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The Collbri™ System is an in vitro diagnostic device comprised of the Collbri™ Preparation Station for use with the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for qualitative identification and with the bioMérieux VITEK® 2 Antimicrobial Susceptibility Testing (AST) system for qualitative testing of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media. The Collbri™ System is a semi-automated pre-analytical processor that picks isolated colonies designated by the operator and uses a pipetting system to prepare MALDI-TOF MS (Matrix-Assisted Laser Desorption/Jonization-Time of Flight Mass Spectrometry) target slides for bacterial identification and microbial suspension at known concentration for Antimicrobial Susceptibility Testing and purity assessment.

The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers.

Bacterial suspensions for AST and purity plates are identified by barcode label.

The Colibr™ System is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory finding Gram staining, to aid in the diagnosis of bacterial infections.

The Collbri™ System has not been validated for use in the identification or processing of yeast species, Mocardia, or mycobacteria.

The Copan Colibrí System is designed to be used as an accessory of the downstream MALDI-TOF MS and antimicrobial susceptibility testing (AST) analyzers automating various manual steps in the workflow for the preparation of samples for the identification of isolated colonies and for AST of isolated colonies of gram-negative and gram-positive bacterial species grown on solid culture media.

The Colibrí System automates the preparation of MALDI target slides for the bioMérieux VITEK MS or the Bruker MALDI Biotyper CA System that are used in clinical laboratories for identification (ID) of organisms grown on plated media by Matrix-Assisted Laser Desorption/Jonization Time-of Flight Mass Spectrometry (MALDI-TOF MS). The Colibri System automates the preparation of microbial suspensions at known concentration for bioMérieux VITEK 2 System that is used in clinical laboratories for AST analyses. Moreover, the Colibri System is used for Purity Plates preparation for purity assessments.

The Colibrí System comprises the Colibrí Vision System and Colibrí Preparation Station hardware modules and pipette tips, Primary Tubes, Spreader and nephelometer Verification Kit as consumables. After appropriate plate incubation, the operator using the graphical User Interface (Image Reading Interface) chooses the plates exhibiting adequate growth and selects the isolated colonies to be processed assigning the automatic ID or AST tasks. By using the Colibrí Vision System, specific colonies to be picked are designated by the operator on a digital plate. The Operator manually loads the plates in the Colibri Preparation Station where colonies are automatically picked, spotted on the target slide and overlayed with the matrix or suspended into the dedicated solution for the preparation of the microbial suspension for AST purposes (Secondary Tube).

When used in conjunction with the bioMérieux VITEK MS, the Colibrí System can prepare the 48spot target slides by performing the direct spotting of colonies. The calibrator used for quality control is manually applied by the operator at the end of the automated colony spotting. When used in conjunction with the Bruker MALDI Biotyper CA System, the Colibrí System can prepare either reusable 48-spot or disposable 96-spot targets by performing the Direct Transfer Sample Procedure. The BTS used for quality control is manually applied by the operator at the automated colony spotting.

When used in conjunction with the bioMérieux VITEK 2, the Colibrí System can prepare the microbial suspension at the proper concentration by direct colony suspension method. The onboard nephelometer allows the preparation of Secondary Tubes (AST suspensions) at the correct concentration and the Colibrí Spreader is used for Purity Plates preparation.

Copan WASP S.r.l., Traditional 510(k)- Colibrí System

The Colibrí software records the identity of each sample and its position on the target slide and communicates this information electronically to the MALDI-TOF MS analyzers.

The traceability of prepared Secondary Tube and Purity Plates is maintained by dedicated labels applications.

Colibri System requires four different calibrations, one on the nephelometer, three on the cameras. None of these calibration activities require user intervention if not in terms of periodical cleaning of the mechanical component as described in the dedicated section of the User Manual. The Set-up calibration of nephelometer and camera units positioned on the Colibrí Vision System and on the Colibrí Preparation Station are performed during the device initial setup. Auto-calibration is performed at the end of the initial set-up and periodically during the preventive maintenance to check that, in the Collbrí Preparation all the mechanical references can be found inside the positioning tolerances, that the I/Os are responsive. Run-time calibration is performed during the normal usage to automatically check the proper functioning of the Colibrí Vision System and the Colibrí Preparation Station.

Colibrí System requires a daily nephelometer verification to check the proper reading of suspensions at different turbidity values.

The provided text describes the performance data for the Colibrí System, an in vitro diagnostic device. The acceptance criteria and performance are primarily focused on its ability to accurately prepare microbial suspensions for Antimicrobial Susceptibility Testing (AST) and for MALDI-TOF MS identification, compared to manual methods.

Here's an attempt to extract the requested information. Please note that the document is a 510(k) summary, which often provides summarized performance data rather than detailed study protocols. Therefore, some information might be explicitly stated as "not applicable" or inferred based on common practices for such device clearances.

1. A table of acceptance criteria and the reported device performance

The document outlines several analytical studies. While explicit "acceptance criteria" are not always presented as target percentages, the performance results are given, implying that these results met the internal pre-defined acceptance thresholds for substantial equivalence.

2. Sample sizes used for the test set and the data provenance

• Nephelometer Calibration Verification: 300 suspensions were prepared (20 suspensions for each of 5 concentrations, across 3 operators and 3 Colibrí systems, though the calculation isn't directly 2053*3).
• Pipettor Trueness and Precision: 10 measurements for each of 4 volumes, across 3 Colibrí System pipettors (10 * 4 * 3 = 120 measurements).
• E. coli Suspensions Preparation Verification: The exact number of suspensions isn't provided, but it states "A variable number of colonies was selected... to create different suspensions... Three Colibrí Systems run by three different operators were included."
• Colony Picking and Microbial Suspensions for AST: 6 bacterial species (3 Gram-Negative and 3 Gram-Positive) grown in 2 polymicrobial mixtures on different culture media.
• AST Challenge Test:
  • Total Tested: 5991 (across various antibiotics and organism groups within the challenge test).
  • Evaluated MIC results: 1883 evaluable MIC results.
  • Organism groups: Enterobacterales (n=62 strains), Staphylococcus (n=16 strains), Streptococcus (n=30 strains), Enterococcus (n=16 strains), and non-fermenters (n=32 strains).
  • Strains: Both susceptible and resistant strains, exhibiting a range of on-scale MIC values.
  • Media: Trypticase Soy Agar + 5% Sheep Blood, MacConkey Agar, and Columbia agar + 5% sheep blood.
  • Incubation times: Varied (e.g., 14h, 24h for Enterobacterales/Non-fermenters, 18h for Staphylococcus/Enterococcus/Streptococcus).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission for a medical device manufacturer (Copan WASP S.r.l., Italy), it's highly likely to be internal, prospective studies conducted at their facilities or collaborator sites.
• Reproducibility Study: Each microorganism was tested with the appropriate antibiotic panel, with each condition tested in triplicate, for a total of 81 replicates for each combination strain-antimicrobial agent across three Colibrí Systems and three operators over three days.
• Purity Plate Growth: 2,364 purity plates.
• QC Sample Preparation: Conducted daily at the beginning of the working session on each instrument involved in the Analytical Studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not explicitly provided in the document.
• For the AST Challenge Test, the "ground truth" (or comparator method) was the MICs obtained by the bioMérieux VITEK 2 using manual sample preparation, interpreted according to FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria. This implies the ground truth relies on established, validated laboratory methods and interpretations, rather than subjective expert consensus.
• For other analytical studies (e.g., nephelometer accuracy, pipettor precision), the ground truth generally relies on quantitative measurements using calibrated instruments and standard protocols (e.g., viable cell counts for McFarland turbidity verification, gravimetric measurements for pipettor accuracy).

4. Adjudication method for the test set

• This is not applicable in the context of this device's performance validation. The device automates a pre-analytical step. The performance is assessed by comparing its output (prepared microbial suspensions) to a reference method (manual preparation for VITEK 2). It's not a diagnostic AI system requiring expert adjudication of image interpretations or clinical diagnoses.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI systems that assist human readers in interpreting medical images (e.g., radiology AI). The Colibrí System is a laboratory automation device for preparing samples. It does not involve human "readers" of AI outputs in a diagnostic context that would require such a study design.

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

• The performance data are essentially standalone (algorithm/device only) in terms of its ability to perform the physical process of colonial picking and suspension preparation. The device's output is then fed into other IVD analyzers (VITEK 2, bioMérieux VITEK MS, Bruker MALDI Biotyper CA System) for identification and AST.
• The comparison in the AST Challenge Test is between the Colibrí System's automated preparation and manual preparation which is the existing standard. So, it's comparing automated device output to a manual, human-executed process, where the subsequent analysis (VITEK 2) is the same. The data provided (EA, CA, error rates) represent the performance of the Colibrí system's prepared samples, which is a form of standalone performance.

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

• Comparatative Ground Truth/Reference Method: For the AST Challenge Test, the ground truth was derived from the MICs obtained by the bioMérieux VITEK 2 using manual sample preparation, interpreted according to FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria. This is a well-established and standardized laboratory reference method.
• Quantitative Ground Truth: For other analytical studies, the ground truth was based on quantitative laboratory measurements, such as:
  • Viable cell counts (CFU/mL) for confirming bacterial concentration for nephelometry.
  • Gravimetric measurements for pipetting accuracy.
  • Visual inspection of purity plates and accepted microbiological methods to ensure monomicrobial suspensions and absence of contamination.

8. The sample size for the training set

• The document describes performance validation studies, not product development or AI model training. Therefore, information about a "training set" (in the context of machine learning) is not applicable or provided. This device automates a physical process, not a machine learning model that needs training data in the traditional sense. The "training" of the device likely refers to physical calibration and quality control.

9. How the ground truth for the training set was established

• As per point 8, the concept of a "training set" for an AI/machine learning model is not applicable to the description of this device's validation. The device's mechanics and software are validated against established engineering and microbiology standards.

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