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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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VITEK® MS is a mass spectrometry system using matrix-assisted laser desorption/ionization – time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens.

The VITEK® MS is a qualitative in vitro diagnostic device in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections.

VITEK® MS is mass spectrometry system using matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS is a qualitative in vitro diagnostic device indicated for use in coniunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections.

The VITEK® MS is intended for laboratory use by professional users who are trained in microbiology and good laboratory practices.

This 510(k) is an update to the VITEK® MS (Mass Spectrometry) clinical knowledge base (KB v3.0.0) for the purposes of identifying Mycobacterium, Nocardia, and mould isolates. As the VITEK® MS KB v3.0.0 update includes new indications for use on the VITEK® MS system, new clinical data was required to establish safety and effectiveness. To account for the detection of higher mass peaks, relevant for some moulds and Mycobacterium, the VITEK® MS acquisition station software was optimized (in v1.5.0) .

Microorqanism identifications are are made via matrix-assisted laser desorption/ionization - time of flight mass spectrometry (MALDI-TOF MS) technology, which includes the three basic principles of ionization, separation, and detection. Depending on the isolate culture, the analyte sample may be directly spotted to a target slide, or for Mycobacterium, Nocardia and mould it must be processed/inactivated before adding to the target slide. Once spotted to the target slide, a matrix is added for the purpose of easy sublimation and strong absorbance in the laser wavelength employed by the instrument.

The slide is then loaded onto the instrument, where a laser targets the sample spot and pulses the isolate spot, resulting in vibrational excitation of matrix and analyte molecules. The matrix transfer protons to the analyte resulting in a positive charge. The ionized molecules are then accelerated in an electromagnetic field and a grid electrode in the ionization chamber. The velocity of the molecules depends on the mass-to-charge (m/z) ratio of the analyte, with heavier molecules having a higher moment of inertia resulting in a lower velocity.

The time of flight is measured precisely by the ions arrival at a particle detector. Based on the time of flight, the m/z ratio of each particle can be determined, and a mass spectrum of the analyte sample mixture is generated. The mass spectrum displays results as a series of peaks (spectrum) which correspond to the ionized proteins derived from the analyte sample. The mass spectra are sufficiently distinctive to allow taxonomic characterization at the genus and species.

The VITEK® MS system is a mass spectrometry system using matrix-assisted laser desorption/ionization – time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. It is a qualitative in vitro diagnostic device used in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast, and mold infections. This summary specifically details the performance of the VITEK® MS with an updated clinical knowledge base (KB v3.0.0) for identifying Mycobacterium, Nocardia, and mold isolates.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VITEK® MS updated with KB v3.0.0 are implied by the reported performance, aiming for high agreement rates and very low error rates when compared against a reference method (molecular sequencing).

Reported Device Performance for Challenge Strains (Mycobacterium, Nocardia, and Mold Combined):

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

• Sample Size (Clinical Strains): A total of 2,695 isolates (Mycobacterium, Nocardia, and mold) were tested.
• Sample Size (Challenge Strains): 100 well-characterized challenge strains were included (50 molds, 35 Mycobacterium, and 15 Nocardia).
• Data Provenance: The study was conducted at five clinical sites. The document does not specify the country of origin of the data, but it is implied to be clinical data from human specimens. The data is prospective in the sense that it was collected specifically for this performance testing, but the isolates themselves would have been collected as part of routine clinical practice.

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 the ground truth beyond stating that the reference method was "molecular sequencing methods." This suggests that the ground truth was established through laboratory testing rather than human expert consensus on morphological characteristics, for example.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method. The performance evaluation was a direct comparison of the VITEK MS identification results to molecular sequencing methods.

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. This device identifies microorganisms and does not involve human readers interpreting images or data directly in a way that an MRMC study would typically assess. The performance is assessed on the accuracy of the device's identification against a reference standard.

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

Yes, the performance study described is a standalone performance assessment of the VITEK® MS system. The device automatically generates an identification based on MALDI-TOF MS data, and its results are compared directly to a molecular sequencing reference method. While professional users trained in microbiology operate the device and interpret its output in a laboratory setting, the core performance reported (agreement, error, no-ID rates) reflects the algorithm's capability without direct human interpretation influencing the primary identification result itself.

