The LOCI 9 Calibrator is a liquid, frozen bovine serum albumin based product packaged as ten vials to a carton, with two vials at each of the 5 levels (A, B, C, D and E), 1.5 mL per vial. The LOCI 9 Calibrator includes progesterone, testosterone, buffers and preservatives.

AI/ML Overview

Here's an analysis of the provided text regarding the Dimension Vista® LOCI 9 Calibrator (KC647), structured to address your specific questions.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format you've requested for typical medical device studies (e.g., AI algorithms, imaging devices). Therefore, some of your requested information (like expert qualifications, MRMC studies, standalone performance with specific metrics, and detailed ground truth generation for training data) is not applicable or not present in this type of regulatory document for a calibrator.

Description of the Acceptance Criteria and Study for the Dimension Vista® LOCI 9 Calibrator (KC647)

This document describes the 510(k) submission for the Dimension Vista® LOCI 9 Calibrator, a product used for calibrating the progesterone (PROG) method on the Dimension Vista® System. The primary goal of the submission is to demonstrate substantial equivalence to an existing predicate device, the Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator (KC676A).

The acceptance criteria for a calibrator like this revolve around its ability to accurately and reliably provide known concentrations for proper instrument calibration. The study performed focuses on verifying the traceability, value assignment, and stability of the calibrator, aligning with established procedures for such in-vitro diagnostic products.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a calibrator and not a diagnostic algorithm, the "acceptance criteria" and "reported device performance" are slightly different from what you might expect for an image-based AI device. The submission primarily focuses on demonstrating that the new calibrator meets the same standards of quality and function as the predicate device and that its critical characteristics (traceability, value assignment, stability) are appropriately managed.

Acceptance Criteria Category	Reported Device Performance
Traceability	Validated following Siemens Healthcare Diagnostics, Inc. procedures.
Value Assignment	Validated following Siemens Healthcare Diagnostics, Inc. procedures.
Stability	Validated following Siemens Healthcare Diagnostics, Inc. procedures.
Substantial Equivalence to Predicate	Determined to be substantially equivalent in design and intended use to KC676A by the FDA.
Intended Use	Successfully established as "calibration of the progesterone (PROG) method on the Dimension Vista® System."
Physical Characteristics (e.g., Matrix, Form, Levels)	Verified to be aligned with or acceptable differences from the predicate device (e.g., bovine serum albumin based, liquid/frozen, 5 levels).
Volume per Vial	1.5 mL per vial (different from predicate's 1.0 mL, but deemed acceptable).
Analyte	Progesterone (different from predicate's Synthetic PBNP, but appropriate for its intended use).
Typical Concentration Levels	Five Levels, (0, 1.0, 8.0, 20.0 and 44.0 ng/mL) (different from predicate's levels, but appropriate for its intended use).

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify a "test set" in the context of individual patient data or diagnostic cases. For a calibrator, the "test set" would typically refer to internal validation runs and stability studies of the calibrator material itself.

Sample Size for Test Set: Specific numbers are not provided in this summary. The validation would involve multiple lots and vials of the calibrator under various conditions (e.g., temperature, duration).
Data Provenance: The studies were conducted internally by Siemens Healthcare Diagnostics, Inc. The data would be prospective, generated during the development and validation of the calibrator. There is no mention of country of origin for the data, but presumably, it would originate from the company's testing facilities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to a calibrator. The "ground truth" for a calibrator is established through highly controlled analytical chemistry methods, often tracing back to reference standards. It's about chemical concentration accuracy, not expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert interpretations, typically in diagnostic imaging or clinical assessment. For a calibrator, the "truth" is determined by the manufacturing and analytical processes, which are highly controlled and validated.

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 diagnostic device. No human-in-the-loop performance or MRMC study was conducted or relevant for a calibrator.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or an AI device. The "standalone performance" refers to the intrinsic accuracy and stability of the calibrator itself, which is what the traceability, value assignment, and stability validations address.

7. The Type of Ground Truth Used

The "ground truth" for a calibrator like the Dimension Vista® LOCI 9 Calibrator is established through:

Reference Standards: The concentration values are traceable to higher-order reference materials and/or methods.
Internal Validation Methods: Siemens Healthcare Diagnostics' own validated procedures for value assignment and characterization of the calibrator's chemical composition and concentration.
Analytical Chemistry: Highly precise and accurate analytical techniques are used to determine the concentration of progesterone (and other components) in each level of the calibrator.

