Search Results

SmartLink™ GOLD blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink™ GOLD meter must be used with SmartLink™ GOLD blood glucose test strip and SD Control solutions.

The SD control solutions Level M and Level H are for use with SmartLink™ GOLD test system as quality controls to verify the accuracy of blood glucose test results.

Testing is done outside the body (in vitro diagnostic use).

This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in · clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

This system should not be used for the screening or diagnosis of diabetes or for testing neonates.

Device Description

The SmartLink™ GOLD Blood Glucose System is an Rx/OTC blood glucose system to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management.

The SmartLink™ GOLD Blood Glucose System consists of a SmartLink™ GOLD Blood Glucose Meter which measures and displays test results, SmartLink™ GOLD test strip, lancet and lancing device for blood sampling, control solution to check the meter and test strip, check strip to check the meter, 3 V battery (type 2032) for power, carrying case, user guide, packaging inserts for the test strip and control solution and a Quick Guide for helping the user with a self test diary to document test results for monitoring the trend of blood glucose.

The system is a battery-operated portable device and stores 500 test results in memory. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The svstem can also set the pre-meal and postmeal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document references compliance with EN ISO 15197:2003. This standard outlines specific accuracy criteria for blood glucose monitoring systems. While the exact numerical criteria from the standard are not explicitly listed in this document, the submission confirms that the device "met all relevant standards requirements" (Page 3).

Acceptance Criteria (Based on EN ISO 15197:2003, typically)	Reported Device Performance
Not explicitly stated in the document, but for lay-user operated blood glucose systems, EN ISO 15197:2003 generally requires: - 95% of results to be within ±15 mg/dL of the reference method for glucose concentrations <100 mg/dL. - 95% of results to be within ±15% of the reference method for glucose concentrations ≥100 mg/dL. (Note: These are common interpretations of the standard; the precise criteria may vary slightly within the standard's nuances.)	The System Accuracy Evaluation (Method Comparison with Predicate Device) was performed according to EN ISO 15197:2003. The conclusion states that "documentation supplied with this submission... demonstrates that the subject device is as safe, as effective, and performs as well as our legally marketed predicate device." This implies the device met the ISO standard's criteria.

Acceptance Criteria (Based on EN ISO 15197:2003, typically)

Reported Device Performance

Not explicitly stated in the document, but for lay-user operated blood glucose systems, EN ISO 15197:2003 generally requires: - 95% of results to be within ±15 mg/dL of the reference method for glucose concentrations <100 mg/dL. - 95% of results to be within ±15% of the reference method for glucose concentrations ≥100 mg/dL. (Note: These are common interpretations of the standard; the precise criteria may vary slightly within the standard's nuances.)

The System Accuracy Evaluation (Method Comparison with Predicate Device) was performed according to EN ISO 15197:2003. The conclusion states that "documentation supplied with this submission... demonstrates that the subject device is as safe, as effective, and performs as well as our legally marketed predicate device." This implies the device met the ISO standard's criteria.

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

Sample Size for System Accuracy Evaluation (Method Comparison): Not explicitly stated.
Sample Size for User Performance Study: Not explicitly stated.
Data Provenance: The manufacturing sites and submitter's identification are in Kyonggi-do, KOREA. The clinical studies were performed in conjunction with the submission requirements, but the specific country of origin for the patient data is not mentioned. It is a prospective study implied by the performance of the studies to support a 510(k) submission.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The "Method Comparison with Predicate Device" implies a comparison to a referencemethod, which would typically be laboratory-based and overseen by qualified laboratory personnel.

4. Adjudication Method for the Test Set

No adjudication method is described. The "Method Comparison with Predicate Device" usually involves comparing device readouts to a laboratory reference method, not a consensus among multiple human readers.

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 MRMC study was done. This device is a blood glucose monitoring system, which directly provides a numerical measurement, so the concept of human readers and AI assistance in interpretation does not apply in the context of this 510(k) submission.

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

Yes, a standalone performance evaluation was done. The "System Accuracy Evaluation (Method Comparison with Predicate Device)" is inherently a standalone performance assessment of the device against a reference standard. The "User performance study" also assesses the device's performance, albeit with lay users operating it.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

The ground truth for the system accuracy evaluation would have been established by a laboratory reference method (e.g., a central lab analyzer using a hexokinase or glucose oxidase method), as is standard for blood glucose monitor comparisons. This is implied by "Method Comparison with Predicate Device" according to EN ISO 15197:2003.

8. The Sample Size for the Training Set

Not applicable / not explicitly stated. For a blood glucose monitoring system, there isn't a "training set" in the sense of machine learning algorithms for image recognition or similar domains. The device's calibration and algorithm are developed during manufacturing and validated through rigorous testing. The clinical studies are for validation, not training.

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

Not applicable. As noted above, typical blood glucose monitors do not use a machine learning "training set" with ground truth in the same way modern AI algorithms do. The "ground truth" for the device's internal calibration and algorithm development would come from precision reference standards and established chemical measurement principles.

Ask a Question

Ask a specific question about this device

Page 1 of 1