(515 days)
Detection of mycobacteria in clinical respiratory specimens
BACTEC® 9000MB: 7H9 Middlebrook broth base with nutrient additives, Fluorescence sensor in silicon rubber base, Fluorescent detection of O₂ consumption by mycobacterial growth, On-board incubation at 37°C ± 1.5°C; internal instrument agitation every 10 minutes.
Here's a breakdown of the acceptance criteria and study information for the BACTEC® 9000MB, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly state "acceptance criteria" in a formal, quantifiable manner for overall device performance. Instead, it compares the BACTEC® 9000MB to other methods (BACTEC® 460TB and Conventional Media) across various technical specifications and time to detection.
However, based on the comparative tables, we can infer some key performance aspects of the BACTEC® 9000MB and frame them as its reported performance relative to the benchmarks. The "acceptance criteria" for this device would likely be implicitly tied to demonstrating comparable or improved performance over existing methods.
| Feature / Performance Metric | Acceptance Criteria (Inferred from comparison) | Reported Device Performance (BACTEC® 9000MB) |
|---|---|---|
| Primary Sample Type | Respiratory specimens (similar to comparators) | Respiratory |
| Growth Medium | 7H9 Middlebrook broth base with | |
| nutrient additives (a specific formulation) | 7H9 Middlebrook broth base with | |
| nutrient additives | ||
| Growth Detection Method | Fluorescence sensor for O₂ consumption (new method compared to comparators) | Fluorescent detection of O₂ |
| consumption by mycobacterial | ||
| growth | ||
| Antimicrobial Supplement | PANTA (similar to BACTEC® 460TB) | Polymixin B, amphotericin B, |
| nalidixic acid, trimethoprim & | ||
| azlocillin (PANTA) | ||
| Incubation Temperature | On-board incubation at 37°C (with internal agitation) | On-board incubation at 37°C ± |
| 1.5°C; internal instrument agitation | ||
| every 10 minutes. | ||
| Time to Detection (TTD) | Faster than Conventional Media (21-49 days); Comparable to BACTEC® 460TB (7-12 days) or slightly longer, but within a reasonable range. | Eleven to fifteen days |
Important Note: The current document is a summary of safety and efficacy and focuses on describing the device and comparing its technical specifications and typical performance to other methods. It does not contain a dedicated section outlining pre-established, quantitative "acceptance criteria" that the device was then tested against in a formal study. The "acceptance" is implied by demonstrating a viable alternative with certain benefits (e.g., non-radiometric, faster than conventional).
2. Sample size 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 given text.
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 given text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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
The BACTEC® 9000MB is a diagnostic instrument for detecting mycobacteria using fluorescence, not an AI-assisted image interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone study of the BACTEC® 9000MB performance was implicitly done. The document describes the technical specifications and "Time to detection (TTD)" of the device itself, comparing it directly to other methods (BACTEC® 460TB and Conventional Media), not human performance. The TTD of 11-15 days is a direct measurement of the device's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance comparisons (e.g., Time to Detection) would have been established by confirming the presence or absence of mycobacterial growth. Given the nature of microbiology diagnostics, this would typically involve:
- Microbiological Culture Confirmation: Positive cultures on other standard media, possibly with further identification techniques.
- Microscopy: Observation of acid-fast bacilli (AFB) in smears.
- Clinical Outcomes/Patient Diagnosis (less likely for TTD, but relevant for overall efficacy): Correlation with the patient's clinical diagnosis of mycobacterial infection.
The text does not explicitly state the specific ground truth method used, but it would undeniably rely on established microbiological techniques for identifying mycobacteria.
8. The sample size for the training set
This information is not applicable as the BACTEC® 9000MB is a laboratory diagnostic instrument, not a machine learning algorithm that requires a "training set" in the context of AI. Its "training" is in its engineering and calibration.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above (not an AI algorithm).
§ 866.2560 Microbial growth monitor.
(a)
Identification. A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.