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The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument. The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. It is not recommended for use with other manufacturer's generators.

The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps Device Description is a sterile, single-use device intended for use in endoscopic procedures where fusion of The device can be used on vessels up to 3 mm vessels or tissue bundles is performed. and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument. The Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps sources RF energy from an electrosurgical generator. Specifically, the Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. This device passes through endoscopes having a 3.7 mm or larger working channels.

This document describes a 510(k) premarket notification for the "Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps". This is a medical device, not an AI/ML algorithm. Therefore, many of the requested categories in the prompt, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to traditional medical device submissions.

However, I can extract information related to performance testing that demonstrates the device meets its intended use.

Here's an analysis based on the provided document:

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

The document lacks a specific table detailing acceptance criteria alongside reported performance for each criterion. It broadly states that "Bench, animal, biocompatibility, and electrical testing was performed to demonstrate that the EES device performs as intended."

Device Performance Claimed:

• Vessel/Tissue Fusion: The device can perform fusion of vessels or tissue bundles.
• Vessel Size: Effective on vessels up to 3 mm.
• Bundle Size: Effective on bundles as large as will fit in the jaws of the instrument.
• Compatibility: Designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System.
• Endoscope Channel: Requires a 3.7 mm or larger working channel.
• Tissue Manipulation: Jaws contain atraumatic "grooves" to grasp and manipulate tissue.

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

The document does not specify sample sizes for the bench, animal, biocompatibility, or electrical testing. It also does not explicitly mention the country of origin of the data or whether the studies were retrospective or prospective.

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)

This concept of "ground truth established by experts" is not typically applicable to the performance testing of a physical medical device like electrosurgical forceps. The "ground truth" would be objective measurements of device function (e.g., burst pressure of fused vessels, thermal spread, electrical impedance).

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

Not applicable, as this refers to expert consensus for ground truth, which isn't detailed for this type of device.

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 is a physical electrosurgical device, not an AI system.

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

Not applicable. This is a physical electrosurgical device, not an AI algorithm.

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

The "ground truth" for this device's performance would be derived from objective measurements and observations during typical medical device performance testing, including:

• Bench Testing: Mechanical properties, electrical safety, fusion strength (e.g., burst pressure), thermal effects.
• Animal Testing: In-vivo performance, tissue effect, hemostasis effectiveness, safety.
• Biocompatibility Testing: Assessment of biological response to materials (e.g., cytotoxicity, irritation, sensitization).

8. The sample size for the training set

Not applicable. This is a physical electrosurgical device, not an AI system that requires a "training set."

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

Not applicable. This is a physical electrosurgical device, not an AI system.

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The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps are intended for use attached by cable to a standard electrosurgical bipolar generator in any general surgery procedure that requires coagulation and or tissue cauterization to achieve hemostasis.

The ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps family are similar in design to the predicate devices. They have various tip lengths and configurations, and are available in insulated and non-insulated versions. They are made from a stainless steel or Titanium alloy with a proprietary non-stick coaling. The proximal end has a protective plastic insulator sheath with industry standard clectrosurgery cable connecting pins. Forceps are packaged individually, sold non-sterile, and intended for steam, and EtO sterilization.

The provided text describes the ITI Medical Technologies, Inc. Midas Touch™ Bipolar Forceps. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the format or level of detail requested in the prompt.

The document primarily focuses on:

• Device Description: Bipolar forceps with various tip lengths, configurations, insulated/non-insulated versions, made from stainless steel or Titanium alloy with a proprietary non-stick coating.
• Intended Use: Attached by cable to a standard electrosurgical bipolar generator for general surgery procedures requiring coagulation and/or tissue cauterization to achieve hemostasis.
• Technological Characteristics: Similar to predicate devices, with the main difference being the type of non-stick coating.
• Compliance with Standards: Designed to comply with ANSI/AAMI HF18-1993, FDA 510(k) Guidelines for Electrosurgical Devices, and other FDA guidance documents.
• Predicate Devices: Ethicon Inc. Non-Stick Bipolar Forceps (K973384).
• FDA Premarket Notification (510(k)) Clearance: The document includes the FDA letter granting substantial equivalence to the predicate device.

The document briefly mentions:
"Comparison tests following written protocols were conducted using the ITI devices and the predicate devices. The performance evaluations indicate that the ITI Medical Technologies, Inc. Midas Touch™ Bipolar forceps met all of the performance requirements, consistently performed within their design parameters; and performed equivalently or superior to the predicate devices, thus demonstrating that they are safe and effective when used as intended."

However, this statement does not provide the specific details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot populate the table or answer the specific questions about the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this document.

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