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The LeMills Valvulotome is intended to cut venous valves.

The LeMills Valvulotome consists of small metal retrograde cutting blade with atraumatic distal edge. The blade is a part of a long section of 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 LeMills Valvulotome is a medical device designed to cut venous valves. The provided text is a 510(k) summary for its clearance.

Here's an analysis of the provided information, specifically addressing the requested points:

K132047: LeMills Valvulotome

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document references "product performance requirements of the device specifications" and "Summary of Product Testing," but it does not explicitly list quantitative acceptance criteria or detailed reported performance values. Instead, it focuses on demonstrating substantial equivalence to a pre-amendment predicate device (Mills Valvulotome) through functional and safety testing.

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

The document does not specify a sample size for any test set related to performance or clinical evaluation. The tests mentioned (dimensional comparison, sharpness) appear to be bench or lab-based assessments rather than patient-based studies. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).

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

This information is not applicable as the studies described are not clinical trials or diagnostic assessments requiring expert established ground truth. The tests are focused on the physical and functional aspects of the device itself.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of clinical studies or diagnostic assessments where adjudication of results would be required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not a diagnostic imaging device typically evaluated with MRMC studies. The approval is based on substantial equivalence to a predicate device, supported by bench testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This concept is not applicable to the LeMills Valvulotome. This is a manual surgical device; there is no "algorithm only" component.

7. The Type of Ground Truth Used:

For the tests performed:

• Dimensional Comparison: Ground truth would be the design specifications and measurements of the device itself and the predicate device.
• Sharpness Test (Effectiveness Test): Ground truth would likely be established by a defined testing methodology to assess cutting efficacy in a simulated environment (e.g., cutting a specific material mimicking venous valve tissue).
• Sterilization: Ground truth is defined by regulatory standards (ANSVAAMI/ISO 11135-1:2007).
• Biocompatibility: Ground truth is defined by regulatory guidelines (ISO 10993).

There is no mention of pathology, expert consensus from clinical cases, or outcomes data used to establish ground truth for the performance tests in this 510(k) summary.

8. The Sample Size for the Training Set:

This information is not applicable. The LeMills Valvulotome is a physical medical device, not a machine learning or AI-based system that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above.

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