(57 days)
The HARMONIC ACE + Shears with Advanced Hemostasis 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), 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 Advanced Hemostasis hand control button.
The Ethicon Endo-Surgery HARMONIC ACE+Shears with Advanced Hemostasis 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.
This document describes a 510(k) submission for the HARMONIC ACE+ Shears with Advanced Hemostasis. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a clinical trial with statistical performance metrics against a defined ground truth.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing and laboratory evaluations in an animal model.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of quantitative metrics or thresholds for specific performance attributes (e.g., success rate for vessel sealing, thermal spread limits). | Bench testing and laboratory evaluations in an animal model demonstrated that the HARMONIC ACE+ Shears with Advanced Hemostasis perform as intended and are as safe and effective as the identified legally marketed predicate devices for cutting and coagulating soft tissue and sealing vessels up to 7 mm in diameter, as measured in situ. |
- Note: The document states that the device "perform[s] as intended" and is "as safe and effective and perform[s] as well as the identified legally marketed predicate devices". This implies the acceptance criteria were to demonstrate non-inferiority or equivalence to the predicate, likely based on established performance characteristics of those predicates (e.g., effective sealing of 7mm vessels, minimal thermal injury). However, no specific numerical thresholds or performance targets are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "laboratory evaluations in an animal model including acute and 30-day chronic survival studies," but does not provide details on the number of animals or procedures performed.
- Data Provenance: The studies were "laboratory evaluations in an animal model." The country of origin is not specified, but the submission is to the U.S. FDA, so it's likely conducted under U.S. regulatory guidelines or by a U.S.-based entity, even if the animals themselves could be from various sources. The studies were prospective in nature, as they were specifically conducted to evaluate the new device.
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)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Standard practice for animal studies evaluating surgical devices would involve veterinary surgeons, pathologists, and potentially histopathologists, but their number and specific qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Comparative Effectiveness Study: No, this type of study was not done. This device is a surgical instrument, not an AI-assisted diagnostic tool or an imaging reader system. Therefore, MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable in the conventional sense. The device does have an "Adaptive Tissue Technology" algorithm that modulates power delivery. The "Performance Data" describes "bench testing and laboratory evaluations in an animal model" which would assess the device's function, including this algorithm's performance in achieving hemostasis and cutting/coagulating tissue. While this is not an "algorithm-only" standalone performance in the context of AI, it represents the device operating as intended to achieve its intended function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the animal studies, the ground truth would likely be established through a combination of:
- Direct observation by trained personnel during the procedures.
- Histopathological analysis of excised tissue specimens to assess seal integrity, thermal spread, and tissue effects.
- Outcomes data from the "acute and 30-day chronic survival studies" (e.g., absence of hemorrhage, wound healing, presence/absence of complications).
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/machine learning model in the sense that it requires a "training set." The "Adaptive Tissue Technology" algorithm is likely pre-programmed and tuned through engineering and empirical testing, rather than trained on a large dataset of patient cases.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there isn't a "training set" in the context of an AI model being trained. The "ground truth" for the development of the Adaptive Tissue Technology algorithm would have been based on engineering principles, material science, and empirical testing to optimize energy delivery for desired tissue effects.
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