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510(k) Data Aggregation
(264 days)
QBQ
The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL. The BacterioScan 216Dx results are intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs).
The 216Dx System is not intended to provide bacteriuria levels, bacterial identification, or differentiation. The system does not distinguish between growth of infecting, colonizing or contaminating bacteria, or if mixed urogenital flora are present. Presumptive positive urine samples must be cultured. Presumptive negative urine samples must be cultured if a low level of bacteriuria is suspected and is clinically relevant. The system also does not detect anaerobic bacteria, fungi/yeasts, fastidious organisms or those associated with sterile pyuria.
The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL. The BacterioScan 216Dx results are intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs).
The BacterioScan 216Dx System uses laser light scattering to measure turbidity (particle density) of a prepared urine-broth sample during a period of incubation. The system is designed to kinetically capture digital measurements of sample turbidity at very low particle densities. Classification software analyzes these optical signal measurements, and interprets increasing turbidity as bacterial growth. Samples with robust growth during the second half of the test cycle, and/or high turbidity, are reported as "Presumptive Positive" for bacteriuria and/or UTI. Low turbidity samples that do not exhibit growth are classified as "Presumptive Negative".
The user logs into the 216Dx interface and is prompted to associate a patient sample ID with a Multicuvette serial number and well location. The user will then pipette the prepared liquid samples into a Multicuvette. Once the Multicuvette is filled, it is loaded into a 216Dx Instrument. The Multicuvette is then incubated for approximately three (3) hours. During the instrument run, the 216Dx appliance will analyze optical measurements to provide a qualitative determination of the presence or absence of viable bacteria in urine specimens at a cut-off of >5x10 CFU/ml. The Classification algorithm qualitatively assesses a result by analyzing periodic measurements taken throughout this incubation period.
Here's a summary of the acceptance criteria and study details for the BacterioScan 216Dx System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in the document, but rather demonstrated through the reported performance data. The device's performance is presented in terms of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for detecting bacteriuria at densities ≥5x10⁴ CFU/mL.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Primary Analysis: Bacteriuria ≥5x10⁴ CFU/mL) | Reported Device Performance (Secondary Analysis: UTI Associated* ≥5x10⁴ CFU/mL) |
|---|---|---|---|
| Sensitivity | High (e.g., above 80-90%) | 89.1% (95% CI: 86.8%; 91.1%) | 97.7% (95% CI: 96.2%; 98.6%) |
| Specificity | Moderate to High (e.g., above 70%) | 74.4% (95% CI: 72.6%; 76.2%) | 72.0% (95% CI: 70.2%; 73.8%) |
| PPV | Moderate (context dependent) | 55.3% (95% CI: 52.6%; 58.0%) | 46.8% (95% CI: 44.1%; 49.6%) |
| NPV | High (e.g., above 90%) | 95.1% (95% CI: 93.9%; 96.0%) | 99.2% (95% CI: 98.7%; 99.5%) |
| Reproducibility | ≥95% for High and Moderate Densities | 91.7-100% across operators/sites/days for High/Moderate densities; 96.5% for negatives | N/A |
| Limit of Detection (LoD) | Approximately equivalent to clinical cut-off (10⁴ CFU/mL) | LoD for most common and rare UTI pathogens confirmed to be approximately equivalent to 10⁴ CFU/mL. Some pathogens showed higher LoD and were noted in limitations. | N/A |
*Limited to bacterial pathogens encountered in the clinical studies.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Method Comparison Study):
- Overall: 3,153 urine samples enrolled, with 3,052 evaluable specimens for primary analysis of bacteriuria (≥5x10⁴ CFU/mL).
- For secondary analysis (UTI Associated*), 3,010 evaluable specimens for ≥5x10⁴ CFU/mL and 3,020 for ≥1x10⁵ CFU/mL.
- Data Provenance: The method comparison study was conducted at three geographically diverse sites. It involved urine samples "received in the laboratory for routine urine culture," suggesting these were clinical samples. The study design implies a prospective collection of samples for the purpose of the comparison. The country of origin is not explicitly stated, but the FDA documentation implies a US context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set was established using "Reference cultures performed simultaneously with 216Dx testing." This involved using 1- and 10μL loops, performing colony count plates in triplicate, and generating a median result. Organisms isolated were identified by MALDI.
The document does not specify:
- The number of experts.
- The qualifications of those experts (e.g., microbiologists, medical technologists).
4. Adjudication Method for the Test Set
The ground truth was established by median colony count from triplicate plating, which acts as a form of internal reconciliation/adjudication. There is no mention of external expert adjudication (e.g., 2+1, 3+1).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a TRADITIONAL MRMC study involving human readers with and without AI assistance was not conducted.
- Instead, this study compared the device (BacterioScan 216Dx System) directly against a reference culture method, not against human interpretation of diagnostic images or data, nor did it involve human readers using or not using the AI to interpret data.
- Therefore, an effect size of how much human readers improve with AI vs without AI assistance is not applicable to this study.
6. Standalone Performance
Yes, the method comparison study directly assesses the standalone performance of the BacterioScan 216Dx System (algorithm only without human-in-the-loop performance) against the reference culture method.
7. Type of Ground Truth Used
The ground truth used was microbiological culture with colony count and identification by MALDI, which is a form of pathology/laboratory ground truth.
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set. It focuses on the validation studies (e.g., LoD, linearity, reproducibility, and method comparison). The "Classification software analyzes these optical signal measurements" suggests an algorithm, but details about its development (and thus training data) are not provided in this excerpt.
9. How the Ground Truth for the Training Set Was Established
Since the document does not mention the training set size, it also does not detail how the ground truth for any training set was established.
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