Search Results

The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

The VARI-LASE procedure kit contains a 600µm fiber and the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150 cm) 5Fr/25. 45, or 55 cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture kit

The provided text is a 510(k) summary for the Vari-Lase Endovenous Laser Procedure Kit. It describes the device, its intended use, and the conclusion that it is substantially equivalent to a predicate device. However, it does not contain any information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics.

Therefore, I cannot populate most of the requested fields. The document primarily focuses on regulatory submission and substantial equivalence rather than detailed performance testing.

Here's what I can extract and what remains unknown based on the provided text:

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

Explanation: The document states, "Testing has been conducted to verify the biocompatibility and performance of the fiber." However, it does not detail what those performance criteria were, how performance was measured, or the results of those tests. It concludes "substantial equivalence" based on indications for use and components, not specific performance metrics.

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

• Sample Size (Test Set): Not specified
• Data Provenance: Not specified (No details provided about the nature or origin of the "testing" mentioned).

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)

• Number of Experts: Not specified
• Qualifications of Experts: Not specified

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

• Adjudication Method: Not specified

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
• Effect Size: Not applicable (No MRMC study mentioned, and the device is a laser procedure kit, not an AI diagnostic tool for human readers).

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

• Standalone Study: Not applicable (The device is a physical medical instrument, not an algorithm, so "standalone" performance in the context of AI does not apply). The "performance of the fiber" mentioned likely refers to physical properties tested in a lab, not an algorithmic standalone performance.

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

• Type of Ground Truth: Not specified (since performance criteria and actual test results are not detailed).

8. The sample size for the training set

• Sample Size (Training Set): Not applicable / Not specified (No "training set" in the context of an algorithm is discussed for this physical device).

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

• Ground Truth Establishment (Training Set): Not applicable / Not specified.

Ask a specific question about this device

The VARI-I.ASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

The VARI-LASE procedure kit contains a 600µm fiber and may contain one ore more of the following accessories used to gain endovascular access: 0.035"/ stainless steel guide wire (lengths from 75 to 150cm) 5Fr/25, 45 or 55cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture Kit

The provided text describes a 510(k) premarket notification for a medical device called the "Vascular Solutions Vari-Lase™ Endovenous Laser Procedure Kit." The submission states, "No testing was required to document the safety and effectiveness of this modified procedure kit." Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (VARI-LASE Procedure Kit, K030654) based on a comparison of indications for use, components supplied, and technological characteristics.

Therefore, the study design elements typically found for novel device performance evaluation are not present here. The following information will reflect that no new performance study was conducted.

Acceptance Criteria and Device Performance

Since no new performance testing was conducted for K032805, there are no specific numeric acceptance criteria or reported device performance metrics for this submission. The basis for clearance was substantial equivalence to a predicate device, meaning the new device is considered as safe and effective as the previously cleared predicate without requiring new clinical or non-clinical performance data.

Study Details

1. Sample size used for the test set and the data provenance: Not applicable, as no new performance study was conducted. The submission states, "No testing was required to document the safety and effectiveness of this modified procedure kit."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no new performance study was conducted that required expert ground truth establishment.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no new performance study was conducted.

4. 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: Not applicable. This device is a laser procedure kit, not an AI-assisted diagnostic or interpretive tool. No MRMC study was performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser procedure kit, not an algorithm. No standalone performance study was conducted.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new performance study was conducted.

7. The sample size for the training set: Not applicable, as no new performance study was conducted, and this is not an AI/machine learning device.

8. How the ground truth for the training set was established: Not applicable, as no new performance study was conducted, and this is not an AI/machine learning device.

Conclusion from the 510(k) Summary:

The conclusion states: "The VARI-LASE Procedure Kit is substantially equivalent to the currently marketed VARI-LASE kit based on a comparison of the indications for use and the components supplied and the technological characteristics of the supplied components." This indicates that the clearance was based on similarity to a previously cleared device (K030654), and thus new performance data was deemed unnecessary by the FDA.

Ask a specific question about this device

The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

The VARI-LASE procedure kit contains a 600µm fiber and may contain one ore more of the following accessories used to gain endovascular access: 0.035" / stainless steel guide wire (lengths from 75 to 150cm) 5Fr/25 or 45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle or Micropuncture Kit

This document is a 510(k) premarket notification for a medical device. It does not describe an AI/ML device, nor does it contain information about acceptance criteria, study performance, or ground truth as requested in the prompt.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission for a physical medical device (a laser procedure kit for treating varicose veins) and details its substantial equivalence to a previously marketed device, not the performance of an AI model.

The sections for AI/ML device evaluation within your prompt (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to the content of this document.

Ask a specific question about this device

The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein

The VARI-LASE procedure kit contains a 600um fiber and the following accessories used to gain endovascular access: 0.035" / 150cm stainless steel guide wire 5Fr/45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle

The provided text is a 510(k) Summary for a medical device (Vari-Lase Endovenous Laser Procedure Kit) and the FDA's clearance letter. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The reasons are as follows:

• No specific acceptance criteria are listed for device performance. The submission relies on comparing the device's characteristics and intended use to an already cleared (predicate) device.
• No detailed study is described to demonstrate performance against acceptance criteria. The "Summary of Non-Clinical Testing" mentions tests for integrity and biocompatibility of marker bands, but these are general safety and materials tests, not performance studies as typically envisioned for clinical efficacy.
• There is no mention of a test set, ground truth, experts, or adjudication methods. These are elements of a clinical trial designed to prove effectiveness, which is not the primary purpose of a 510(k) submission focused on substantial equivalence.
• No information on MRMC studies or standalone algorithm performance is present, as this device is a physical instrument, not an AI or imaging diagnostic tool.
• No sample size for training or establishment of ground truth for a training set is applicable here, again because it's not an AI or algorithm-driven device.

In summary, the provided document is a regulatory submission for substantial equivalence, not a performance study report. It shows that the device is considered safe and effective because it is very similar to other devices already on the market, not through a head-to-head performance study against derived acceptance criteria.

Ask a specific question about this device