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The Livongo Blood Glucose Monitoring System (BG1000) is composed of the Livongo Blood Glucose Meter (BG1000) and Livongo Blood Glucose Test Strips (BG1000).

The system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The system is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control programs. The Livongo Blood Glucose Monitoring System (BG1000) is intended for single-patient use and should not be shared.

The system is for in vitro diagnostic use and is not intended for the diagnosis of or diabetes, nor intended for use on neonates.

Device Description

The Livongo Blood Glucose Monitoring System (BG1000) is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components:

Livongo Blood Glucose Meter (BG1000) ("Livongo meter")
Livongo Blood Glucose Test Strips (BG1000) ("Livongo test strips")
Livongo Lancing Device - class I accessory
Livongo Lancets
Livongo Level 1 Control Solution
Livongo Level 2 Control Solution
AC Adapter (wall charger) and USB Charger Set
Carrying Case

The Livongo meter is a cellular-connected handheld device that monitors glucose in the blood to help with the management and treatment of diabetes. The meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs. The blood glucose levels are displayed on the screen and stored in the meter's memory, and may also be transmitted over a cellular network to a secure server.

The Livongo test strips will be packaged in 50 count of strips in sealed vials.

The Livongo Control Solutions consist of an aqueous based mixture prepared with a known amount of glucose concentration. It is available in two levels, Level 1 and Level 2.

AI/ML Overview

The Livongo Blood Glucose Monitoring System (BG1000) underwent extensive testing to establish its performance and demonstrate substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for blood glucose monitoring systems typically align with ISO 15197 standards. While specific acceptance criteria are not explicitly enumerated with numerical targets for each performance metric in the provided text, the qualitative statements and the nature of the tests performed (precision, linearity, interference, user evaluation) imply adherence to recognized standards for accuracy and reliability in blood glucose measurement. The "Discussion of Substantial Equivalence" explicitly states that testing demonstrated the candidate device is substantially equivalent, which implies meeting performance benchmarks comparable to predicate devices and relevant standards.

To infer the implied acceptance criteria from the reported performance, we look for statements confirming the results were "within" acceptable ranges or demonstrated "accurate readings."

Acceptance Criteria (Inferred from Performance Statements)	Reported Device Performance (Summary from provided K200277)
Precision: Glucose readings are consistent within acceptable ranges.	Within-Run Precision: SD or %CV values reported are low (e.g., 1.49 mg/dL to 2.33 mg/dL for lower concentrations, 2.5% to 2.7% for higher concentrations).
Intermediate Precision: SD or %CV values reported are low (e.g., 1.41 mg/dL to 2.30 mg/dL for lower concentrations, 2.2% to 2.9% for higher concentrations).
Linearity: Device accurately measures glucose across its specified testing range.	Linear regression analysis results show high R² values (0.9968 to 0.9984) and slopes close to 1, with small y-intercepts. This "support[s] the glucose measurement range of 40-600 mg/dL."
Interference (Hematocrit): Glucose measurement is not significantly affected by varying hematocrit levels.	Bias of measurement was within ±10 mg/dL for glucose concentration level 1, and within ±8% for glucose concentration levels 2-6, with no individual value having a bias greater than 15%. This confirms "accurate readings for the specified hematocrit range of 10%-70%."
Robustness (Flex Studies): System maintains performance under various environmental and operational stresses.	"System operated within its specified operating ranges even under stress conditions, and errors were correctly displayed when outside the meter's operating ranges." This includes mechanical vibration and shock, operating conditions (temperature/humidity), altitude, stability, samples outside range, short sample detection, sample perturbation, intermittent sampling, and used strips.
Electromagnetic Interference (EMI) & Electrical Safety: Device complies with relevant safety and EMI standards.	System "passed electrical and safety testing according to national and international standards including IEC 61010-1, IEC 61010-2-101, IEC 61000-3-2, IEC 61000-3-3, IEC 61000-4-2, and IEC 61000-4-8." Also passed EMC testing to "IEC 60601-1-2, FCC 47 CFR 15 Part B, and PTCRB."
Software: Software functionality meets design requirements and safety standards.	"Testing and documentation for Moderate level of concern software was completed" per FDA guidance.
Clinical Performance (User Evaluation): Lay users can operate the device accurately and are satisfied with ease of use.	Study results indicated that "non-professional, inexperienced lay persons were able to obtain blood glucose readings... comparable to the comparator YSI 2300 obtained by trained technicians." Furthermore, "participating lay persons were questioned and responded as satisfied with the ease of operation... and the overall performance."

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

Precision Evaluation (Within-Run & Intermediate):
- Sample Size: Ten replicate assays were run on ten Livongo meters using three strip lots for each of six glucose concentration levels.
- Data Provenance: The study used "heparinized venous blood samples." The document does not specify the country of origin, but it is a non-clinical/laboratory study.
Linearity Evaluation:
- Sample Size: Blood samples were prepared at eleven glucose concentration levels and run on 10 meters using test strips from three lots.
- Data Provenance: The document does not specify the country of origin. It is a non-clinical/laboratory study using prepared blood samples.
Interference – Hematocrit:
- Sample Size: Whole blood samples were prepared to hematocrit levels across the claimed range at 5% intervals with six glucose concentration levels. Test strips from three lots were used.
- Data Provenance: The document does not specify the country of origin. It is a non-clinical/laboratory study using prepared blood samples.
Clinical (User Evaluation) Study:
- Sample Size: Not explicitly stated but implied to be a cohort of "lay persons."
- Data Provenance: "Simulated home environment." The document does not specify the country of origin or whether it was retrospective or prospective, but a "user evaluation" implies a prospective study.

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

All Non-Clinical Studies (Precision, Linearity, Hematocrit): The ground truth was established by a "YSI (Model 2300 STAT PLUS) Glucose Analyzer reference instrument, which is traceable to NIST reference standard." This is an analytical reference method, not human experts.
Clinical (User Evaluation) Study: The ground truth for comparative blood glucose readings was obtained by "trained technicians" using the YSI 2300 Stat Plus Glucose Analyzer. The number and specific qualifications of these technicians are not provided.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. The ground truth was established by a reference analytical instrument or trained technicians using a reference instrument, not by expert consensus requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The clinical study was a user evaluation demonstrating the ability of lay persons to use the device accurately, not a comparative study of human readers with vs. without AI assistance. The device itself is a standalone measurement system, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

Yes, the device's performance in the non-clinical studies (precision, linearity, interference, flex studies) directly demonstrates its standalone (algorithm only) performance when measuring glucose. The "user evaluation" study then assessed the ability of lay users to successfully operate this standalone system.

7. Type of Ground Truth Used

Non-Clinical Studies (Precision, Linearity, Hematocrit): The ground truth was established using an analytical reference instrument, specifically the "YSI (Model 2300 STAT PLUS) Glucose Analyzer," which is traceable to the NIST reference standard.
Clinical (User Evaluation) Study: The ground truth was established by trained technicians using the "YSI 2300 Stat Plus Glucose Analyzer."

8. Sample Size for the Training Set

The document does not provide information about a "training set" in the context of machine learning or AI. This device is a blood glucose meter, and its performance is typically evaluated through analytical and clinical validation studies, not by training a machine learning model on a distinct training set.

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

Not applicable, as no training set for a machine learning model is mentioned in the context of this device.

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