The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance.

Device Description

The Osteomark® NTx Point of Care Control Set is a human urine-based, liquid, 2-level control set to be used in quality control procedures with the Osteomark® NTx Point of Care test. The assayed control set is used for evaluating precision and systematic analytical deviations that may arise from reagent or device variations.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: Osteomark® NTx Point of Care (POC) Control Set

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in terms of precision or accuracy targets. Instead, it describes the purpose of the controls and the method used to demonstrate their functionality. The acceptance criteria can be inferred from the study's objective: to demonstrate the control set's ability to evaluate the quality of day-to-day performance.

Acceptance Criteria (Inferred)	Reported Device Performance
The control set must be able to evaluate the quality of day-to-day performance of the Osteomark® NTx POC device.	The data demonstrated that Osteomark® NTx POC Control Set will evaluate the quality of day to day performance of the Osteomark® NTx POC device.
The control set should demonstrate consistent performance over time (precision).	(Implied by testing each control level six times a day for five days.) The study design aimed to assess day-to-day performance, which inherently includes demonstrating consistent results over that period.
The control values should be known concentrations to assess analytical precision and device performance.	The controls are "assayed for the verification of device performance" and are "consistent test samples of known nM BCE/mM creatinine concentration." The study confirms this functionality.

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

Sample Size: The study used three manufactured lots of the Osteomark® NTx POC Control Set. For each control lot, each of the two control levels was tested six times a day for five days.
- This equates to: 3 lots * 2 control levels/lot * 6 tests/day * 5 days = 180 data points (measurements).
Data Provenance: Not explicitly stated, but it is a premarket submission for a medical device in the US, so the study was likely conducted by the manufacturer (Metrika, Inc.) or a contracted lab under their supervision. It appears to be prospective data collection as it describes an evaluation study performed for regulatory submission. Country of origin is not specified for the data itself, but the applicant and reviewer are US-based.

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

This device is a quality control material, not a diagnostic device that requires expert interpretation of results. Therefore, the concept of "ground truth" established by experts in a diagnostic context (like radiologists) does not directly apply here.
The "ground truth" for a control material is its assigned value (concentration). How these assigned values were originally established for the control lots is not detailed in this 510(k) summary, but it would typically involve rigorous analytical methods and calibration traceable to reference materials.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1) are typically used in studies where multiple human readers interpret results and discrepancies need to be resolved.
Since this study involves the analytical performance of an in vitro diagnostic control, there is no human adjudication method described or typically applicable. The results are quantitative measurements from an instrument.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

No, an MRMC comparative effectiveness study was not done.
This device is an in vitro diagnostic quality control material. It does not involve human readers interpreting images or data for diagnostic purposes, nor does it incorporate AI. Therefore, concepts like human reader improvement with or without AI assistance are not relevant to this submission.

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

This device is a physical control material, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.
The study does evaluate the device (control set) in a standalone analytical context, meaning its performance characteristics are assessed independently to verify its utility in controlling the main diagnostic assay.

7. The Type of Ground Truth Used

For the Osteomark® NTx POC Control Set, the "ground truth" for the controls themselves are their known or assigned quantitative concentrations of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine. These values are pre-assigned to the control lots.
The study then assessed how well the Osteomark® NTx POC device measured these known values from the control set to demonstrate the control set's utility for evaluating the device's performance.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a "training set" in the context of device development. This is because the Osteomark® NTx POC Control Set is a control material, not an algorithm that requires machine learning training data. There is no algorithm being trained here.
The study mentioned (testing three lots, etc.) served as the validation/verification study for the control product itself.

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

As there is no training set for an algorithm, this question is not applicable.
The ground truth (assigned values/concentrations) for the control materials themselves would be established through a characterization process, including:
- Analytical testing using established reference methods.
- Calibration against traceable standards.
- Statistical analysis to assign a target value and acceptable range.
- This process is not detailed in the provided summary.

Summary

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JUL 1:2 1999

M 三 T R I K A

Metrika Inc 510 Oakmead Parkway Sunnyvale, CA 94086 main 408 524 2255 fax 408 524 2252

510(k) SUMMARY

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:	K991917
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807.92(a)(1) Submitters Information

Contact Person:	Nancy Mallinakor	Stephen J. Hardt
Address:	Ostex International, Inc.2203 Airport Way South,Suite 400Seattle, WA 98134	Metrika, Inc.510 Oakmead ParkwaySunnyvale, CA 94086
Phone:Fax:	(206) 292-8082(206) 292-9519	(408) 524-2255(408) 524-2252

Date Summary Prepared: June 4, 1999

807.92 (a)(2) Device Information
Trade Name:	Osteomark® NTx Point of Care (POC) Control Set
Common Name:	Assayed Urine Controls
Classification Name:(Regulation number)	Quality Control Material (Assayed and Unassayed)21 CFR 862.1660

807.92 (a)(3) Predicate Device Information
Name:	UrichemTRAK Liquid Assayed Control
Manufacturer:	Medical Analysis System Inc

807.92 (a)(4) Device Description

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807.92 (a)(5) Statement of Intended Use

807.92 (a)(6) Summary of Technological Characteristics

CHARACTERISTIC	Osteomark® NTx Point of Care Control Set	UrichemTRAK Liquid Assayed Control K981933
Intended Use	The Osteomark NTx Point of Care (POC) Controls are assayed for the verification of device performance when using the Osteomark NTx POC for the quantitative measure of cross-linked N-telopeptides of type I collagen (NTx) normalized to urinary creatinine (nM Bone Collagen Equivalents/mM creatinine). The controls are used as consistent test samples of known nM BCE/mM creatinine concentration that may be measured over time as a means of evaluating analytical precision, as well as device performance.	UrichemTRAK Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK Control with patient urine specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Matrix	Human urine-based materials, preservative, and food coloring	Human urine-based material and preservative
Testing Environment	professional use	professional use

Similarities Between Osteomark® NTx Point of Care Control Set and UrichemTRAK Liquid Assayed Control

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807.92 (a)(6) Summary of Technological Characteristics (continued)

CHARACTERISTIC	Osteomark® NTx Point of CareControl Set	UrichemTRAK Liquid AssayedControlK981933
Analyte(s)	cross-linked N-telopeptides of type 1collagen and creatinine	(Various urinary constituents)AmylaseCalciumGlucoseMagnesiumTotal proteinUric acidPhosphorusUrea NitrogenCreatinineChloridePotassiumSodiumMicroalbumin
Test Method	quantitative	quantitative and qualitative

Differences Between Osteomark® NTx Point of Care Control Set and UrichemTRAK Liquid Assayed Control

The differences in the two assayed control materials do not raise new issues of safety and effectiveness.

807.92 (b)(1) to b(3) Performance Data and Conclusion

Three manufactured lots of the Osteomark® NTx POC Control Set were evaluated to assess day to day performance with a single lot of Osteomark® NTx POC device. Each control level per control lot was tested six times a day for five days. The data demonstrated that Osteomark® NTx POC Control Set will evaluate the quality of day to day performance of the Osteomark® NTx POC device. Therefore, Osteomark® NTx POC Control is substantially equivalent to existing products in commercial distribution such as the UrichemTRAK Liquid Assayed Control system.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is black and the background is white. The text is slightly tilted.

JUL 1:2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Stephen J. Hardt Metrika, Inc. 510 Oakmead Parkway Sunnyvale, California 94086

K991917 Re:

Trade Name: Osteomark® NTx Point of Care (POC) Control Set Regulatory Class: I Product Code: JJW Dated: June 4, 1999 Received: June 7, 1999

Dear Mr. Hardt:

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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman

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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June 4, 1999 Premarket Notification

510(k) Number: K 991917

Device Name: Osteomark® NTx Point of Care Control Set

INDICATIONS FOR USE

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of Clinical Laboratory Devices K991917
510(k) Number

Prescription Use (Per 21 CFR 801.109

Over-The-Counter Use (Optional Format 1-2-96)

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.