(16 days)
The Precision Xtra Advanced Diabetes Management 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 Xtra is also intended for the quantitative measurement of ß-hydroxybutyrate (ßketone) in fresh capillary whole blood. The Precision Xtra system is indicated for home (lay user) or professional use in the management of Patients with diabetes.
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 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 Xtra™ Advanced Diabetes Management System and its 510(k) summary, but it does not contain the specific acceptance criteria or detailed study results that would allow for the completion of the requested table and comprehensive study description.
The document primarily focuses on the device's intended use, classification, comparison to a predicate device, and a general statement about performance studies. It states that "The studies demonstrated that lay users can obtain blood glucose and blood β-Ketone results that are substantially equivalent to the current methods for blood glucose and blood β-ketone measurements," but does not provide the acceptance criteria or the reported performance metrics (e.g., accuracy, precision, bias).
Therefore, I cannot fully complete the requested information based only on the provided text. I will indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (as stated in the document) |
|---|---|---|
| Blood Glucose | Specific criteria not provided in the document | "lay users can obtain blood glucose... results that are substantially equivalent to the current methods for blood glucose... measurements." |
| Blood β-Ketone | Specific criteria not provided in the document | "lay users can obtain... blood β-Ketone results that are substantially equivalent to the current methods for... blood β-ketone measurements." |
| Overall Performance | Specific criteria not provided in the document | "acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose and blood β-ketone testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: Not specified in the provided document.
- Data provenance: Not explicitly stated (e.g., country of origin). The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users," which suggests a prospective clinical study component.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of experts: Not specified beyond "healthcare professionals" being involved in clinical settings.
- Qualifications of experts: Not specified (e.g., specific medical titles, years of experience). The document generally refers to "healthcare professionals."
4. Adjudication Method for the Test Set
- Adjudication method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC study: Not explicitly mentioned as an MRMC comparative effectiveness study. The document states that "lay users can obtain blood glucose and blood β-Ketone results that are substantially equivalent to the current methods," which implies a comparison with existing methods, but not necessarily an MRMC study format examining human reading improvement with AI assistance. This device is a blood glucose/ketone meter, not an imaging AI device that assists human readers.
6. Standalone Performance Study
- Standalone performance study: The document states, "The performance of the Precision Xtra Diabetes Monitoring System was studied in the laboratory and in clinical settings by healthcare professionals and lay users." This indicates that the device's performance was evaluated independently, without requiring human-in-the-loop assistance for its operation and result generation. The statement "lay users can obtain blood glucose and blood β-Ketone results" further supports that the device performs its intended function to provide results on its own.
7. Type of Ground Truth Used
- Type of ground truth: Not explicitly stated, but for glucose and ketone measurements, the ground truth would typically be established by a laboratory reference method (e.g., a laboratory analyzer considered the gold standard for glucose and β-ketone levels). The phrase "substantially equivalent to the current methods" suggests comparison to such reference methods.
8. Sample Size for the Training Set
- Sample size for training set: This device, being an amperometric biosensor, does not typically use a "training set" in the machine learning sense. Its performance is based on its electrochemical design and calibration. Therefore, this question is not applicable in the context of this type of medical device.
9. How the Ground Truth for the Training Set Was Established
- Ground truth for training set: As mentioned above, this question is not applicable as the device's mechanism does not involve a "training set" for an AI algorithm. Its calibration would be established against known concentrations of glucose and β-ketone using 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.