(94 days)
LabPro Data Management System is a Microsoft® Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes Beckman Coulter ID and AST data, or other pre-defined parameters, against a series of established rules/ alerts and notifies the user of unusual, and/or critical conditions, which may warrant further analysis or action.
LabPro-MBT software is a functional subset of LPDMS intended to electronically transfer and display organism identifications from the Bruker MALDI Biotyper System to the LabPro Data Management System. LabPro-MBT software is a device that is intended to electronically transfer medical device data, without controlling or altering the functions or parameters of any connected medical devices.
The proposed LabPro Data Management System device is a system intended to be used in laboratory settings by trained personnel to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from Beckman Coulter instruments, manually entered panels and select third party microbiology instruments.
The LabPro AlertEx is a functional subset of the LabPro Data Management System and analyzes Beckman Coulter ID and AST data against a series of established rules/alerts and notifies the user of unusual, and/or critical conditions.
The LabPro MBT is an optional subset of the LabPro Data Management System that provides connectivity to a Bruker MALDI Biotyper (MBT) System. The LabPro MBT subset software allows for transfer and display of organism identifications from the Bruker MALDI Biotyper System to the proposed LabPro Data Management System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LabPro Data Management System:
The provided text is a 510(k) summary for the LabPro Data Management System. It states that clinical trials are not applicable, and instead, "Performance Bench Testing" was performed. However, the document does not provide specific acceptance criteria or detailed results of this performance bench testing. It only generally states that "All testing passed demonstrating that the proposed LabPro Data Management System device is substantially equivalent to the predicate device."
Therefore, much of the requested information cannot be definitively extracted from this document. I will provide what can be inferred or is explicitly stated and note where information is missing.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (General) |
|---|---|
| Maintain parity with currently available operating systems and databases, cybersecurity, programming languages, and hardware platforms. | The device has been updated to meet these standards. |
| Consolidate AlertEx into the LabPro Data Management System software. | Achieved. |
| Support additional languages. | Achieved. |
| Reorganize to improve the presentation of help documentation and Alert rules. | Achieved. |
| Connectivity of multiple computers into a single network to improve system usability. | Achieved. |
| Connectivity to multiple WalkAway and autoSCAN-4 instruments to improve usability. | Achieved. |
| Connectivity to a Bruker MALDI Biotyper. | Achieved (via LabPro-MBT software). |
| Function as intended to manage microbial identification (ID) and antimicrobial susceptibility test (AST) results. | The proposed device performs as intended in all aspects of the predicate device's mapped functionality characteristics, and "all testing passed." |
| Provide a safe and secure software product. | The safety aspects were "thoroughly tested in accordance with validation practices." |
| Functionality and performance demonstrate substantial equivalence to the predicate device. | The device "performs as intended in all aspects of the predicate devices' mapped functionality characteristics." |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document states "Performance Bench Testing was performed" but does not give the number of cases, data points, or a description of the dataset used for this testing.
- Data Provenance: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Since the testing was "Performance Bench Testing" for a data management system, it's unlikely that traditional "ground truth" derived from human experts in a diagnostic context (e.g., radiologists) would be directly applicable. The "ground truth" for a data management system would likely refer to the correctness and accuracy of its data handling, processing, and display abilities, which would be verified against expected outputs or known correct data.
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Adjudication method for the test set:
- Not specified. This is typically relevant for studies involving human interpretation or subjective assessments. For a data management system's "Performance Bench Testing," adjudication methods like 2+1 or 3+1 are generally not applicable. Verification would likely involve comparing software outputs to expected correct results.
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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:
- No MRMC study was done. The device is a "software only product" for data management, not an AI diagnostic tool that assists human readers. The document explicitly states, "Clinical performance testing is not applicable for the proposed LabPro Data Management System, as it is a software only product."
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, "Performance Bench Testing" was done, which would evaluate the algorithm/software's standalone performance in managing and processing data. However, the details of what this testing involved (e.g., specific metrics, test cases) are not provided. The phrase "algorithm only" is perhaps not the most precise for a data management system, as its core function is to handle data correctly and robustly.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For a data management system, the "ground truth" would likely involve the correctness of data transfer, storage, processing, and adherence to defined rules/alerts. This would be established by comparing the software's output/behavior against pre-defined, known-correct inputs and expected outputs, as validated by internal testing protocols and specifications.
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The sample size for the training set:
- Not applicable/Not specified. This is not a machine learning or AI algorithm in the context of generating predictive outputs from training data. It is a data management system. Therefore, there is no "training set" in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the software's functionality is its adherence to design specifications and correct operation, which would be established during its development and verification/validation processes.
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”