VALIDATE® CM2 Calibration Verification / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi automated, and manual chemistry systems. Each VALIDATE® CM2 Calibration Verification / Linearity Test Set consists of two sets of bottles. Set 1 contains BNP, hs-CRP, Troponin-1, and MPO. Set 2 contains NT-proBNP, hs-CRP, Troponin-T and MPO.

Device Description

Quality control material (assayed and unassayed). VALIDATE® CM2 Calibration / Linearity Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "VALIDATE® CM2 Calibration Verification / Linearity Test Set." This device is a quality control material used to verify calibration and linearity of chemistry analyzers, rather than an AI-powered diagnostic device or an imaging device.

Therefore, many of the requested categories in the prompt (e.g., sample size for the test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training set was established) are not applicable to this type of device and the information available in the provided 510(k) summary.

However, I can extract the relevant information regarding acceptance criteria and device performance based on the provided text.

Here's a summary tailored to the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VALIDATE® CM2 are implicitly tied to demonstrating "substantial equivalence" to its predicate device, the VALIDATE® CM1, in terms of performance for establishing linearity and verifying calibration. The key performance comparison is based on the ability of the CM2 set to function as intended on various chemistry analyzers for the specified analytes, showing a linear relationship across the different levels.

Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance
Functional Equivalence: Ability to quantitatively verify calibration, validate reportable ranges, and determine linearity in automated, semi-automated, and manual chemistry analyzers.	The performance of VALIDATE® CM2 Calibration Verification / Linearity Test Set solutions on the Beckman Access II (TnI, BNP), the Beckman Immage 800 (hsCRP), the Beckman Synchron DxC with Diazyme reagent (MPO), the Roche e411 (TNT, NTproBNP), and the Roche Integra 400+ (hsCRP) has been shown to be substantially equivalent using pre-production lots of VALIDATE® CM2 Calibration Verification / Linearity Test Sets to the VALIDATE® CM1 Calibration Test Set.
Analytical Scope: Cover specific analytes.	VALIDATE® CM2 covers TnI, TnT, BNP, NT-proBNP, hsCRP, MPO. (This is an expansion from CM1 which covered CK-MB, MYO).
Matrix: Human serum.	Human Serum (Matches predicate).
Number of Levels: Sufficient to establish linearity.	2 sets of 6 including base matrix (Expanded from CM1's 5 levels, suggesting enhanced linearity assessment).
Preparation & Packaging: Liquid, ready to use; specific volume.	Liquid, ready to use; 12 x 2.0 mL (Different packaging volume from CM1, but still liquid, ready to use).
Stability & Storage: Until expiration, -10 to -20°C.	Until expiration, -10 to -20°C (Matches predicate).

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

Sample size: Not explicitly stated as a "sample size" in the conventional sense for patient data. The study used "pre-production lots" of the VALIDATE® CM2 Test Sets. The number of individual test sets or runs conducted is not specified.
Data provenance: Not directly described, but the study involved testing on various commercial chemistry analyzers: Beckman Access II, Beckman Immage 800, Beckman Synchron DxC with Diazyme reagent, Roche e411, and Roche Integra 400+. This implies the testing was conducted in a laboratory setting, likely in the US, given the submission to the FDA. The study is prospective in the sense that the new device (CM2 pre-production lots) was developed and then tested.

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

Not applicable. This device is a calibration verification material. Its "ground truth" is its known concentration levels and its ability to demonstrate linearity on analytical instruments, rather than diagnostic interpretations from experts.

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

Not applicable. There is no expert adjudication for this type of device. Performance is objectively measured by the analytical instruments.

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 is not an AI or imaging device with human readers.

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

Not applicable. This is not an algorithm. The "performance" is the material's function in an in vitro diagnostic context on automated analyzers, which inherently involves the "human-in-the-loop" in setting up the test and interpreting results from the analyzer.

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

The "ground truth" for this device would be the assigned, analytically-derived target values for each level within the VALIDATE® CM2 test sets and the theoretical linear relationship between these levels. These values are established through rigorous analytical methods (e.g., reference methods, gravimetric dilutions, primary calibrator traceability) during the manufacturing and characterization of the quality control material. The study then verifies that the instrument measures these levels linearly and accurately.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a "training set."