8. The Sample Size for the Training Set

Not applicable. Calibrators are not "trained" in the machine learning sense. Their properties are determined by their chemical formulation and manufacturing process, and then validated.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for a calibrator in the AI context. The manufacturing and QC processes define the "truth" of the calibrator's assigned values.

Summary

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510(k) Summary of Safety and Effectiveness for the Dimension Vista® LOCI 9 Calibrator (KC647)

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.

A. 510(k) Number: K113373

B. Date of Preparation: October 28, 2011

C. Proprietary and Established Names:

Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC647)

D. Applicant:

Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Frances A. Dillon, Regulatory Affairs & Compliance Manager Office: (302) 631-6951 Fax: (302) 631-6299

E. Regulatory Information:

Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC647)

1. Regulation section: 21 CFR § 862.1150 Calibrator
1. Classification: Class II
1. Product Code: JIT Calibrator, Secondary
1. Panel: Clinical Chemistry

F. Predicate Device:

The predicate device used to demonstrate substantial equivalence is the Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator, PBNP CAL (KC676A), cleared under K080578.

G. Device Description:

Note: Although testosterone is present in this formulation, the LOCI 9 Calibrator will only be used with the Dimension Vista® Progesterone assay.

H. Intended Use:

The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.

I. Substantial Equivalence Information:

The Dimension Vista® LOCI 9 Calibrator, LOCI 9 CAL (KC4647) was compared to the predicate device, Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator, PBNP CAL (KC676A), cleared under K080578. The following tables provide a comparison of the important similarities and differences between the devices:

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Similarities

Feature	New DeviceDimension Vista® LOCI 9Calibrator, LOCI 9 CAL (KC647)	PredicateDimension Vista® N-terminal Pro-Brain Natriuretic PeptideCalibrator, PBNP CAL (KC676A)
Intended Use	For in vitro diagnostic use.	For in vitro diagnostic use.
Matrix	Bovine serum albumin based	Bovine serum albumin based
Form	Liquid, frozen	Liquid, frozen
# Levels	Ten vials, two vials per level, 5 levels(A, B, C, D and E)	Ten vials, two vials per level, 5levels (A, B, C, D and E)

Differences

Feature	New DeviceDimension Vista® LOCI 9Calibrator, LOCI 9 CAL (KC647)	PredicateDimension Vista® N-terminal Pro-Brain Natriuretic PeptideCalibrator, PBNP CAL (KC676A)
Intended Use	The LOCI 9 CAL is an in vitrodiagnostic product for the calibrationof the progesterone (PROG) methodon the Dimension Vista® System.	The PBNP CAL is an in vitrodiagnostic product for the calibrationof the N-terminal Pro-BrainNatriuretic Peptide (PBNP) methodon the Dimension Vista® System.
Analyte	Progesterone	Synthetic PBNP
Volume	1.5 mL per vial	1.0 mL per vial
TypicalConcentrationLevels	Five Levels, (0, 1.0, 8.0, 20.0 and44.0 ng/mL)	Five levels, (0, 250, 1500, 12,000and 36,750 pg/mL)

J. Performance:

The traceability, value assignment and stability of the Dimension Vista® LOCI 9 Calibrator have been validated following procedures of Siemens Healthcare Diagnostics, Inc.

K. Conclusion:

The Dimension Vista® LOCI 9 Calibrator (KC4647) is substantially equivalent in design and intended use to the previously cleared Dimension Vista® N-terminal Pro-Brain Natriuretic Peptide Calibrator (KC676A).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Frances A. Dillon P.O. Box 6101 Mailstop 514 Newark, DE 19714-6101 USA

DEC 3 0 2011

Re: K113373

Trade Name: Dimension Vista® LOCI 9 Calibrator Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: November 15, 2011 Received: November 16, 2011

Dear Ms. Dillon:

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).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

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

Enclosure

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Indications For Use

510(k) Number (if known):

Device Name:

Dimension Vista® LOCI 9 Calibrator

Indications for Use:

The LOCI 9 CAL is an in vitro diagnostic product for the calibration of the progesterone (PROG) method on the Dimension Vista® System.

X and/or Over-the-counter Use Prescription Use (Part 21 CFR 801 Subpart D) (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)

Heonath

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113373

Page 1 of

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.