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510(k) Data Aggregation
(182 days)
QNJ
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.
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
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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(384 days)
QNJ
The MBT Sepsityper is a qualitative in vitro diagnostic device consisting of a MBT-CA (Sepsityper) software extension and a reagent kit (MBT Sepsityper Kit US IVD) for use in conjunction with other clinical and laboratory findings to aid in the early diagnosis of bacterial and yeast infections from positively flagged blood cultures using the MALDI Biotyper CA System.
The MBT Sepsityper Kit US IVD is a disposable blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed to demonstrate the presence of a single organism as determined by Gram stain. This sample preparation manual method is performed by laboratory health a clinical diagnostic setting.
Subculturing of positive blood cultures is necessary to recover organisms for identification of organisms not identified by the MBT-CA System, for susceptibility testing and for differentiation of mixed growth.
Positive MBT Sepsityper results do not rule out co-infection with organisms that may not be detected by the MBT-CA System. Results of the MBT Sepsityper should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Results of the MBT Sepsityper should be correlated with Gram stain results and used in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast bloodstream infections.
The MBT Sepsityper is a qualitative in vitro diagnostic device consisting of a MBT-CA (Sepsityper) software extension and a reagent kit (MBT Sepsityper Kit US IVD). The MBT Sepsityper Kit US IVD is a disposable blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed to demonstrate the presence of a single organism as determined by Gram stain. This sample preparation manual method is performed by laboratory health a clinical diagnostic setting.
The provided text is related to an FDA 510(k) clearance for a medical device (MBT Sepsityper) and primarily describes its indications for use, regulatory classification, and the types of organisms it can identify. It does NOT contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and the study proving the device meets those criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, or data provenance.
- Information on expert ground truth establishment (number of experts, qualifications, adjudication).
- Details about MRMC comparative effectiveness studies or standalone algorithm performance.
- Specifics on how ground truth was established for training or test sets (e.g., pathology, outcomes data).
Therefore, I can only address the parts for which information is implicitly or explicitly available in the provided text.
Based on the provided information, here's what can be gathered:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document is an FDA clearance letter, which typically summarizes the outcome of the review rather than providing the raw performance data or the detailed acceptance criteria used in the validation study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document mentions that the device is "for use in conjunction with other clinical and laboratory findings to aid in the early diagnosis of bacterial and yeast infections from positively flagged blood cultures." It also lists a wide range of bacteria and yeasts the device is intended to identify, implying that a significant amount of data was used for validation, but specific sample sizes and provenance are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. For in vitro diagnostic microbiology devices like this, ground truth is typically established by definitive laboratory methods (e.g., sequencing, advanced biochemical tests) rather than expert human interpretation of images, but the specifics are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation of complex medical images, which is not the primary function of this device.
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:
This information is not provided in the document. MRMC studies are generally applicable to imaging devices where human interpretation plays a significant role. This device is an in vitro diagnostic system for microorganism identification using mass spectrometry, not an AI-assisted diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is described as "a qualitative in vitro diagnostic device consisting of a MBT-CA (Sepsityper) software extension and a reagent kit." This implies that the software performs the identification based on mass spectrometry data, making it a standalone algorithm in terms of the identification process itself. However, the clearance states it is "for use in conjunction with other clinical and laboratory findings," and that "results should not be used as the sole basis for diagnosis," indicating that human oversight and integration with other clinical data are required downstream. The document does not explicitly state if standalone performance metrics (e.g., sensitivity, specificity) of the algorithm alone were evaluated as a distinct part of the study, separate from its overall clinical utility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
While not explicitly stated in detail, for an in vitro diagnostic device identifying microorganisms, the ground truth would almost certainly be established by definitive microbiological methods, such as:
- Reference culture methods: Gold standard growth and biochemical identification.
- Molecular methods: DNA sequencing (e.g., 16S rRNA gene sequencing for bacteria, ITS region sequencing for fungi) which provides highly accurate species-level identification.
The document lists specific organisms the device can identify, implying that the ground truth for these organisms was established by such highly accurate methods.
8. The sample size for the training set:
This information is not provided in the document.
9. How the ground truth for the training set was established:
This information is not provided in the document, but similar to point 7, it would logically be established by definitive microbiological or molecular methods.
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