(194 days)
The Reprocessed HARMONIC ACE®+7, 5 mm Diameter 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, 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.
Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an ergonomic handle and 3 hand-controlled activation buttons. The handle includes a mechanism that provides both audible and tactile feedback indicating full closure. The instruments utilize Adaptive Tissue Technology which provides the generator with the ability to identify and monitor the instrument during use and enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. Each instrument is shipped with one sterile, single-use, disposable torque wrench.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, specifically "Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis". This document details the comparison to a predicate device and various tests conducted to demonstrate substantial equivalence, rather than a clinical study evaluating a diagnostic or AI-driven device's performance against specific acceptance criteria like accuracy, sensitivity, or specificity.
Therefore, the requested information regarding acceptance criteria, reported device performance in those terms, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth for a diagnostic AI device is not applicable to this document.
The document focuses on demonstrating that the reprocessed surgical shears are as safe and effective as the original, legally marketed predicate device through a series of engineering and performance tests.
Here's what can be extracted regarding the device's performance demonstration:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines functional performance tests and other validations, rather than specific diagnostic accuracy metrics. The "acceptance criteria" are implied to be achieving performance comparable to the predicate device and meeting safety standards.
| Acceptance Criteria Category | Specific Test/Validation | Reported Device Performance |
|---|---|---|
| Safety & Biocompatibility | Biocompatibility | Conducted |
| Validation of Reprocessing | Conducted | |
| Sterilization Validation | Conducted (Sterile by Ethylene Oxide) | |
| Pyrogen Free | No (Same as Predicate) | |
| Electromagnetic Compatibility & Electrical Safety Testing | Conducted (in accordance with IEC 60601-1-2) | |
| Functional Performance | Blade to Clamp Arm Angle | Conducted |
| Actuating Trigger Force | Conducted | |
| MIN/MAX Button Activation Force | Conducted | |
| Advanced Hemostasis (AH) Button Activation Force | Conducted | |
| Rotation Knob Force – Actuating Trigger Disengaged | Conducted | |
| Rotation Knob Force Actuating Trigger Engaged | Conducted | |
| Jaw Clamp Force | Conducted | |
| Tissue Retention Force | Conducted | |
| Shaft Straightness | Conducted | |
| ATT Functionality and Transection Time | Conducted. Evaluation of device's performance and ability to seal and divide vessels up to 7mm, including transection time. | |
| Burst Pressure | Conducted. Evaluation of device's performance and ability to seal and divide vessels up to 7mm, including burst pressure. | |
| Maximum Jaw and Shaft Temperature | Conducted. Evaluation of device's performance and ability to seal and divide vessels up to 7mm, including thermal spread. | |
| Reliability Testing | Conducted | |
| Packaging & Labeling | Packaging Validation | Conducted |
| Clinical Equivalence | Pre-Clinical Testing (Acute Animal Study, Chronic Animal Study) | Conducted. "The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate devices and operate as originally intended." |
2. Sample size used for the test set and the data provenance:
- This document does not specify exact sample sizes for each test. It generally states that "Bench and laboratory testing was conducted" and includes "verification/comparative testing (to the predicate device)."
- Data provenance: Not explicitly stated, but assumed to be internal laboratory testing by Stryker Sustainability Solutions. It is not clinical data from specific countries or indicated as retrospective/prospective in a diagnostic sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a diagnostic device relying on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a diagnostic device requiring adjudication of interpretations.
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:
- Not applicable. This is a reprocessed surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a reprocessed surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests, the "ground truth" would be established by engineering specifications, validated test methods, and comparison against the performance of the original, new predicate device. For animal studies, the "ground truth" would be physiological outcomes observed by veterinarians or pathologists.
8. The sample size for the training set:
- Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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