(69 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, 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 provided document describes the HARMONIC ACE® Shears + Adaptive Tissue Technology, an ultrasonic surgical instrument. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and animal model evaluations. It does not contain the specific information requested in your prompt regarding acceptance criteria, a detailed study proving performance against those criteria, or the specific breakdown of data provenance, expert involvement, and MRMC studies you've asked for in the context of an AI/algorithm-based device study.
Therefore, I cannot extract the information to fulfill your request in the format you've provided. The document describes a traditional medical device (surgical shears), not a device involving AI or machine learning algorithms that would typically require the types of studies and acceptance criteria you've outlined for "device performance" in that context.
Summary of what can be extracted from the provided text, relevant to performance but not fitting your requested table format directly (as it's not an AI device):
- Device: HARMONIC ACE® Shears + Adaptive Tissue Technology
- Purpose: Coagulation and mechanical transection of soft tissue; soft tissue incisions where bleeding control and minimal thermal injury are desired.
- Performance Claim: As safe and effective and perform as well as the legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 5 mm in diameter, as measured in situ.
- Studies Conducted:
- Bench testing
- Laboratory evaluations in an animal model (acute and 30-day chronic survival studies)
- Conclusion: These studies demonstrate the device performs as intended and is equivalent to the predicate device.
To reiterate, the document does not provide the following information from your request:
- A table of acceptance criteria and the reported device performance in the context of AI/algorithm metrics (e.g., sensitivity, specificity, AUC).
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size of AI assistance.
- Standalone (algorithm-only) performance results.
- Type of ground truth (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
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