7. The Type of Ground Truth Used

The ground truth used was molecular sequencing methods. This is considered a highly accurate and definitive method for identifying microorganisms at the species level. Clinical strains included samples from both solid and liquid culture media.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It refers to the "VITEK® MS clinical knowledge base (KB v3.0.0)," implying a database of known mass spectra used for identification. The development of this knowledge base would have involved a large and diverse collection of characterized organisms, but the specific numbers for the training set are not provided in this summary.

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

The document does not explicitly detail how the ground truth for the training set (clinical knowledge base) was established. However, for such diagnostic platforms, the ground truth for training data is typically established through a combination of:

• Reference methods: Including molecular sequencing (e.g., 16S rRNA gene sequencing for bacteria, ITS sequencing for fungi), conventional biochemical tests, and expert microbiological characterization.
• Pure, well-characterized strains: Often sourced from culture collections (e.g., ATCC).
• Clinical isolates: Confirmed by multiple reliable methods.

The knowledge base would be built by acquiring mass spectral profiles from these ground-truthed organisms.

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The Bruker Daltonics, Inc. MALDI Biotyper 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 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 Bruker Daltonics, Inc. MALDI Biotyper 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 measures the time (in the nanosecond range) between pulsed acceleration and the corresponding detector signal, the speed is converted into an exact molecular mass. The mass-to-charge ratio of an ion is proportional to the square of its drift time. Highly abundant microbial proteins (mainly ribosomal proteins) result in a mass spectrum with characteristic mass and intensity distribution. It is specific for many bacteria and is interpreted as a molecular fingerprint to identify the test organism.

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal table format with numerical targets. However, based on the performance data presented, the implicit acceptance criteria for identification confidence (log(score) ≥ 2.00) are assessed. The reported performance for "Overall Isolate Performance" (Table 6) shows the aggregate performance across all claims.

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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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VITEK MS is a mass spectrometer system using matrix-assisted laser desorption/ionization time to flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

The VITEK®MS 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 VITEK® MS v2.0 system is a system consisting of kit reagents (VITEK MS-CHCA, VITEK MS-FA), VITEK MS-DS target slides, VITEK® MS Prep Station, Knowledge Base, software, and the VITEK®MS (original equipment manufacturer (OEM)-labeled Shimadzu AXIMA® Assurance mass spectrometer).

The VITEK® MS v2.0 system includes an OEM-labeled Shimadzu AXIMA® Assurance mass spectrometer linked to a reference database, referred to as Knowledge Base. Matrix assisted laser desorption ionization (MALDI) is the process used to ionize a sample in to the gas phase. A pulsed laser beam is directed on to the sample. Energy from the laser beam desorbs and ionizes the sample. Extraction plates provide high-voltage electrical fields to accelerate the ionized particles upwards through the time-of-flight (TOF) vacuum tube. An ion lens focuses the ions. Deflector plates steer the ions on a path towards the linear detector at the flight-tube. An ion gate blanks out low mass ions (for example, derived from the matrix). The detector detects the ions directly from the sample (lower-molecular weight ions followed by highermolecular weight ions). Ions hitting the detector cause an electrical signal which is recorded. The recorded signal is processed by the software and presented as a spectrum of intensity versus mass, in Daltons (Da).

During target ionization, mass spectra within a range of 2,000-20,000 Daltons are recorded in linear positive mode at a laser frequency of 50 Hz. For each interrogation, laser shots at different positions within the target well produce up to 100 mass profiles that are summed into a single, raw mass spectrum. The spectrum is then processed by baseline correction, de-noising, and peak detection to identify well-defined peaks. The list of these significant peaks is subjected to a proprietary process called "mass binning". The processed (binned) data are used to query the Knowledge Base to determine the unknown's taxonomic identity. These results are then provided in the form of a single, species-level (and sometimes subspecies-level) identification, a split (low discrimination) identification with up to four species-level alternatives displayed, or no identification.

