(74 days)
SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent, when used in conjunction with SYNCHRON® Systems Lipid Calibrator, is intended for the quantitative determination of HDL cholesterol in the high-density lipoprotein (HDL) fraction of serum or plasma on SYNCHRON Systems.
SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent, when used in conjunction with SYNCHRON® Systems Lipid Calibrator, is intended for the quantitative determination of HDL cholesterol in the high-density lipoprotein (HDL) fraction of serum or plasma on SYNCHRON Systems.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary document for K040767 does not explicitly state pre-defined acceptance criteria for the "Method Comparison Study Results" in terms of specific thresholds for slope, intercept, or correlation coefficient (r). Instead, it presents the results from a comparison to a predicate device and implies that these results demonstrate substantial equivalence.
However, based on standard expectations for method comparison studies in clinical chemistry, the "acceptance criteria" can be inferred based on what is generally considered acceptable for demonstrating equivalence. The reported performance is directly from the document.
| Metric | Inferred Acceptance Criteria (Typical) | Reported Device Performance (SYNCHRON® Systems HDLD Reagent) |
|---|---|---|
| Method Comparison | ||
| Slope | Ideally close to 1.0 (e.g., within 0.95-1.05 or similar range, depends on assay and clinical impact) | SYNCHRON CX: 0.991 |
| SYNCHRON LX: 0.973 | ||
| Intercept | Ideally close to 0.0 (e.g., within a predefined range, depends on assay and clinical impact) | SYNCHRON CX: 2.2 |
| SYNCHRON LX: 0.5 | ||
| Correlation (r) | Ideally > 0.975 - 0.98 (often >0.95 or higher, depending on the assay and clinical impact) | SYNCHRON CX: 0.956 |
| SYNCHRON LX: 0.972 | ||
| N (Sample Size) | Sufficiently large to provide statistical power (e.g., usually >40, 60, or 100 samples are common) | SYNCHRON CX: 63 |
| SYNCHRON LX: 66 |
Note: The "Inferred Acceptance Criteria" are based on common industry practices for method validation and are not explicitly stated as pass/fail criteria in the provided text. The document states "Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments," implying that these results were deemed acceptable by the manufacturer and FDA.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set:
- SYNCHRON CX Comparison: 63 samples (n=63)
- SYNCHRON LX Comparison: 66 samples (n=66)
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions the "Method Comparison Study Results."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. For an in vitro diagnostic (IVD) device like an HDL cholesterol reagent, the "ground truth" for a method comparison is typically established by comparing the results of the new method to a well-established, often FDA-cleared, predicate method (or a reference method). In this case, the SYNCHRON HDLC method serves as the comparison method, not human expert interpretation.
4. Adjudication Method for the Test Set
This concept of "adjudication" is typically relevant for studies where subjective interpretation is involved (e.g., medical imaging or pathology). For a quantitative chemical assay, adjudication is not applicable in the same way. The comparison is between two quantitative measurements.
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. An MRMC study is relevant for devices that involve human interpretation, often aided by AI. This device is a quantitative chemical reagent where the output is a numerical value, not an image or complex data needing human interpretation. No AI component is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone diagnostic reagent system for quantitative measurement. Its performance described in the method comparison is inherently "standalone" in the sense that it produces a result directly from a sample without human interpretive intervention. There is no "algorithm" in the context of AI being evaluated here; it's a chemical assay.
7. The Type of Ground Truth Used
For the method comparison study, the "ground truth" (or reference standard for comparison) used was the SYNCHRON HDLC method, which is a previously cleared and established method for HDL cholesterol determination by Beckman Coulter, Inc. (K934045). This is an example of comparing to an existing
predicate device performance.
8. The Sample Size for the Training Set
This information is not provided. The document focuses on performance data for the commercialization of the device, with existing predicate data likely used for initial development and validation. The concept of a "training set" is more commonly associated with machine learning algorithms, which are not applicable here. However, similar to a training set, the initial development and optimization of the reagent involved a larger set of samples and experiments, but these are not distinctively labeled in this summary.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" explicitly identified in the context of a machine learning algorithm, and the device is a chemical reagent, this question is not applicable in the way it's phrased. Development of chemical assays relies on validated reference methods and analytical techniques to establish accuracy, linearity, and precision during the research and development phase. If we consider the predicate device (SYNCHRON HDLC) as a "ground truth" reference against which this new reagent was developed or compared, its ground truth would have been established through its own validation studies, likely including comparison to a definitive method (e.g., CDC reference method for cholesterol).
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.