DRIED GRAM-NEGATIVE MIC/COMBO PANELS by DADE INTL., INC.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Acceptance Criteria (Implicit from FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991))	Reported Device Performance
Overall Essential Agreement	Not explicitly stated in the provided text, but implied to be high for "substantially equivalent performance"	100%
Reproducibility (Inoculum Method)	Acceptable reproducibility	Acceptable for Turbidity and Prompt methods
Reproducibility (Instrument)	Acceptable reproducibility	Acceptable for autoScan-40 and WalkAway™ instruments
Precision	Acceptable precision	Acceptable
Quality Control Performance	Acceptable performance	Acceptable

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

Sample Size: Not explicitly stated. The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used, but the specific number is not provided.
Data Provenance: The study involved "external evaluations." The country of origin is not specified, but the manufacturer is based in the US (West Sacramento, CA). The data is retrospective in the sense that existing "isolates" and "strains" were used, but the testing itself would be prospective.

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

This type of study does not typically utilize human experts in the same way as an imaging or diagnostic AI study to establish ground truth.
Ground Truth Establishment: The ground truth for antimicrobial susceptibility is established by the NCCLS Frozen Levofloxacin Reference Panels. These reference panels are standardized laboratory methods, not subjective expert interpretations. Therefore, the concept of "number of experts" and "qualifications of experts" does not directly apply here.

4. Adjudication Method for the Test Set:

Adjudication methods like 2+1 or 3+1 are primarily relevant for human interpretation tasks where disagreements between experts need resolution.
In this study, the comparison is made against a reference standard (NCCLS Frozen Levofloxacin Reference Panel). The "adjudication" is essentially a direct comparison of the MIC results from the MicroScan™ panel to the established MICs from the reference panel. There's no human adjudication process described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret data, and the goal is to assess the impact of an AI tool on human performance (e.g., radiologists reading medical images).
This submission describes a direct comparison of one in vitro diagnostic (IVD) device (MicroScan™ panel) against a reference standard (NCCLS Frozen Levofloxacin Reference Panel) to determine "substantially equivalent performance" in antimicrobial susceptibility testing. It does not involve human readers interpreting data that is then improved by AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in the context of IVD performance, this is a standalone performance study. The MicroScan™ Dried Gram-Negative MIC/Combo Panels are an automated or semi-automated system designed to produce an MIC result. The "algorithm" here is the chemical and optical detection system within the MicroScan™ device itself, and its performance is evaluated independently against a reference method. There isn't a human actively "in the loop" interpreting the final MIC result from the MicroScan device in the same way a radiologist interprets an image generated by an AI tool.

7. The Type of Ground Truth Used:

Reference Standard / Standardized Laboratory Method: The ground truth was established by the NCCLS Frozen Levofloxacin Reference Panels. NCCLS (National Committee for Clinical Laboratory Standards, now CLSI - Clinical and Laboratory Standards Institute) provides widely accepted, standardized methods for antimicrobial susceptibility testing. These reference panels are considered the gold standard for determining true MIC values.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided. This document describes a premarket notification for a specific product, not the development or training of a machine learning model. The MicroScan™ panels are a chemical/biological system. They are "developed" through R&D, but not "trained" in the machine learning sense with a distinct training set. The "external evaluations" represent verification and validation, not model training.

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

Not Applicable. See point 8.

Summary

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Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin Premarket Notification February 21, 1997

K970676 MAY - 2 1997

DADE

DADE NIERN

MicroScan Inc 1584 Enterprise Boulevard West Sacramento, CA 95691 916.372.1900

510(k) Submission Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Sharolyn Lentsch, Sr. Regulatory Affairs Administrator
Fax:	916-374-3144
Date prepared:	February 21, 1997
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan™ Dried Gram-Negative MIC/Combo Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	New antimicrobial - Levofloxacin
Predicate device:	NCCLS Frozen Levofloxacin Reference Panels

510(k) Summary:

The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel with Levotloxacin demonstrated substanially equivalent performance when compared with an NCCLS frozen Levolloxacin Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).

The Premarket Notification (510/k)) presents data in support of the new antimicrobial, Levofloxacin, for the MicroScan® Dried Gram-Negative MIC/Combo Panels

The external evaluations were conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MicroScan® Dried Gram-Negative Levolloxacin Panel by comparing their performance with an NCCLS frozen Levofloxacin Reference panel.

The MicroScan® Dried Gran-Negative LevoNoxacin Panel demonstrated acceptable efficacy performance with an overall Essential Agreement of 100% when compared with the frozen Levolloxacin Reference panel.

Inoculum and instrument reproducibility testing was conducted; the MicroScan® Dried Gram-Negative Levolloxacin Panel demonstrated accepable reproducibility and precision, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoScan-40 and WalkAway") was used.

Quality Control performance was acceptable for the MicroScan® Dried Gram-Negative Levolloxacin Panel.

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).