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Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

This document pertains to the 510(k) premarket notification for the "Laparoscope Lens Shield Device (LENS)" by Medeon Biodesign, Inc., designated K200902. The focus of the information provided within this document is on establishing substantial equivalence to a predicate device (K192891) for a slightly modified version of the device, specifically to accommodate a 5mm/30°/30cm standard laparoscope.

Therefore, the acceptance criteria and study proving the device meets these criteria are primarily comparative and based on demonstrating that the modifications do not negatively impact the safety or effectiveness already established for the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is based on demonstrating substantial equivalence for a modified device to a predicate device, the "acceptance criteria" here are implicitly related to ensuring the modified device performs comparably and safely to the predicate. The performance testing focuses on verifying that the changes do not introduce new risks or reduce performance.

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

The document does not explicitly state the sample size (number of devices) used for the mechanical performance tests. It mentions "The following mechanical tests have been successfully performed," implying that a sufficient number of samples were tested to demonstrate compliance.

• Sample Size: Not explicitly stated, but implies a sufficient number of devices were tested to validate mechanical performance.
• Data Provenance: The tests were conducted internally by Medeon Biodesign, Inc. ("The mechanical function and structure integrity of modified device were tested..."). The document does not specify the country of origin of the data beyond Taiwan, where the submitter is located. The tests appear to be prospective as they were performed specifically for this 510(k) submission to demonstrate substantial equivalence of the modified device.

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

Not applicable in this context. This is a medical device (laparoscope lens shield) that operates on physical principles (shielding debris, maintaining view). The "ground truth" for its performance is directly measurable through engineering and mechanical tests (e.g., light reflection, field of view). It is not a diagnostic device that requires expert interpretation of outputs to establish ground truth (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is established through direct physical/mechanical testing, not through expert consensus or interpretation requiring adjudication.

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

No, an MRMC study was not done. This device is a physical accessory designed to maintain a clear surgical view, not a diagnostic imaging AI algorithm. Therefore, human reader performance (with or without AI assistance) is not a relevant metric for this device.

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 or AI.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established through direct engineering and mechanical measurements against pre-defined specifications (design input). For example, "Field of view test" and "Light reflection test" would have clear, measurable pass/fail criteria.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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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 <151>) 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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