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The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

The AbClose™ - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques.

The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.

This document describes the AbClose - Port Site Closure Device, which is a sterile, single-use device used in laparoscopic procedures for tissue approximation and percutaneous suturing to close incision sites.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance in a quantitative table. Instead, it states that various tests were performed and "all the results were passed," indicating that the device met the internal design specifications and requirements. The core acceptance is framed around demonstrating substantial equivalence to the predicate device (K160117).

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

• The document does not specify the sample sizes used for each of the mechanical tests or the animal study. It only states that the tests were "successfully performed" with "all the results were passed."
• Data Provenance: The animal study was mentioned, implying prospective data collection for the functional testing. The biocompatibility and mechanical tests are typically lab-based studies. The country of origin for the data is implied to be related to the manufacturer, Medeon Biodesign, Inc., which is based in Taipei, Taiwan.

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

• This information is not provided in the document. The studies described are primarily engineering/laboratory tests and an animal model, not studies requiring human expert adjudication for ground truth (e.g., image interpretation).

4. Adjudication Method for the Test Set:

• This information is not applicable/provided as the studies described do not involve human expert adjudication in the context of diagnostic accuracy or similar tasks.

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:

• An MRMC study was not performed. The device described is a surgical instrument (port site closure device), not an AI-assisted diagnostic or interpretive tool.

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

• A standalone performance study in the context of an algorithm or AI was not performed, as the device is a physical surgical tool. The functional animal study could be considered a "standalone" performance test of the device itself.

7. The Type of Ground Truth Used:

• Biocompatibility: Ground truth is established by the well-defined scientific standards and recognized guidance (ISO 10993 series, USP Chapter ) which describe the expected biological responses to materials.
• Mechanical Testing: Ground truth is established by the engineering design specifications and predefined pass/fail criteria for each test (e.g., minimum force, number of cycles, dimensional tolerances).
• Functional Testing (Animal Model): Ground truth is established by the successful execution of the intended surgical function (approximating tissues, closing incision sites) in the animal model, as defined by appropriate veterinary/surgical endpoints. This typically involves observation of successful closure, absence of complications related to the device, and potentially histological examination of the tissue if relevant.

8. The Sample Size for the Training Set:

• This is not applicable as the device is a mechanical surgical instrument, not an AI/ML algorithm that requires a training set.

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

• This is not applicable for the reason stated in point 8.

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The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures. facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.

The provided document indicates that the AbClose - Port Site Closure Device has undergone performance testing to demonstrate that it meets performance specifications for its intended use. However, it does not explicitly state acceptance criteria in a quantifiable manner (e.g., specific thresholds for success/failure rates, mechanical strength, etc.) or provide detailed device performance data in a table format.

Instead, the document broadly describes the types of studies conducted and their general conclusions regarding device functionality and safety.

Here's an attempt to structure the information based on your request, with missing information clearly noted:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific, quantifiable acceptance criteria for mechanical tests (e.g., force thresholds, cycles to failure).
• Specific, quantifiable acceptance criteria for animal tests (e.g., success rate of closure, absence of complications).
• Detailed performance results (e.g., numerical data, statistical analysis) from any of these tests.

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

• Sterilization Validation: The document states "Sterilization validation was conducted." It does not specify the sample size (e.g., number of devices tested).
• Mechanical Testing: The document states "Abclose - Port Site Closure Device's mechanical function and structure integrity were tested." It does not specify the sample size (e.g., number of devices tested).
• Animal Test: The document states "The intended use has been conducted by animal test." It does not specify the sample size (number of animals, number of procedures).
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter is in Taipei, Taiwan, it's plausible the studies were conducted there, but this is not confirmed. The context implies these were prospective studies designed to evaluate the device.

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

• This information is not provided in the document. The studies described (sterilization, mechanical, animal) do not typically involve human experts establishing "ground truth" in the same way, for instance, a clinical trial with diagnostic image interpretation would. For animal models, the "ground truth" would be established by the observed physiological and anatomical outcomes/observations by veterinary professionals/researchers, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided and is generally not applicable to the types of studies (sterilization, mechanical, animal) described in the document. Adjudication is typically used in studies involving subjective assessments or different interpretations (e.g., clinical trials, image reading).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document describes sterilization validation, mechanical testing, and an animal test. These are not MRMC studies.

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

• This question is not applicable as the AbClose - Port Site Closure Device is a manual medical instrument, not an AI algorithm or a device with an automated "algorithm only" component. Performance is inherent to its mechanical function and interaction within an anatomical context.

7. The Type of Ground Truth Used

• Sterilization Validation: The "ground truth" is measured against industry standards (ISO 11135:2014) for sterility, achieving a specified SAL.
• Mechanical Testing: The "ground truth" is based on the device's design input specifications and the requirement for structural integrity and safety.
• Animal Test: The "ground truth" is the successful physical approximation of tissues and percutaneous suturing for closing incision sites, assessed through direct observation and potentially histological examination in an animal model.

8. The Sample Size for the Training Set

• This information is not applicable as the document describes a mechanical medical device, not a device that utilizes machine learning and therefore does not have a "training set."

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

• This information is not applicable for the same reason as above; there is no training set for this type of device.

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