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The Weck® Vista™ Optical Bladeless Laparoscopic Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.

Weck® Vista™ Optical Bladeless Laparoscopic Access Port is used to establish a port of entry into the abdominal cavity, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The port is positioned into the peritoneum during minimally invasive surgical procedures, in order to provide a pathway for the insertion and removal of various sized surgical devices. The obturator of the Optical Bladeless Laparoscopic Access Port provides a channel for the insertion of a camera. At the proximal end of the obturator is a clear dilating tip for initial port entry to have visibility of the fasical layers. Additional stability ridges have been added to the outer cannula wall to enhance port fixation during surgery. Weck® Vista™ Optical Bladeless Laparoscopic Access Port is intended to be used by trained physicians.

The provided text is a 510(k) summary for a medical device (Weck® Vista™ Optical Bladeless Laparoscopic Access Port), which is a premarket notification to the FDA. This type of document focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria, ground truth, and statistical analysis typically associated with new drug applications or certain high-risk medical devices.

Therefore, many of the requested categories for "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not explicitly detailed in this 510(k) summary for this type of device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that "The bench testing has been performed to verify that the performance of the proposed Weck® Vista™ Optical Bladeless Laparoscopic Access Port is substantially equivalent to the predicate devices, and that the Weck® Vista™ Optical Bladeless Laparoscopic Access Port will perform as intended."

This implies that the acceptance criteria for this 510(k) were based on demonstrating comparable performance to the predicate devices for the new features (stability ridges, modified obturator for camera, modified funnel seal). However, the specific quantitative acceptance criteria (e.g., "stability must be X% better than predicate," "seal leakage must be less than Y ml/min") and the exact "reported device performance" against those criteria are not explicitly detailed in this summary. The summary concludes that the device is substantially equivalent and will perform as intended, but doesn't provide the raw data or specific metrics.

Therefore, a table cannot be accurately constructed from the provided information.

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

The document mentions "bench testing" but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). For this type of device, bench testing typically involves laboratory-controlled experiments on physical samples of the device.

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 and hence not provided. For physical device performance testing (bench testing), "ground truth" is typically established by engineering specifications, validated test methods, and quantitative measurements, not by expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for evaluating diagnostic performance with human readers, which is not the nature of this device's evaluation.

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 a medical device (surgical access port), not an AI diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

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

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device would be established by the engineering and design specifications for its intended function (e.g., maintaining insufflation, allowing instrument passage, providing stability, allowing camera use). Performance would be measured against these technical specifications and compared to the predicate devices. The document states "The bench testing has been performed to verify that the performance... is substantially equivalent to the predicate devices, and that the Weck® Vista™ Optical Bladeless Laparoscopic Access Port will perform as intended." This implies that the 'ground truth' is the expected performance of a functional and safe laparoscopic access port, as embodied by the predicate devices and general performance standards.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model that requires a 'training set.'

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary of what is known from the document:

• Acceptance Criteria (Implicit): Substantial equivalence in performance to predicate devices and performing as intended for its stated Indications for Use.
• Study Type: Bench testing.
• Performance: The device was found to be substantially equivalent in performance to the predicate devices (K010007 and K082156).
• Modifications: The key modifications relate to enhanced stability (ridges), accommodation for a camera (modified obturator and cap), and improved instrument guiding (conical entry feature in the floating top seal).
• Materials: All patient-contacting materials comply with ISO10993-1.

It's crucial to understand that 510(k) submissions for devices like this typically contain detailed technical reports of bench testing, including specific test protocols, acceptance criteria, and raw data, which are not included in the public 510(k) summary. The summary only presents the conclusion of these tests.

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