DRIED GRAM-POSITIVE MIC/COMBO PANELS

• K Number: K972524
• Device Name: DRIED GRAM-POSITIVE MIC/COMBO PANELS
• Manufacturer: DADE INTL., INC.
• Date Cleared: 1997-09-08 ( 63 days)
• Product Code: JWY
• Regulation Number: 866.1640
• Type: Traditional
• Panel: MI
• Reference & Predicate Devices: N/A

Intended Use

To determine gram-positive bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Sparfloxacin Gram-Positive Bacteria Staphylococcus aureus

Device Description

Microdilution Minimum Inhibitory Concentration (MIC) Panels

AI/ML Overview

This document describes the acceptance criteria and the study that proves the MicroScan® Dried Gram-Positive MIC/Combo Panels with Sparfloxacin meet those criteria.

1. Table of acceptance criteria and the reported device performance:

   Performance Metric	Acceptance Criteria (implied from predicate)	Reported Device Performance
   Essential Agreement	Substantially equivalent performance compared to NCCLS frozen Sparfloxacin Reference Panels (implied overall >90%)	98.4% overall Essential Agreement
   Reproducibility	Acceptable reproducibility and precision	Acceptable reproducibility and precision across inoculum methods (Turbidity, Prompt) and instruments (autoScan-4, WalkAway Systems)
   Quality Control	Acceptable Quality Control performance	Acceptable Quality Control performance

   Note: The specific numerical acceptance criteria for Essential Agreement were not explicitly stated in the provided text but are implied by the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991), which typically requires high agreement for such devices.

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The study used "fresh and stock Efficacy isolates and stock Challenge strains" for gram-positive external evaluations.
   • Data Provenance: Not explicitly stated, but given this is a US regulatory submission, it is highly likely the data was generated in the US or in compliance with US regulatory standards. The study appears to be prospective in the sense of evaluating the new Sparfloxacin panel against a reference standard in a controlled manner, though the originating isolates (efficacy and challenge strains) could have been collected retrospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as the "ground truth" was established by a reference method (NCCLS frozen Sparfloxacin Reference Panels), not by individual expert consensus readings of data.

4. Adjudication method for the test set:

   • Not applicable, as the evaluation was a direct comparison to a reference standard, not an expert consensus process.

5. 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:

   • Not applicable. This is a study for an antimicrobial susceptibility device, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this was a standalone performance study of the MicroScan® Dried Gram-Positive MIC/Combo Panels compared to a reference method. Human interpretation of the panel results is inherent to its use, but the study itself is evaluating the device's accuracy against a gold standard, not human performance with or without the device.

7. The type of ground truth used:

   • Reference Method: The "ground truth" was established by the NCCLS frozen Sparfloxacin Reference Panels. This is a recognized standard method for determining antimicrobial susceptibility.

8. The sample size for the training set:

   • Not applicable. This device is a diagnostic panel, not a machine learning algorithm that requires a training set in that context. The "development" of the panel would involve internal optimization, but there isn't a "training set" in the sense of AI/ML.

9. How the ground truth for the training set was established:

   • Not applicable (see point 8).

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).