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For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures

Three laparoscopic trocars and an insufflation tube bound by a flexible port.

The provided text is a 510(k) summary for the SILS™ Port, a surgical trocar. It includes information about the device's intended use and performance data, but it does not contain the specific details required to answer your questions about acceptance criteria, study design, and ground truth establishment.

The document states: "In-vitro and in-vivo testing has been performed in support of the intended use of this device." However, it does not elaborate on the specific acceptance criteria, the results of these tests, sample sizes, expert qualifications, or how ground truth was established.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone study was done: While "in-vitro and in-vivo testing" is mentioned, the specific nature of these studies (e.g., standalone vs. human-in-the-loop) and their results are not detailed.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, material biocompatibility, and the general statement of performance testing, rather than a detailed breakdown of a specific clinical or performance study with acceptance criteria and ground truth methodology.

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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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Both the Auto Suture* Cannula** and the Auto Suture* Modified Versaport* Trocar (K954108) are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry

The Auto Suture* Cannula** is a two piece device which consists of a reusable sleeve and a disposable plastic housing with seal adapter. While the Auto Suture* Modified Versaport* Trocar (K954108) is a totally disposable trocar with cannula.

The provided text is a 510(k) summary for a surgical instrument (Trocar Cannula) from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than conducting extensive clinical studies with acceptance criteria for performance metrics like accuracy, sensitivity, or specificity that are common for diagnostic AI devices.

Therefore, the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not applicable to this 510(k) summary for a manual surgical instrument.

Here's why each point isn't applicable:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) process for this type of device relies on comparing design, materials, and intended use to a legally marketed predicate, not on quantitative performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for this device.
4. Adjudication method for the test set: Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

The 510(k) summary provided details about:

• Submitter and Contact Person: United States Surgical Corporation, Janet G. Johnson.
• Date Prepared: August 9, 1996.
• Classification Name: Manual Surgical Instrument for general use.
• Common Name: Trocar Cannula.
• Proprietary Name: Trademark name not yet determined.
• Predicate Device: Auto Suture* Modified Versaport* Trocar (K954108).
• Device Description: A two-piece device consisting of a reusable sleeve and a disposable plastic housing with seal adapter. Compared to the predicate which is totally disposable.
• Intended Use: For use in various endoscopic procedures (gynecologic, general, thoracic, urologic) to create and maintain a port of entry.
• Materials: Component materials are in accordance with ISO Standard #10993-1, indicating biocompatibility assessment.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic AI or imaging device, and therefore the requested information regarding performance studies and acceptance criteria is not found within this context.

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