(28 days)
The Precision Xceed Diabetes Monitoring System is intended for in vitro diagnostic use (i.e. external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision Xceed is also intended for the quantitative measurement of β-hydroxybutyrate (β-ketone) in fresh capillary whole blood. The Precision Xceed system is indicated for home (lay user) or professional use.
The Precision® Xceed™ Diabetes Monitoring System utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose or β-hydroxybutytate (β-ketone) present in the sample, providing a quantitative measure of glucose or β-ketone in whole blood and control solutions.
The provided text describes the Precision Xceed Diabetes Monitoring System and its substantial equivalence to a predicate device, but it lacks detailed acceptance criteria and the specific study report details that would allow for a comprehensive answer to all questions.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document states that the studies "demonstrated that lay users can obtain blood glucose and ß-Ketone results that are substantially equivalent to the current methods for blood glucose and ß-ketone measurements." and that the "performance... is acceptable and comparable to the performance of the previously mentioned predicate device".
However, specific numerical acceptance criteria (e.g., accuracy, precision targets) and the corresponding reported performance values are NOT provided in this summary. To create such a table, more detailed study results are needed.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in this document. The text only mentions "clinical settings by healthcare" and "lay users".
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings". The country of origin and whether the studies were retrospective or prospective are not specified.
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)
This information is not specified. For a glucose/ketone monitoring system, "ground truth" would typically be established by laboratory reference methods, not by human experts in the way clinical images might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable in the context of a glucose/ketone monitoring system where the "ground truth" is typically a quantitative measurement from a reference lab method. There would be no need for expert adjudication.
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: Not applicable. This device is a standalone blood glucose and ketone monitoring system, not an AI-assisted diagnostic tool that aids human readers in image interpretation.
- Effect Size of Human Reader Improvement: Not applicable for the same reason above.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes. The performance studies for the Precision Xceed Diabetes Monitoring System itself, measuring glucose and β-ketone levels, represent its standalone performance. The document states "Results of laboratory and clinical testing demonstrate that the Conclusion: Rooms of the Precision Xceed Diabetes Monitoring System, when used according to the intended use stated above, is acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose and ß-ketone testing." This indicates that the device's output (glucose/ketone readings) was evaluated directly against reference methods or the predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a glucose and ketone monitoring system, the ground truth would inherently be established by comparison to accepted laboratory reference methods for glucose and β-ketone measurements. The document implies this by stating the results are "substantially equivalent to the current methods for blood glucose and ß-ketone measurements."
8. The sample size for the training set
Not specified. Given that this is a 2004 submission for a biosensor technology, it's highly unlikely that a "training set" in the context of modern machine learning algorithms as we understand it today was used. The device's calibration would be based on chemical and electrical engineering principles and likely internally validated, but not via an external "training set" of patient data that would then be distinct from a "test set" for performance evaluation.
9. How the ground truth for the training set was established
Not applicable or not specified. As explained above, for a device of this nature and era, a distinct "training set" with established ground truth as used in contemporary AI/ML development is improbable. The calibration and internal validation of the biosensor would be part of its engineering design and manufacturing process.
§ 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.