(248 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 coaqulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an erqonomic 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. The only difference between the three (3) model numbers subject of this submission is the shaft length detailed in the table below.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis. This is crucial as the acceptance criteria and supporting studies are focused on demonstrating that the reprocessed device is substantially equivalent to the original, legally marketed predicate device, and operates as originally intended.
Therefore, the studies and acceptance criteria are not about establishing the primary clinical efficacy of a new device, but rather validating the safety and functionality of a reprocessed version against an established benchmark.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it broadly states that the performance testing "demonstrates that reprocessed devices are as safe and effective as the predicates and operate as originally intended."
The types of tests conducted suggest the implicit acceptance criteria would be that the reprocessed device's performance is comparable or equivalent to the predicate device within acceptable limits for:
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Device materials are not cytotoxic, irritating, sensitizing, or otherwise harmful. | Not explicitly stated, but validated by "Biocompatibility" testing. |
| Validation of Reprocessing: The reprocessing procedure effectively cleans, sterilizes, and restores the device, without compromising material integrity. | Not explicitly stated, but validated by "Validation of Reprocessing" testing. |
| Sterilization Validation: The sterilization method achieves the required Sterility Assurance Level (SAL). | Not explicitly stated, but validated by "Sterilization Validation" testing. |
| Functional Performance (General): Device functions as specified, with no degradation in operation. | "Device functionality" and "device reliability" were evaluated. Performance "as originally intended" was concluded. |
| Electrical Safety: Meets relevant electrical safety standards. | Validated in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Electromagnetic Compatibility: Does not interfere with, or is not affected by, electromagnetic fields. | Validated in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Software Validation: Any embedded software functions correctly and reliably. | Validated by "Software Validation" testing. |
| Packaging Validation: Packaging maintains sterility and device integrity until use. | Validated by "Packaging Validation" testing. |
| Thermal Spread: Comparable thermal spread to the predicate device. | Evaluated in bench and acute/chronic pre-clinical testing. Concluded as "safe and effective as the predicates." |
| Transection Time: Comparable transection time to the predicate device. | Evaluated in bench testing. Concluded as "safe and effective as the predicates." |
| Burst Pressure: Comparable burst pressure to the predicate device for sealed vessels. | Evaluated in bench testing. Concluded as "safe and effective as the predicates." |
| Ability to Seal and Divide Vessels (up to 7mm): Maintained efficacy in sealing and dividing vessels of specified size. | Evaluated in bench and acute/chronic pre-clinical testing. Concluded as "safe and effective as the predicates." |
| Hemostasis: Ability to achieve hemostasis is maintained. | Evaluated in acute/chronic pre-clinical testing ("ability to achieve hemostasis of vessels and tissues"). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each test. It generally refers to "bench and laboratory testing" and "acute and chronic pre-clinical testing."
- Data Provenance: The studies were conducted as part of a 510(k) submission by Stryker Sustainability Solutions. The data would be internally generated through laboratory and pre-clinical animal studies. No information is provided regarding the country of origin of the data beyond the applicant company's location (Tempe, Arizona, USA). These studies are inherently prospective as they are specifically designed and executed to support the regulatory submission for the reprocessed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
This information is not applicable in the context of this 510(k) submission. For reprocessed devices, the "ground truth" for performance is typically established by comparing the reprocessed device's objective physical and functional parameters against those of the original, new predicate device, and ensuring it meets its performance claims. This involves engineering and scientific testing rather than expert-derived ground truth based on cases (e.g., in medical image analysis).
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant in studies where human readers are interpreting data (e.g., medical images) and their decisions need to be reconciled to form a consensus ground truth. The studies described here are primarily objective, bench, and pre-clinical tests comparing device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic or screening devices (e.g., AI in radiology) to evaluate the impact of a system on human reader performance. This submission is for a reprocessed surgical instrument.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the way it's typically understood for AI/software devices. The device is a surgical instrument. However, the "Functional Performance Tests" and "Electrical Safety Testing," "Electromagnetic Compatibility Testing," and "Software Validation" can be considered "standalone" evaluations of the device's inherent physical and functional properties, independent of a human operator, to ensure it meets its specifications.
7. The type of ground truth used
The "ground truth" for the performance evaluations performed for this reprocessed device is established through:
- Engineering and Scientific Measurements: Objective laboratory measurements of device characteristics (e.g., thermal spread, transection time, burst pressure, electrical parameters).
- Pre-clinical Animal Model Observations: Direct observation of the device's effects in acute and chronic animal studies (e.g., hemostasis, tissue effects).
- Comparison to Predicate Device Performance: The underlying ground truth is that the reprocessed device must perform equivalently to the original predicate device (HARMONIC ACE+ Shears with Advanced Hemostasis, K132612) and meet its stated indications.
8. The Sample Size for the Training Set
This information is not applicable. This device is a reprocessed physical medical instrument, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable per the reason stated in point 8.
N/A