(24 days)
the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED
Not Found
This 510(k) submission describes modifications to the HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System (K121366). The provided text indicates this is a "SPECIAL 510(k): Device Modification OIR Review Memorandum" and focuses on verifying that the modifications do not change the fundamental scientific technology or intended use of the device.
Crucially, the provided document does NOT contain a study with acceptance criteria and device performance results as typically requested for demonstrating clinical effectiveness or accuracy. Instead, it focuses on design control and regulatory compliance for minor device changes.
Therefore, many of the requested sections (sample size, experts, adjudication, MRMC, standalone performance, ground truth details, training set details) cannot be answered from this document as it does not contain information about a clinical performance study. The document explicitly states that the "INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED." This type of 510(k) often relies on demonstrating that the changes do not negatively impact the previously established performance.
However, based on the provided text, we can infer some information about acceptance criteria in a general design control context:
Acceptance Criteria and Reported Device Performance
The document states: "Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied." And further: "a statement signed by the individual responsible, that, as required by the risk analysis, all i) verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met".
This indicates that internal verification and validation activities were performed with predetermined acceptance criteria. However, the specific acceptance criteria and the quantitative or qualitative results of these activities (i.e., the "reported device performance") are not detailed in this review memorandum. The modifications are related to usability, appearance, and internal checks of the device, not its core HbA1c measurement performance.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the provided document. Likely pertains to functional checks of new features (e.g., color change visibility, shelf life functioning, initialization check, automatic mode change logic), and ensuring existing performance is not degraded. | Not explicitly stated in the provided document. The submission asserts that verification and validation activities were performed and acceptance criteria were met. |
Study Details (Based on what can be inferred/is absent from the document):
- Sample size used for the test set and the data provenance: Not applicable or not provided. This document does not describe a clinical performance study with a test set of patient samples. The "test set" here refers to internal verification and validation tests for the modifications.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. No clinical "ground truth" establishment is described for these device modifications.
- Adjudication method: Not applicable or not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This document describes a Special 510(k) for device modifications, not a comparative effectiveness study of the device's diagnostic performance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a point-of-care analytical device, not an AI algorithm requiring standalone performance evaluation in the typical sense.
- The type of ground truth used: Not applicable for a clinical performance evaluation. For the modifications, the "ground truth" would be the successful functioning of the new features as per design specifications (e.g., correct light intensity check, accurate shelf-life display, proper initialization sequence).
- The sample size for the training set: Not applicable or not provided. This is not an AI/machine learning device with a "training set."
- How the ground truth for the training set was established: Not applicable or not provided.
In summary, the provided document is a regulatory review memorandum for a Special 510(k) focusing on design control and confirming that minor modifications do not alter the fundamental scientific technology or intended use of a previously cleared device. It does not contain the details of a clinical performance study with specific acceptance criteria, reported performance, or ground truth establishment as would be typically found for an initial clearance or a significant change requiring new performance data.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).