MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel is used to determine Microboun - Bynergios prac - etimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic Gram-Negative bacilli (Enterobacteriaceae, glucose non-fermenters, and non-Enterobacteriaceae glucose (Enerobution, After inoculation, panels are read on the WalkAway® S/ System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.

This particular submission is for the antimicrobial Trimethoprim/Sulfamethoxazole on the Synergies plus™ Gram-Negative MIC/Combo Panels.

The Gram-Negative organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing in this panel are:

Escherichia coli Enterobacter spp Klebsiella spp Proteus spo Shigella flexneri Shigella sonnei

The MicroScan® Synergies plus™ Gram-Negative with Trimethoprim/Sulfamethoxazole is not intended for use with:

P. aeruginosa

Device Description

MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. The MicroScan® rapID/S plus ™ Cram-Negative MIC/Combo Panels are read on the WalkAway 57 System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device meets the criteria based on the provided document. The document is an FDA 510(k) clearance letter for a medical device and its associated "Indications for Use Statement" and "510(k) Summary".

While it mentions some performance metrics (like "Essential Agreement of 97.5%"), it does not explicitly state the acceptance criteria that were set before the study. It only reports the results of the performance.

Furthermore, the document does not provide the detailed information required for the other points of your request, such as:

Sample size used for the test set and data provenance: It mentions "fresh and stock Efficacy isolates and stock Challenge strains" but not specific numbers or their origin.
Number of experts and qualifications: Not mentioned.
Adjudication method: Not mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned or described. The analysis compares the device to a reference panel, not human readers with or without AI assistance.
Standalone performance: The document describes the device's performance against a reference standard, which is essentially a standalone performance, but doesn't explicitly frame it as such for human-in-the-loop comparison.
Type of ground truth: It states comparison to an "NCCLS frozen Reference Panel" and "Expected Results," but doesn't elaborate on how that ground truth was established (e.g., pathology, outcomes data).
Sample size for the training set: Not applicable as this device is not described as an AI/ML device that requires a training set in the conventional sense. It's an antimicrobial susceptibility testing device.
How the ground truth for the training set was established: Not applicable.

Therefore, I cannot extract the specific information you requested from the provided text.

Summary

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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three curved lines representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

AUG 3 0 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

K020248 Re: Trade/Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Trimethoprim/ Sulfamethoxazole (0.25/4.75- 64/1216 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: July 30, 2004 Received: August 3, 2004

Dear Mr. Eusebio:

This letter corrects our substantially equivalent letter of March 14, 2002, regarding the trade name which was changed to MicroScan® Synergies Plus to better reflect the intended use of the device.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-3084. Additionally, for questions on the promotion and advertising of your device, al (301) of the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html.

Sincerely yours,

Luddiu. Roofe for

ly A. Hojvat, M.Sc., Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K020248

Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Trimethoprim/Sulfamethoxazole (0.25/4.75 - 64/1216 ug/ml)

Indications For Use:

This particular submission is for the antimicrobial Trimethoprim/Sulfamethoxazole on the Synergies plus™ Gram-Negative MIC/Combo Panels.

The Gram-Negative organisms which may be used for Trimethoprim/Sulfamethoxazole susceptibility testing in this panel are:

Escherichia coli Enterobacter spp Klebsiella spp Proteus spo Shigella flexneri Shigella sonnei

The MicroScan® Synergies plus™ Gram-Negative with Trimethoprim/Sulfamethoxazole is not intended for use with:

P. aeruginosa

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 020248

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510(k) Summary

K020248

510(k) Submission Information:

Device Manufacturer:	Dade Behring Inc.
Contact name:	Maureen Mende, Group Manager Regulatory Affairs
Fax:	916-374-3144
Date prepared:	January 22, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® rapID/S plus™ Gram-Negative MIC/Combo panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	Antimicrobials: Trimethoprim/Sulfamethoxazole
Predicate device:	MicroScan Dried Gram Negative MIC/Combo Panels

510(k) Summary:

The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices" dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel with Trimethoprim/Sulfamethoxazole.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed rapID/S plus ™ Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 97.5% for Trimethoprim/Sulfamethoxazole when compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Trimethoprim/Sulfamethoxazole with Turbidity inoculum preparation method and the WalkAway® System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

Quality Control testing demonstrated acceptable results for Trimethoprim/Sulfamethoxazole.

Regulation Number and Section

§ 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.”