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Eu-tTG®IgA assay is a qualitative ELISA test for the in vitro diagnostic detection of IgA antibody against the enzyme tissue Transglutaminase in human serum. This test is designed for use as an aid in the diagnosis of Celiac Disease.

Enzyme Immunoassay Kit

The provided text is a 510(k) clearance letter from the FDA for a device called "Eu-tTG® IgA Assay." This document is a regulatory communication, not a study report or clinical trial summary.

Therefore, it does not contain the information requested regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets and ground truth establishment.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the indicated use as "an aid in the diagnosis of Celiac Disease."

To obtain the requested information, one would need to consult the actual 510(k) submission document (K994379) itself, which would include the study data and performance claims.

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The SCIMED EXPO and Impulse Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

The modified SCIMED EXPO and Impulse angiographic catheters are the same as the SCIMED EXPO and Impulse angiographic catheters currently on the market with the exception of the new hub material.

The provided document describes a 510(k) submission for a device modification (K992142) for SCIMED EXPO and Impulse Angiographic Catheters. The modification is a change in the hub material. This submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving overall effectiveness or providing a detailed study of an AI/ML algorithm's performance.

Therefore, many of the requested categories are not applicable to this type of regulatory submission. The document reports on functional testing and biocompatibility testing of the new hub material to ensure the modified device maintains its safety and effectiveness, but it does not describe an AI/ML device study.

Here's a breakdown of the requested information based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to a device modification submission of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not provided. The document mentions "functional testing" and "biocompatibility testing" but does not specify the number of units or samples tested.
• Data Provenance: Not applicable/Provided. This is a technical performance test, not a clinical data study with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. Ground truth for functional and biocompatibility testing is typically established through direct measurement against predefined specifications, not expert consensus on clinical cases.

4. Adjudication Method for the Test Set

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This device is an angiographic catheter, not an AI/ML diagnostic tool requiring MRMC studies for human reader improvement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a medical instrument, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the functional testing, the ground truth would be the established performance specifications for the catheter (e.g., flow rates, pressure resistance, structural integrity). For biocompatibility, it would be the established safety standards for biological interaction (e.g., cytotoxicity, sensitization, irritation). These are determined through engineering and materials science standards.

8. Sample Size for the Training Set

• Not applicable. There is no AI/ML algorithm discussed that would require a training set.

9. How the Ground Truth for the Training Set was Established

• Not applicable. There is no AI/ML algorithm discussed.

Explanation for Limited Information:

The document is a 510(k) submission for a minor device modification (change in hub material for an angiographic catheter). For such submissions, the focus is on demonstrating that the new material does not negatively impact the device's safety and effectiveness compared to the predicate device. This is typically achieved through engineering tests (functional testing) and materials science tests (biocompatibility testing) rather than clinical studies or AI/ML evaluations. The provided text is a summary and does not delve into the detailed methodologies or quantitative results of these tests, which would be part of a more comprehensive submission not fully included here.

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