VITEK®MS Device Acceptance Criteria and Study Summary

Here's an analysis of the VITEK®MS device's acceptance criteria and the study data provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical thresholds in the provided document, but rather implied by the overall performance demonstrated in the clinical study and the defined operational characteristics. The key performance indicators for a diagnostic device like VITEK®MS are typically related to its accuracy in identifying organisms. Based on the clinical study results, here's a table summarizing the performance in terms of "Correct Identification":

Note: Specific, pre-defined numerical acceptance criteria for each organism group (e.g., "Gram-positive bacteria must have >90% combined correct identification") are not explicitly listed as "acceptance criteria" in the text, but the demonstrated performance would be evaluated against what is considered clinically acceptable for such a device. The FDA's decision to classify it as Class II with special controls suggests these performance levels were deemed acceptable.

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

• Sample Size for the Test Set:
  • Challenge Study: 300 isolates (3 panels of 100 strains each).
  • Prospective Clinical Study: 7068 isolates in total, broken down as:
    • Gram-positive bacteria: 2256 isolates
    • Gram-negative bacteria: 3656 isolates
    • Yeasts: 1156 isolates
• Data Provenance: Prospective clinical study data was collected from five clinical microbiology laboratories in the United States. The study involved patient cultures.

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

The document states that the reference identification for the prospective clinical study was "determined by molecular sequencing supplemented as needed by additional molecular sequencing and/or biochemical testing."

• Number of Experts: Not explicitly stated. The process "determined by molecular sequencing" implies laboratory personnel trained in molecular biology and biochemical identification methods, but not a specific count of "experts."
• Qualifications of Experts: Not explicitly stated, but inferred to be laboratory professionals skilled in molecular sequencing and biochemical testing for microbial identification. No specific years of experience or board certifications (e.g., radiologist) are mentioned, as this is a microbiology device.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal "adjudication method" in the sense of multiple experts reviewing and resolving discrepancies in the VITEK®MS results against a ground truth.

Instead, the process described for establishing ground truth is:

• "molecular sequencing supplemented as needed by additional molecular sequencing and/or biochemical testing."
• This suggests that molecular sequencing was the primary reference method, and if there were ambiguities or needs for further confirmation for the ground truth itself, additional molecular or biochemical tests were used. The document does not describe a process for resolving disagreements between the VITEK®MS result and the reference identification by a panel of human experts. Discrepancies are simply reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly reported or described in the provided document. The study focuses on evaluating the standalone performance of the VITEK®MS device against a reference method (molecular sequencing), not on how human readers' performance improves with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was clearly done. The "Prospective Clinical Study" and the "Challenge Study" evaluate the VITEK®MS device's identification performance (algorithm only) against a reference standard. The results are presented as percentages of correct identification by the device itself. The device is described as a "mass spectrometer system for clinical use for the identification of microorganisms...a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens." Its output is an identification with a confidence value.

7. The Type of Ground Truth Used

The ground truth used for both the challenge study and the prospective clinical study was molecular sequencing supplemented as needed by additional molecular sequencing and/or biochemical testing.

8. The Sample Size for the Training Set

The training set details are described under "Knowledge Base":

• Reference database: Data representing 755 taxa, including 645 bacteria and 110 fungi.
• Isolates per species group: An average of 10 isolates (range 2-475) per species group.
• Reference spectra per species: An average of 40 reference spectra per species.

Therefore, the training set effectively included data from at least 755 taxa, with extensive spectral data (average 40 spectra per species) generated from these isolates. The total number of individual isolates used for training would be at least 755 taxa * (average 10 isolates/taxa) = ~7550 isolates if each isolate was distinct. The total number of spectra would be at least 755 taxa * (average 40 spectra/taxa) = ~30,200 spectra.

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

For the training set (Knowledge Base development):

• Each reference isolate was grown on multiple media types under several growth conditions.
• Raw spectra were acquired by more than one technician using multiple instruments.
• The raw spectra were processed (baseline correction, de-noising, peak detection) to identify well-defined peaks.
• The list of significant peaks was subjected to a proprietary process called "mass binning."
• These processed (binned) data were then used to build the Knowledge Base, implying that the taxonomic identity of these reference isolates was established through standard microbiological and molecular methods prior to their inclusion in the database. While the specific methods for establishing the identity of each isolate for the knowledge base are not explicitly detailed in the same way as the clinical study's ground truth, it is understood that such reference strains would have their identities confirmed by established, reliable methods (e.g., 16S rRNA gene sequencing, traditional biochemical tests, etc.) before being used to build a diagnostic database.

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