Search Results

Sigma Diagnostics Valproic Acid FPIA Reagent Set is intended to measure valproic acid, an anticonvulsant drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

Device Description

The method of testing used by Sigma Diagnostics follows closely the antibody-antigen reaction scheme first introduced by Berson and Yallow (1) with a monitoring method employed by Dandlicker, et al.(2)

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to Sigma Diagnostics for their Valproic Acid FPIA Reagent Set and Calibrators. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for an AI/ML medical device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or available in this type of regulatory document for an in-vitro diagnostic reagent set from 1997.

However, I can extract the relevant information and infer the "acceptance criteria" based on the provided "Summary of Safety and Effectiveness":

Inferred Acceptance Criteria and Reported Device Performance for Sigma Diagnostics Valproic Acid FPIA Reagent Set:

Acceptance Criteria Category	Specific Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Correlation with Predicate Device	The device's measurements for valproic acid in serum should correlate strongly with those obtained by a legally marketed predicate device (Abbott TDx Valproic Acid Reagent Pack).	"Results of the regression analysis gave a correlation coefficient of 0.996" when patient samples were assayed using both the Sigma Diagnostics Valproic Acid Reagents and the Abbott TDx Valproic Acid Reagent Pack.
Precision	The device should demonstrate sufficient precision to accurately differentiate between subtherapeutic, therapeutic, and toxic levels of valproic acid.	"Precision studies indicate acceptable values can be obtained to differentiate between subtherapeutic, therapeutic, and toxic levels."
Specificity	The monoclonal antibody used in the reagent set should exhibit acceptable specificity for valproic acid.	"Specificity of the monoclonal antibody used was assessed and found to be acceptable."
Safety and Effectiveness	The device must be demonstrated as safe and effective for its intended use, typically by showing substantial equivalence to a predicate device already deemed safe and effective.	"The safety and effectiveness of the Sigma Diagnostics Valproic Acid FPIA Reagent Set is demonstrated by its substantial equivalency to the Abbott Laboratories Valproic Acid TDx Reagent Set."

Given the nature of the document (a 510(k) summary for an in-vitro diagnostic reagent set from 1997), most of the detailed questions regarding AI/ML device studies, ground truth establishment, training sets, and expert adjudication are not applicable (N/A). However, I will address what can be gleaned:

1. A table of acceptance criteria and the reported device performance:
Provided in the table above.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size for Test Set: The document states, "Patient samples, ranging from 13.63 to 131.08 ug/mL, were assayed..." It does not specify the number of patient samples.
Data Provenance: Not explicitly stated in terms of country of origin. Given Sigma Diagnostics is a US company, it is highly probable the samples were from the US. The context suggests a prospective comparison with a predicate device, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This is an in-vitro diagnostic assay for measuring a chemical compound (valproic acid). The "ground truth" for each sample would be the actual concentration of valproic acid in the sample, typically validated by a reference method or assumed from the predicate device's measurement. Experts in the sense of clinicians or radiologists establishing a diagnosis from an image are not involved.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

N/A. Adjudication methods are typically relevant for subjective interpretations (e.g., image reading). For a reagent set measuring a chemical concentration, the comparison is quantitative.

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:

N/A. This applies to AI/ML devices often used in diagnostic imaging or clinical decision support. This document is for a chemical assay reagent set.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

N/A. This concept is for AI/ML algorithms. The device is a FPIA (Fluorescence Polarization Immunoassay) reagent set, which is a laboratory assay. While an instrument is used, the "performance" is of the reagent's ability to measure the target analyte, not an AI algorithm's interpretive output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this type of device is the actual concentration of valproic acid in the patient samples. In the context of a substantial equivalence submission, the predicate device's measurements serve as the de facto reference for comparison.

8. The sample size for the training set:

N/A. This concept is for AI/ML models. A chemical reagent set does not have a "training set" in this sense. Quality control and calibration are part of standard manufacturing and laboratory practice.

9. How the ground truth for the training set was established:

N/A. As above, no "training set" for a chemical reagent.

Ask a Question

Ask a specific question about this device

Page 1 of 1