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510(k) Data Aggregation
(123 days)
The GlycoMark™ test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in serum or plasma. The test is for professional use, and is indicated for the intermediate term monitoring of glycemic control in people with diabetes.
The GlycoMark™ reagents provide for a fully automated enzymatic test for 15AG. The assay requires the two-reagent boxed set (Reagent 1 and Reagent 2) and the 15AG standard (purchased separately). A two-level control set ("Low" and "High") is also available separately.
The provided text describes the 510(k) summary for the GlycoMark™ device. It includes nonclinical and clinical data, but it does not specify acceptance criteria for the device's performance in a traditional sense (e.g., a specific sensitivity or specificity threshold that must be met). Instead, it presents performance characteristics and clinical study results primarily for comparison with a predicate device and to demonstrate safety and effectiveness for its intended use.
However, I can extract the reported device performance and infer "acceptance" by its successful 510(k) clearance by the FDA, implying these performance characteristics were deemed adequate.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since explicit "acceptance criteria" are not stated as quantitative targets that the device must meet (e.g., "sensitivity must be >X%"), I will present the reported performance characteristics. The FDA's clearance (K031604) implies these performance results were acceptable for market entry.
| Characteristic | Inferred Acceptance Criteria (Meeting predicate similarities & clinical relevance) | Reported Device Performance (GlycoMark™) |
|---|---|---|
| Analytical Sensitivity | Should be sufficient to detect clinically relevant levels of 15AG. | 0.2 µg/mL (defined as mean 15AG concentration plus one standard deviation of a saline blank). |
| Within-Assay Precision | Comparable to predicate or clinically acceptable for monitoring. (Predicate: Intra-run %CVs less than 2%) | Between 1.28 %CV and 3.83 %CV at two levels (low 4.6 µg/mL, high 14.7 µg/mL). |
| Between-Assay Precision | Comparable to predicate or clinically acceptable for monitoring. (Predicate: Between-day %CVs between 3% and 4%) | Between 0.79 %CV and 3.71 %CV with two control samples and two serum pool samples (concentrations 4.7 µg/mL to 27.0 µg/mL). |
| Linearity | Should be linear across the expected physiological range of 15AG. | Linear up to at least 110 µg/mL 15AG. |
| Sample Stability | Samples should be stable under appropriate storage conditions for practical laboratory use. | Serum samples stable at room temperature or 2-8°C for up to seven days; endures up to three freeze/thaw cycles. |
| Interfering Substances | Should not be significantly affected by common interfering substances encountered in blood samples. | Not affected by hemoglobin up to 125 mg/dL, triglycerides up to 1153 mg/dL, and bilirubin up to 53.3 mg/dL. |
| Clinical Performance | Should demonstrate responsiveness to changes in glycemic control, similarly to or with advantages over existing markers, for intermediate-term monitoring. | Demonstrated significant changes vs. baseline (p<0.05, Wilcoxon signed-rank test) at Visit 2, similar to fructosamine and glucose, and earlier than A1C (which showed significant change at Visit 3). Indicated for intermediate-term monitoring of glycemic control. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set (Clinical Data): 77 patients with diabetes (both Type 1 and Type 2).
- Data Provenance: The study was a "prospective, longitudinal study." The text does not specify the country of origin, but given the submission is to the FDA from Tomen America, Inc. in New York, N.Y., it is highly probable the study was conducted in the USA or adhering to international standards accepted by the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The device is an assay for a biomarker (1,5-anhydroglucitol). The "ground truth" for evaluating its performance isn't typically established by expert consensus on image interpretation, but rather through comparison with other established clinical markers and the physiological changes observed in patients.
- Number of Experts: Not applicable in the context of establishing a ground truth for a quantitative biomarker assay in the same way it would be for an AI diagnostic imaging device.
- Qualifications of Experts: Not applicable. The "ground truth" here is the actual physiological state of glycemic control, as measured by various established biomarkers (A1C, fructosamine, glucose) and changes in patient treatment.
4. Adjudication method for the test set
Not applicable for a quantitative biomarker assay. Adjudication methods like "2+1" are typically used in studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. The clinical study tracked changes in biomarker levels over time.
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
Not applicable. This device is a standalone assay, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the GlycoMark™ device is a standalone in vitro diagnostic (IVD) assay. Its performance characteristics (analytical sensitivity, precision, linearity, stability, interference) and clinical correlation were evaluated as an automated enzymatic test without human interpretation as part of the measurement process. The results are quantitative measurements of 15AG.
7. The type of ground truth used
The "ground truth" in the clinical study was the physiological state of glycemic control, as evidenced by:
- Changes in A1C levels (a long-term glycemic control marker, used as a reference).
- Changes in fructosamine levels (an intermediate-term glycemic control marker).
- Changes in glucose levels.
- The initiation or modification of antihyperglycemic treatments in patients with suboptimal glycemic control.
The GlycoMark™'s performance was assessed by its ability to reflect changes in this physiological state, and its responsiveness compared to parallel measurements of A1C, fructosamine, and glucose.
8. The sample size for the training set
Not applicable. This is an IVD assay, not a machine learning model that requires a training set in that sense. The "development" and "optimization" of the assay chemistry would involve laboratory experimentation rather than a data training set.
9. How the ground truth for the training set was established
Not applicable, as it is not an AI/ML model with a discrete training set.
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