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KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.

Device Description

The KARL STORZ New Generation Trocars provide a port of entry during endoscopic and laparoscopic procedures in pediatric and adult patients. The New Generation Trocars are available in diameters 2.5mm to 13.5mm and consist of a cannula, trocar, and a valve seal. The trocars combine single-use and reusable components since the valve seal is single use while the cannula and trocar are reusable components. The trocars are color coded by size and are available with pyramidal, conical, or conical-blunt tips. Reducers can be used to reduce the size of the trocar to accommodate a smaller instrument without losing pneumoperitoneum.

AI/ML Overview

The KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance
Seal Leak Test	Adequate sealing to maintain pneumoperitoneum	Bench verification performance testing was performed.
Seal Leak Test while Under Torque	Adequate sealing under torque conditions	Bench verification performance testing was performed.
Instrument Insertion and Retention Test	Instruments can be inserted smoothly and retained securely	Bench verification performance testing was performed.
Penetration Force	Acceptable force required for tissue penetration	Bench verification performance testing was performed.
Compression Testing of the Cannula	Cannula withstands compressive forces without failure	Bench verification performance testing was performed.
Bending Testing of the Cannula	Cannula withstands bending forces without failure	Bench verification performance testing was performed.
Torsional Testing of the Cannula	Cannula withstands torsional forces without failure	Bench verification performance testing was performed.
Biocompatibility
Biocompatibility	Compliant with ISO 10993 standards	Biocompatibility evaluation was performed to ISO 10993.
Sterility (Reusable Components)
Sterility (Reusable Cannula, Trocar, Reducer)	Compliant with ISO 11135 (Steam sterilization)	Sterility of the Reusable Components was validated in accordance with ISO 11135.
Sterility (Sterile Single-Use Components)
Sterility (Sterile Single-Use Valve Seals)	Compliant with ISO 11135 and ISO 10993	Sterility of the Sterile Single Use Components was validated in accordance with ISO 11135 and ISO 10993.
Packaging (Sterile Single-Use Components)
Packaging (Sterile Single-Use Valve Seals)	Compliant with ISO 11607 and ISO 11737	Packaging for the Sterile Single Use Components was validated to ISO 11607 and ISO 11737.
Clinical Performance	Demonstrate substantial equivalence to predicate device in terms of safety and effectiveness for intended use	Clinical testing was not required; non-clinical bench testing and medical literature review were considered sufficient to assess safety and effectiveness and establish substantial equivalence.
Usage in Pediatric Population	Safe and effective for use in pediatric patients	Supported by real-world evidence (medical literature) referencing pediatric minimally invasive surgery effectiveness and safety.
Electromagnetic Compatibility (EMC)	Not applicable	The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation.
Electrical Safety	Not applicable	The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation.
Software Validation	Not applicable	The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation.

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

The document does not specify exact sample sizes for each bench test performed. It generally states that "Bench verification performance testing has been performed" for the listed parameters.

Data Provenance: The studies were bench tests performed by the manufacturer, KARL STORZ Endoscopy-America, Inc. There is no information about the country of origin of the data beyond the manufacturer's location in El Segundo, CA. All testing appears to be retrospective in the sense that it was completed prior to the 510(k) submission.

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

Not applicable. The "ground truth" for the performance tests was established through direct measurement against pre-defined engineering and regulatory standards (e.g., ISO standards, specific force/leakage thresholds set by the manufacturer for functional performance). There is no mention of human experts establishing ground truth for these objective bench tests.

4. Adjudication Method for the Test Set

Not applicable. For objective bench tests, results are typically determined by measurement against specified criteria, not by human adjudication.

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

Not applicable. This device is a mechanical surgical instrument (trocar), not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance. No MRMC study was performed.

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

Not applicable. This device is a mechanical surgical instrument; it does not involve algorithms or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the bench tests was based on engineering specifications and established regulatory standards (e.g., ISO standards). For example, for biocompatibility, the ground truth was compliance with ISO 10993. For sterility, the ground truth was validation against ISO 11135 and ISO 11737. For mechanical tests, the ground truth would be the defined acceptable ranges for forces, leakage, etc.

For the expansion of indications to include a pediatric population, the "ground truth" was established through medical literature review (real-world evidence) from various peer-reviewed publications covering pediatric minimally invasive surgery.

8. The Sample Size for the Training Set

Not applicable. This device does not use an algorithm that requires a training set. The term "training set" is typically associated with machine learning or AI models.

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

Not applicable. As there is no algorithm or AI, there is no training set or ground truth associated with it.

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