The Precision Xtra Advanced Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose and/or ketone in fresh capillary whole blood. The Precision Xtra System is for home (lay user) or professional use.

The Precision Xtra System may also be used for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.

Device Description

The Precision™ Xtra™ Advanced Diabetes Management System for Blood Glucose and Ketone Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose (or Beta-Hydroxybutyrate ketone) present in the sample, providing a quantitative measure of glucose (or ketone) in whole blood and control solutions.

AI/ML Overview

The provided text describes the regulatory submission for the Precision™ Xtra™ Advanced Diabetes Management System but does not contain the detailed performance study results, acceptance criteria, or specific data about ground truth determination, reader studies, or sample sizes for testing and training sets.

The document states that "The studies demonstrated that lay users can obtain blood glucose and ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements," and "Results of laboratory and clinical testing demonstrate that the performance of the Precision Xtra Advanced Diabetes Management System... is acceptable and comparable to the performance of the previously mentioned predicate devices." However, it does not present the raw data, statistical analysis, or predefined acceptance criteria.

Therefore, many of the requested fields cannot be filled directly from this document.

Here's a breakdown of what can be inferred or explicitly stated from the provided text, and what is missing:

Acceptance Criteria and Device Performance (Based on Inferred Information)

The document implies that the acceptance criteria are met if the device demonstrates "substantial equivalence" to the predicate devices for blood glucose and ketone measurements in both laboratory and clinical settings, for both healthcare professionals and lay users. Specific numerical acceptance criteria are not provided.

Metric (Inferred)	Acceptance Criteria (Not Explicitly Stated, Inferred as "Substantially Equivalent")	Reported Device Performance (General Statement)
Blood Glucose Measurement	Performance comparable to Precision QID and Precision G systems	Substantially equivalent to current methods
Ketone Measurement	Performance comparable to GDS Ketosite and Sigma B-Hydroxybutyrate systems	Substantially equivalent to current methods
Lay User Performance	Results equivalent to trained operators	Lay users obtain equivalent results
Professional User Performance	Results equivalent to trained operators	Trained operators obtain equivalent results

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted in "laboratory and clinical settings" but no further detail is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided. The "ground truth" for the device's performance seems to be established by comparing its results to "current methods for blood glucose and ketone measurements," which include predicate devices. There's no mention of independent expert adjudication for establishing ground truth in the context of diagnostic interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of this device type (blood glucose/ketone meter) as there isn't a complex diagnostic image or clinical case requiring expert adjudication in the traditional sense. The comparison is against established laboratory methods or predicate devices.
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-assisted diagnostic imaging device. The "readers" are the users of the device (lay users and healthcare professionals) obtaining direct measurements. The study did compare "trained operators and lay users" to show they "obtain equivalent whole blood glucose and ketone results," but this is not an MRMC study comparing AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device inherently produces a quantitative measurement, which is its standalone performance. The "human-in-the-loop" refers to the user operating the device and interpreting the numerical output. The studies included both laboratory testing (likely more controlled, akin to standalone) and clinical settings with users, demonstrating the device's ability to provide measurements directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by comparison to results from "current methods for blood glucose and ketone measurements," specifically the listed predicate devices (Precision QID, Precision G, GDS Stat-Site Meter, Sigma Diagnostics β-Hydroxybutyrate Procedure No. 310-UV). These are established, validated methods for measuring glucose and ketones.
The sample size for the training set:
- Not applicable as this is not an algorithm-based device that undergoes a "training" phase in the machine learning sense. The device's performance is based on its biosensor technology and calibration.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.

Summary

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Precision Xtra Advanced Diabetes Ma 510(k) Submission - 10/05

Summary of Safety and Effectiveness

Submitted by:	Denise HaleyRegulatory Affairs SpecialistMediSense, Inc.4A Crosby DriveBedford, MA 01730
Device Name:	Precision™ Xtra™ Advanced Diabetes Management System
Common Name:	Self-Monitoring Blood Glucose and Ketone System
Classification:	Glucose Test SystemClass II per 21 CFR 862.1345Ketones Test SystemClass I per 21 CFR 862.1435
Predicate Devices:	Precision QID® Blood Glucose Testing System--K963676Precision QID® and Precision G® Blood Glucose Test Strip--K945887, K962295, K971812GDS Stat-Site Meter/GDS KETOSITE® Blood Ketone Test--K911801Sigma Diagnostics β-Hydroxybutyrate Procedure No. 310-UV--K850368
Description:	The Precision™ Xtra™ Advanced Diabetes Management Systemfor Blood Glucose and Ketone Testing utilizes amperometricbiosensor technology to generate a current. The size of the currentis proportional to the amount of glucose (or Beta-Hydroxybutyrateketone) present in the sample, providing a quantitative measure ofglucose (or ketone) in whole blood and control solutions.
Intended Use:	The Precision Xtra Advanced Diabetes Management System isintended for in vitro diagnostic use (i.e. for external use only) forthe quantitative measurement of glucose and/or ketone in freshcapillary whole blood. The Precision Xtra is for home (lay user) orprofessional use.

Medisense Confidential

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Comparison to

The Precision Xtra Advanced Diabetes Management System has Predicate Device: equivalent technological characteristics as the Precision QID Blood Glucose Testing System (K963676, K971812) and the Precision G Blood Glucose Testing System (K963676). The Precision Xtra also has the same intended use as the Precision OID and Precision G Systems for glucose testing and the GDS Ketosite Test Card on the GDS Stat-Site Meter(K911801) and Sigma B-Hydroxybutyrate Procedure 310-UV (K850368) for ketone testing.

Performance Studies:

The performance of the Precision Xtra Diabetes Management System was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that lay users can obtain blood glucose and ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements, which include the predicate devices listed above.

Conclusion: Results of laboratory and clinical testing demonstrate that the performance of the Precision Xtra Advanced Diabetes Management System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate devices for blood glucose and ketone testing. In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose and ketone results.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 9 1999

Ms. Denise Haley Regulatory Affairs Specialist Abbott Laboratories MediSense Products 4A Crosby Drive Bedford, Massachusetts 01730-1402

Re: K983504

Trade Name: Precision™ Xtra" Advanced Diabetes Management System Regulatory Class: II Product Code: CGA Dated: April 29, 1999 Received: May 3, 1999

Dear Ms. Haley:

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

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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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INDICATIONS FOR USE FORM

510(k) Number (if known):

Device Name: Precision™ Xtra™ Advanced Diabetes Management System

Indications For Use:

Dean Cooper
(Division Sign-Off)
Division of Clinical Laikrak
510(k) Number K983504

(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 801.108) Over-The-Counter Use

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.