(160 days)
The Precision G Plus Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision. G Plus Point of Care Management System is for home (lay user) or professional use.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial or neonatal whole blood, provided the sample is used within 30 minutes.
The Precision·G Plus Point of Care Management System for Blood Glucose Testing utilizes amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample providing a quantitative measure of glucose in whole blood and control solutions.
The provided text is a summary of a 510(k) premarket notification for a medical device (a blood glucose testing system). It doesn't contain detailed information about specific acceptance criteria or a dedicated study report with performance metrics. Rather, it states that performance studies were conducted and the device met substantial equivalence.
Therefore, many of the requested fields cannot be filled directly from the provided text. However, based on the general information available in a 510(k) summary for a blood glucose monitor, I can infer what common acceptance criteria and study designs are for such devices and how the provided text aligns with that.
Here's an attempt to answer your questions based on the available information and general knowledge of blood glucose meter submissions:
Acceptance Criteria and Study for K987303: Precision·G Plus Point of Care Management System for Blood Glucose Testing
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state the specific acceptance criteria (e.g., ISO 15197 accuracy limits such as "X% of results within ±Y mg/dL" or "X% within ±Z%"). It generally states that the device demonstrated "substantially equivalent" results and "acceptable" performance when compared to predicate devices and current methods.
| Acceptance Criteria Category (Inferred) | Specific Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Summary from document) |
|---|---|---|
| Accuracy (Against Lab Reference) | (Likely ISO 15197 or similar) | "user can obtain blood glucose results that are substantially equivalent to the current methods for blood glucose measurement" |
| Accuracy (Against Predicate Devices) | (Likely statistical equivalence limits) | "substantially equivalent to both the Precision·G® Blood Glucose Testing System and the Precision QID® Blood Glucose Testing System. In addition, ... substantially equivalent to an additional competitive predicate device, the Johnson and Johnson Surestep Pro Blood Glucose Monitoring System." |
| Precision/Reproducibility | (Likely within-run, between-run CV% or SD limits) | Implied as acceptable given the "substantially equivalent" conclusion. |
| User Performance (Lay User/Professional) | (Likely specific error rates or success rates for testing steps) | "Performance ... studied in the laboratory and in clinical settings by healthcare professionals and lay users." Implied as acceptable. |
| Interferences | (Likely no significant interference from common substances) | Not explicitly mentioned but assumed to be evaluated as part of "current methods" equivalence. |
| Linearity/Reportable Range | (Likely performance across the intended glucose range) | Not explicitly mentioned but assumed to be evaluated. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. For blood glucose meters, clinical studies typically involve hundreds of samples from patients (capillary, venous, arterial, neonatal, as per intended use) to cover the analytical range and demonstrate accuracy.
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings." The country of origin is not specified, but given the submitter's address in Massachusetts, USA, it's highly probable the studies were conducted in the US. The studies are prospective, as they involved "user[s]" obtaining results in these settings.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications: "Healthcare professionals" were involved in the clinical settings, implying medical professionals qualified to perform blood draws and potentially operate reference laboratory instruments. The "current methods for blood glucose measurement" (likely laboratory-based glucose analyzers, sometimes referred to as "gold standard" or "reference" methods) would have established the ground truth. These reference methods are themselves operated by trained laboratory personnel.
4. Adjudication Method for the Test Set:
Not explicitly mentioned. For blood glucose meters, adjudication (in the context of expert consensus) is less common for establishing the primary glucose value, as a reference laboratory method provides the quantitative "ground truth." Any discrepancies would typically be resolved by investigation into sample handling, instrument malfunction, or procedural errors, rather than expert consensus on the glucose value itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was one done? Not explicitly mentioned. MRMC studies are more common for imaging devices where human interpretation is a primary component. For a blood glucose meter, the focus is on the device's accuracy in providing a quantitative result, not on human interpretation of complex data. The "lay user" and "professional" studies evaluate the usability and performance of different user types, which has some overlap with reader variability, but it's not typically described as an MRMC comparative effectiveness study in the same way an imaging or diagnostic AI product would be.
- Effect size of human readers with vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic imaging or interpretation device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was one done? Yes, implicitly. The core performance of the device's "amperometric biosensor technology to generate a current" and subsequent calculation is a standalone function. The "laboratory" studies would likely represent a standalone assessment of the device's analytical performance against a reference method, without necessarily accounting for all human-in-the-loop variables that are tested in clinical settings with different user types. The clinical studies with "healthcare professionals and lay users" then assess the human-in-the-loop performance.
7. Type of Ground Truth Used:
The ground truth was established by "current methods for blood glucose measurement," which typically refers to reference laboratory-based glucose analyzers (e.g., hexokinase method) known for their high accuracy and precision. This is a form of "reference method comparison" or "established analytical standard."
8. Sample Size for the Training Set:
Not applicable/not specified. For an amperometric biosensor system like this, there isn't a "training set" in the machine learning sense. The device's calibration and algorithm are developed through engineering and chemistry principles, and then validated with the test set studies described.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set in the machine learning context for this type of device. The device's internal calibration parameters would be set during manufacturing based on known glucose standards, not through a "training set" with established ground truth in the AI sense.
§ 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.