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The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.

The PhasTIPP System consists of an Illuminator and a Resector. During the surgical procedure, the illuminator shaft is placed through an incision under the skin with its light-emitting end to provide intense light for a better visualization of the varicose veins. A port that runs along the illuminator shaft is used to infuse tumescence solution to cause the contraction of varicosities, which aids vein visualization by creating a subcutaneous fluid pocket through which the illuminator's light can disperse. A powered resector, positioned through a different incision can then be used to morcellate and aspirate the varicosities.

The PhasTIPP Illuminator consists of two devices: a reusable Illuminator Handpiece and a disposable Illuminator.

The Handpiece provides illumination controls and contains an LED to provide intense light. The Handpiece is powered with new batteries for each new surgical procedure (Duracell CR 123a cell). The handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Illuminator in the sterile field before the procedure begins.

The Disposable Illuminator includes, in addition to the microbial barrier sheath, a distal stainless steel fiber optic light shaft. When connected to a peristaltic pump, the Disposable Illuminator can also infuse tumescence.

The PhasTIPP Resector consists of two devices: a reusable Resector Handpiece and a Resector Disposable (available in two diameters, 4.5mm and 5.5mm). The Disposable Resector also connects to a peristaltic suction pump to remove the resected varicosities.

The Resector Handpiece provides controls for the operation of the rotation blades on the Disposable Resector and is powered with a set of new batteries (TLM-1550 HPM cell), for each surgical procedure. The Resector Handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Resector in the sterile field.

The Control Unit that was a large equipment in the predicate device is displaced in the subject device. Instead, the Resector Handpiece and the Illuminator Handpiece control the disposable resector and illuminator in the subject device.

This document describes the PhasTIPP System, an external vein stripper. The FDA's 510(k) summary provides details about the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.

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

The provided document doesn't explicitly state "acceptance criteria" in a tabulated format alongside "reported device performance" in the way one might expect for a clinical study with primary endpoints. Instead, it lists various design validation, system validation, and performance tests that were completed to demonstrate the device meets product performance specifications and for substantial equivalence.

For the purpose of this request, I will infer the "acceptance criteria" from the types of tests performed and the "reported device performance" as the overall statement that the device meets these specifications.

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The Smith & Nephew Tumescent Catheter Inversion System is intended to provide a system for removal of incompetent greater saphenous veins.

The Smith & Nephew Tumescent Catheter Inversion System provides a system for removal of incompetent greater saphenous veins. The system also provides the capability to flush the tunnel left behind from the removal of the vein with tumescent solution.

The provided text is a 510(k) summary for the Smith & Nephew Tumescent Catheter Inversion System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed performance metrics commonly associated with such studies (like sample sizes, ground truth establishment, or expert qualifications).

The document explicitly states:

H. Summary Performance Data

"There are no known performance standards or special controls promulgated under section 514 of the Act for this device has been tested and found to be in compliance with ISO 10993-1 and at the time of commercialization will be in compliance with applicable sterilization standards. This device has been tested and found to be safe and effective for its intended use."

This statement indicates that while the device was tested for safety and effectiveness and compliance with ISO 10993-1 (biocompatibility) and sterilization standards, the submission does not include a detailed study with acceptance criteria and reported performance data in the manner typically seen for complex diagnostic or AI-based devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a pre-amendment device based on similar design, materials, function, and intended use, rather than presenting a detailed performance study against quantified acceptance criteria.

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Indicated for use in ambulatory phlebectomy procedures for resection and ablation of varicose veins.

The Smith & Nephew TriVex™ System consists of a control unit mounted on a pedestal stand, dual peristaltic pumps, an illuminator, resector handpiece and footswitches.

The Smith & Nephew TriVex™ System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

The provided document does not contain any information about sample sizes for a test set or the provenance of any clinical data (e.g., country of origin, retrospective or prospective). The submission primarily focuses on substantial equivalence based on technological characteristics and safety standards.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

This information is not provided in the document. As no clinical test set performance data is detailed, information about experts for ground truth establishment is absent.

4. Adjudication Method for Test Set:

This information is not provided in the document.

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

The document does not mention or describe any MRMC comparative effectiveness study comparing human readers with and without AI assistance. This device is not an AI-powered diagnostic system; it's a surgical tool.

6. Standalone (Algorithm Only) Performance Study:

The document does not describe any standalone algorithm performance, as the device is a physical surgical system, not an algorithm.

7. Type of Ground Truth Used:

Based on the provided text, the "ground truth" for the device's acceptance is based on its compliance with established safety and biocompatibility standards (ISO 10993-1, UL 60601-1, IEC 60601-1) and its substantial equivalence to existing legally marketed predicate devices in terms of intended use, design, materials, and function. There is no mention of clinical outcome ground truth in a study.

8. Sample Size for Training Set:

This information is not applicable and not provided. The TriVex™ System is a medical device, not an AI model requiring a training set in the conventional sense. Its "training" would be through engineering design, material selection, and manufacturing processes, guided by established standards and predicate device characteristics, not data-driven machine learning.

9. How Ground Truth for Training Set Was Established:

This information is not applicable and not provided. The "ground truth" for the development of such a device stems from engineering principles, regulatory compliance requirements, and the established safety and efficacy of the predicate devices it aims to be equivalent to.

In summary:

The acceptance of the Smith & Nephew TriVex™ System by the FDA, as indicated by the 510(k) clearance (K032387), is based on its demonstration of substantial equivalence to existing predicate devices and its compliance with relevant biocompatibility and electrical safety standards. The submission focuses on these aspects rather than detailed clinical performance studies with specific patient or image-based test sets, which are typically required for diagnostic algorithms or novel therapeutic devices requiring extensive clinical validation.

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