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The CA-Guard Irrigating Cannula is intended to provide an access port to body cavities for endoscopes and endoscopic accessories when intraoperative irrigation or infusion of trocar wound surfaces is desired. The cannula has been tested for compatibility with lidocaine and marcane. Saline and water may also be used as irrigants. The CA-Guard Irrigating Cannula is inherently a needleless system and therefore, minimizes the possibility of "needle sticks" for healthcare workers, in accordance with the Needlestick Safety and Prevention Act of 2000.

The Irrigating Cannula is a non-toxic, sterile, single use, disposable surgical access port. The device is intended to be inserted percutaneously into the peritoneal cavity to provide access for endoscopic instruments. The cannula is intended to replace the cannula that is supplied with the United States Surgical Versaport® 11mm Trocar System.

The proximal end of the cannula is equipped with a female luer connector. The luer communicates with 6 longitudinal grooves on the surface of the inner member of the cannula. The inner member is covered with polyolefin shrink tubing. An array of twenty-four (24) holes deliver infusate to the compromised tissue surfaces of the trocar wound.

This document is a 510(k) premarket notification for an "Irrigating Cannula." This type of submission generally establishes substantial equivalence to a predicate device rather than strictly proving effectiveness against predefined acceptance criteria for a new clinical claim. Therefore, the information provided focuses on demonstrating equivalence through comparison and performance testing, rather than a clinical study with typical acceptance criteria for a diagnostic or AI-driven device.

Based on the provided text, here is an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of human data or a clinical trial. The performance evaluation appears to be based on laboratory or bench testing of the device itself and comparison to the predicate. No information is provided regarding the number of devices tested, the country of origin of data, or whether it was retrospective or prospective, as these are typically not applicable to this type of performance testing for a 510(k) submission of a cannula.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as there was no "test set" involving human data or expert review to establish ground truth in the clinical sense for this device. The evaluation was primarily engineering and materials-based.

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

This information is not applicable as there was no "test set" involving human data or expert review requiring 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

This information is not applicable. The device is an "Irrigating Cannula," a physical surgical instrument, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm.

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

The "ground truth" for this device's evaluation is not a clinical "ground truth" derived from patient outcomes or expert consensus. Instead, it relies on:

• Predicate device performance: The performance of the legally marketed United States Surgical Versaport® Trocar System (K954108) serves as the benchmark or "ground truth" for equivalence.
• Material properties and established biocompatibility: Existing scientific knowledge and history of use for chosen materials.
• Engineering specifications and functional testing: Device performance against its own design specifications and functional requirements (e.g., fluid flow, mechanical fit).

8. The sample size for the training set

This information is not applicable. The device is a physical surgical instrument, not an AI model requiring a training set.

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

This information is not applicable. The device is a physical surgical instrument, not an AI model that utilizes a training set with established ground truth.

Summary of the Study (as described in the document):

The "study" for the Irrigating Cannula was a performance characterization and comparison to a legally marketed predicate device (United States Surgical Versaport® Trocar System K954108) for the purpose of demonstrating substantial equivalence under a 510(k) submission.

• Comparison Basis: The new device was compared across "14 points of comparison" for technological characteristics, finding them "essentially identical" or equivalent.
• Performance Testing: "5 tests" were utilized to characterize and compare the performance of the Irrigating Cannula to the predicate device. The specific nature of these tests is not detailed, but they demonstrated substantial equivalence. These likely included tests related to mechanical integrity, fluid flow, and compatibility.
• Infusate Compatibility Testing: The cannula was specifically tested for compatibility with lidocaine and marcaine, finding it suitable for use with these and other common irrigants (saline, water).
• Biocompatibility: Relied on the "long history of biocompatibility" of the selected materials.
• Design & Manufacturing: The device was designed and developed using design control methods compliant with Quality System Regulations (QSR), and will be manufactured per specifications and Good Manufacturing Practices (GMP).

In essence, the "study" was a robust technical and engineering assessment, coupled with a formal comparison to a predicate device, focusing on functional equivalence, material safety, and compatibility rather than clinical efficacy or diagnostic accuracy, which are not relevant for this class of device in a 510(k) context.

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The Port-site Protector may be utilized in conjunction with devices intended for general laparoscopic cannula/trocar procedures.

The device contains an elastomeric mechanism, which tethers the device to the inside of the abdominal wall. This mechanism affords the device a known insertion depth as well as a conductive path to the abdominal wall.

This is an FDA premarket notification (510(k)) for a medical device called the "Port Site Protector". This document is a clearance letter, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study that proves the device meets those criteria, as typically found in a clinical trial report or a performance validation study.

The FDA 510(k) pathway is primarily to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through extensive clinical trials.

Therefore, I cannot provide the requested information based solely on the provided input. The input is a clearance letter, not a scientific study or a detailed technical documentation with performance metrics.

To answer your questions accurately, I would need access to the actual 510(k) submission document (which is usually much more extensive than this clearance letter) or publicly available summaries of its contents, if they exist and include performance data.

Based on the provided clearance letter (K992182) for the "Port Site Protector", I can state the following, but cannot fill in the details regarding acceptance criteria and study particulars because they are not present in this document:

• Device Name: Port Site Protector
• Regulatory Class: II
• Product Code: GCJ
• Regulatory Pathway: 510(k) Premarket Notification
• FDA Determination: Substantially Equivalent to predicate devices. This means the FDA agreed that the device is as safe and effective as a legally marketed device that existed before May 28, 1976, or has been reclassified.

I cannot create the requested table or answer the specific questions about sample size, ground truth, expert qualifications, etc., because those details are not in the provided clearance letter. These are generally found in the actual 510(k) submission, which would have included performance data or rationale for substantial equivalence.

In summary, the provided document does not contain the information requested to describe the acceptance criteria and the study that proves the device meets them. The letter confirms the FDA's decision but does not detail the evidence presented in the submission.

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