OXOID PBP2 1 LATEX AGGLUTINATION TEST by OXOID, LTD.

This Kit detects penicillin binding protein 2' in isolates of Staphylococcus as an aid in identifying Methicillin Resistant Staphylococcus aureus (MRSA) and methicillin resistant coagulase-negative staphylococci.

Device Description

PBP21 Latex Agglutination Test

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the Oxoid PBP2' Latex Agglutination Test. It includes a general description of the device and its intended use, but it does not contain the detailed information necessary to answer all sections of your request. Specifically, it lacks the actual study design, acceptance criteria, reported performance, and ground truth establishment methods.

Based on the information available, here's what can be extracted:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria or provide a table of reported device performance values such as sensitivity, specificity, or accuracy. It only states the device's indications for use.

Acceptance Criteria (Not explicitly stated in the document)	Reported Device Performance (Not explicitly stated in the document)
(e.g., Sensitivity ≥ X%)	(e.g., Sensitivity = Y%)
(e.g., Specificity ≥ Z%)	(e.g., Specificity = W%)
...	...

Study Information

The document is a regulatory approval letter and does not include the details of the study that underpinned the 510(k) submission. Therefore, much of the requested information regarding the study is not available in this text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not specified in the provided text.
Data provenance: Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text, as the method for establishing ground truth is not described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text, as the study design is not described.

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

This device is a latex agglutination test, which is a laboratory diagnostic assay, not an AI-assisted imaging device or system that would typically involve human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not applicable to this type of device and is not mentioned.

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

This device is a standalone diagnostic test kit that provides a direct result for the presence of PBP2'. Its performance is inherently "standalone" in that it produces a result without human interpretation of complex images or data that an algorithm might process. However, the document does not describe the specific performance study that would detail whether "standalone" performance in a clinical laboratory setting was evaluated and how.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The document does not specify the type of ground truth used. For an antimicrobial susceptibility test, ground truth would typically be established by a reference method for detecting PBP2' or by phenotypic susceptibility testing interpreted against clinical breakpoints (e.g., oxacillin or cefoxitin disk diffusion, broth microdilution).

8. The sample size for the training set

This information is not available in the provided text. As this is a latex agglutination test, the concept of a "training set" in the context of machine learning algorithms is not directly applicable. However, similar to an algorithm, the test would have been developed and optimized using a set of isolates, but the document does not detail this.

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

This information is not available in the provided text for the reasons mentioned above.

In summary, the provided document is a regulatory letter of approval and not the detailed technical submission or study report itself. Therefore, much of the specific study design and performance data you requested is absent.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke, Hants RG24 8PW England

APR 0 2 2002

Re: K011710

Trade/Device Name: PBP21 Latex Agglutination Test Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: MYI Dated: January 29, 2002 Received: January 30, 2002

Dear Mr. Hollingsworth:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/cdrb/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) Submission for Oxoid PBP21 Latex Agglutination Test

Oxoid Ltd

이 위 해 이어 에 대해 대해 이 대 (이 역) 이 역 에 대해 대 대

Unknown (510K) Number :

PBP21 Latex Agglutination Test Device Name :

Indications for Use :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	OR	Over the Counter
✓
(Division Sign Off)
Division of Clinical Devices		(Division Sign-Off)
510(K) Number		Division of Clinical Laboratory Devices
		510(k) Number K011710

Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England Telephone (01256) 841144 Facsimile (01256) 463388 Telex 858793 Oxoid G ... .. ... ...

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).