The Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry system.

Device Description

ENZ II CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase from porcine heart.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Dimension® ENZ II CAL," an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT I) method on the Dimension® clinical chemistry system.

However, the document does not contain the following information that you requested:

A table of acceptance criteria and the reported device performance. The document focuses on comparing the new device to a predicate device based on features and intended use, rather than presenting specific performance data against predefined acceptance criteria.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size. This type of study is not relevant for a calibrator device.
If a standalone performance study was done. This study type is not explicitly mentioned with performance metrics.
The type of ground truth used. For a calibrator, "ground truth" would likely refer to the assigned values based on a primary reference method, which is mentioned, but not in the context of a "test set" for performance evaluation in the way it would be for a diagnostic algorithm.
The sample size for the training set. Calibrators are not typically "trained" in the sense that an AI algorithm is.
How the ground truth for the training set was established. Again, not applicable to a calibrator in the context of machine learning.

What is available in the document regarding "acceptance criteria" and "study":

The document establishes substantial equivalence to a predicate device (Dimension Vista® ENZ 2 CAL) as its primary method of demonstrating safety and effectiveness. This means the "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as a legally marketed device.

The "study" that proves the device meets (implicitly) the acceptance criteria is a comparative analysis of features and intended use between the new device and the predicate device, along with verification that the new device's calibration is traceable to an established standard.

Here's a breakdown of what can be extracted from the provided text, addressing your points where possible:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with reported device performance in the traditional sense for a diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is implied by its intended use as a calibrator and its traceability to a reference method.

The key "performance" aspect mentioned is:

Traceability: ENZ II CAL's ALT I is traceable to the IFCC ALT @ 37°C primary reference method. This ensures its accuracy as a calibrator.

2. Sample sized used for the test set and the data provenance

Not applicable/Not provided. The document outlines a comparison of features for substantial equivalence, not a performance study on a "test set" of patient data for diagnostic accuracy.

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

Not applicable/Not provided.

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

Not applicable/Not provided.

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 a calibrator for a clinical chemistry system, not an AI-powered diagnostic tool for human readers.

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

This concept is not directly applicable to a calibrator product. The calibrator itself performs no "algorithm" to generate a diagnostic result. Its "performance" is in its ability to accurately set the measurement scale for an analyzer. The document implies that the device's ability to calibrate is verified by its traceability.

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

For the calibrator, the "ground truth" for the assigned values is established through traceability to a primary reference method: "ALT I traceable to the IFCC ALT @ 37°C primary reference method."

8. The sample size for the training set

Not applicable. This device is a calibrator, not an AI algorithm requiring a training set.

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

Not applicable.

Summary for the Calibrator Device:

Acceptance Criteria & Performance: The primary "acceptance criterion" is establishing substantial equivalence to a predicate device (Dimension Vista® ENZ 2 Calibrator) regarding intended use, form, packaging, stability, and storage. Differences pertain to specific constituents and traceability methods.
- New Device Performance Claim: ALT I traceable to the IFCC ALT @ 37°C primary reference method.
Study Proving Compliance: The "study" is a comparative analysis documented in the 510(k) submission, highlighting similarities and differences between the new Dimension® ENZ II Calibrator and the predicate Dimension Vista® ENZ 2 Calibrator. The traceability claim is fundamental to its "performance."
Ground Truth: For the calibrator's assigned values, the ground truth is established by its traceability to the IFCC ALT @ 37°C primary reference method.
Other details (sample sizes, experts, adjudication, MRMC, standalone performance, training sets): These concepts are not applicable or not provided in the context of this calibrator device's submission. The 510(k) focuses on equivalence to a predicate based on manufacturing, content, and intended use, rather than a clinical performance study with patient data for diagnostic accuracy.

