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The Port Access System is indicated for use in laparoscopic procedures to the abdominal and thoracic cavities while maintaining pneumoperitoneum.

The Port Access System consists of reusable and single use components sold in various configurations. The ports accommodate laparoscopic instrument diameters from 5mm up to the diameter indicated on the chosen accompanying cannula. All single use parts are sterlised using gamma irradiation and supplied to the customer in a sterile condition.

In order to obtain access to the surgical site during laparoscopic surgery, the trocar is introduced into the cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the single use seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments.

This document is a 510(k) Premarket Notification from the FDA regarding a device called the "Port Access System." It details the device's indications for use, comparison with a predicate device, and performance data. However, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI-powered system or a study involving human readers.

Here's why the prompt's requested information cannot be fully extracted from the provided text:

• Type of Device: The "Port Access System" is a surgical instrument (laparoscopic port system), not an AI-powered diagnostic or decision-making tool. Therefore, many of the requested criteria (e.g., AI model performance metrics, ground truth establishment for AI, MRMC studies) are not applicable.
• Nature of Performance Data: The performance data discussed are related to the physical characteristics and functionality of the surgical device (biocompatibility, sealing performance, insertion force, fatigue, shelf life, cleaning/sterilization), not to diagnostic accuracy or human interpretation tasks.
• Absence of Specific Acceptance Criteria Table: While safety and effectiveness are general criteria, there isn't a table of specific numerical acceptance criteria for performance metrics (like sensitivity, specificity, AUC) and reported device performance against those criteria in the context of an AI study.
• No Clinical Studies: The document explicitly states, "No Clinical Studies were conducted as part of this submission. Non-Clinical Testing was sufficient to demonstrate substantial equivalence to the predicate device." This means there would be no data on human reader performance, expert ground truth, or adjudication methods in a clinical setting for this device regarding diagnostic or interpretive tasks.

Given the context of the provided document, the following points can be addressed, and others explicitly stated as not applicable or not found:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for the type of device described (surgical instrument, not AI/diagnostic). The document broadly states "safety and effectiveness" and "performs within its design specifications" were evaluated through non-clinical testing. Specific numerical acceptance criteria for functional performance tests (e.g., maximum insertion force, minimum seal integrity) are likely present in the underlying test reports but are not provided in this summary document.

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

• Test Set Sample Size: Not specified for individual non-clinical tests. The tests were performed on components and the system itself (e.g., seals, cannulas, trocars). This is not a "dataset" in the sense of AI or clinical studies.
• Data Provenance: The device is manufactured by Surgical Innovations Limited in the United Kingdom. Testing was conducted to US FDA guidance and international standards (ISO 10993-1).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. "Ground truth" in the context of AI or diagnostic accuracy studies is not relevant for a physical surgical instrument's mechanical and material performance testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1) are used for resolving disagreements in expert interpretations, which is not relevant for the non-clinical testing of a surgical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC comparative effectiveness study was not done. The device is a surgical instrument, not an AI-assisted diagnostic tool.

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

No. This concept is not applicable as the device is a physical surgical port system, not an algorithm.

7. The type of ground truth used

Not applicable in the sense of diagnostic/AI ground truth. For the non-clinical tests, the "ground truth" would be the measured physical properties and performance characteristics against pre-defined engineering specifications and regulatory standards. For example, "sealing performance" would be measured directly against a specified leakage rate.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable, as there is no training set.

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The EndoDirect arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The cannula is intended to deliver oxygenated blood for cardiopulmonary bypass for a duration of less than 6 hours. The EndoDirect arterial cannula also allows the hemostatic introduction and removal of vascular catheters such as the Port Access EndoClamp aortic catheter. The EndoDirect arterial cannula is intended for introduction and use through a thoracic trocar or incision.

The AutoIncisor Introducer is intended for use with Port Access arterial cannulae. It is intended for incising the aorta and introducing the cannula into the aorta.

Edwards EndoDirect arterial cannula is a flexible plastic tube intended to provide a means of safely delivering oxygenated blood for cardiopulmonary bypass procedures and allows for the hemostatic introduction and removal of vascular catheters.

The EndoDirect arterial cannula has the following features: a beveled tip with an end hole, side perfusion holes, and a stabilizer ring for suture and tourniquet, a wirewound shaft for flexibility and kink resistance, a barbed connection site with 3/8 in. acceptance, a hemostasis valve, and a mark indicating tip orientation. A lubricious coating is applied to the surface of the cannula body to facilitate ease of insertion and retraction of the EndoClamp aortic catheter.

The provided text describes a 510(k) submission for the Edwards Lifesciences EndoDirect Arterial Cannula. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, study design elements (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance), and training set details are not applicable or not provided in a 510(k) summary for a device like an arterial cannula.

Here's an explanation based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in this context. For a 510(k) submission of a device like an arterial cannula, the "acceptance criteria" are related to demonstrating substantial equivalence to a predicate device, not necessarily meeting a predefined set of performance thresholds in a clinical study with specific sensitivity/specificity metrics.

• The document states: "The functional data indicate that the proposed device performs in a substantially equivalent manner when compared with the predicate device."

  Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
  Intended Use: Comparable	"comparable to the predicate device in intended use and other labeling"
  Fundamental Scientific Technology: Comparable	"comparable... fundamental scientific technology"
  Material Type: Comparable	"comparable... material type"
  Principles of Operation: Comparable	"comparable... principles of operation"
  Functional Performance: Substantially Equivalent	"The functional data indicate that the proposed device performs in a substantially equivalent manner when compared with the predicate device."

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

• Not Provided / Not Applicable in this context. The 510(k) summary does not describe a clinical "test set" in the way one would for an AI/diagnostic device. The "functional data" mentioned is likely from bench testing (e.g., flow rates, pressure resistance, kink resistance, material compatibility, etc.) rather than a clinical trial with human subjects. The details of such functional testing (sample size, specific test protocols, etc.) are typically submitted as part of the full 510(k) but are not included in the public summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As there's no clinical test set with a "ground truth" to establish in the context of an AI/diagnostic device, this information is not provided.

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

• Not Applicable. No clinical test set requiring adjudication is described.

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. This is a medical device (arterial cannula), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant and was not conducted.

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable in the AI/diagnostic sense. For a physical device, the "truth" is typically defined by engineering specifications, material properties, and performance metrics measured through bench testing. The substantial equivalence argument relies on comparing these aspects to a legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

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

• Not Applicable. As there is no training set, this information is not relevant.

In summary: The provided document is a 510(k) summary for a physical medical device (an arterial cannula). The primary goal of this submission is to demonstrate substantial equivalence to an existing predicate device, not to prove performance against specific acceptance criteria in a clinical study for a diagnostic algorithm. Therefore, many of the detailed questions related to AI/diagnostic device evaluation do not apply. The "study" mentioned is the "Functional/Safety Testing" which concluded that the proposed device performs in a "substantially equivalent manner when compared with the predicate device."

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