(140 days)
The GLUCOMETER DEX Diabetes Care System is for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.
The GLUCOMETER DEX Diabetes Care System consists of the GLUCOMETER® DEX™ Blood Glucose Meter; GLUCOMETER® DEX™ Blood Glucose Test Sensor Disc; and the GLUCOMETER® DEX™ Controls (Normal, Low and High). The GLUCOMETER DEX Diabetes Care System is an over-the-counter (OTC) home test for glucose in blood. It is for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
The provided text does not contain detailed acceptance criteria and a study to prove the device meets these criteria in the format requested. The document is a 510(k) Safety and Effectiveness Summary from 1997 for the GLUCOMETER® DEX™ Diabetes Care System.
Here's an analysis of what is available in the document related to your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with specific numerical thresholds for accuracy, sensitivity, or other performance metrics. It generally states:
- "The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose."
- "The results of in-house and clinical evaluations of the GLUCOMETER DEX Diabetes Care System demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use."
The "Technological Characteristics" section mentions:
- "The System has a linear response to glucose from 10 - 600 mg/dL."
Without specific numerical criteria, a table cannot be constructed from the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "studied in-house and in clinical settings by healthcare professionals and by persons with diabetes." However, it does not specify:
- The exact sample size of patients or samples used in these studies.
- The country of origin for the data.
- Whether the studies were 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 states that studies were conducted by "healthcare professionals and by persons with diabetes." It also refers to predicate devices like the YSI Model 2300 STAT Plus Analyzer, ACA® Discrete Clinical Analyzer, Hitachi 704 chemistry analyzer, and Hitachi 747 chemistry analyzer, which would likely be used for comparison (ground truth). However, it does not specify:
- The number of experts.
- Their specific qualifications or experience.
- How ground truth was established, beyond implying comparison to established clinical laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method.
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
This document describes a blood glucose monitoring system, not an AI-based diagnostic tool for interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not relevant to this type of device and is not mentioned in the text.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The GLUCOMETER® DEX™ is a self-monitoring device, implying standalone performance of the device itself (algorithm only, without a human "interpreting" the result other than reading the display). The performance assessment implicitly refers to this standalone performance. However, there's no explicit mention of a "standalone study" in the modern sense of algorithm evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for blood glucose measurements would typically be established by comparison to a reference laboratory method (e.g., YSI Model 2300 STAT Plus Analyzer, ACA® Discrete Clinical Analyzer, Hitachi 704 chemistry analyzer, Hitachi 747 chemistry analyzer, as listed under predicate devices). The document states, "Blood glucose results are referenced to plasma glucose," which is a standard clinical practice.
8. The sample size for the training set
The document refers to "in-house and clinical evaluations" but does not distinguish between training and test sets, nor does it provide sample sizes for either.
9. How the ground truth for the training set was established
As above, no distinction between training and test sets, and the method for establishing ground truth is implied as comparison to established clinical laboratory methods for plasma glucose.
§ 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.