(70 days)
The Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure of orthopedic structures (such as spine and joint space) and other open procedures.
The Harmonic WAVE™ Coagulating Shears with Scissor Handle and Hand Control is a sterile, single patient use instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). The handle housing has an integrated audible/tactile mechanism for indicating full closure. The instrument has a straight blade and clamp arm and is designed to function through an incision without the use of a trocar. The instrument is 18cm long with a shaft diameter of 8.5mm and an active blade length of 18mm.
The provided text describes a 510(k) submission for the Harmonic WAVE™ Coagulating Shears. It outlines the device's description, indications for use, and a brief summary of performance data. However, it does not contain detailed information about specific acceptance criteria or a dedicated study report that "proves the device meets the acceptance criteria" in the way a clinical or in-vitro diagnostic study would.
The relevant section, "Performance Data," states: "Bench testing and preclinical laboratory evaluations were performed to demonstrate that the new device performs as intended. In vivo animal testing has shown the ability of the Harmonic WAVE™ Coagulating Shears to seal arteries less than or equal to 5mm in diameter."
From this, we can infer a single performance metric and an implied acceptance criterion based on the animal testing.
Here's the information derived from the provided text, along with clear indications of what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Ability to seal arteries ≤ 5mm in diameter (implied) | "In vivo animal testing has shown the ability of the Harmonic WAVE™ Coagulating Shears to seal arteries less than or equal to 5mm in diameter." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document only mentions "in vivo animal testing."
- Data Provenance: "in vivo animal testing" (implies preclinical, likely laboratory setting). The country of origin is not specified, but the submission is to the US FDA.
- Retrospective/Prospective: Not specified, but animal testing is typically prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. The described testing is "in vivo animal testing" focused on a direct physiological outcome (artery sealing). There is no mention of human expert interpretation for establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe an MRMC study. The device is a surgical instrument, not an AI or imaging diagnostic tool that would typically undergo such a study. There is no mention of human readers or AI assistance in the context of performance improvement.
6. Standalone (Algorithm Only) Performance Study
- No. This is a physical surgical device, not an algorithm. Standalone performance as typically understood for AI algorithms is not relevant here.
7. Type of Ground Truth Used
- Direct Physiological Outcome/Observation: The ground truth for the animal testing would be the direct observation of successful artery sealing (or lack thereof) in the animal models, likely assessed by surgical observers or pathologists.
8. Sample Size for the Training Set
- Not Applicable. This is a hardware device; the concept of a "training set" for an algorithm is not relevant.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
In summary, the provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a predicate device for a surgical instrument. It includes minimal, high-level performance data from preclinical animal testing rather than a detailed study report with explicit acceptance criteria, statistical analysis, or complex ground truth establishment as would be present for a diagnostic AI device.
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