Search Results

Reprocessed trocars are intended to provide a pathway for entry of instruments during minimally invasive surgery, with particular applications in abdominal, gynecological, urological, and thoracic procedures.

Vanguard Reprocessed Trocar is a previously used device that has been cleaned, inspected, packaged and sterilized by Vanguard Medical Concepts, Inc.

Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 5-15cm length. Cannulae are equipped with a pressure seal for maintenance of pneumopertineum during insertion and withdrawal of instruments. Some models are equipped with a luer stopcock port for insufflation and desufflation of the operative cavity. Some models are provided with stability anchors inserted over the cannula sleeve to help seal the incision site and maintain cavity pressure.

Trocar Obturator is available in shielded and non-shielded configurations sized 5-15mm. Models equipped with a safety shield are designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated, so as to reduce the risk for vascular or visceral injury. Non-shielded optical obturators are equipped with a clear tip and an 11-12mm video laparoscopy channel to allow trocar insertion under direct visual guidance and minimize the risk for internal injury.

The provided text describes a 510(k) summary for Vanguard Reprocessed Dilating Tip and Blunt Trocars. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics for the reprocessed device. Therefore, much of the requested information regarding detailed study design, statistical analysis, and clinician-based performance metrics is not available within this document.

Here's an attempt to answer based on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally claims that "cleaning, sterilization, packaging validations, and performance and biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective."

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

The document does not specify a separate "test set" in the context of evaluating algorithm performance or diagnostic accuracy. It refers to "cleaning, sterilization, packaging validations, and performance and biocompatibility testing" as the basis for demonstrating safety and effectiveness.

• Sample Size: Not specified for each type of testing.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's likely these were laboratory or bench tests conducted by Vanguard Medical Concepts, Inc.

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

Since this is a reprocessed medical device approval, not an AI/diagnostic software approval, the concept of "ground truth" derived from experts in a clinical diagnostic context does not apply in the same way. The ground truth for the reprocessed device's safety and effectiveness would be established through:
* Bench testing: Measuring physical properties, functional performance against specifications.
* Sterilization validation: Demonstrating sterility.
* Biocompatibility testing: Ensuring material safety.

No "experts" in the sense of clinicians establishing ground truth for diagnostic accuracy are mentioned or relevant here.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic study requiring expert adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No MRMC comparative effectiveness study was done, as this is a device reprocessing approval for physical instruments, not a diagnostic AI or imaging interpretation system requiring human-in-the-loop performance evaluation.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

As this concerns a reprocessed physical device, the "ground truth" refers to established engineering standards, material science specifications, and regulatory requirements for sterility and biocompatibility.

• Engineering Specifications: Functional performance validated against the original equipment manufacturer's (OEM) device specifications.
• Sterility Assessment: Meeting established sterility assurance levels (e.g., 10^-6).
• Biocompatibility Standards: Adherence to ISO 10993 or similar standards.
• Cleaning Efficacy Standards: Demonstrating removal of organic and inorganic contaminants to acceptable levels.

8. The Sample Size for the Training Set

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device