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HARMONIC 1100 Shears: The HARMONIC 1100 Shears instrument is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.

Ethicon Generator G11: The Generator G11 provides radiofrequency power to drive ENSEAL electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive HARMONIC ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

ENSEAL and HARMONIC instruments, when used with the Generator G11, have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.

HARMONIC 1100 Shears: The HARMONIC 1100 Shears are sterile, single-patient use devices for the dissection, grasping, coagulation, and cutting of soft tissue between the blade and clamp arm. The device consists of an ergonomic grip housing assembly with two-hand control buttons: 1) Energy button for power levels 1-5, and 2) Energy with Advanced Hemostasis button for large vessel sealing. The device is available in two shaft lengths (20 cm and 36 cm), and both device shafts can be rotated continuously to facilitate visualization and access to targeted tissue. An integrated audible and tactile mechanism in the grip housing indicates full trigger closures. The device has a clamp arm and coated curved blade that is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The Energy button is indicated for vessels up to 5 mm in diameter. When the Energy button is used, cutting speed is the fastest. The Energy with Advanced Hemostasis button is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy with Advanced Hemostasis button is used, cutting speed is reduced and hemostasis is maximized. The device utilizes Adaptive Tissue Technology (the technological characteristics of which were first cleared under K120729 on May 17, 2012 and incorporated into multiple Ethicon devices). This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output, as well as provide audible feedback to the user as appropriate. The HARMONIC 1100 Shears are designed for use exclusively with the Ethicon Generator 11 (GEN11), last cleared under K160554 on September 9, 2016.

Generator G11: The Generator G11 supplies energy to the HARMONIC® and ENSEAL® surgical instruments. The generator uses a touchscreen display interface and has a unique receptacle port that accepts either a HARMONIC or an ENSEAL instrument. Connectors (HGA11 for HARMONIC and EGA11 for ENSEAL) are used to enable the generator to power legacy instruments. All ENSEAL and HARMONIC devices compatible with the generator and provided by Ethicon and authorized manufacturers undergo an extensive verification and validation process. The Ethicon Endo-Surgery Generator G11 System is not designed to operate unauthorized devices. Such use is not in accordance with the design and use parameters, instructions and guidelines for the product.

The provided text is a 510(k) Summary for the Ethicon HARMONIC 1100 Shears and the Generator G11. It focuses on demonstrating substantial equivalence to predicate devices rather than describing a study with acceptance criteria and device performance in the context of AI or diagnostic accuracy.

Therefore, the document does not contain the information requested in most of the points of your prompt. It describes a regulatory submission for a medical device (ultrasonic surgical instruments and generator) and details about its intended use, technological characteristics, and comparison to predicate devices, but lacks the specific elements of an AI-related study or performance evaluation against defined acceptance criteria.

Here's what can be extracted and what is missing:

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

• Missing. The document talks about "Verification testing for the design modifications was provided to demonstrate safety and effectiveness" but does not specify acceptance criteria or quantitative performance results (e.g., sensitivity, specificity, accuracy, etc.) in a table format.

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

• Missing. This type of information is not relevant to a 510(k) submission focused on substantial equivalence of an electrosurgical device based on design modifications and technological characteristics.

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

• Missing. This is not an AI/diagnostic study, so there is no "ground truth" in this context.

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

• Missing. Not applicable to this type of regulatory submission.

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:

• Missing. This is not an AI-assisted diagnostic device.

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

• Missing. Not an AI algorithm.

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

• Missing. Not an AI/diagnostic study.

8. The sample size for the training set:

• Missing. Not an AI algorithm.

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

• Missing. Not an AI algorithm.

Summary of available information (related to the device in general, not an AI study):

The document states that "Verification testing for the design modifications was provided to demonstrate safety and effectiveness" for both the HARMONIC 1100 Shears and the Generator G11. This suggests that some form of testing was conducted to ensure the device performs as intended and is safe. However, the specifics of these tests, including acceptance criteria and detailed performance results, are not included in this summary.

Key takeaway: This document is a regulatory submission demonstrating substantial equivalence for a medical device. It does not describe an AI-related study or a study with specific acceptance criteria and detailed performance metrics as would be expected for an AI-powered diagnostic tool.

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