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510(k) Data Aggregation
(58 days)
MICROLET**®**NEXT 2 Lancing Device
The MICROLET®NEXT 2 Lancing Device is used with the disposable MICROLET®NEXT Lancet to obtain capillary blood samples.
The proposed MICROLET®NEXT 2 Lancing Device falls under multiple Use Blood Lancet for Single Patient Use Only category. The proposed MICROLET®NEXT 2 Lancing Device is a pen-like instruments to be used with the compatible MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing.
The provided FDA 510(k) clearance letter and summary for the MICROLET®NEXT 2 Lancing Device (K250813) addresses the device's technical characteristics, regulatory classification, and substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria or detailed study results (like numerical performance metrics) typically found in a clinical study report for AI/ML-based medical devices or diagnostics.
The document describes a usability study rather than a performance study focused on specific numerical criteria for the lancing device's function (e.g., depth of penetration accuracy, blood sample volume consistency). The "acceptance criteria" in this context appear to be related to the usability and safety of the device by lay users.
Based on the provided text, here's a breakdown of the requested information, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance for MICROLET®NEXT 2 Lancing Device (K250813)
Note: The provided document describes a lancing device and its clearance based on substantial equivalence, primarily focusing on usability and safety. It does not contain quantitative performance metrics or specific "acceptance criteria" (e.g., sensitivity, specificity, accuracy percentages) typically seen for diagnostic devices or AI algorithms. The "performance" here refers to the device's ability to be used effectively and safely by lay persons.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Study Purpose) | Reported Device Performance (Summary of Clinical Testing Results) |
|---|---|
| Primary Goal: Users can successfully obtain adequate blood samples. | "Subjects demonstrated that they could use the proposed MICROLET®NEXT 2 Lancing Device to obtain adequate blood volume from fingertip and palm lancing to obtain a numerical or non-numerical result on the BGMS (Blood Glucose Monitoring System), after reading the IFU to learn the basic operation of the system." |
| Device is safe for intended use. | "No adverse events were reported." (Clinical Testing Adverse Events) |
| Device is effective for intended use. | (Implied by the success in obtaining adequate samples and equivalence to predicate) |
| Device is usable by lay persons with diabetes. | (Implied by the successful completion of the study by 120 lay persons) |
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- Enrolled: 131 lay persons with diabetes.
- Completed Study: 120 lay persons with diabetes.
- Data Provenance:
- Country of Origin: Not explicitly stated but implied to be within the US given the FDA submission and contact information.
- Retrospective or Prospective: Prospective ("enrolled into the study at a single clinical site").
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This was a usability study with lay users, not an expert-driven validation of a diagnostic ground truth. The "ground truth" was the ability of the lay person to successfully use the device to obtain a blood sample.
4. Adjudication Method for the Test Set
- Not Applicable. No expert adjudication of results was mentioned as the study was about user proficiency and device function in obtaining a sample, rather than interpretation of diagnostic results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is typically performed for AI-assisted image interpretation or diagnostic systems to evaluate how AI improves human reader performance. The device in question is a lancing device, which provides a blood sample, not an interpretation tool.
6. Standalone (Algorithm Only) Performance
- Not Applicable. This is a mechanical lancing device, not a software algorithm.
7. Type of Ground Truth Used
- Functional Success / User Proficiency: The ground truth was whether the enrolled lay users could successfully operate the device to "obtain adequate blood volume from fingertip and palm lancing to obtain a numerical or non-numerical result on the BGMS."
8. Sample Size for the Training Set
- Not Applicable. This device is hardware (a lancing device), not an AI/ML algorithm that requires a training set. The "training" for the users in the study was reading the Instructions for Use (IFU).
9. How the Ground Truth for the Training Set was Established
- Not Applicable. See point 8.
Summary Limitations of this Document:
This document is a regulatory clearance letter and 510(k) summary, specifically for a mechanical lancing device. It is not a document for an AI/ML-based diagnostic device. Therefore, it lacks the detailed performance metrics (like sensitivity, specificity, AUC), expert read studies, and training/test set data provenance typically associated with the evaluation of AI/ML algorithms. The "clinical study" described is a usability and safety study for the physical device, demonstrating that lay users can operate it safely and effectively.
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