(71 days)
The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s. Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.
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Due to the limited information in the provided document, I cannot fulfill all parts of your request. This document is a 510(k) clearance letter for a medical device (Triglycerides Reagent) and does not contain detailed study information regarding acceptance criteria or performance data.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. The FDA letter confirms the device is "substantially equivalent" to predicate devices, implying it meets general performance expectations for this type of in-vitro diagnostic. Specific numerical acceptance criteria (e.g., accuracy, precision limits) are not provided.
- Reported Device Performance: Not included in the document. The letter acknowledges that the manufacturer provided information to support substantial equivalence, but the actual performance data is not detailed here.
2. Sample size used for the test set and the data provenance:
- Sample size: Not mentioned in this document.
- Data provenance: Not mentioned in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned in this document.
4. Adjudication method for the test set:
- Not mentioned in this document.
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:
- This device is a Triglycerides Reagent, an in-vitro diagnostic (IVD) for quantitative determination of serum triglycerides. It is not an AI-assisted diagnostic imaging device or a device involving human "readers" in the context of imaging interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question also appears to be framed from the perspective of an AI/algorithm-based diagnostic device. As a chemical reagent, the concept of "standalone algorithm performance" doesn't directly apply. The performance of the reagent would be assessed through analytical and clinical validation studies, but not in the sense of a standalone algorithm for image analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For an in-vitro diagnostic like a triglycerides reagent, the "ground truth" would typically be established through:
- Reference methods: Comparing the device's results to a more established, highly accurate reference method for triglyceride measurement.
- Clinical correlation: Showing that the triglyceride levels determined by the device correlate with clinical conditions (e.g., risk of coronary artery disease, pancreatitis) or patient outcomes as expected.
- Known concentration controls: Testing the device with samples of known triglyceride concentrations.
- This document does not specify which type of ground truth was used for the submission.
8. The sample size for the training set:
- Not mentioned in this document. (Training sets are more relevant for machine learning algorithms, which this device is not).
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device requiring a "training set" in that context.
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(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.