AUTOREADER 2 by TREK DIAGNOSTIC SYSTEMS

The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram positive cocci to include Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae and, other Streptococcus spp.

This 510(k) is for the addition of: "Sensititre® OptiRead™"

The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious and fastidious Gram positive cocci. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

Device Description

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

AI/ML Overview

The provided text is a 510(k) summary from the FDA for a medical device called Sensititre® OptiRead™. It discusses the regulatory approval, but it does not contain the specific detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a more extensive 510(k) submission.

Here's a breakdown of why I cannot fulfill your request based solely on the provided text, and what kind of information would be needed:

This document is a regulatory approval letter, not a study report. It confirms that the device has been found substantially equivalent to a predicate device, allowing it to be marketed. It does not detail the technical performance studies in depth.

To answer your request comprehensively, I would need a different type of document, such as:

The full 510(k) submission: This would contain the study protocols, results, and acceptance criteria.
A clinical study report or technical file: These documents detail the performance evaluation of the device.

Therefore, based on the provided text, I cannot furnish the requested information.

What I can infer from the provided text, which hints at the device's function and purpose, is:

Device Name: Sensititre® OptiRead™
Intended Use: To be used with the Sensititre® MIC or BP Susceptibility Test System. It is a fluorescence-based detection instrument used to read Sensititre® MIC or BP Susceptibility plates for clinical susceptibility testing of non-fastidious Gram positive cocci (Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae, and other Streptococcus spp.). Results are transferred to SWIN software for generation.
Regulatory Clearance: K103532, cleared on August 26, 2011.

To illustrate what you would generally expect to find if the information were present, here's how a hypothetical response might look if the data were available in the document:

Hypothetical Response (if the information were available in the document):

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (e.g., % Agreement vs. Predicate)	Reported Device Performance (Sensititre® OptiRead™)
Essential Agreement (EA)	≥ 90%	97.2%
Category Agreement (CA)	≥ 90%	98.5%
Major Discrepancies (MD)	≤ 3.0%	1.2%
Very Major Discrepancies (VMD)	≤ 1.5%	0.5%
Minor Discrepancies	Not exceeding [specific threshold]	[specific percentage]
Time to Result	Comparable to predicate (e.g., within X minutes)	Matches manual reading time
Fluorescence Readout Reproducibility	CV < 5%	CV = 2.1%

2. Sample Size and Data Provenance

Test Set Sample Size: A total of [e.g., 2,500 clinical isolates and 200 challenge isolates] were tested.
Data Provenance: The data was collected prospectively from multiple clinical sites across the United States and Europe.

3. Number of Experts and Qualifications

Number of Experts: [e.g., 5 clinical microbiologists]
Qualifications: All experts were board-certified clinical microbiologists with an average of [e.g., 15 years] of experience in antimicrobial susceptibility testing and interpretation.

4. Adjudication Method

Ground Truth Adjudication: For any discrepancies between the test device and the reference method, an adjudication panel of two independent experts reviewed the original isolate and reference results. A consensus was required for final determination of the true MIC. If consensus was not reached, a third expert was consulted (2+1 method).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Conducted?: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not applicable to this device. This device is an automated reader, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study

Standalone Study Conducted?: Yes, a standalone performance study was conducted to evaluate the device's accuracy in reading fluorescence values and determining MICs without human intervention. The reported performance metrics (EA, CA, MD, VMD) reflect this standalone performance compared to a reference method (e.g., broth microdilution).

7. Type of Ground Truth Used

Ground Truth: The ground truth for the test set was established using a CLSI (Clinical and Laboratory Standards Institute) recommended reference broth microdilution method, which is considered the gold standard for antimicrobial susceptibility testing.

8. Sample Size for Training Set

Training Set Sample Size: The device's algorithm was developed and trained using a dataset of [e.g., 10,000 isolates] covering a wide range of common pathogens and resistance profiles.

9. How Ground Truth for Training Set Was Established

Training Set Ground Truth: The ground truth for the training set was established through a combination of CLSI-recommended broth microdilution reference method and expert review of phenotypic susceptibility patterns, ensuring accurate MIC values and categorical interpretations (Susceptible, Intermediate, Resistant).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002

TREK Diagnostic Systems C/o Cynthia Knapp, Director of US Regulatory and Global Clinical Affairs 982 Keynote Circle, Suite 6, Cleveland, OH 44131

AUG 26 2011

Re: K103532

Trade Name: Sensititre® OptiRead™ Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LRG Dated: August 11, 2011 Received: August 15, 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

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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 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/ReportalProblem/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 vours.

Vair actyns

Sally Hojvat, M.Sc. F 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 Sensititre® OptiRead™M

510(k) Number (if known):

Device Name: The Sensititre® OptiRead™

Indications for Use:

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

This 510(k) is for the addition of: "Sensititre® OptiRead™™

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)

Freddie K. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103532

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).