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

Not applicable. As above, there is no training set for this type of device.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for Maine Standards Company. The logo consists of the word "maine" above a horizontal line that is intersected by a diagonal line. Below the horizontal line is the word "standards" and below that is the word "COMPANY" in smaller letters.

510(k) SUMMARY

APR 1 6 2009

"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 090475."

Submitter: Maine Standards Company Address: 765 Roosevelt Trail Windham, ME 04062 Telephone: 207-892-1300 Fax: 207-892-2266 Contact:

Summary prepared on: February 23, 2009

Device classification name:	Multi-Analyte Controls, All Kinds (Assayed and Unassayed)
Device description:	Quality control material (assayed and unassayed)*
Proprietary Name:	VALIDATE® CM2 Calibration Verification / Linearity TestSet
Regulation Number:	21 CFR 862.1660
Product Code:	JJY*

*Note: There is no FDA product code for calibration / linearity materials. Therefore, as with previous submissions by Maine Standards and other calibration verification / linearity manufacturers, JJY has been selected as the "best fit" FDA code for this product.

Regulatory Class: Class I

Predicate Device:

VALIDATE® CM1 Calibration Verification / Linearity Test Set, Maine Standards Company, Windham, ME.

Device description: VALIDATE® CM2 Calibration / Linearity Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.

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

Intended use: The VALIDATE® CM2 Calibration Verification / Linearity Test Sets are used by trained laboratory professionals for quantitatively verifying calibrating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert. These materials are not intended for use as routine quality control materials or as calibration materials.

Comparison of VALIDATE® CM2 Calibration Verification / Linearity Test Set to the predicate device:

Table 1 compares characteristics of the VALIDATE® CM2 Calibration Verification / Linearity Test Set with those of the VALIDATE® CM1 Calibration Verification / Linearity Test Set.

	VALIDATE®CM1	VALIDATE®CM2
Catalog #	401	402
IntendedUse	For in vitro diagnostic usein quantitatively verifyingcalibration, validatingreportable ranges, anddetermining linearity inautomated, semi-automated and manualchemistry analyzers.	For in vitro diagnostic usein quantitatively verifyingcalibration, validatingreportable ranges, anddetermining linearity inautomated, semi-automated and manualchemistry analyzers.
Analytes	CK-MB, MYO	Tnl, TnT, BNP, NT-proBNP,hsCRP,MPO
Matrix	Human Serum	Human Serum
Number ofLevels	5	2 sets of 6 including basematrix
Preparation	Liquid, ready to use	Liquid, ready to use
Packaging	5 x 3.0mL	12 x 2.0 mL
Stability	Until expiration	Until expiration
Storage	-10 to -20°C	-10 to -20°C

TABLE 1 - Comparison of Devices

The performance of VALIDATE® CM2 Calibration Verification / Linearity Test Set solutions on the Beckman Access II (Tnl, BNP), the Beckman Immage 800 (hsCRP), the Beckman Synchron DxC with Diazyme reagent (MPO), the Roche e411 (TNT, NTproBNP), and the Roche Integra 400+ (hsCRP) has been shown to be substantially equivalent using pre-production lots of VALIDATE® CM2 Calibration Verification / Linearity Test Sets to the VALIDATE® CM1 Calibration Test Set.

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

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is presented in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Maine Standards Company c/o Ms. Holly A. Cressman Manager QA/RA 765 Roosevelt Trail Windham, ME 04062

APR ] 6 2009

K090475 Re:

Trade/Device Name: VALIDATE CM2 Calibration Verification/Linearity Test Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: February 23, 2009 Received: February 24, 2009

Dear Ms. Cressman:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

Page - 2

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Corg C. He

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

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

Indications for Use

K090475 510(k) Number:

VALIDATE® CM2 Calibration Verification / Linearity Test Set Device Name:

Indications For Use:

Prescription Use × (Part 21 CFR 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 IF NEEDED)

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

Lucy Phillips
Division City Off

Division Sian-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 199 0475

Page 1 of

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.