FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

To determine gram-negative bacterial susceptibility against the antimicrobial agent Meropenem. Organisms with indications for testing* include: Gram-Negative Bacteria Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

Device Description

Microdilution Minimum Inhibitory Concentration (MIC) Panel, MicroScan® Dried Gram-Negative MIC/Combo Panels

AI/ML Overview

This document describes the acceptance criteria and study for the MicroScan® Dried Gram-Negative MIC/Combo Panels with Meropenem.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Overall Performance	Acceptable performance when compared with an NCCLS frozen Meropenem Reference panel (as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" dated May 31, 1991).	Demonstrated substantially equivalent performance with an overall Essential Agreement of 99.1% when compared with the frozen Meropenem Reference panel.
Reproducibility	Acceptable reproducibility and precision for gram-negative Dried Meropenem panels, regardless of inoculum method or instrument used.	Demonstrated acceptable reproducibility and precision with both Turbidity and Prompt inoculum methods, and with autoScan-4 and WalkAway instruments.
Quality Control	Acceptable Quality Control performance for gram-negative Dried Meropenem panels.	Acceptable Quality Control performance.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The external evaluations were conducted on "fresh and stock Efficacy isolates and stock Challenge strains" of gram-negative bacteria.
Sample Size: The exact number of isolates/strains used for the test set is not explicitly stated in the provided text.
Data Provenance: Not specified directly (e.g., country of origin). The evaluation used "fresh and stock Efficacy isolates and stock Challenge strains," implying a laboratory-based evaluation with well-characterized samples. It is a prospective study in the sense that performance was evaluated against a reference standard in a controlled setting for premarket notification.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The ground truth for the test set was established by the NCCLS frozen Meropenem Reference Panel, which is a standardized method, not by individual experts in a subjective assessment. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically applied in image analysis or clinical diagnosis studies is not directly applicable here. The "expertise" is embedded in the scientific rigor and standardization of the NCCLS reference method.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1) is mentioned. The comparison was directly between the test device's results and the results from the NCCLS frozen Meropenem Reference panel, which serves as the established gold standard. Discrepancies would be analyzed according to the "FDA DRAFT document Review Criteria for Assessment of Antimicrobial Susceptibility Devices," but no "adjudication" by multiple human reviewers for individual cases is implied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed in the context of human readers improving with or without AI assistance. This study evaluates an automated diagnostic device (MIC panel) against a reference standard, not the performance of human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Yes, a standalone performance study was done. The entire evaluation focuses on the performance of the MicroScan® Dried Gram-Negative MIC/Combo Panels with Meropenem itself (the "algorithm/device") in determining antimicrobial susceptibility. The "Essential Agreement" of 99.1% is a direct measure of this standalone performance compared to the reference. Human intervention is limited to standard laboratory procedures for preparing and reading the panels, not interpreting complex outputs.

7. Type of Ground Truth Used

The ground truth used was a reference standard method: the NCCLS frozen Meropenem Reference Panel. This is a scientifically established and recognized method for determining antimicrobial susceptibility, serving as the benchmark for accuracy.

8. Sample Size for the Training Set

The provided text does not specify a sample size for a training set. For this type of device (microbiological susceptibility panel), the "training" analogous to machine learning often involves extensive R&D, formulation optimization, and preliminary testing, rather than a distinct "training set" of patient data as might be found in AI/ML applications. The reported study focuses on validation against a reference standard.

9. How the Ground Truth for the Training Set Was Established

As no distinct "training set" is mentioned, the method for establishing its ground truth is also not applicable or described in the provided text. The development of such panels relies on established microbiological principles, reference strains, and internal validation, rather than a formal "training set" with independently established ground truth in the context of this 510(k) summary.

Summary

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).