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The flexible laproscope can be used to view complete therapeutic procedures using approved laproscopic instrumentation. The laproscope is used as a viewing device to complete procedures such as Laprosopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Mtritus: Cervical Myoma. Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube toracistomy pierodesis, thoracoscopy pleurodesis.

EL2-TF410 Video Laproscope

I am referencing the provided text about the Fujinon EL2-TF410 Video Laproscope for the following response.

Based on the provided document, the device in question is a "Video Laproscope" and the document is a 510(k) clearance letter from the FDA. This type of document declares the device to be "substantially equivalent" to a predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness.

This document is a marketing clearance letter and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. It primarily focuses on the regulatory determination of substantial equivalence.

Therefore, I cannot provide the specific details requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

The document states:

• Trade Name: EL2-TF410 Video Laproscope
• Regulatory Class: II
• Product Code: GCJ
• Indications For Use: The flexible laparoscope can be used to view complete therapeutic procedures using approved laparoscopic instrumentation. The laparoscope is used as a viewing device to complete procedures such as Laparoscopic Cholecystectomy: Separation of Adhesions: Tubal Pregnancy: Uterine Hypoplasia: Infertilization: Metritis: Cervical Myoma. Also procedures within the Thoracic Cavity such as the diagnosis and staging of Intrathoracic disease, therapeutic thoracic procedures, wedge resections, tube thoracostomy pleurodesis, thoracoscopy pleurodesis.

To address your specific prompt, if this were a document containing performance study details, here's what would be expected:

1. A table of acceptance criteria and the reported device performance: This would typically list quantitative metrics (e.g., resolution, illumination, field of view, color accuracy, distortion) with specific thresholds for acceptance and the actual measured performance of the EL2-TF410.
2. Sample size used for the test set and the data provenance: Details on how many trials, images, or observations were used to evaluate the device's performance, and whether the data was collected retrospectively or prospectively, and from what geographical region.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For a device like a laparoscope, this isn't typically applicable in the same way as AI algorithms. Ground truth for a laparoscope is usually based on the physical characteristics of the device and its ability to provide clear visualization, rather than interpreting medical images for diagnosis.
4. Adjudication method for the test set: Again, not directly applicable to the physical performance of a laparoscope. This is more relevant for diagnostic AI tools where expert disagreement on ground truth might occur.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: MRMC studies are usually for diagnostic interpretation and comparing human readers with and without AI assistance. This device is a viewing tool, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a medical instrument, not a standalone algorithm.
7. The type of ground truth used: For a laparoscope, ground truth would be established through physical measurements and optical testing against industry standards or the performance of the predicate device.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory clearance for marketing and does not contain the detailed performance study information requested.

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