HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE by TREK DIAGNOSTIC SYSTEMS, INC.

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Moxifloxacin in the dilution range of 0.004 - 8 ug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The approved primary "Indications for Use" and clinical significance of Moxilloxacin is for: Streptococcus pneumoniae (penicillin-susceptible strains only) In vitro data, without clinical correlation is provided for: Streptococcus pneumoniae (penicillin- resistant strains)

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) approval letter and associated documentation for a medical device called "Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates," specifically for the addition of Moxifloxacin. It does not contain the detailed information necessary to complete most of the requested fields in the table, as it is a regulatory approval rather than a scientific study report.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Reported Device Performance: This information is typically found in the clinical or analytical study section of a 510(k) summary, which is not fully provided here. The document mentions "clinical susceptibility testing" but doesn't detail performance metrics like sensitivity, specificity, accuracy, or specific MIC agreement rates against a reference method (which would be the common acceptance criteria for such a device).
Sample Size and Data Provenance: Not available in this document.
Number of Experts and Qualifications: Not available. This primarily applies to diagnostic imaging or interpretation tasks, not usually to automated susceptibility testing.
Adjudication Method: Not applicable or available.
MRMC Comparative Effectiveness Study: Not applicable to this type of device (an in vitro diagnostic susceptibility plate). This is relevant for devices providing interpretations for human readers (e.g., AI in radiology).
Standalone Performance: The general nature of an in vitro diagnostic susceptibility plate is that it's a standalone test. However, specific performance metrics (accuracy, etc.) are not detailed.
Type of Ground Truth: For antimicrobial susceptibility testing, the ground truth is typically established by a reference method, such as broth microdilution or agar dilution, performed according to CLSI (Clinical and Laboratory Standards Institute) guidelines. This document doesn't explicitly state the reference method used.
Training Set Sample Size and Ground Truth: Not available, as the document describes a device, not an AI/ML algorithm that requires a training set.

Based on the provided text, here is what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Not explicitly stated in text, typical for AST devices)	Reported Device Performance (Not explicitly stated in text)
Essential Agreement (EA)	Typically >90-95% for each drug-bug combination	Not provided in the document
Category Agreement (CA)	Typically >90-95% for each drug-bug combination	Not provided in the document
Major Discrepancies (MD)	Typically <3%	Not provided in the document
Very Major Discrepancies (VMD)	Typically <3%	Not provided in the document

Note: The acceptance criteria and performance metrics for in vitro diagnostic antimicrobial susceptibility tests (AST) like the Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates are typically defined by regulatory guidance (e.g., FDA guidance for AST devices) and industry standards (e.g., CLSI guidelines). These generally involve demonstrating high percentages of essential agreement (agreement between the MIC values of the device and a reference method within one doubling dilution) and categorical agreement (agreement on whether the organism is susceptible, intermediate, or resistant). The provided document is an FDA approval letter and does not contain the detailed study results that would report these specific performance metrics or the explicit acceptance criteria used by the manufacturer in their submission.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not mentioned in the provided text.
Data Provenance: Not mentioned in the provided text.

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

Not applicable/Not mentioned. The ground truth for antimicrobial susceptibility testing is typically established by laboratory reference methods, not human expert consensus, for this type of device.

4. Adjudication method for the test set:

Not applicable/Not mentioned.

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 device is an in vitro diagnostic test for antimicrobial susceptibility, not an AI/ML device intended for human interpretation or assistance.

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

Yes, this device is inherently standalone in its function as an in vitro diagnostic susceptibility plate that determines MIC values. However, specific quantitative standalone performance metrics (e.g., accuracy, agreement rates) are not provided in this document.

7. The type of ground truth used:

Based on the context of an antimicrobial susceptibility plate, the ground truth would typically be established by a broth microdilution or agar dilution reference method performed according to recognized standards (e.g., Clinical and Laboratory Standards Institute - CLSI guidelines). The document itself does not explicitly state the ground truth method.

8. The sample size for the training set:

Not applicable. This device is an in vitro diagnostic product, not an AI/ML algorithm that requires a training set.

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

Not applicable.

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 stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 3 0 2001

Ms. Cynthia C. Knapp Director Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145

Re: K012895

Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates. Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: JWY Dated: August 28, 2001 Received: August 28, 2001

Dear Ms. Knapp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (If known): Kola895

Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

Indications For Use:

This 510(k) is for the addition of Moxifloxacin in the dilution range of 0.004 - 8 ug/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Streptococcus pneumoniae and Haemophilus influenzae isolates. The approved primary "Indications for Use" and clinical significance of Moxilloxacin is for: Streptococcus pneumoniae (penicillinsusceptible strains only) In vitro data, without clinical correlation is provided for: Streptococcus pneumoniae (penicillin- resistant strains)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie W. Cook

ision Sian-C Division of Clinical Laboratory Devices

510(k) Number K012895

Prescription Use
(Per 21 CFR 801.109

Over-The-Counter Use

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).