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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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