SENSITITRE VIZION by TREK DIAGNOSTIC SYSTEMS, INC.

The Sensititre Vizion is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The "Sensititre" Vizion" is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for non-fastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae.

Device Description

The "Sensititre" Vizion" is an instrument that takes a digital image of a Sensititre® susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizion® captures an image of a Sensititre 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the presence or absence of growth in the wells. The "Vizion" can be used as an alternate method where the user manually read the MIC result on the Sensititre System.

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the "Sensititre® Vizion®" device. It indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria.

The letter explicitly states that the device is intended for use with the Sensititre® MIC or BP Susceptibility Test System as an alternate manual reading method. The Vizion® captures an image of a susceptibility plate and projects it onto a monitor for a user to visually determine the MIC (Minimum Inhibitory Concentration) by looking for growth in the wells. This implies that the performance evaluation would likely focus on the agreement between readings obtained using the Vizion® system and a traditional manual reading method or a reference method for antimicrobial susceptibility testing.

Therefore, I cannot provide the requested information based solely on the provided text. The document is an FDA clearance letter, not a detailed study report or performance specification document.

To answer your request, I would need access to the 510(k) summary, the full 510(k) submission, or a specific study report that would have been submitted to the FDA for the K081520 clearance. These documents would typically contain:

Acceptance criteria and reported device performance: These would likely be defined in terms of agreement with a reference method or predicate device for MIC readings, often using metrics like Essential Agreement (EA) and Category Agreement (CA).
Sample size, data provenance, ground truth establishment, adjudication: Details regarding the clinical or laboratory studies—including the number of isolates, their origin, the method for establishing true MIC values, and how discrepancies were resolved—would be in the study reports.
MRMC study: A device that facilitates manual reading rather than automated interpretation might not be the subject of a traditional MRMC study in the same way an AI-driven diagnostic would be. Its "improvement" would be in ease of reading, magnification, or potentially reduction of interpretation errors compared to reading with the naked eye.
Standalone performance: Since it's an alternate manual reading method, the device's "performance" is inherently tied to the human user; it's not a standalone algorithm making automated diagnoses in the sense of AI.
Training set: As a device that magnifies and displays images for human interpretation, it likely doesn't have a "training set" in the context of machine learning. The "training" would be for the human users to learn to operate the system.

In summary, the provided document does not contain the information required to populate the requested table and details about acceptance criteria and study particulars.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT 2 4 2008

Re: K081520 Trade/Device Name: The Sensititre® Vizion® Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: October 21, 2008 Received: October 22, 2008

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attaynta

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 STATEMENT Vizion®

510(k) Number (K081520):

Device Name:

The "Sensititre® Vizion®

Indications for Use:

NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert for additional instructions, limitations, and references.

This 510(k) is for the addition of: "Vizion®"

The Vizion® captures an image of a Sensititre 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the presence or absence of growth in the wells.

The "Vizion" can be used as an alternate method where the user manually read the MIC result on the Sensititre System.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

	Leslie L. Poole
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Salety

510(k) K081526

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).