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The Harmonic HD 1000i 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, plastic, pediatric, gynecologic, thoracic, exposure to orthopedic structures (such as spine and joint space), 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.

The HARMONIC HD 1000i 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 HD 1000i Shears are designed for use exclusively with the Ethicon Generator 11 (GEN 11), last cleared under K160554 on September 9, 2016.

Here's a breakdown of the acceptance criteria and study information for the HARMONIC HD 1000i Shears, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

This document primarily describes a substantial equivalence submission, meaning the acceptance criteria are largely based on demonstrating that the new device (HARMONIC HD 1000i Shears K191555) is as safe and effective as a legally marketed predicate device (HARMONIC HD 1000i Shears K160752). Therefore, "acceptance criteria" here refers to the aspects of the device that need to match or perform equivalently to the predicate. The "reported device performance" is implicitly that the subject device is substantially equivalent across these characteristics.

The document states: "Minor design modifications have been made to improve device performance. The fundamental technological characteristics (ie, design, material, chemical composition, energy source) of the HARMONIC HD 1000i Shears are equivalent to the predicate." and "Performance Data: Minor design modifications have been made to improve device performance. Verification testing for the design modifications was provided to demonstrate safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a "test set" in the context of an independent performance study with defined metrics. Instead, it refers to "Verification testing for the design modifications" that was provided to demonstrate safety and effectiveness.

• Sample Size: Not explicitly stated for any specific test sets.
• Data Provenance: Not specified, but generally, premarket submissions like this would involve internal company testing. The document does not indicate country of origin or whether data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not mention the use of external experts or the establishment of ground truth by experts for the purpose of a study to evaluate the device's performance against specific clinical outcomes or diagnoses. The submission focuses on demonstrating substantial equivalence based on engineering and performance characteristics compared to a predicate device.

4. Adjudication Method

As there's no mention of a study involving expert review or a "test set" requiring adjudication of results, an adjudication method is not discussed in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not mentioned or described in the provided document. The submission is for a surgical instrument, not an AI/imaging diagnostic device where such studies are common.

6. Standalone Performance Study (Algorithm Only)

A standalone performance study (algorithm only) was not mentioned or described. This device is a physical surgical instrument, not a software algorithm.

7. Type of Ground Truth Used

For this 510(k) submission, the "ground truth" implicitly refers to the established performance and safety profile of the predicate device (HARMONIC HD 1000i Shears K160752). The new device is deemed acceptable because it maintains or improves upon these characteristics. The supporting data would be engineering tests and comparative data, rather than expert consensus on clinical findings, pathology, or outcomes data from independent clinical trials.

8. Sample Size for the Training Set

The document does not mention a "training set" as this is not an artificial intelligence/machine learning submission. If "training set" were interpreted as data used during the R&D phase to develop the minor design modifications, that information is not provided.

9. How Ground Truth for the Training Set Was Established

Since a "training set" in the context of AI/ML is not applicable, the method for establishing its ground truth is not discussed in the document.

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The Harmonic HD 1000i 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, plastic, pediatric, gynecologic, thoracic, exposure to orthopedic structures (such as spine and joint space), 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.

The HARMONIC HD 1000i Shears are a sterile, single patient use device used for dissection, grasping, coagulation, and cutting between the blade and clamp arm. It 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 closure. 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 blade used in the HARMONIC HD 1000i Shears has a slightly different blade design than that of the predicate device, the HARMONIC ACE+Shears with Advanced Hemostasis (cleared under K132612 on October 17, 2013), and is also slightly longer and more tapered than the predicate device. Additionally, two dashes have been added to the device which are intended to represent relative vessel size. The distal/front Energy button is indicated for vessels up to 5 mm in diameter. The Energy with Advanced Hemostasis button (the Green button), which is found on the side of the device handle, is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. The device utilizes Adaptive Tissue Technology (the technological characteristics of which were first cleared under K120729 on May 17, 2012). This technology provides the generator with the ability to identify and monitor the instrument during use. The HARMONIC HD 1000i Shears are designed for use exclusively with the Ethicon Generator 11 (GEN11).

The provided text describes the HARMONIC HD 1000i Shears. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance & Adjudication method

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes various tests performed and states that the "Data generated from the bench testing met the predetermined acceptance criteria" and that "the results of the acute/survival studies demonstrated that the tissue effects were not different than the predicate device."

Here's an attempt to structure the information into a table format based on the descriptions:

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The HARMONIC ACE® Shears + Adaptive Tissue Technology are 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, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The Ethicon Endo-Surgery HARMONIC ACE® Shears + Adaptive Tissue Technology incorporate an ergonomic handle and tapered blade geometry. The instruments have a coated ultrasonic blade and an EEPROM memory chip that stores device identification, usage tracking, and operating parameters for use by the Generator G11 that provides power for the HARMONIC ACE® Shears + Adaptive Tissue Technology.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HARMONIC ACE® Shears + Adaptive Tissue Technology:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are implied by the "substantially equivalent" determination to the predicate device. The performance data presented focuses on demonstrating that the device performs as intended and is as safe and as effective as the predicate device.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated regarding specific numbers of animals or tests. The phrasing is "Bench testing and laboratory evaluations of thoracic procedures in an animal model including acute and 30-day chronic survival studies."
   • Data Provenance: Animal model (unspecified species) and bench testing. No country of origin is specified. The studies were likely prospective in nature as they were conducted to demonstrate performance.

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

   • This information is not provided in the given text. The studies were "bench testing and laboratory evaluations," implying technical assessments rather than expert clinical review of test data for ground truth establishment.

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

   • This information is not provided as the "test set" described is material/animal performance, not human clinical data requiring adjudication of interpretations.

4. 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:

   • No, an MRMC study was not done. This device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve human "readers" or AI assistance.

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

   • This device includes "Adaptive Tissue Technology" which is described as a "power output algorithm." The performance data for this algorithm appears to be integrated into the overall bench and animal testing of the device for its intended function (cutting, coagulating, sealing). Therefore, the "algorithm only" performance is implicitly part of the overall device performance demonstrated without a separate standalone study detailed for the algorithm in isolation. Human interaction is inherent in using a surgical instrument.

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

   • For the animal model: Outcomes data (acute and 30-day chronic survival) and direct in situ measurements (e.g., vessel seal diameter, effectiveness of cutting and coagulation).
   • For bench testing: Likely objective physical measurements related to cutting efficiency, coagulation effectiveness, thermal injury, and seal strength.

7. The sample size for the training set:

   • This information is not applicable in the traditional sense for this device. The "Adaptive Tissue Technology" involves an algorithm, but the text describes it as using "parameters stored on the device EEPROM" and "monitors the frequency of the instrument blade and determines when there is a change in the thermal condition of the blade." This suggests a pre-programmed or rules-based algorithm rather than a machine learning model that would require a "training set" in the common understanding. The parameters would have been developed and refined through engineering and testing, not by training on a large dataset in the way an AI diagnostic tool would.

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

   • As noted above, a "training set" in the conventional machine learning sense is not applicable. The "ground truth" for the development of the Adaptive Tissue Technology's parameters would have been based on engineering principles, material science, and experimental data on tissue interaction with ultrasonic energy, likely derived from extensive R&D bench testing and possibly earlier animal studies.

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