(18 days)
SYNCHRON® Controls are made from stabilized human serum and are designed to monitor the performance of SYNCHRON Systems in the clinical laboratory. SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each other; Level 2 is manufactured by combining equal quantities of levels 1 and 3. The use of three levels enable the laboratorian to monitor changes in calibration and linearity along with analytical error and imprecision.
The SYNCHRON® Control kit consists of three levels of controls (Level 2, and Level 3) for use on the SYNCHRON Systems. There are a total of 6 bottles (two 20-mL bottles per level). SYNCHRON® Controls are made from stabilized human serum and are designed to "monitor" the "performance" of SYNCHRON Systems in the clinical laboratory. The controls are made of frozen human plasma that has been defibrinated and, then, it is stabilized with ethylene glycol.
The provided text is a 510(k) Summary for a medical device called "SYNCHRON® Control". This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than detailing a specific clinical study with acceptance criteria and performance metrics typically found in clinical trial reports for device efficacy or diagnostic accuracy.
Therefore, many of the requested sections about clinical study details cannot be fully answered from the provided text.
Here is an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of numerical thresholds for a specific performance study. Instead, it relies on demonstrating stability and substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stability claim of 18 months | Stress stability studies of the SYNCHRON® Control support the stability claim of 18 months. |
| Substantial Equivalence to Predicate | The modified SYNCHRON® Control contains vancomycin and the current product does not. This change is considered to maintain substantial equivalence. |
Note: The nature of this device (Quality Control Material) means that "performance" refers to its stability and its ability to consistently monitor the performance of diagnostic systems (SYNCHRON Systems), rather than direct diagnostic accuracy of a patient's condition.
Study Details
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Sample size used for the test set and the data provenance:
- The document mentions "Stress stability studies" but does not specify the sample size (e.g., number of control lots, number of measurements per lot) used in these studies, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a quality control material used to monitor analytical systems, not a diagnostic device that requires expert interpretation of results to establish ground truth for a test set. The "ground truth" for a control material would be its known target values, established by the manufacturer, against which the system's measurements are compared.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in studies involving human interpretation of data where consensus on ground truth is critical (e.g., image reading). This is not relevant for a stability study of a quality control material.
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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 is not an AI-assisted diagnostic device, nor is it a device where human reader performance is being evaluated.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical quality control material, not an algorithm. Its "performance" is its intrinsic stability and its reference values for analytical systems.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a quality control material, the "ground truth" would be the assigned target values and their acceptable ranges, established during the manufacturing and characterization process of the control material itself. These values are determined through rigorous analytical testing and standardization, not typically through pathology or expert consensus on clinical cases. The document implies that the "SYNCHRON Control levels, 1, 2, and 3 bear a quantitative relationship to each other" and are designed to monitor analytical performance.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
In summary: The provided 510(k) summary focuses on regulatory approval based on stability and substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic performance. As such, many of the requested details concerning human readers, AI, and ground truth establishment in a diagnostic context are not relevant or present in this document.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.