Summary

{0}------------------------------------------------

SIEMENS

510(k) Summary for Dimension ® ENZ II CAL

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _ K |03836

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

Manufacturer:	Siemens Healthcare Diagnostics, Inc.
	500 GBC Drive
	Newark, DE 19714

Contact Information: Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, DE 19714 Attn: A. Kathleen Ennis Tel: 302-631-9352 Fax: 302-631-6299
Preparation date: November 15, 2010
1. Device Name: ENZ II CAL
  Classification: Class II

Product Code: JIX;

Panel: Clinical Chemistry (75)

1. Identification of the Legally Marketed Device:
  Dimension Vista® ENZ 2 CAL K061390

4. Device Descriptions:

ENZ II CAL is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase from porcine heart.

5. Device Intended Uses:

Dimension Vista ® ENZ 2CAL

{1}------------------------------------------------

SIEMENS

The ENZ II CAL is an in vitro diagnostic product for the calibration of the alanine aminotransferase (ALT I) method on the Dimension® clinical chemistry system.

6. Medical device to which equivalence is claimed and comparison information:

The Dimension® ENZ II CAL, modified, is substantially equivalent to the Dimension Vista® ENZ 2 CAL. ENZ II CAL like the predicate, is an in vitro diagnostic product intended to be used for the calibration of the alanine aminotransferase assay.

7. Comparative Features Table

Feature	Predicate DeviceDimension Vista® ENZ 2 Calibrator	New DeviceDimension® ENZ II Calibrator
Similarities
Intended Use:	ENZ 2 CAL is an in vitro diagnosticproduct for calibration of automatedclinical chemistry analyzers.	ENZ II CAL is an in vitrodiagnostic product for calibrationof automated clinical chemistryanalyzers
Form:	liquid, bovine serum albumin based	liquid, bovine serum albuminbased
Packaging:	ENZ 2 CAL is packaged in plasticvials containing 1.5 mL/vial. Eachcarton contains 2 vials of each level.	ENZ II CAL is packaged in plasticvials containing 1.5 mL/vial. Eachcarton contains 2 vials of eachlevel.
Stability andstorage	ENZ 2 CAL is stored at 2 to 8 °C	ENZ II CAL is stored at 2 to 8 °C
Differences
Intended Use:	ENZ 2 CAL is an in vitro diagnosticproduct for calibration of theAspartate Aminotransferase (AST)and Alanine Aminotransferase (ALT)methods on the Dimension Vista®System.	ENZ II CAL is an in vitrodiagnostic product for calibrationof the Alanine Aminotransferase(ALTI) method on the Dimension® clinical chemistry system.
AssignedConstituents:	aspartate aminotransferase andalanine aminotransferase fromporcine heart	alanine aminotransferase fromporcine heart
Traceability ofconstituents:	ALT and AST traceable to Masterpool, Dimension® clinical chemistrysystem values	ALT I traceable to the IFCCALT @ 37°C primary referencemethod.
Levels:	2 levelsLevel 1 - 0 U/LLevel 2 - 1047 U/L	3 levelsLevel 1 - 0 U/LLevel 2 - 550 U/LLevel 3 - 1100 U/L

{2}------------------------------------------------

SIEMENS

8. Conclusion

Dimension ENZ II CAL is substantially equivalent in intended use to the legally marketed device, Dimension Vista® ENZ 2 Calibrator based on the information described above.

{3}------------------------------------------------

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

FEB 1 6 2011

Siemens Healthcare Diagnostics, Inc. c/o Anna Marie Kathleen Ennis. Regulatory Affairs Manager 500 GBC Drive PO Box 6101 Newark, DE 19714-6101, USA

Re: K103836

Trade Name: Siemens Dimension® ENZ II Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrators Regulatory Class: Class II Product Codes: JIT Dated: February 9, 2011 Received: February 10, 2011

Dear Ms. Ennis:

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); 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).

{4}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro 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.

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K1038360 Device Name: Dimension® ENZ II CAL Indications for Use:

The Enzyme II Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI) on the Dimension® clinical chemistry system.

Prescription Use XX(Part 21CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
---------------------------------------------------------	--------	------------------------------------------------

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

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

District Court Officer

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 12/0383

Page 1 of 1

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.