(155 days)
The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (Dglucose) in fresh capillary whole blood (fingertip), and of B-Ketone (beta hydroxybutyrate) in fresh capillary whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs.
Healthcare professionals may also use the product 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.
The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System (BGKMS) utilizes amperometric biosensor technology to measure glucose and ß-ketone in the sample found in the Precision Xceed Pro test strips to quantitatively measure glucose and Bhydroxybutyrate (B-ketone) concentrations in whole blood samples and Precision, MediSense or Optium Control Solutions.
The Precision Xceed Pro BGKMS measures glucose electrochemically. The glucose biosensor is capable of determining glucose oxidized by the enzyme (Glucose Dehydrogenase, GDH) catalysed reaction with Nicotinamide Adenine Dinucleotide (NAD') cofactor. The reduced form of NAD (NADH) is re-oxidized by reaction with the electrochemical mediator, 1,10-phenanthroline quinone (1,10-PQ). The reduced mediator is re-oxidized via electron transfer at the electrode surface. This current is translated into a number by the monitor, after applying lot specific calibration information and after a 20 second countdown, a concentration value is presented to the user. In this same manner, the biosensor electrode utilizes the enzyme hydroxybutyrate Dehydrogenase (HBDH). which reacts with the ß-hydroxybutyrate (ß-ketone) concentration in the sample. This reaction is transferred to the monitor through an electrical current generated proportional to the level of ß-ketone in the sample. This current is translated into a number by the monitor, after applying lot specific calibration information and after a 10 second countdown, a concentration value is presented to the user.
Here's an analysis of the acceptance criteria and study information for the Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System (K080960), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text states that the device was tested in accordance with ISO 15197:2003. While specific numerical acceptance criteria (e.g., % within ±15% of reference) are not explicitly detailed in the provided document, the study's conclusion clearly states that the device met these criteria. We can infer the categories of performance assessed.
| Performance Metric Category | Acceptance Criteria (Implied by ISO 15197:2003 Compliance) | Reported Device Performance |
|---|---|---|
| Dynamic Range | Conforms to ISO 15197:2003 standards for glucose sensing. | Passed |
| Precision | Conforms to ISO 15197:2003 standards for glucose sensing. | Passed |
| Linearity | Conforms to ISO 15197:2003 standards for glucose sensing. | Passed |
| Accuracy | Conforms to ISO 15197:2003 standards. (e.g., typically a certain percentage of results within a defined margin of a reference method) | Passed |
| Temperature Effects | Conforms to ISO 15197:2003 standards. | Passed |
| Lay User Acceptability | Demonstrated acceptable for intended lay use. | Passed |
| Ease of Use | Demonstrated acceptable for intended lay use. | Passed |
Note: Specific quantitative acceptance criteria (e.g., 95% of results within ±15 mg/dL or ±15% for glucose values > 100 mg/dL) as defined by ISO 15197:2003 are not provided in this summary. The summary simply states that the device was tested in accordance with the standard and passed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- "Non-clinical testing": No specific sample size is provided for these laboratory tests (dynamic range, precision, linearity, accuracy, temperature).
- "Clinical fingertip studies": No specific sample size for the clinical studies is provided.
- Data Provenance: The document does not explicitly state the country of origin for the data. The manufacturer is based in Alameda, CA, USA, suggesting the studies likely occurred in the USA. The studies were described as "non-clinical testing in the laboratory" and "clinical fingertip studies," indicating they were prospective as they were conducted to evaluate the performance of this specific device.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
The document does not provide information on the number of experts or their qualifications for establishing ground truth. For blood glucose monitoring systems, the "ground truth" (or reference method) is typically established by laboratory-grade analyzers, not human experts in the same way as, for example, image interpretation. The comparison is usually against these standardized laboratory methods.
4. Adjudication Method for the Test Set
Not applicable in this context. Adjudication methods like 2+1 or 3+1 are typically used when subjective expert interpretation is involved (e.g., in medical image analysis). For a blood glucose meter, the device's reading is compared directly to a quantitative reference measurement; there's no "adjudication" necessary between experts in this evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance
Not applicable. This device is a blood glucose and ß-ketone monitoring system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and the concept of AI assistance for human readers are not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the primary performance evaluation described is standalone performance. The device itself (Precision Xceed Pro BGKMS) is the "algorithm" in this context, and its readings are directly compared to reference methods. While human users operate the device, the performance being evaluated is the device's ability to accurately measure glucose and ketones, independent of human interpretive judgment. The clinical studies also assessed "lay user acceptability and ease of use," which involves human interaction, but the core accuracy validation is standalone device performance.
7. Type of Ground Truth Used
The ground truth for both glucose and ß-ketone measurements would have been established using laboratory reference methods/analyzers. These are validated, highly accurate methods typically used in clinical laboratories. The document states "The modified blood glucose monitoring system was tested in accordance with ISO 15197:2003," which specifies comparing the device's results to a laboratory reference method.
8. Sample Size for the Training Set
Not applicable. This device is a measurement system based on biosensor technology, not a machine learning model that requires a "training set." Its calibration would involve manufacturing processes and quality control, but not a "training set" in the sense of AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an AI/ML model for this device. Calibration of the device and test strips would rely on precisely prepared reference solutions and standardized analytical methods.
§ 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.