(68 days)
The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is intended for outside-of-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger), or by health care professionals. The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System is to be used for the monitoring of blood glucose concentrations in persons with diabetes and other conditions.
The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System for blood glucose testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in whole blood and control solutions.
Here's an analysis of the provided text regarding the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System, structured to address your specific points.
The provided document is a 510(k) summary (K022182) for a blood glucose monitoring system, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and extensive study results in the manner you might expect for a novel or high-risk device. Therefore, some of your requested information (e.g., specific statistical acceptance criteria thresholds, detailed study designs for human reader improvement with AI, specific sample sizes for test/training sets with ground truth establishment) is not explicitly present in this type of regulatory document.
However, I will extract and infer as much as possible based on the provided text.
Acceptance Criteria and Device Performance for MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Overall Performance | Substantial equivalence to predicate devices (Precision QID Blood Glucose Testing System, K944195, K971812) in terms of accuracy and reliability for blood glucose measurements. | "Results of laboratory and clinical testing demonstrate that the performance of the MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate devices for blood glucose testing." |
| Usability/Lay User Performance | Lay users (self-testers) should obtain blood glucose results substantially equivalent to current methods and trained operators. | "In addition, results of clinical performance testing demonstrate that trained operators and lay users obtain equivalent whole blood glucose results." |
| Technological Characteristics | Equivalent technological characteristics. | "The MediSense Precision Easy / MediSense Optium Easy Blood Glucose Monitoring System has equivalent technological characteristics as the Precision QID Blood Glucose Testing System (K944195, K971812)." |
| Intended Use Equivalence | Same intended use as the predicate device. | "The Precision Easy also has the same intended use as the Precision QID." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "laboratory and clinical settings" and "clinical performance testing" involving "healthcare professionals and lay users," but does not provide specific numbers for the test set size.
- Data Provenance: The document implies the studies were conducted within the context of Abbott Laboratories, MediSense Products, likely in the US given the submission to the FDA. The data is prospective as it's generated for the purpose of demonstrating the device's performance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The studies involved "healthcare professionals" and "trained operators," implying individuals with clinical expertise in blood glucose measurement. Specific qualifications (e.g., years of experience, specific medical degrees) are not detailed in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The document refers to "results of laboratory and clinical testing" and "current methods" for comparison, which suggests reference standard measurements were used, but the specific process for resolving discrepancies or establishing the 'true' glucose value is not detailed.
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
- MRMC Study: No, this is not an MRMC study and AI is not mentioned as a component of this blood glucose monitoring system. This device is a standalone diagnostic tool, not an AI-assisted diagnostic aid for human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Standalone Performance: Yes, the core of the submission relies on the standalone performance of the blood glucose monitoring system. While human users operate the device, the "performance" described refers to the accuracy of the device's measurement relative to a reference standard, which is a standalone assessment of the device's accuracy. The text emphasizes that the device itself (using "amperometric biosensor technology") generates the current and provides the quantitative measure.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for blood glucose measurements would typically be established by a highly accurate laboratory reference method for blood glucose, often referred to as a "gold standard." The document mentions "current methods" and "predicate devices listed above" as benchmarks, implying that these established, accurate methods served as the ground truth or reference for comparison.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not explicitly stated for this type of device. Blood glucose meters do not typically have a "training set" in the machine learning sense. Their performance is inherent in their design and manufacturing, validated through testing with known glucose concentrations and patient samples.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As noted above, this device doesn't use a "training set" with ground truth in the context of an algorithm that learns from data. Instead, the device is designed based on known electrochemical principles (amperometric biosensor technology), and its accuracy is verified against reference 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.