(114 days)
The Elect II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect II System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor effectiveness of diabetes control.
The Elect II Blood Glucose Monitoring System comprises a glucose reagent test strip, a amperometric meter and a quality control solution. The user inserts a test strip in the Elect II Meter and applies a small drop of blood from a fingerstick to the sample point on the strip. The meter measures the electrical current that is generated which is proportional to the concentration of glucose present in the blood sample. The blood glucose result is displayed in 15 seconds. The system is calibrated to give a result equivalent to a plasma value, the measurement used by most clinical laboratories.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
The provided text is a 510(k) summary for the Elect II Blood Glucose Monitoring System, which primarily focuses on establishing "substantial equivalence" to predicate devices rather than fully detailing acceptance criteria and studies demonstrating performance against those criteria. As such, much of the requested information is not explicitly present in the provided document.
However, I will extract what can be inferred and explicitly stated from the document, and note where information is missing.
Acceptance Criteria and Device Performance Assessment for the Elect II Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., accuracy percentages, precision ranges) in a tabulated format. It focuses on demonstrating "substantial equivalence" to predicate devices. It also does not provide specific performance data (e.g., clinical study results with numbers, statistical outcomes) for accuracy, precision, or other relevant metrics against any criteria.
Missing Information: Specific numerical acceptance criteria and the device's reported performance against those criteria are not detailed in this document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe any specific test set size, nor does it mention data provenance (e.g., country of origin, retrospective/prospective nature) for an independent verification study. The 510(k) process for this type of device often relies on demonstrating equivalence through comparison to existing predicate devices and, potentially, internal validation data, which is not described.
Missing Information: Sample size for the test set and data provenance are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not describe a study involving human experts to establish ground truth for a test set. For a blood glucose monitoring system, the "ground truth" would typically refer to a reference method (e.g., laboratory analyzer results) rather than expert interpretation of an image or signal.
Missing Information: There is no mention of experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
As no test set involving expert review is described, no adjudication method is mentioned.
Missing Information: Adjudication method is not applicable due to the absence of a described expert-reviewed test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically assesses human reader performance with and without AI assistance, is not applicable to this type of device. The Elect II is a standalone diagnostic device, not an AI-assisted diagnostic tool that interprets complex outputs for human readers.
Missing Information: MRMC study is not mentioned as it's not relevant to this device type.
6. Standalone Performance Study
While the document implies that internal testing was conducted to support the claim of substantial equivalence, it does not explicitly describe a standalone performance study with detailed results for the Elect II Blood Glucose Monitoring System. The description of the product ("measures the electrical current... result is displayed in 15 seconds") is about its operational mechanism, not a formal standalone performance study outcome. The statement about being "calibrated to give a result equivalent to a plasma value" hints at internal validation, but no study details are provided.
Missing Information: Specific details and results of a standalone performance study are not provided.
7. Type of Ground Truth Used
The most relevant statement regarding ground truth for the Elect II system is: "The system is calibrated to give a result equivalent to a plasma value, the measurement used by most clinical laboratories." This indicates that the ground truth for calibration and likely internal validation is established by comparison to a reference laboratory method that measures plasma glucose. This would typically involve a laboratory analyzer providing quantitative results.
Type of Ground Truth: Reference laboratory method measuring plasma glucose values.
8. Sample Size for the Training Set
The document does not mention any "training set." This device is a biosensor-based system, not typically a machine learning or artificial intelligence (AI) device that requires traditional training data sets in the way that image recognition algorithms do. Its calibration would be based on chemical and electrical principles rather than statistical learning from a large dataset.
Missing Information: Not applicable; no training set is described for this type of device.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, the method for establishing its ground truth is also not applicable.
Missing Information: Not applicable due to the absence of a described training set.
Summary of Inferences from the 510(k) Document:
The provided 510(k) summary for the Elect II Blood Glucose Monitoring System primarily serves to establish "substantial equivalence" to previously cleared devices. It describes the device's technical principles and intended use. It lacks detailed information on specific acceptance criteria, comprehensive study designs, sample sizes, expert involvement, or quantitative performance data that would typically be found in a full performance study report. The implicit "ground truth" used for calibration and validation appears to be established via comparison to reference laboratory plasma glucose values.
§ 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.