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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 consisted of multi-lumen sheath that slides over the laparoscope. The sheaths assembly consists of 3 concentric sheaths: one outer and two 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 Laparoscope Lens Shield Device (LENS) is intended to be used by clinicians through prescription use only.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML device performance. The document is a 510(k) premarket notification from the FDA regarding a "Laparoscope Lens Shield Device (LENS)."

It outlines:

• Device Description and Intended Use: The device is a sterile, single-use, disposable accessory lens shield intended to maintain intra-operative view during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
• Substantial Equivalence: The document asserts substantial equivalence to a predicate device (Clear-Vu System) based on similar intended use, target patient/user population, anatomical site, use location, performance, and biocompatibility.
• Differences: Differences from the predicate device are noted in sterilization method (Ethylene Oxide vs. Radiation), energy source (None vs. CO2 Gas), and physical barrier material (PET film vs. CO2 Gas).
• Performance Testing: General categories of performance testing are listed:
  • Biocompatibility testing (in accordance with ISO standards)
  • Sterilization validation (in accordance with ISO 11135)
  • Mechanical testing (to demonstrate design specification fulfillment and structural integrity)
  • Image quality test: "Laparoscope Lens Shield Device (LENS) had been tested for view quality during laparoscopic procedures regarding the resolution, distortion, field of view, depth of view, and color, to demonstrate that adequate view quality of laparoscopy is maintained to a safe and effective clinical use."

However, the document does not provide any specific acceptance criteria (metrics or thresholds) or detailed results from these tests. It merely states that the tests were performed and that the device meets performance specifications or demonstrates adequate view quality.

Therefore, I cannot populate the requested table and information points as there is no data on acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth details.

The device described is a physical medical device, not an AI/ML diagnostic tool, which the detailed questions about "test set," "training set," "ground truth," "MRMC," and "effect size" typically pertain to.

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