The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for the removal of limitation number 22 in the Sensititre technical insert. The limitation to be removed is: "The ability of the Sensititre system to detect resistance to vancomycin for Staphylococcus aureus is unknown because there are not an adequate number of strains available for testing. An alternate procedure such as broth microdilution or agar dilution with a full 24 hour incubation should be used to confirm results. CDC has reported (26) that BHI agar supplemented with 6ug/mL vancomycin is useful in detecting staphylococci with reduced susceptibilities to vancomycin and that this method is also reliable with the first three recognized VRSA isolated reported to CDC." Then the following statement would be added to the technical insert: Sensititre 18-24 hour MIC susceptibility plates is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing. The ability of the Sensititre 18-24 hour MIC susceptibility plates to detect vancomycin resistance in other S. aureus strains is unknown due to the limited number of resistant strains available for comparative testing.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Susceptibility Test Panel for Vancomycin VRSA 1-128µg/ml." It's an in vitro diagnostic product used for clinical susceptibility testing of gram-positive and gram-negative organisms. The 510(k) specifically aims to remove a previous limitation regarding the device's ability to detect vancomycin resistance in Staphylococcus aureus (VRSA) and add a new statement about its capability.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Information:

The document is a regulatory approval letter and an "Indications for Use" statement, not a detailed study report. Therefore, it does not contain specific acceptance criteria values or detailed study results. It mentions that the device "is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing" but does not quantify this capability with metrics like sensitivity, specificity, or agreement rates. It also explicitly states that the ability to detect resistance in other S. aureus strains is unknown due to the limited number of available resistant strains.

However, based on the context of removing a limitation and adding a positive statement, we can infer the intent of the acceptance criteria was to demonstrate the device's capability to detect vancomycin resistance in the available VRSA strains, likely against a reference method (broth microdilution or agar dilution).

Information that CANNOT be extracted from the provided text:

A table of acceptance criteria and reported device performance (specific values are missing).
Sample sizes for the test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts used to establish ground truth or their qualifications.
Adjudication method.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
Effect size of human reader improvement.
Information about a standalone (algorithm only) performance study (as this is a test panel, not an AI algorithm in the contemporary sense).
Sample size for the training set.
How ground truth for the training set was established.

Information that CAN be inferred or directly stated from the provided text:

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

Acceptance Criteria (Inferred Intent)	Reported Device Performance (Directly Stated)
Ability to detect vancomycin resistance in available VRSA S. aureus strains.	"Sensititre 18-24 hour MIC susceptibility plates is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing."
Performance against an alternate procedure (broth microdilution or agar dilution).	(Implicit, as the previous limitation suggested using "an alternate procedure such as broth microdilution or agar dilution with a full 24 hour incubation to confirm results." The removal of this limitation implies sufficient agreement, but specific metrics are not provided.)
Detection of VRSA using a method like BHI agar with 6ug/mL vancomycin.	(Implicit in the removal of the limitation, which referenced CDC reporting this method as reliable with the first three recognized VRSA isolates. The device is now considered capable of detection.)

2. Sample sized used for the test set and the data provenance

Sample Size: Not specified in the provided text. It mentions "VRSA S. aureus strains available at the time of comparative testing" but does not give a number. The text also notes "the limited number of resistant strains available for comparative testing," indicating a small, possibly very small, number.
Data Provenance: Not specified.

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

Not specified. This type of device relies on microbiological culture and reference methods rather than human expert interpretation of images or complex data.

4. Adjudication method

Not applicable/specified. For a microbiological susceptibility test, ground truth is typically established by agreed-upon reference methods and not by expert adjudication in the way it's done for image analysis.

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 not an AI-assisted diagnostic device, nor is it an imaging device that would involve human readers in that sense.

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

The device itself is a standalone test panel. Its performance is evaluated directly against reference methods, so in a sense, it's "algorithm-only" if you consider the panel's reaction as the algorithm. It does not involve human interpretation in the loop in the same way an AI image analysis tool would.

7. The type of ground truth used

Reference Microbiological Methods: The previous limitation explicitly mentioned "broth microdilution or agar dilution with a full 24 hour incubation" as an alternate procedure for confirmation. It also referenced "BHI agar supplemented with 6ug/mL vancomycin." Therefore, the ground truth for evaluating the Sensititre panel's performance would have been established by these recognized reference microbiological methods for determining vancomycin susceptibility.

8. The sample size for the training set

Not applicable/specified. This type of device does not typically involve a "training set" in the machine learning sense. Its design and performance are based on biochemical reactions and known antimicrobial susceptibility patterns.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic Systems, Inc. 982 Keynote Circle, Suite 6 Cleveland, OH 44131

MAY 16 2006

K060783 Re:

Trade/Device Name: Susceptibility Test Panel for Vancomycin VRSA 1-128µg/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY, LRG Dated: March 20, 2006 Received: March 24, 2006

Dear Ms. Knapp:

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 application (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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales a Hon

Sally A. Hojvat, M.Sc., Ph.D. 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

510(k) Number (if known):

Device Name: Susceptibility Test Plate for Vancomycin VRSA Range 1-128ug/ml

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility Indications For Use: System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms.

This 510(k) is for the removal of limitation number 22 in the Sensititre technical insert. The limitation to be removed is:

"The ability of the Sensititre system to detect resistance to vancomycin for Staphylococcus aureus is unknown because there are not an adequate number of strains available for testing. An alternate procedure such as broth microdilution or agar dilution with a full 24 hour incubation should be used to confirm results. CDC has reported (26) that BHI agar supplemented with 6ug/mL vancomycin is useful in detecting staphylococci with reduced susceptibilities to vancomycin and that this method is also reliable with the first three recognized VRSA isolated reported to CDC."

Then the following statement would be added to the technical insert:

Sensititre 18-24 hour MIC susceptibility plates is capable of detecting vancomycin resistance in the VRSA S. aureus strains available at the time of comparative testing. The ability of the Sensititre 18-24 hour MIC susceptibility plates to detect vancomycin resistance in other S. aureus strains is unknown due to the limited number of resistant strains available for comparative testing.

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)

Freddie M. Poole

Division Sign-Off

Office of In With Diegnostic Device Evaluation art الحكومات تاقل

510(k) K060.783

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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).