Search Results

Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, 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 Laparoscope Lens Shield Device (LENS) is a laparoscope 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 document describes the Medeon Biodesign, Inc. Laparoscope Lens Shield Device (LENS). However, it does not contain a detailed study report that proves the device meets specific acceptance criteria for its performance (e.g., maintaining intra-operative view consistently), nor does it provide a table of acceptance criteria with reported device performance metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.

The provided information primarily focuses on establishing substantial equivalence to a predicate device (K151117) for a modified version of the LENS device, and lists types of tests conducted (biocompatibility, mechanical, functional).

Here's an analysis of what information is available and what is missing based on your specific questions:

1. A table of acceptance criteria and the reported device performance

• Missing. The document confirms that functional testing was performed ("Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled."). However, it does not provide a table of quantitative acceptance criteria for this functional performance (e.g., a specific percentage reduction in lens soiling, or a duration for which the view is maintained without cleaning) nor the reported performance against such criteria. It only states qualitatively that "design modifications do not alter the device function and intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document mentions "animal model" for functional testing but does not specify the sample size (e.g., number of animals, number of trials).
• Data Provenance: The document does not specify the country of origin for the animal model data. It is implied to be prospective testing carried out for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not specified. For a device like a lens shield, ground truth would likely be established based on direct observation of the lens cleanliness or image clarity during the functional tests, not typically through expert consensus on interpretations of output. The document does not mention experts or their qualifications being used to establish ground truth for the functional testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not specified. Adjudication methods are typically relevant for studies where subjective interpretation or classification is involved, often in diagnostic imaging. For a functional device like this, the assessment of "device function and intended use" would likely be based on objective observations (e.g., visual clarity, presence of debris) rather than an adjudication process among multiple reviewers.

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 device is a physical laparoscopic accessory, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related metrics are not relevant to this product.

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

• Not applicable. This device is a physical shield, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the functional testing, the ground truth would likely be based on:
  • Direct observation of the laparoscopic view: Assessment of image clarity, presence or absence of debris on the lens.
  • Measurement of physical parameters: Potentially measuring the time before the lens requires cleaning, or the number of cleanings prevented.
• The document states testing was done "to demonstrate that the intended use is fulfilled," which implies a ground truth defined by the successful maintenance of the intra-operative view. However, the specific criteria for this "ground truth" are not detailed.

8. The sample size for the training set

• Not applicable. Historical data or previous versions of the device might implicitly "train" the design process, but for a physical device, there isn't a "training set" in the sense of a machine learning algorithm.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

Summary Table of Available Information vs. Missing Information:

Ask a specific question about this device