(126 days)
The ACCU-CHEK Inform II Test strip is for use with the ACCU-CHEK Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heelstick, or fresh capillary whole blood samples drawn from the fingertip as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
The ACCU-CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.
The ACCU-CHEK Inform II Controls are intended for quality control performance checks on the ACCU-CHEK Inform II system with ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II Linearity Test Kit is intended for use for periodic verification of linearity of the ACCU-CHEK Inform II system using ACCU-CHEK Inform II test strips.
The ACCU-CHEK Inform II System includes the following components and accessories: Meter, Code Key Reader, Base Unit (with power supply) test strips, and controls.
When an ACCU-CHEK Inform II test-strip is inserted into the ACCU-CHEK Inform II meter, a small alternating current (AC) is applied until the application of blood causes a spike in the conductivity to be observed at the measurement and sample-sufficiency electrodes - both are used to assure an adequate sample has been applied.
The instrument then applies a series of AC voltages at four frequencies and reads the AC responses. These carry information about the sample type and environmental temperature; they also allow the system to perform various internal quality checks.
After the AC measures are completed, a small (DC) voltage is applied and current is observed which is proportionate to the glucose. The AC and DC information are then combined to provide a hematocrit and temperature compensated glucose result.
ACCU-CHEK Inform II System is the first point-of-care glucose meter featuring wireless connectivity functionality. Unlike the predicate device, ACCU-CHEK Inform II meter has the capability of direct data transfer right after each measurement, thus ensuring actual patient data to appear on the doctor's desk shortly after these data have been created at the bedside. It is understood that a transfer of data can only occur, when a stable communication with the Data Management System has been built up by the devices before transfer of data.
The glucose meter system has been designed in a way that its connectivity feature is virtually invisible to the operator. Only the appearance of an icon at the lower edge of the touch screen display indicates potential radio frequency activity to allow new information on control material or strip code files to be downloaded.
Even when there is no wireless WLAN available, the ACCU-CHEK Inform II meters work fine as long as the necessary information like operator list, strip code, and control lot is available. The device can store as many as 2000 measurement results in its memory which will be transferred as soon as there is a stable connection to the WLAN and no measurement operation pending.
Acceptance Criteria and Device Performance for ACCU-CHEK Inform II Blood Glucose Monitoring System (K121679)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a blood glucose monitoring system are typically based on the ISO 15197:2003 standard for blood glucose monitoring systems for in vitro diagnostic testing. While the document doesn't explicitly state the numerical thresholds for each acceptance criterion, it indicates compliance with the standard. The reported device performance is presented as the percentage of glucose results that fit within accuracy requirement limits.
| Performance Characteristic | Acceptance Criteria (Stated as ISO 15197:2003 Compliance) | Reported Device Performance (ACCU-CHEK Inform II System) |
|---|---|---|
| Arterial Blood Samples | ISO 15197:2003 accuracy requirement limits | 100% of glucose results fit within accuracy requirement limits |
| Capillary Blood Samples | ISO 15197:2003 accuracy requirement limits | 100% of glucose results fit within accuracy requirement limits |
| Neonate Capillary Blood Samples | ISO 15197:2003 accuracy requirement limits | 99.4% of glucose results fit within accuracy requirement limits |
| Venous Blood Samples | ISO 15197:2003 accuracy requirement limits | 100% of glucose results fit within accuracy requirement limits |
| Consumer User Performance Evaluation | ISO 15197:2003 accuracy requirement limits | 98.9% of glucose results fit within accuracy requirement limits |
| Precision | Not explicitly stated as a percentage, but predicate shows ≤ 3.2% variation (ISO 15197 typically has limits for repeatability and intermediate precision) | Repeatability and reproducibility studies show a variation from strip to strip ≤ 3.4% |
| Measuring Range | Implied by predicate for substantial equivalence: 10-600 mg/dL | 10-600 mg/dL |
| Measuring Time | Implied by predicate for substantial equivalence: 5 seconds | 5 seconds |
| Sample Volume | Implied by predicate for substantial equivalence: 0.6 µL | 0.6 µL |
| Hematocrit Range | Implied by predicate for substantial equivalence: 20-65% (with sub-ranges) | 10-65% |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. Typically, clinical studies for medical devices are prospective.
- Arterial Blood Samples: N = 214
- Capillary Blood Samples: N = 200
- Neonate Capillary Blood Samples: N = 191
- Venous Blood Samples: N = 439
- Consumer User Performance Evaluation: N = 174
- Precision (Repeatability and Reproducibility studies): Sample sizes for these studies are not specified, only the resulting variation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a central laboratory analyzer traceable to a recognized standard), not directly by expert consensus in the same way an imaging study would.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. For blood glucose monitoring systems, ground truth is usually established by a laboratory reference method, eliminating the need for reader adjudication.
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
This is not applicable. The ACCU-CHEK Inform II Blood Glucose Monitoring System is a standalone diagnostic device for measuring glucose levels, not an AI-assisted diagnostic tool that would involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance study was conducted. The data presented in the table under "Reported Device Performance (ACCU-CHEK Inform II System)" represents the algorithm's performance in measuring glucose from various blood sample types without human intervention (beyond standard operation of the device). The system provides a direct numerical glucose reading.
7. The Type of Ground Truth Used
The ground truth for the glucose measurements is implicitly established by comparing the device's readings against a reference laboratory method. This is indicated by the regression equations (y = mx + b) and correlation coefficients (r) provided, where 'x' typically represents the reference method value and 'y' represents the device's reading. While not explicitly stated, this is the standard practice for evaluating blood glucose meters. This would fall under the category of comparison to an established reference method or laboratory standard.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for any training set. Blood glucose meters do not typically involve "training sets" in the same way machine learning algorithms do. Their calibration and performance are based on analytical methods and extensive testing during development, rather than machine learning on a large dataset.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and establishing "ground truth for the training set" is not applicable to this type of device in the context of machine learning. Device calibration and analytical performance are established through rigorous laboratory experiments and comparisons to reference methods, which are part of the device's design and manufacturing process.
§ 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.