(89 days)
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.
| Acceptance Criteria Category | Reported Device Performance (Implicit from substantial equivalence) |
|---|---|
| Safety | Demonstrated to be "as safe" as the predicate device through bench testing and animal model studies (acute and 30-day chronic survival studies). |
| Effectiveness | Demonstrated to be "as effective" as the predicate device in cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ, in thoracic surgical procedures. |
| Intended Use | Performed as intended for soft tissue incisions where bleeding control and minimal thermal injury are desired, and in specific surgical procedures (general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures). |
Study Details
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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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