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The disposable Trocar has application in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Disposable trocar is mainly composed of Obturator with bladeless tip, Outer Seal Release Lever, Trocar Stability Sleeve, Obturator Locking Button, etc.

AI/ML Overview

The document provided describes a 510(k) premarket notification for a Class II medical device, the "Disposable Trocar," manufactured by Wuxi Shukang Medical Appliance Co., Ltd. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on comparative testing against a predicate, rather than a full, de novo study with acceptance criteria in the traditional sense of a clinical trial.

Here's an breakdown of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Disposable Trocar, and the "acceptance criteria" here are demonstrating equivalency to the predicate device in various non-clinical performance tests and biocompatibility.

Test Type	Acceptance Criteria (Implied: Demonstrate equivalency/compliance with standards)	Reported Device Performance
Visual Inspection	Meet design specifications	Conducted and met design specifications (conclusion implies).
Insertion and Removal Force	Comparable to predicate device	Conducted and demonstrated substantial equivalency (conclusion implies).
Leakage	Comparable to predicate device	Conducted and demonstrated substantial equivalency (conclusion implies).
In Vitro Penetration Force	Comparable to predicate device	Conducted and demonstrated substantial equivalency (conclusion implies).
In Vitro Retention Force	Comparable to predicate device	Conducted and demonstrated substantial equivalency (conclusion implies).
Biocompatibility (ISO 10993)	Compliance with standards for: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Test	Evaluated and supports that the subject devices are biocompatible.
Sterilization (ISO 11737-2)	Validation of Gamma irradiation process	Validation report provided.
Shelf Life (Accelerated Aging)	3 Years Shelf Life	Test of Sterile Barrier System validated for 3 years.

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

The document does not specify the exact sample sizes used for each non-clinical test (e.g., how many disposable trocars were tested for insertion force). It only states that "Performance tests were conducted."

Data Provenance: The tests were conducted internally by the manufacturer or by contract labs on behalf of the manufacturer, to demonstrate conformance with various international standards and equivalency to the predicate device. The country of origin of the data is not explicitly stated beyond the manufacturer being based in China. The data is from non-clinical (bench and lab) studies.

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

Not applicable in the context of this 510(k) submission. This is a non-clinical evaluation, not a clinical study involving human reads or expert consensus for "ground truth." The "ground truth" here is objective physical measurements and biochemical test results compared against established standards and predicate device performance.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study requiring adjudication of expert opinions. The assessment of test results would be based on comparison to pre-defined acceptance criteria (e.g., within a certain range of the predicate, or passing a specific threshold in a standard).

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

No MRMC study was done, as this is a medical device (trocar) and not an AI/imaging diagnostic device.

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

Not applicable, as this is a physical medical device, not an algorithm or AI.

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

The "ground truth" in this context is based on:

Objective physical measurements: For bench performance tests like insertion force, leakage, penetration force, and retention force, the ground truth is the measured values themselves, compared against the predicate device or a defined specification.
Established
biocompatibility standards (ISO 10993): For biocompatibility, the ground truth is defined by the results of specific standardized assays (e.g., cell viability in cytotoxicity tests), which determine if the material is biocompatible according to the standard.
Sterilization validation standards (ISO 11737-2): For sterilization, the ground truth is the validated sterility assurance level (SAL).
Accelerated aging protocols: For shelf life, the ground truth is determined by testing product performance after simulated aging, demonstrating it maintains its functionality for the claimed shelf life.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

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