Search Results

The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.

The EndoHelix endarterectomy device is a tubular device with an expanding helical element at the distal tip. The expandable helical element is controlled by the user with a sliding tab on the handle. The device is designed to be used with or without a guidewire. The device is packaged in an industry standard Tyvek/Mylar pouch and is provided sterile. The EndoHelix device is a single use product and is not intended to be resterilized or reused.

This document, a 510(k) summary for the EndoHelix™ Endarterectomy Device, does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria. The level of detail you are requesting, commonly found in clinical trial reports or pre-market approval (PMA) applications, is not typically present in a 510(k) summary like this one.

Here's a breakdown of why each specific piece of information from your request is largely absent or unaddressed by the provided text:

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

• Absence: The document states, "Testing was performed to assess product compliance with the product specification. Testing included device operation, wire actuation, and bond pull strengths. All product met specification."
• Explanation: This is a very high-level statement. It indicates some testing was done and that the device passed its own specifications, but it does not define what those specifications (acceptance criteria) were, nor does it provide any quantitative performance data. For example, it doesn't give a specific "bond pull strength" target (e.g., 5 N) and the achieved result (e.g., 5.2 N).

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

• Absence: No information provided regarding sample sizes for any tests. The document only mentions "Testing was performed..."
• Explanation: This document focuses on demonstrating substantial equivalence, not on providing results from a controlled clinical study with human subjects. The "testing" mentioned likely refers to bench testing (e.g., mechanical tests, material compatibility) rather than clinical performance testing with a specific "test set" of patients.

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)

• Absence: Not applicable. There is no mention of a "test set" that would require expert-established ground truth.
• Explanation: This type of information is relevant for studies involving diagnostic accuracy or clinical outcomes where a "ground truth" needs to be established (e.g., by expert consenso, biopsy). The EndoHelix device is an interventional device, and the provided document does not include such clinical study details.

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

• Absence: Not applicable. No clinical test set requiring adjudication is described.
• Explanation: Similar to point 3, adjudication methods are used in clinical studies when multiple observers interpret data and discrepancies need to be resolved to establish ground truth. This is not touched upon in this 510(k) summary.

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

• Absence: Not applicable.
• Explanation: This document describes a mechanical endarterectomy device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and discussions of "human readers improve with AI" are entirely irrelevant to this submission.

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

• Absence: Not applicable.
• Explanation: This question refers to the performance of an algorithm (typically AI or software). The EndoHelix is a physical medical device.

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

• Absence: Not applicable.
• Explanation: As discussed, no clinical performance testing with a "ground truth" is detailed in this 510(k) summary.

8. The sample size for the training set

• Absence: Not applicable.
• Explanation: There is no "training set" as this is a physical medical device, not an algorithm that requires training data.

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

• Absence: Not applicable.
• Explanation: Similar to point 8, there is no training set mentioned or implied.

In summary, the provided 510(k) document focuses on demonstrating substantial equivalence based on device description, materials, and a general statement about meeting internal product specifications. It does not contain the detailed clinical or performance study information you are asking for, which would be typical for a dataset used to validate specific acceptance criteria in a clinical context.

Ask a specific question about this device