Search Results

Architect FSH MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the FSH assay on the Abbott Architect i System.

Architect FSH MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.

Architect FSH MasterCheck Levels 1, 2, 3 and 4 contain FSH (human) prepared in HEPES buffer with protein (bovine) stabilizers.

Preservative: Antimicrobial Agent.

The provided text describes a 510(k) submission for the "Architect FSH MasterCheck" which is a control device for verifying the performance of FSH assays. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria for the performance of the Architect FSH MasterCheck itself as a diagnostic tool.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this type of regulatory submission. The document defines the intended use and compares the characteristics of the new device to a predicate, not its diagnostic accuracy in a clinical setting.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document. The document describes the device's characteristics and its intended use as a verifier for an assay, but not performance metrics (e.g., sensitivity, specificity, accuracy) that would typically have acceptance criteria for a diagnostic device. The comparison table focuses on characteristics like form, matrix, storage, and analytes.

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

This information is not present. The document does not describe a "test set" in the context of evaluating diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present. Ground truth for diagnostic performance is not discussed in this type of regulatory submission for a control device.

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

This information is not present.

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 information is not present. This is a control device, not an AI-assisted diagnostic tool, so such a study would not be relevant.

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

This information is not present. This is a control device, not an algorithm.

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

This information is not present.

8. The sample size for the training set

This information is not present. There is no mention of a training set as this is not an AI/ML device.

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

This information is not present.

Summary regarding the Architect FSH MasterCheck:

The document is a 510(k) summary for a control device. Its purpose is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, not to prove its diagnostic performance against a clinical ground truth through a detailed study. Therefore, the information requested regarding acceptance criteria, study design, ground truth, and expert evaluation for diagnostic performance is not relevant to this type of submission and is consequently not provided. The "study" here is essentially a comparison of the device's characteristics and intended use with a predicate device.

Ask a specific question about this device