VIZION by TREK DIAGNOSTIC SYSTEMS

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 Sensitities 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 nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp.

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

This 510(k) is for the addition of: "Vizion® for reading Sensititre YeastOne Plates" The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert.

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

Device Description

The Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Sensititre® Vizion® device:

The provided document is a 510(k) clearance letter from the FDA for the Sensititre® Vizion®. It indicates that the device has been reviewed and found substantially equivalent to legally marketed predicate devices. However, the document itself DOES NOT contain the detailed acceptance criteria or the specific study data proving the device meets those criteria.

This type of FDA letter is a summary of the FDA's decision, not the full submission with all the study details. The study data and acceptance criteria would have been part of the original 510(k) submission (K112276) made by TREK Diagnostic Systems.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text. I can only infer some high-level information.

Here's what can be extracted and what cannot:

What can be inferred from the document:

Device Performance: The device's primary function is to capture a digital image of a Sensititre susceptibility plate, magnify it, and project it onto a monitor to assist a user in manually reading MIC results by visually detecting color changes. The performance described is its use as an "alternate manual reading method."
Device Use Case: It's intended for use with Sensititre MIC or BP Susceptibility Test Systems for nonfastidious Gram positive, Gram negative, and fastidious organisms (Haemophilus influenzae, Streptococci pneumoniae, Streptococci other than S. pneumoniae), and Candida spp. Specifically, this 510(k) addition is for reading "Sensititre YeastOne Plates."
Ground Truth (for device function): The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. This implies the "ground truth" for the device's function is the visually determined color change criterion set by the existing Sensititre/YeastOne methods itself, as interpreted by a human user.

What CANNOT be determined from the provided text:

Specific Acceptance Criteria: The document does not list any quantitative or qualitative acceptance criteria (e.g., accuracy percentages, concordance rates, error rates) that the device had to meet.
Reported Device Performance against specific criteria: Since criteria aren't listed, the specific reported performance in relation to those criteria is absent.
Sample size for the test set: Not mentioned.
Data provenance (country of origin, retrospective/prospective): Not mentioned.
Number of experts and qualifications for ground truth: Not mentioned.
Adjudication method: Not mentioned.
MRMC comparative effectiveness study and effect size: No mention of such a study or human-in-the-loop performance improvement. The device explicitly states it's an "alternate manual reading method," suggesting it's an aid, but not comparing its impact on a human reader's improvement.
Standalone (algorithm only) performance: The device requires a "user" to determine the MIC by "visually looking for the color change." This clearly indicates it's not a standalone algorithm, but a tool to assist human interpretation.
Type of ground truth used: While the method of determining the MIC (visual color change) is described, the specific nature of the "ground truth experts" or "reference method" used for validation of the Vizion's assistance is not elaborated upon. It relies on the established protocol of the Sensititre system.
Sample size for the training set: Not mentioned (and likely not applicable in the AI sense, as this is an image magnification and display tool, not a machine learning algorithm detecting MICs autonomously).
How the ground truth for the training set was established: Not mentioned.

Summary Table (based on what can be inferred, with significant gaps):

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Primary Function	Not explicitly stated in the provided document. Likely implicit criteria related to clear image capture, magnification, and accurate display of color changes on Sensititre plates for manual interpretation.	The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. It is described as an "alternate manual reading method."
Clinical Use	Not explicitly stated in the provided document. Likely implicit criteria related to supporting accurate manual MIC reading for the specified organisms and plate types.	"Intended for use with the Sensititre® MIC or BP Susceptibility Test System... an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp." Also, specifically for "reading Sensititre YeastOne Plates."
Safety and Effectiveness	Not explicitly stated in the provided document. FDA's clearance implies that the device was found substantially equivalent to predicate devices, meaning it is considered as safe and effective as those existing devices for its intended use as an aid for manual interpretation.	Substantially equivalent to legally marketed predicate devices.

Other Study Information (mostly "Cannot be determined"):

Sample size used for the test set and the data provenance: Cannot be determined from the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Cannot be determined from the document.
Adjudication method: Cannot be determined from the document.
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 mentioned. The device is described as an aid for manual reading, not an AI for autonomous interpretation or a tool explicitly studying reader improvement with assistance in the way a diagnostic AI would.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, the device explicitly requires a user ("The user determines the MIC by visually looking for the color change"). It is a human-in-the-loop device.
The type of ground truth used: The "ground truth" for the interpretation itself is the visual color change according to the existing Sensititre/YeastOne technical inserts, as interpreted by a human user. For validating the performance of the Vizion as an aid, it would likely involve concordance studies against direct visual reading or a reference method, but the details are not present.
The sample size for the training set: Not applicable and not mentioned, as this is not an AI/machine learning algorithm in terms of training on large datasets to make diagnostic decisions. It's an imaging and display tool.
How the ground truth for the training set was established: Not applicable for the reasons above.

To get the detailed information you are requesting, you would need to access the full 510(k) submission (K112276) documents from the FDA, which are typically much more extensive than the clearance letter.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, with three human profiles incorporated into the design of the bird's body.

10903 New Hampshire Avenue Silver Spring, MD 20993

TREK Diagnostic Systems c/o Cynthia C. Knapp Director of U.S. Regulatory and Global Affairs 982 Keynote Circle, Suite 6 Cleveland, OH 44131

NOV 1 6 2011

Re: K112276

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 12, 2011 Received: October 24, 2011

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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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

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Page 2 - Cynthia C. Knapp

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vayada

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

Device Name: The "Sensititre® Vizion®

Indications for Use:

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

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

Prescription Use

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)

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

Office of In Vitro Diagnostic Device Evaluation and Safet

510(4) K 112276.

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).