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K Number
K990722
Device Name
ETEST FOR CEFUROXIME
Manufacturer
AB BIODISK
Date Cleared
1999-04-22

(48 days)

Product Code
JWY
Regulation Number
866.1640
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For in vitro diagnostic use:

Etest is a quantitative technique for the determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This Etest 510(k) application is for MIC determination of Cefuroxime in the range of 0.016 - 256 µg/ml with S. pneumoniae.

Previously cleared applications for Cefuroxime are non-fastidious Gram negative and Gram positive aerobic bacteria and H. influenzae.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Etest® Cefuroxime." It indicates that the device has been found substantially equivalent to a predicate device for its intended use. The document discusses regulatory aspects, but it does not contain a detailed study report with acceptance criteria and device performance statistics as would typically be found in a clinical trial or validation study summary.

Therefore, many of the requested elements cannot be extracted from this specific document.

Based on the provided text, here's what can be inferred:

1. A table of acceptance criteria and the reported device performance

  • Acceptance Criteria: Not explicitly stated in this clearance letter. The letter only indicates that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets certain unstated criteria similar to those predicates.
  • Reported Device Performance: The document specifies the "Indications For Use" as "MIC determination of Cefuroxime in the range of 0.016 - 256 µg/ml with S. pneumoniae." This range itself is not a performance metric but rather a functional scope. No specific performance metrics like accuracy, sensitivity, or specificity are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Sample Size for Test Set: Not provided.
  • Data Provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

  • Not provided.

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/Not provided. This device is for determining Minimum Inhibitory Concentration (MIC) for antimicrobial susceptibility, not for image interpretation by human readers. It's an in-vitro diagnostic device.

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

  • The Etest is inherently a standalone device in that it provides a direct MIC reading. However, the document does not detail validation studies, so specific "standalone performance" metrics are not available. The application is for "MIC determination," which is an algorithm's output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

  • Not provided, but for MIC determination devices, ground truth would typically be established by a reference method (e.g., broth microdilution or agar dilution as per CLSI standards).

8. The sample size for the training set

  • Not provided.

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

  • Not provided.

§ 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).