(53 days)
MYCO/F-Sputa culture media BACTEC Supplement /F when used with the BACTEC Brand 9000MB fluorescent series instrument is a qualitative procedure for the in vitro culture and recovery of mycobacteria from digested decontaminated clinical specimens and sterile body fluids other than blood.
MYCO/F-Sputa culture media with the addition of BACTEC Supplement/F when used with the BACTEC Brand 9000MB fluorescent series instrument is a qualitative test for the in-vitro culture and recovery of mycobacteria from digested decontaminated clinical specimens and sterile body fluids other than blood from patients suspected of pulmonary or disseminated mycobacterial infection.
BACTEC® MYCO/F-Sputa Culture Vials containing 7H9 Middlebrook broth base with nutrient additives and antimicrobial supplement (Polymyxin B, amphotericin B, nalidixic acid, trimethoprim & azlocillin (PANTA)). Growth detection is by fluorescent detection of O₂ consumption by mycobacterial growth using the BACTEC® 9000MB automated system.
Here's the analysis of the provided text regarding the BACTEC® MYCO/F-Sputa Culture Vials, structured according to your request:
Acceptance Criteria and Study Performance for BACTEC® MYCO/F-Sputa Culture Vials
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by comparing the new device against two predicate devices: BACTEC 12B Culture Vials (using the BACTEC 460TB system) and Conventional Media (Lowenstein-Jensen agar slants). The study aims to demonstrate "equivalence of mycobacterial growth detection methods".
| Acceptance Criterion (Implicit) | Predicate 1: BACTEC 460TB System | Predicate 2: Conventional Media (Lowenstein-Jensen) | BACTEC® MYCO/F-Sputa Culture Vials Performance | Device Meets Criterion? |
|---|---|---|---|---|
| Time to Detection (Overall All Isolates) | 13.3 days | 24.3 days | 12.2 days | Yes (No significant difference vs. BACTEC 460TB, statistically significantly faster than Conventional Media) |
| Time to Detection (MTB Complex) | 17.2 days | 22.1 days | 18.4 days | Yes |
| Time to Detection (M Avium Complex) | 10.2 days | 28.3 days | 7.9 days | Yes |
| Mycobacterial Recovery (Pathogenic Isolates) | 30 (78.9%) of 38 total | 24 (63.2%) of 38 total | 29 (76.3%) of 38 total | Yes (No statistical difference vs. either predicate) |
| Combined Recovery (New Device + Conventional Media) | Not applicable | Not applicable | 89.5% of total pathogenic isolates | N/A (reported, but not a direct comparison for equivalence) |
| False Positive Rate | Not explicitly stated for predicates, but generally accepted to be low for equivalent predicate systems | Not explicitly stated, but generally accepted to be low for equivalent predicate systems | 5.0% (Overall for the BACTEC 9000MB system) | Yes (Reported, and context implies acceptance despite variation from respiratory specimens) |
| Breakthrough Contamination Rate (Norm. Sterile Specimens) | Not explicitly stated for predicates | Not explicitly stated for predicates | 4.7% - 18.9% | Yes (Reported, acceptance implied through clearance) |
| Breakthrough Contamination Rate (Non-sterile Specimens) | Not explicitly stated for predicates | Not explicitly stated for predicates | 8.2% - 73.9% | Yes (Reported, acceptance implied through clearance) |
| Overall Breakthrough Contamination Rate | Not explicitly stated for predicates | Not explicitly stated for predicates | 14.9% | Yes (Reported, acceptance implied through clearance) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Time to Detection Study: The document mentions "Paired t-tests were performed to compare time to detection...". It does not explicitly state the total number of positive cultures included in these specific analyses, but it does provide overall average detection times.
- Recovery Performance Study: 803 non-respiratory specimens were tested. From these, 38 pathogenic mycobacteria positive isolates were recovered.
- Data Provenance: The recovery performance study was conducted "at a large tertiary care teaching hospital". This suggests a real-world clinical setting. The document does not specify the country of origin, but given the FDA 510(k) submission, it is highly likely to be U.S.-based. The study appears to be prospective in nature, as it describes a controlled comparison of testing methods on collected specimens.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing the ground truth. However, for mycobacterial culture and identification, ground truth is typically established by:
- Standard microbiological culture techniques and subsequent identification methods (e.g., biochemical tests, genetic probes).
- Clinician's diagnosis and patient outcomes.
Given the context of an in vitro diagnostic device for culture and recovery, the "ground truth" for recovery and time to detection would be based on the established gold standard methods for mycobacterial identification. It's implied that the results from the predicate devices (BACTEC 460TB and Conventional Media) served as reference points or "ground truth comparators" for the new device.
4. Adjudication Method for the Test Set
The document does not describe a formal "adjudication method" in the sense of multiple independent reviewers resolving discrepancies. The comparison is between the performance metrics of the BACTEC MYCO/F-Sputa culture vials and the predicate devices (BACTEC 12B and Conventional Media). Statistical tests (paired t-tests and McNemar's paired comparison) were used to determine the significance of observed differences, which is a form of objective comparison rather than expert adjudication of individual case disagreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
This question is not applicable. The device described (BACTEC® MYCO/F-Sputa Culture Vials) is an in vitro diagnostic device for laboratory use to detect microbial growth. It is not an AI-assisted diagnostic tool that directly aids human readers in interpreting medical images or other complex data. Therefore, an MRMC study and effects on human reader performance with AI assistance are outside the scope of this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies described are essentially "standalone" performance evaluations of the device. The BACTEC® 9000MB system automates the incubation, agitation, and fluorescent detection of oxygen consumption, indicating mycobacterial growth. The reported time to detection and recovery rates are inherent to the device and system, operating without direct human interpretation of a reading (other than setting up the culture and interpreting the system's output). The "human-in-the-loop" component primarily involves collecting and processing the specimen, loading it into the system, and then acting on the system's results.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Microbial Culture and Identification: The actual recovery and identification of mycobacteria from clinical specimens by established laboratory methods, including conventional culture and the predicate BACTEC 12B system. The "total pathogenic mycobacteria positive isolates" (38 cases) serves as the reference for recovery studies. The time until growth is detected by these established methods serves as the ground truth for time to detection.
8. The Sample Size for the Training Set
The document does not explicitly state a sample size for a "training set." This is because the BACTEC® MYCO/F-Sputa Culture Vials are a culture medium used with an instrument, not a machine learning or AI algorithm that requires a distinct training phase. The development of the medium and the BACTEC 9000MB system would have involved extensive R&D, but not a "training set" in the context of AI. The described studies are performance validation studies.
9. How the Ground Truth for the Training Set Was Established
As there is no distinct "training set" in the AI sense for this type of device, this question is not applicable. The development of the culture medium would have been guided by traditional microbiological principles and established methods for optimizing microbial growth and detection.
§ 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.