AVOCET ACUSURE SYSTEM by AVOCET MEDICAL, INC.

The Avoceter-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.

Device Description

The AvocetpT-Home is a membrane-based, dry-reagent system for use with fresh capillary whole blood. The system uses a membrane to separate plasma from red cells. The membrane contains calcium and thromboplastin, and permits the reactions of the complete extrinsic pathway to occur with minimal distortion from membrane surface interactions. Thrombin generation is monitored optically using a rhodamine-110-based fluorescent thrombin substrate. Fluorescence kinetics are analyzed to produce a prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value. The AvocetpT-Home is the same device as the Avocetpт, except that it has the citrated whole blood and plasma sample modes deactivated in the meter software, a test strip CAL code is only given for capillary whole blood and the labeling has been modified for readability by the lay user.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on regulatory approval and equivalence, not specific quantitative acceptance criteria with numerical targets. Instead, it states the device was found to perform "equivalently" to a reference method and between different user groups. Therefore, the table will reflect this qualitative equivalence.

Criterion Type	Acceptance Criteria (Implied)	Reported Device Performance
Equivalence to Predicate Device	The AvocetpT-Home must be substantially equivalent in materials, design, and intended use to the AvocetpT predicate device.	The AvocetpT-Home is stated to be "identical in materials, design and function to the AvocetpT," with only labeling changes for home use.
Performance by Different User Groups	Performance when used by trained lay users should be equivalent to performance by healthcare professionals.	The AvocetpT-Home System "was found to perform equivalently when used by trained lay users and healthcare professionals."
Equivalence to Reference Method	Results generated by both user populations (lay and healthcare professionals) should be equivalent to an established reference method.	"Furthermore, both user populations generated results found to be equivalent to an established reference method."

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

The document does not explicitly state the specific sample size used for the performance study. It mentions the study involved "trained lay users" and "healthcare professionals." The provenance of the data (country of origin, retrospective/prospective) is also not specified.

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

The document refers to an "established reference method" for ground truth but does not mention the involvement of experts in establishing this ground truth, nor their number or qualifications. This suggests the reference method itself is the standard against which the device is compared, rather than a panel of human experts.

4. Adjudication Method for the Test Set

No adjudication method is described. The comparison is made against an "established reference method."

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

An MRMC study was not conducted. This device is a standalone in vitro diagnostic system for Prothrombin Time/INR measurement, not an AI-assisted diagnostic tool for human readers. Therefore, there's no mention of human reader improvement with or without AI assistance.

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

Yes, a standalone performance assessment was effectively done. The device, AvocetpT-Home, generates a quantitative result (INR) directly. The study evaluated its performance (accuracy and equivalence) when used by different types of users and compared to a reference method, which is characteristic of a standalone diagnostic device. The "algorithm" here is the device's internal process for measuring PT and calculating INR.

7. The Type of Ground Truth Used

The ground truth used was an "established reference method" for Prothrombin Time/INR testing. This implies a gold standard laboratory method or a highly accurate and validated prothrombin time testing system.

8. The Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the context of machine learning, as this is a medical device, not an AI algorithm in the traditional sense. The device's internal algorithms would have been developed and validated during its design and engineering phases, but no specific training set size is provided for that process.

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

As this is not an AI algorithm with a distinct "training set" in the machine learning sense, the concept of establishing ground truth for a training set does not directly apply. The device's underlying principles are based on established biochemical reactions (thrombin generation, fluorescence kinetics) for PT/INR measurement. The "ground truth" for its development would be derived from fundamental principles of coagulation testing and validation against known standards.

Summary

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K991286

Attachment F 510(k) Summary

Introduction:	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
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Avocet Medical, Inc. 1. Submitter's name 100 Great Oaks Blvd. Suite A address, contact San Jose, CA 95119 (408) 574-7855 (phone) (408) 574-7865 (fax)
Contact person: Judith Blunt

Date prepared: April 13, 1999

1. Device name Common or Usual Name: Prothrombin Time Test
  Classification Name: Prothrombin Time Test

Trade or Proprietary Name: AvocetpT-Home

1. Predicate device: The AvocetpT System: device for testing Prothrombin Time and INR in whole blood.
  The Avoceter-Home is a membrane-based, dry-reagent 4. Device description: system for use with fresh capillary whole blood. The system uses a membrane to separate plasma from red cells. The membrane contains calcium and thromboplastin, and permits the reactions of the complete extrinsic pathway to occur with minimal distortion from membrane surface interactions. Thrombin generation is monitored optically using a rhodamine-110-based fluorescent thrombin substrate. Fluorescence kinetics are analyzed to produce a prothrombin-time-equivalent parameter that is converted to an international normalized ratio (INR) value. The AvocetpT-Home is the same device as the Avocetpт, except that it has the citrated whole blood and plasma sample modes deactivated in the meter software, a test strip CAL code is only given for capillary whole blood and the labeling has been modified for readability by the lay user.

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1. Intended use: The AvocetpT is an in vitro diagnostic system that provides a quantitative prothrombin time result, expressed as an International Normalized Ratio (INR). The AvocetpT-Home is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.
The Avoceter-Home is substantially equivalent in 6. Comparison to materials, design and intended use to other products predicate device that measure Prothrombin Time INR in human blood. Most notably, it is substantially equivalent to the Avocet вт. manufactured by Avocet Medical Incorporated. In fact, it is identical in materials, design and function to the Avoceter, but the labeling has been changed for physician directed, home use.
- The AvocetpT.Home System was found to perform 6. Summary of performance data equivalently when used by trained lay users and healthcare professionals. Furthermore, both user populations generated results found to be equivalent to an established reference method.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.

Nov 1 8 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Jill Falcone Vice President of Regulatory Affairs and Quality Assurance AVOCET Medical Incorporated 100 Great Oaks Boulevard San Jose, California 95119-1347

K991286 Re: Trade Name: Avocet AcuSure System Regulatory Class: II Product Code: GJS Dated: October 22, 1999 Received: October 25, 1999

Dear Ms. Falcone:

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 Section 522 (a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA, are required to conduct postmarket surveillance studies. The FDA believes that under Section 522 (a) (2), discretionary postmarket surveillance will be in order for the Avocet AcuSure System. Please contact Valerie Dada at (301) 594-1293 within 15 days of receipt of this letter, to arrange a meeting to discuss the objectives and design of a future discretionary postmarket surveillance study.

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/dsmamain.html".

Sincerely yours.

Steven Sutman

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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Attachment G Premarket Notification Indications for Use Statement

Device Name: AvocetpT-Home

Indications for Use:

Peter E. Makin

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

Prescription ✓

000268

Regulation Number and Section

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).