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AI/ML Overview

The provided document is a 510(k) Summary for the A1c-Chex device, a quality control material for monitoring the performance of HbA1c analysis procedures. The document focuses on demonstrating substantial equivalence to a predicate device and does not include a detailed study proving specific acceptance criteria for a new AI-powered medical device.

Therefore, many of the requested details about acceptance criteria, efficacy studies with AI, and detailed ground truth methodologies are not present in this type of regulatory submission. The information below is extracted from the provided text, and where information is not available, it is noted as "Not applicable" or "Not provided".

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria (e.g., a target precision value or stability range). Instead, it states general conclusions about performance in relation to the predicate device.

Acceptance Criteria (General)	Reported Device Performance (as stated in document)
Reproducibility	A1c-Chex is consistently reproducible.
Substantial Equivalence	A1c-Chex is substantially equivalent to the effective predicate device.
Performance over product dating	Maintains performance over the entire product dating.
Safety and Effectiveness	A1c-Chex is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.
Closed Vial Stability	Studies were conducted to establish this. Conclusion: maintained performance over entire product dating.
Open Vial Stability	30 days (compared to 14 days for predicate). Studies were conducted to establish this. Conclusion: maintained performance over entire product dating.
Precision	Studies were conducted to establish this. Conclusion: consistently reproducible.
Proposed Assay Sheet accuracy	Studies were conducted to establish this. Conclusion: substantially equivalent to predicate.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Studies were conducted" for stability, precision, and the proposed assay sheet, but does not provide details on the number of samples or tests performed.
Data Provenance: Not provided. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided. The testing relates to the performance of a quality control material, not a diagnostic device requiring expert interpretation of results to establish ground truth.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for diagnostic interpretation where there's a need to resolve discrepancies between readers. This device is a quality control material.

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

No. This is a quality control material for laboratory tests, not a diagnostic device involving human readers or AI assistance. An MRMC study is not relevant here.

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

Not applicable. This device is a quality control material, not an algorithm, and does not involve AI or human-in-the-loop performance in the context of its regulatory submission.

7. The type of ground truth used

For a quality control material, the "ground truth" is typically established by the manufacturer through a rigorous process of characterizing the material's properties (e.g., target analyte concentration, stability over time). This is done through internal analytical testing rather than external expert consensus, pathology, or outcomes data in the way it's understood for diagnostic devices. The document implies that the studies conducted (stability, precision, assay sheet) directly characterize the material itself.

8. The sample size for the training set

Not applicable. This device is a quality control material, not an AI algorithm requiring a training set.

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

Not applicable. This device is a quality control material, not an AI algorithm requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the date "MAR - 2 2004". The month is "MAR", the day is "2", and the year is "2004". The text is black and the background is white.

K040025

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck Laboratories7002 South 109th StreetLa Vista, NE 68128
Official Correspondent:	Carol Thompson, Quality Assurance Manager(402) 537-5313
Date Prepared:	January 7, 2004
Names of Device:Trade Name:Common Name:Classification Name:	A1c-ChexClinical Chemistry Test SystemsQuality Control Material, 21CFR862.1660
Predicate Device:	MAS® Medical Analysis Diabetes Control – 510(k) #K023307

Description:

Intended Use:

Monitoring the concentration of glycated hemoglobin is an important part of diabetes management. Momioning the concentration of gryssted in by several methods, which are based on mmmodest and Hemogram ATC IS the analyte medding by overal moets as a whole blood material that closely lori exchange and boronato animaly the complete analytical process.

Comparison with Predicate Device:

rison with Preuileate Device:
A1c-Chex and MAS® Diabetes Control are similar and have the same intended application,

A1c-Chex is a whole blood control. It should be treated the same as a patient specimen and A1c-Chex is a whole blood control. It should be teated the spealent being used. MAS®
tested following the instructions included with the instrument, Kiss of Chiles in tested following the instructions included prepared from human whole blood adjusted to specific concentrations of glycated hemoglobin.

A1c-Chex has an open vial stability of 30 days and MAS® Diabetes Control has an open vial stability of 14 days.

Testing Performed:

Studies were conducted to establish performance of A1c-Chex:

a.) Stability closed and open vial stability
b.) Percision Test
c.) Proposed Assay Sheet

Conclusions Drawn from the Tests:

Study results show A1c-Chex to be consistently reproducible, substantially equivals to the offective Study Testills show A16-Ohex to be entire product dating. A1c-Chex is a safe and effective product, which fulfills its intended use when used as instructed in the product package insert.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the symbol in a circular fashion.

MAR - 2 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kerrie Oetter Quality Assurance/Regulatory Affairs Streck Laboratories®, Inc. 7002 South 109th Street LaVista, NE 68128

K040025 Re:

Trade/Device Name: A1c-Chex Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: January 7, 2004 Received: January 7, 2004

Dear Ms. Oetter:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bected. o reley person is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosal of to 10gains acted of the Medical Device Amendments, or to conninered print to may 20, 1978, in ecordance with the provisions of the Federal Food, Drug, devices mat nave been rechasined in avire approval of a premarket approval application (PMA). alle Cosmetic recry treef market the device, subject to the general controls provisions of the Act. The 1 but may, mercere, manxer alle act include requirements for annual registration, listing of general controls provision 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 If your device is classified (too as ontrols. Existing major regulations affecting your device can may be subject to Such adultions (CFR), Parts 800 to 895. In addition, FDA be found in This 21, oncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that i be resum that your device complies with other requirements of the Act that I Dr has Intact a determinations administered by other Federal agencies. You must or any I cachar stutures and registments, including, but not limited to: registration and listing (21 Comply with and the 11et 67equire.Parts 801 and 809); and good manufacturing practice CFR Part 801), labeling systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your he FDA finding of substantial equivalence of your device to a legally premarket notineated. "The stars 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 or questions on the Presise 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,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis procedures for HbA1c.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

ાર

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Carol C Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and

510(k) K040025

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.