(29 days)
The LeMills Valvulotomes are intended to cut venous valves.
The Antegrade LeMills Valvulotome consists of small metal antegrade cutting blade with atraumatic distal edge. The blade is a part of a long stainless steel wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.
The provided document is a 510(k) premarket notification for the Antegrade LeMills Valvulotome, a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on novel performance studies and acceptance criteria as would typically be found for AI/ML-based devices or those requiring clinical trials for efficacy.
Based on the content provided, it is not possible to extract the information requested regarding acceptance criteria and a study proving the device meets them in the context of AI/ML performance, multi-reader multi-case studies, or complex ground truth establishment. This is because the device is a physical surgical tool (a valvulotome) designed to cut venous valves, and its approval relies on bench testing and comparison to existing predicate devices, not on diagnostic performance or AI algorithm validation.
However, I can extract the available information related to performance testing that was conducted:
1. A table of acceptance criteria and the reported device performance:
The document mentions "Functional/Safety Testing" and "Summary of Product Testing" but does not provide a specific table with acceptance criteria and corresponding reported device performance values. It generally states that the device meets performance requirements.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document for specific numerical thresholds. | The verification activities conducted indicate that Antegrade LeMills Valvulotome device meets the product performance requirements of the device specifications and does not raise any additional safety issues. |
| Tests listed: | |
| Dimensional Comparison | (Implied to meet specifications) |
| Sharpness Test (Effectiveness Test) | (Implied to be effective for cutting venous valves) |
| Visual Inspection | (Implied to meet quality standards) |
| Joint Tensile Strength (Pull Test) | (Implied to meet required strength) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the document. The tests appear to be bench-top physical tests performed on the device itself, rather than studies involving patient data.
- Data Provenance: Not applicable as it's not a data-driven diagnostic or AI device. The tests are for the physical properties and function of the surgical tool.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts/Qualifications: Not applicable. Ground truth for physical device testing is typically established through engineering specifications, material standards, and functional performance benchmarks, not expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. This concept is relevant for interpreting ambiguous clinical data, not for physical device testing.
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:
- MRMC Study: No. This device is a surgical tool, not a diagnostic imaging device or an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used:
- Ground Truth Type: For the physical tests mentioned (Dimensional Comparison, Sharpness Test, Visual Inspection, Joint Tensile Strength), the 'ground truth' would be the engineering specifications and design requirements for the device. For biocompatibility and sterilization, the ground truth is adherence to recognized standards (ISO 10993, ANSI/AAMI/ISO 11135-1:2007).
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).