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510(k) Data Aggregation
(153 days)
Reprocessed HARMONIC ACE® Shears without 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.
Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology are sterile, single patient use instruments consisting of an ergonomic grip housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instruments have a clamp arm and coated curved blade that are designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated 360° to facilitate visualization and access to targeted tissue. The instruments allow for the coagulation of vessels up to and including 5 mm in diameter. Each instrument is shipped with one sterile, single-use, disposable torque wrench. HARMONIC ACE® Shears without Adaptive Tissue Technology are designed for use exclusively with the Generator G11 (GEN 11) software version X or later. The scope of this Traditional 510(k) only includes the reprocessed Ethicon Harmonic Shears and not the generator.
The provided document, K133672, describes a 510(k) premarket notification for Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology. The document details the device's indications for use, technological characteristics, and performance data. The core of the submission is to demonstrate substantial equivalence to predicate devices, particularly in performance after reprocessing.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative, tabular format with specific thresholds. Instead, it describes performance through a general statement of equivalency to the predicate device and lists types of tests conducted. The implied acceptance criterion is that the reprocessed device performs "as originally intended" and is "as safe and effective as the predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (meet standards for patient safety) | Bench and laboratory testing was conducted to demonstrate biocompatibility. (Specific results or standards met are not detailed, but the FDA's clearance implies acceptance.) |
| Validation of Reprocessing (ensure effective cleaning and sterilization) | Validation of reprocessing was conducted. (Specific methods or quantitative outcomes are not detailed, but deemed sufficient for FDA clearance.) |
| Sterilization Validation (ensure sterility) | Sterilization Validation was conducted. (Specific methods or quantitative outcomes are not detailed, but deemed sufficient for FDA clearance.) |
| Functionality (cutting, coagulating, vessel sealing) | "Function test(s)" were conducted. "Performance testing demonstrates that Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology perform as originally intended for cutting and coagulating soft tissue and sealing vessels up to 5mm in diameter." This statement indicates the reprocessed device matches the functional performance of the original device in these key areas. |
| Packaging Validation (maintain sterility and integrity) | Packaging Validation was conducted. (Specific methods or quantitative outcomes are not detailed, but deemed sufficient for FDA clearance.) |
| Overall Safety and Effectiveness (equivalent to predicate) | "Stryker Sustainability Solutions concludes that the reprocessed devices are as safe and effective as the predicate devices as described herein." The FDA's 510(k) clearance implies agreement with this conclusion, indicating that the performed tests were sufficient to demonstrate substantial equivalence to the predicate devices (HARMONIC ACE® Shears + Adaptive Tissue Technology (K120729) and Harmonic Scalpel Blades and Shears, Models ACE36E and ACE23E (K060245)). |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for performance testing (e.g., number of reprocessed shears tested for function). It only states that "Bench and laboratory testing was conducted." The provenance of this data is internal to Stryker Sustainability Solutions (presumably their labs in Tempe, Arizona) and is prospective for the purpose of this 510(k) submission, meaning the tests were performed specifically to support this application. There's no mention of country of origin for the data beyond where the company is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not mention the use of external experts or a formal ground truth establishment process for the performance testing of the reprocessed device itself. The "ground truth" for this type of submission is typically the established performance characteristics of the predicate device, which the reprocessed device aims to match. The testing conducted by Stryker Sustainability Solutions would then aim to confirm that the reprocessed device's performance aligns with these known characteristics of the original device.
4. Adjudication Method for the Test Set:
Not applicable. This type of submission involves bench and laboratory testing against established device specifications, not subjective interpretation requiring expert adjudication of results.
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 not a study involving human readers, AI, or diagnostic image interpretation. It concerns the reprocessing of a surgical instrument.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" implicitly used for this submission is the performance and functional characteristics of the original, new HARMONIC ACE® Shears (the predicate devices). The reprocessing process is validated to ensure that the reprocessed device retains these characteristics. The document states: "The mechanism of action of Reprocessed HARMONIC ACE® