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The Accelerate Arc system is an automated sample preparation device that uses lysis and centrifugation to prepare concentrated microbial suspensions from positive blood culture samples that can be used for bacterial and yeast identification with the Bruker MALDI Biotyper CA System (MBT-CA System) with MBT-CA Sepsityper software extension. Samples are processed directly from BD BACTEC blood culture bottles identified as positive by a continuous monitoring blood culture system. Samples should be confirmed as monomicrobial by Gram stain.

The Accelerate Arc system is an in vitro diagnostic device comprised of the Accelerate Arc system software, and the Accelerate Arc BC kit. The Accelerate Arc BC kit is a disposable consumable that includes reagents to concentrate and purify microbial cells from positive blood culture samples.

Microbial suspensions prepared by the Accelerate Arc system can be used to identify bacterial species and yeasts in accordance with the Bruker MBT-CA reference library.

Subculture of positive blood culture is necessary to recover organisms not identified by the Bruker with MBT-CA Sepsityper software extension, species not indicated for testing with the Bruker MBT-CA System with MBT-CA Sepsityper software extension, for susceptibility testing, and for differentiation/recovery of organisms present in polymicrobial samples.

The Accelerate Arc system is intended for use by trained healthcare professionals in clinical laboratories in conjunction with other clinical and laboratory findings, including Gram staining, to aid in the diagnosis of bloodstream infections.

Device Description

The Accelerate Arc system is an automated sample preparation device with associated consumables that uses lysis and centrifugation to prepare microbial suspensions from positive blood culture (PBC) samples from BD BACTEC™ bottles that have rung positive on a continuous monitoring system and confirmed to be monomicrobial by Gram stain. Suspensions containing concentrated, monomicrobial microorganisms are intended for use with the downstream mass spectrometry (MS) analyzer Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension for qualitative identification and differentiation of microorganisms to aid in the early diagnosis of bacterial and yeast infections. This device is comprised of an automated sample preparation instrument (Accelerate Arc instrument), system software (Accelerate Arc system software), and sample preparation kit (Accelerate Arc BC kit).

The Accelerate Arc system was designed to standardize workflow to minimize operator error and variability. The Accelerate Arc instrument, system software and BC kit rapidly clean up and concentrate microorganisms from positive blood culture samples for downstream identification of the microorganism using the Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software extension. The confidence score range from the MBT-CA Sepsityper® software extension is used to denote high confidence (1.8 to 3), low confidence (1.6 to 1.79), and no identification (0 to 1.59). Altogether, rapid microorganism identification direct from PBC can be achieved in about 1 ½ hours following this workflow.

The maximum system configuration of eight Accelerate Arc modules can process greater than 150 PBCs in a single day.

The Accelerate ArcTM system is comprised of:

. Accelerate Arc™ instrument
Accelerate Arc™ system software .
. Accelerate Arc™ BC kit

Samples prepared by the Accelerate Arc system are intended for use with:

Bruker MALDI Biotyper® CA System with MBT-CA Sepsityper® software . extension

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Accelerate Arc System

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria. Instead, performance characteristics are described qualitatively and with percentages for identification rates. Based on the "Performance Characteristics" section, key aspects for successful identification (High or Low Confidence ID) and accuracy are derived as acceptance indicators.

Acceptance Criterion (Inferred)	Reported Device Performance
Precision/Reproducibility	96% of all samples tested produced a High or Low confidence ID result. No incorrect identifications.
Detection Limit	For bacteria, sufficient biological material at positivity for successful identification. For yeast, successful ID after ~1 hour post-positivity. Lower concentrations from 1:10 dilution did not produce false identifications.
Sample Stability (Post-Positive Blood Culture)	Successful identification after 16 hours in incubator or 24 hours at ambient temperature.
Sample Stability (Post-Processing)	Stable for up to 8 hours refrigerated or at ambient temperature prior to spotting.
Sample Stability (Post-Matrix Application)	Stable for up to 24 hours at ambient temperature prior to MALDI-ToF analysis.
Blood Culture Bottle Type Compatibility	No difference in performance for Gram-negative organisms across 7 BD BACTEC bottle types. Some lower performance observed with Staphylococcus aureus and Streptococcus agalactiae in Myco/F Lytic bottles, and Candida tropicalis in Standard Aerobic/Anaerobic bottles.
Carry-over/Cross Contamination	No evidence of carry-over or cross contamination.
Interfering Substances (Routine Blood/Media)	No inaccurate identifications, except Candida tropicalis affected by high protein (120 g/L) and all organisms by high WBC (1.5x10^10 cells/L). Performance improved at clinically relevant concentrations (60 g/L protein, 3.75x10^9 cells/L WBC).
Interfering Substances (Drugs)	No inaccurate identifications observed from tested drug and antibiotic interferents.
Polymicrobial Interference	No inaccurate identifications were observed; reportable IDs were accurate for at least one organism or no identification was made. (Device not for polymicrobial samples, but study confirms no false IDs when present).
Method Comparison (Overall Accuracy)	100% accuracy for all samples that produced valid identification results (meaning reported result matched reference for isolates identified).
Method Comparison (Identification Rate - All Types)	85.4% High Confidence ID; 90.7% High or Low Confidence ID.
Method Comparison (Identification Rate - Gram-negative)	~90% to ~99% High or Low Confidence ID.
Method Comparison (Identification Rate - Gram-positive)	~78% (fresh) to ~93% (contrived) High or Low Confidence ID.
Method Comparison (Identification Rate - Yeast)

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