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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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The Bruker Daltonics, Inc MALDI Biotyper CA System is a qualitative in vitro diagnostic mass spectrometer system for the identification of Gram-negative bacterial colonies cultured from human specimens using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) mass spectrometry technology.

The MALDI Biotyper CA System is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Gram negative bacterial infections.

The MBT-CA 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

The provided text describes the acceptance criteria and a detailed study for the MALDI Biotyper CA System, a mass spectrometer used for identifying Gram-negative bacterial colonies.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied throughout the performance studies, aiming for high correct identification rates and low false identification/no identification rates for organisms within the claim, and "No Identification" for organisms outside the claim.

• Average log(score): All tested organisms in DT+Ext method showed high average log(scores) well above the 2.0 threshold (ranging from 2.138 to 2.587), with low standard deviations.
• Conclusion: Study confirms repeatability and precision independent of system operators, microflex instruments, target lots, matrix lots, and BTS lots. |
  | Limit of Detection | Ability to correctly identify organisms (log(score) ≥2.00) within a specified dynamic range of cell concentrations for both Direct Transfer (DT) and Extraction (Ext) methods. | - Dynamic Range (DT): Lower limit: 6.3x10³-1.4x10⁴ cells/µL, Upper limit: 1.4x10⁶- ≥ 6.5x10⁷ cells/µL.
• Dynamic Range (Ext): Lower limit: 9.0x10³-1.3x10⁵ cells/µL, Upper limit: 1.1x10⁷- ≥ 6.9x10⁷ cells/µL.
• Conclusion: The device successfully identified organisms within these estimated dynamic ranges. |
  | Specificity | - Organisms not included in the reference library should be reported as "No Identification" (Phase 1).
• Closely related species not in the reference library should not produce incorrect identifications. (Phase 1)
• Closely related claimed species should be uniquely identified (Phase 2). | - Phase 1 (Non-claimed organisms): 100% (2/2 for all tested strains) of Anaerobes, Mycobacteria, Gram-Negative (not claimed), Gram-Positive, and Yeast organisms returned "No Identification" with zero false identifications.
• Phase 2 (Closely related claimed species): 100% (2/2 for all tested strains) of Burkholderia cepacia, B. multivorans, and B. gladioli were correctly identified with zero false identifications.
• Conclusion: High confidence in specificity, demonstrating non-claimed organisms are not falsely identified and closely related species are differentiated. |
  | Mixed Culture | No false identifications when a mixed culture is analyzed, even with varying concentrations of target and non-target organisms. (Users are still instructed to test single isolated colonies). | - Performance: 0/32 false identifications across all tested conditions (100% target, 75% target/25% non-target, 50% target/50% non-target, 25% target/75% non-target).
• Conclusion: No false results were obtained, and the impact on final test results is "greatly reduced" compared to biochemical methods. |
  | Media and Colony Stability | - Acceptability of specified culture media (TSA, CBA, MAC, CHOC).
• Colony stability for up to 12 hours post-incubation at room temperature. | - Media Acceptability: All four media (TSA, CBA, MAC, CHOC) showed high identification rates (263/288 to 288/288) with 0/288 false identifications for both DT and Ext methods.
• Colony Stability: Confirmed stability for up to 12 hours post-incubation. |
  | Influence of Agar Media | - Agar media alone should not generate mass spectra leading to false identification (100% "No ID" for agar alone).
• Agar media should not interfere with MBT-CA performance or organism identification when present with the isolate. | - Agar Alone: 100% (12/12) of agar only replicates resulted in "No ID".
• Target + Agar: 100% (10/12 to 12/12, depending on media) of target organism + agar replicates showed 0% false identifications.
• Conclusion: Media do not interfere with performance or identification and do not generate false identifications on their own. |
  | Organism Stability prior to MBT-CA Analysis | - Isolate stability on the target plate (prior to matrix overlay) for up to 60 minutes via DT and Ext.
• Stability of extracted material (prior to target plate inoculation) for up to 24 hours at room temperature. | - Isolate on Target (DT/Ext): 100% correct identification (24/24 or 6/6) at all time points up to 120 minutes for DT and 60 minutes for Ext, with 0 false identifications.
• Extracted Material Stability: 100% correct identification (24/24) for up to 24 hours when stored at room temperature, with 0 false identifications.
• Conclusion: Samples are stable on the target plate for up to 60 minutes, and extracts are stable for up to 24 hours at room temperature. |
  | Sample Stability overlaid with Matrix | - Stability of test organisms on the spotted target plate after matrix addition for up to 24 hours across various temperature and humidity conditions.
• Matrix alone should not interfere or influence identification (should result in "No Peaks Found"). | - Organism Stability: Mostly 100% correct identification across various temperature/humidity conditions and time points up to 24 hours. A few instances showed 23/24 or 18/24 correct identifications at 8 hours under specific stressed conditions, but the 24-hour mark returned to 24/24, suggesting good overall stability.
• Matrix Alone: 100% "No Peaks Found" for matrix alone across all conditions and time points.
• Conclusion: Inoculated test organisms overlaid with matrix are stable for up to 24 hours at room temperature, and matrix alone does not interfere. |
  | Bacterial Test Standard (BTS) Stability | - BTS stability for 3 weeks at 37±2ºC (accelerated/shipping).
• BTS stability for 12 months at

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