(276 days)
The Precision Xtra Advanced Diabetes Management System is intended for in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose and/or ketone in fresh capillary whole blood. The Precision Xtra System is for home (lay user) or professional use.
The Precision Xtra System may also be used 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™ Xtra™ Advanced Diabetes Management System for Blood Glucose and Ketone Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose (or Beta-Hydroxybutyrate ketone) present in the sample, providing a quantitative measure of glucose (or ketone) in whole blood and control solutions.
The provided text describes the regulatory submission for the Precision™ Xtra™ Advanced Diabetes Management System but does not contain the detailed performance study results, acceptance criteria, or specific data about ground truth determination, reader studies, or sample sizes for testing and training sets.
The document states that "The studies demonstrated that lay users can obtain blood glucose and ketone results that are substantially equivalent to the current methods for blood glucose and ketone measurements," and "Results of laboratory and clinical testing demonstrate that the performance of the Precision Xtra Advanced Diabetes Management System... is acceptable and comparable to the performance of the previously mentioned predicate devices." However, it does not present the raw data, statistical analysis, or predefined acceptance criteria.
Therefore, many of the requested fields cannot be filled directly from this document.
Here's a breakdown of what can be inferred or explicitly stated from the provided text, and what is missing:
Acceptance Criteria and Device Performance (Based on Inferred Information)
The document implies that the acceptance criteria are met if the device demonstrates "substantial equivalence" to the predicate devices for blood glucose and ketone measurements in both laboratory and clinical settings, for both healthcare professionals and lay users. Specific numerical acceptance criteria are not provided.
| Metric (Inferred) | Acceptance Criteria (Not Explicitly Stated, Inferred as "Substantially Equivalent") | Reported Device Performance (General Statement) |
|---|---|---|
| Blood Glucose Measurement | Performance comparable to Precision QID and Precision G systems | Substantially equivalent to current methods |
| Ketone Measurement | Performance comparable to GDS Ketosite and Sigma B-Hydroxybutyrate systems | Substantially equivalent to current methods |
| Lay User Performance | Results equivalent to trained operators | Lay users obtain equivalent results |
| Professional User Performance | Results equivalent to trained operators | Trained operators obtain equivalent results |
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies were conducted in "laboratory and clinical settings" but no further detail is provided.
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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 provided. The "ground truth" for the device's performance seems to be established by comparing its results to "current methods for blood glucose and ketone measurements," which include predicate devices. There's no mention of independent expert adjudication for establishing ground truth in the context of diagnostic interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of this device type (blood glucose/ketone meter) as there isn't a complex diagnostic image or clinical case requiring expert adjudication in the traditional sense. The comparison is against established laboratory methods or predicate devices.
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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. This is not an AI-assisted diagnostic imaging device. The "readers" are the users of the device (lay users and healthcare professionals) obtaining direct measurements. The study did compare "trained operators and lay users" to show they "obtain equivalent whole blood glucose and ketone results," but this is not an MRMC study comparing AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device inherently produces a quantitative measurement, which is its standalone performance. The "human-in-the-loop" refers to the user operating the device and interpreting the numerical output. The studies included both laboratory testing (likely more controlled, akin to standalone) and clinical settings with users, demonstrating the device's ability to provide measurements directly.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by comparison to results from "current methods for blood glucose and ketone measurements," specifically the listed predicate devices (Precision QID, Precision G, GDS Stat-Site Meter, Sigma Diagnostics β-Hydroxybutyrate Procedure No. 310-UV). These are established, validated methods for measuring glucose and ketones.
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The sample size for the training set:
- Not applicable as this is not an algorithm-based device that undergoes a "training" phase in the machine learning sense. The device's performance is based on its biosensor technology and calibration.
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How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
§ 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.