(52 days)
The BioScanner Beyond Glucose test system is intended to be used to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.
Glucose in the whole blood sample reacts with glucose oxidase and ferricyanide. The reaction liberates electrons, which produce a small electrical current. The BioScanner Beyond reads the current produced across two electrodes and converts current into glucose concentration.
The provided text describes a glucose test system and its substantial equivalence to a predicate device, but it does not contain the detailed study information required to fully answer the request. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, and ground truth establishment specifics for the test set.
- Information on expert adjudication, MRMC studies, or standalone performance studies.
- Details about the training set.
However, based on the provided text, I can extract and infer some high-level information.
Here's an attempt to answer your questions to the extent possible with the given input:
1. A table of acceptance criteria and the reported device performance
The provided document does not include a specific table of acceptance criteria nor detailed reported device performance data. It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study's quantitative results against predefined metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective).
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)
The document does not mention the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for a test set.
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
The device described is a glucose test system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The BioScanner Beyond Glucose Test System is a device that directly measures glucose. Its performance is inherently "standalone" in that it provides a quantitative measurement. The document does not explicitly describe a "standalone algorithm performance study" in the context of typical AI/software device evaluations, but the system itself functions independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document states:
- "Both systems (BioScanner Beyond and predicate Accu-Chek Comfort Curve) are calibrated with a glucose hexokinase laboratory method as the reference."
This implies that the glucose hexokinase laboratory method was used as the reference standard or "ground truth" for calibration and presumably for performance comparisons, as it's a widely accepted and accurate method for glucose determination.
8. The sample size for the training set
The document does not provide information about a "training set" or its sample size. This context typically applies to machine learning models, which is not what this glucose measurement device is described as.
9. How the ground truth for the training set was established
As no training set is mentioned in the context of the device's development, this information is not provided.
§ 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.