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510(k) Data Aggregation
(106 days)
The BD BACTEC Plus Aerobic/F medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of this medium is with the BD BACTEC fluorescent series instruments.
The sample to be tested is inoculated into one or more vials which are inserted into the BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO2 produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO2 present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.
Resins have been described for the treatment of blood specimens both prior to and after their inoculation into culture media. Resins have been incorporated into BACTEC culture media to enhance recovery of organisms without a need for special processing.
The provided submission describes a device comparison study rather than independent validation against a predefined acceptance criterion. The study aims to demonstrate substantial equivalence of the new device (BD BACTEC Plus Aerobic/F in a plastic bottle) to a predicate device (BD BACTEC Plus Aerobic/F in a glass bottle) in terms of performance. Therefore, the "acceptance criteria" are implicitly defined by the performance of the predicate device.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
Since specific, quantitative acceptance criteria are not explicitly stated in isolation (i.e., "device must achieve X accuracy"), the acceptance criteria are inferred as demonstrating statistical equivalence or non-inferiority to the predicate device in various performance metrics.
| Performance Metric | Implied Acceptance Criteria (relative to predicate device) | Reported Device Performance (BD BACTEC Plus Aerobic/F (plastic)) |
|---|---|---|
| Instrument Time to Detection (TTD) | No significant difference in recovery and TTD difference should be minimal. | Wilcoxon estimated median TTD difference of 0.083 hours (5 minutes) across 726 positive paired sets. A few organisms showed TTD differences >1 hour, but overall considered minimal. |
| Percent Recovery | No statistically detectable difference in percent recovery. | McNemar p-value of 1 for 738 paired sets (726 positive in both), indicating no statistically detectable difference. |
| False Positive Rate | No false positives within the recommended usage range (3-10 mL blood). | No false positive bottles observed within the recommended usage range. Two false positives with |
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(21 days)
BD BACTEC Plus Aerobic/F Blood Culture medium is used in a qualitative procedure for the aerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principle use of this medium is with BD BACTEC Fluorescent Series Instruments.
BD BACTEC Plus Aerobic/F Blood Culture medium is a bacterial growth medium intended for use in the qualitative culture and recovery of aerobic microorganisms (bacteria and yeast) from human blood. It has been design for blood volumes of three (3) to ten (10) milliliters and is used specifically with the BD BACTEC Fluorescent Series Instruments in monitoring of clinical blood specimens for the presence of microorganisms.
The provided text describes modifications to a blood culture medium and details studies to demonstrate substantial equivalence to a previously marketed device. However, it does not explicitly contain all the requested information for acceptance criteria and a detailed study report. Based on the available text, here's a structured response:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the modified device met all current product claims for performance and that the overall performance is equivalent to the current formulation. The specific numerical acceptance criteria (e.g., a percentage for sensitivity/specificity or a threshold for false positive/negative rates) are not explicitly stated in the provided text.
| Parameter | Acceptance Criteria (Not explicitly stated numerically, but implied equivalence) | Reported Device Performance |
|---|---|---|
| Medium Sensitivity/Specificity | Equivalent to the current formulation | Overall medium performance for the modified formulation is equivalent to the current formulation |
| False Positive Rate | Equivalent to the current formulation | False positive rate for the modified formulation is equivalent to the current formulation |
| False Negative Rate | Equivalent to the current formulation | False negative rate for the modified formulation is equivalent to the current formulation |
| Instrument Compatibility | Usable in any BD BACTEC Fluorescent Series Instrument | The modified formulation can be used in any BD BACTEC Fluorescent Series Instrument |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "internal studies conducted by BD Diagnostic Systems" and refers to "validations and verifications," but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document describes a device (microbial growth medium) and does not involve human readers interpreting images or data in a way that would typically require an MRMC comparative effectiveness study. Therefore, no MRMC study was done or is applicable in this context.
6. Standalone (Algorithm Only) Performance Study
The focus of this submission is on a modified blood culture medium and a complementary algorithm modification for the BACTEC Fluorescent Series instruments. While it tests the medium's performance, it is intrinsically tied to the instrument it's designed for. The "algorithm modification will be made for processing late protocol (>35 hours) growth" and "Both the modified and current BD BACTEC Plus Aerobic/F Blood Culture medium will utilize this modified algorithm." This implies a combined system performance rather than a standalone algorithm evaluation. The document does not explicitly describe a standalone algorithm-only performance study separate from the medium's use with the instrument.
7. Type of Ground Truth Used
Given the nature of a microbial growth monitor, the ground truth would typically be established through laboratory culture results, likely confirmed by subsequent identification of microorganisms and/or clinical correlation. However, the document does not explicitly state how the ground truth was established, beyond inferring it would be based on actual microbial growth and identification.
8. Sample Size for the Training Set
The document does not specify the sample size used for any training set. This is generally not applicable in the same way as an AI/ML model where a distinct training and test set are defined. The "algorithm modification" mentioned is more likely a fixed rule-based adjustment rather than a trained model in the modern AI sense.
9. How Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or detailed in the context of an AI/ML model, the document does not describe how ground truth for a training set was established.
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