clinical isolates.

• Challenge Panel Study:

  • Sample Size: 46 organisms.
  • Data Provenance: Selected from stored organisms from the clinical study, prepared by the interim reference laboratory. Tested at three (3) study sites (US, likely).

• Biological/Technical Equivalency Studies:

  • Sample Size: 34 species for laser equivalency (4080 spectra). Multiple species for target equivalency (e.g., 1000 measurements for repeatability/precision, 1500 for LOD, 2500 for sample stability prior to matrix, 3000 for post-matrix stability, 50 FDA cleared organisms, 1500 for mass accuracy/edge effects). Nocardia Study: 30 strains covering 6 species, resulting in ~15,000 measurements.
  • Data Provenance: Not explicitly stated for specific origin, but these are technical validation studies performed by the manufacturer, likely controlled lab settings.

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

• Method Comparison Study:

  • The ground truth was established by sequencing (16S rRNA or ITS sequencing and protein gene sequencing). This relies on established molecular biology techniques, not human expert interpretation. While experts run and interpret these sequences, the core ground truth is the genetic information itself. The document does not specify a number or qualification of "experts" in the sense of clinical reviewers for ground truth determination but implies reliance on the robust and objective results of gene sequencing performed by a sequencing reference laboratory.

• Reproducibility Study:

  • Organisms were "well-characterized." The ground truth was presumably established by prior definitive identification methods, likely including gene sequencing or reputable reference lab methods. No mention of independent experts for this study's ground truth.

• Challenge Panel Study:

  • Organism identifications were "blinded to test sites," and the panel was prepared by the study interim reference laboratory. The ground truth was established by the reference lab, again likely through gold standard methods like sequencing.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method involving multiple human readers or a specific consensus process for discrepancies in the generated log(scores) or identifications against a human-read ground truth. Instead:

• The ground truth for the organism identity itself (reference algorithm) was established by molecular sequencing.
• The device's log(score) provides a quantitative measure of confidence. If the log(score) is too low (

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