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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 is a 510(k) Premarket Notification for a Laparoscope Lens Shield Device (LENS) for which the device is a laparoscopic accessory lens shield device 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 document describes modifications to a previously cleared predicate device (K170103) to accommodate laparoscopes with a 5mm outer diameter (the previous model accommodated 10mm). The submission is a "Special 510(k) Notification," indicating that the modifications do not raise new questions of safety or effectiveness. As such, the performance testing focuses on demonstrating that these modifications maintain substantial equivalence to the predicate device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics for the modified device in the manner typically seen for diagnostic AI/ML devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating that the modified device performs similarly to the predicate device and meets established medical device standards.

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

• Sample Size for Test Set: Not specified in terms of number of cases or specific specimens.
• Data Provenance:
  • Biocompatibility: Tested materials (implicitly, the materials used in the modified device). No geographic provenance for materials is given.
  • Mechanical Testing: Performed on the modified device itself.
  • Functional Testing: Performed in an animal model. No specific details on the animal model (e.g., species, number of subjects) or geographic origin are provided.

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

• Not Applicable. This device is a physical medical device (a lens shield), not a diagnostic AI/ML algorithm that requires expert-established ground truth for its performance evaluation (e.g., for image interpretation). The evaluation focuses on physical, chemical, and biological performance characteristics, verified through established testing protocols and animal studies.

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this is a physical device, and its performance evaluation does not involve diagnostic interpretation or adjudication typically associated with AI/ML systems where ground truth is derived from human expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No such study was done. This is a physical accessory device, not a diagnostic AI/ML algorithm that assists human readers in interpreting medical images. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This is a physical medical device, not an algorithm. Its function is to physically shield a laparoscope lens, not to perform a standalone diagnostic interpretation.

7. Type of Ground Truth Used

• Biocompatibility: Ground truth is established by meeting the specific pass/fail criteria outlined in the referenced ISO and USP standards (e.g., no cytotoxicity, no irritation, no systemic toxicity above thresholds).
• Mechanical Testing: Ground truth is established by verifying that the device meets its design specifications and maintains structural integrity under tested conditions.
• Functional Testing: Ground truth is established by observing that the device fulfills its intended use (maintaining the intra-operative view by shielding the lens) in the animal model. This is an observational functional assessment rather than a diagnostic "ground truth."

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device. It does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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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.

The Medeon Biodesign, Inc. Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device designed to maintain the intra-operative view during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids. The device was deemed substantially equivalent to a previously cleared predicate device (K160172).

Here's an analysis of the acceptance criteria and supporting studies, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provided does not explicitly define quantitative acceptance criteria for device performance as would be expected for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing intended use, technological characteristics, and showing that design modifications do not negatively impact safety or effectiveness.

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

The document describes performance testing which can be likened to a "test set" for evaluation.

• Biocompatibility Testing: The sample size for biocompatibility testing is not explicitly stated in terms of number of devices or test repetitions. The provenance is implied to be laboratory testing conducted according to recognized international standards (ISO 10993).
• Mechanical Testing: The sample size for mechanical testing is not explicitly stated. This would involve specific numbers of devices or components undergoing various mechanical stresses. The provenance is implied to be laboratory testing.
• Functional Testing: "Device functionality was tested in the animal model." The document does not specify the number of animals used, the species, or other details of the animal model. The provenance is an animal study.

Given the nature of the device (a physical accessory, not an AI/ML system), the concept of "country of origin of the data" and "retrospective or prospective" as typically applied to clinical data or AI training/test sets is not directly applicable here. The testing described is primarily in-vitro (biocompatibility, mechanical) and pre-clinical (animal model functional).

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

This question is not applicable in the context of this device and the provided document. The ground truth for biocompatibility is established by the results of standardized assays against ISO 10993 criteria, not expert consensus. The "ground truth" for mechanical integrity is adherence to design specifications verified through engineering tests. The "ground truth" for functional testing in the animal model would be the observable ability of the device to shield the lens and maintain the intra-operative view, likely assessed by the surgical team performing the animal procedure, but explicit expert involvement and qualifications for establishing this "ground truth" are not detailed.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for AI/ML devices to resolve discrepancies in expert interpretation of medical images or data. The testing described for this physical device does not involve such expert review or adjudication processes for its performance metrics.

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

This question is not applicable. The device is a physical laparoscopic accessory, not an AI/ML system, and therefore does not involve "human readers" or "AI assistance" in the sense of an MRMC study for diagnostic or prognostic AI.

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

This question is not applicable. The device is a physical laparoscopic accessory, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is implicitly derived from:

• Biocompatibility: Adherence to established biological safety standards (ISO 10993) based on laboratory assays.
• Mechanical Integrity: Compliance with engineering design specifications validated through mechanical testing.
• Functional Performance: Observable effectiveness in maintaining intra-operative view in an animal model. This would likely be clinical observation by the surgical team in the animal study.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product, not an AI/ML system, and therefore does not have a "training set."

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

This question is not applicable, as it relates to AI/ML systems which this device is not.

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