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Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cut sutures and cut nonmetallic materials during all flexible endoscopic procedures.
Ensizor® Monopolar Endoscopic Scissors are designed to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

The Ensizor Monopolar Endoscopic Scissors is a single-use ethylene oxide sterile electrosurgical scissors. This device is designed to be used with an electrosurgical monopolar HF generator to cut and dissect tissue, cauterize tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures.

The device is compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The maximum insertion portion diameter is 2.6 mm, and insertion lengths are 165 cm and 235 cm. The patented Edge Flex™ technology used for the Scissor Blades ("Blades") enhances the cutting performance of this flexible endoscopic scissors. The Ensizor's rotation feature enables accurate-radial positioning, and the nitinol actuator wire allows for tortuous endoscopic paths while minimizing loss of distal control. The Blades are designed with blunt tips to enable the atraumatic dissection of tissue planes and when closed, make a non-sharp rounded cauterizing surface.

The provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria, as requested in the prompt's outlined structure. Instead, the text is a 510(k) summary for the Ensizor Monopolar Endoscopic Scissors, comparing its technological characteristics and performance data to predicate devices to demonstrate substantial equivalence.

Specifically, the document includes:

• Trade/Device Name: Ensizor® Monopolar Endoscopic Scissors
• Indications for Use: Designed to cut and dissect tissue, cut sutures and cut non-metallic materials during all flexible endoscopic procedures, and also cauterize tissue.
• Predicate Devices: Ensizor® Endoscopic Scissors (K150939) and the Apollo Endosurgery Endoscopic Scissors (K090583).
• Performance Data: Nonclinical testing was performed to evaluate substantial equivalence. This involved "Product Attribute Testing," "Product Performance Testing," "Sample Cutting" various materials (rubber, polyethylene, different types of sutures), and an "Insulation Test." In all listed tests, both the Ensizor® Monopolar Endoscopic Scissors and the Apollo Endosurgery Endoscopic Monopolar Scissors "All units passed."
• Conclusion: Based on non-clinical performance data, the device is concluded to be as safe, as effective, and performs as well as or better than the predicate devices.

However, the summary does not provide:

1. A table of specific acceptance criteria (e.g., minimum tensile strength, maximum cutting force) and the reported device performance against those predefined criteria. Instead, it states "All units passed" for broad test categories and material cutting.
2. Sample size used for the test set or data provenance beyond "nonclinical testing."
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI assistance (this device is a surgical instrument, not an AI diagnostic tool).
6. Standalone performance (while non-clinical testing was done, the "acceptance criteria" against which it was measured are not detailed).
7. The specific type of ground truth used (e.g., pathology, outcomes data), beyond stating "raw chicken for electrocautery functionality test." The "All units passed" suggests qualitative or pass/fail criteria rather than quantitative ground truth.
8. Sample size for the training set (not applicable as this is not an AI/machine learning device).
9. How the ground truth for the training set was established (not applicable).

Therefore, I cannot fulfill the request using the provided input as the necessary information is not present.

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Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and dissect tissue and sutures during all flexible endoscopic procedures.

The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection and the cutting of sutures during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue and suture materials during all flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and study proving device performance as it relates to AI/ML devices. The document describes a 510(k) submission for "Ensizor Endoscopic Scissors," which are mechanical, non-AI medical devices.

Therefore, I cannot extract:

1. A table of acceptance criteria and reported device performance related to an AI/ML device.
2. Sample size used for the test set or data provenance for an AI/ML study.
3. Number of experts or their qualifications for establishing ground truth in an AI/ML context.
4. Adjudication method for an AI/ML test set.
5. MRMC comparative effectiveness study results (effect size of human readers with/without AI assistance).
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
8. Sample size for the training set of an AI/ML model.
9. How ground truth for the training set was established for an AI/ML model.

The document discusses non-clinical performance data for the endoscopic scissors, including:

• Operation in Tortuosity: Ensuring the device can open and close when the distal shaft is formed into a 20 cm diameter circle.
• Sample Cutting: Cutting various suture and polyethylene materials at least 10 times.
• Comparative Testing to US Endoscopy Suture Cutter: Functional testing in straight and tortuous pathways, and simulation testing to grasp and cut various sutures.

The table provided in the document summarizes acceptance criteria and performance for these mechanical tests, not AI/ML performance.

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Slater Endoscopy Ensizor Endoscopic Scissors are designed to cut and dissect tissue during flexible endoscopic procedures.

The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue during flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.

The provided text is a 510(k) Summary for the Slater Endoscopy Ensizor Endoscopic Scissors, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with all the specific elements requested for acceptance criteria and device performance evaluation.

Therefore, much of the requested information, particularly regarding the methodology of a detailed clinical or comparative effectiveness study (like MRMC studies, details on ground truth establishment for large datasets, or specific expert qualifications for adjudication), is not present in this type of regulatory submission. The document primarily details non-clinical bench testing.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set (Ensizor™ Endoscopic Scissors):
  • 15 units of 235 cm length
  • 15 units of 165 cm length
• Sample Size for Predicate Device (Apollo Endosurgery Endoscopic Monopolar Scissors):
  • 1 unit of 235 cm length
• Data Provenance: The data appears to be from in-house bench testing conducted by the manufacturer, Slater Endoscopy, LLC. The document does not specify country of origin for the data or if it's retrospective/prospective, but given it's a 510(k) submission for a new device, it's inherently prospective testing for regulatory approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes non-clinical bench testing, not a study requiring expert-established ground truth. The "ground truth" here is the objective performance of cutting and operation in tortuosity as measured by the testing protocols.

4. Adjudication method for the test set

Not applicable. There was no clinical study involving human assessment or adjudication described. The tests were objective performance evaluations.

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 document is for a mechanical surgical device (endoscopic scissors), not an AI/imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was included.

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

Not applicable. This is not an AI/algorithm device. The "standalone" performance here refers to the device's mechanical function, which was indeed tested independently.

7. The type of ground truth used

For the non-clinical testing described, the "ground truth" was established by the objective physical performance criteria for cutting and operation in tortuosity (e.g., successful cutting of LDPE sheet 10 times, successful opening and closing in a tortuous path).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

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

Not applicable. This is not an AI/machine learning device.

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