(85 days)
The SoloV2TM Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates.
The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions.
This system contains a speaking function that provides audible test results for users with low vision.
The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets said criteria. The document is a 510(k) summary for a blood glucose monitoring system, primarily focused on demonstrating substantial equivalence to a predicate device.
Here's a breakdown of the information that is and is not present, based on your request:
1. A table of acceptance criteria and the reported device performance:
- Not present. The document states that Biotest Medical Corp. "has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements." However, it does not detail what those acceptance criteria were (e.g., accuracy standards like ISO 15197) or present specific performance data.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not present. The document mentions "Performance Studies" in a very general way, but does not provide any specifics about sample sizes, study design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not present. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation), where expert consensus establishes ground truth. For a blood glucose monitoring system, the "ground truth" would typically be established by a laboratory reference method, not by expert consensus interpreting images. The document does not describe how ground truth was established for any performance studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not present. Similar to point 3, adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant for a blood glucose meter's performance assessment.
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:
- Not applicable/Not present. MRMC studies are used to evaluate the impact of AI on human reader performance, particularly in diagnostic imaging. This device is a blood glucose monitoring system and does not involve AI assistance for human readers in the way an imaging AI would.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. While the device itself is a "standalone" system for measuring glucose, the concept of "standalone (algorithm only without human-in-the-loop performance)" is usually applied to AI algorithms that process data independently. This device is a physical diagnostic tool; its performance is inherently a standalone measurement. The document does not describe any specific "algorithm-only" performance study in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated, but inferred to be a laboratory reference method. For blood glucose meters, the ground truth is typically a highly accurate laboratory reference method (e.g., hexokinase method). The document does not explicitly state this, but it's the standard for such devices.
8. The sample size for the training set:
- Not applicable/Not present. This device is not described as involving machine learning or AI models that require a "training set" in the conventional sense. Its performance is based on its electrochemical measurement technology.
9. How the ground truth for the training set was established:
- Not applicable/Not present. As there's no mention of a training set for an AI/ML model, this information is not provided.
In summary:
The provided 510(k) summary for the SoloV2™ Blood Glucose Monitoring System focuses on demonstrating substantial equivalence to a predicate device (SuperCheck 1 Blood Glucose Monitoring System) by listing modifications and asserting that "necessary verification and validation activities" were performed. It does not include detailed performance data, specific acceptance criteria, or study methodologies that would address most of your requested points, which are more typically found in documents for AI/ML-based medical devices or more comprehensive clinical study reports.
§ 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.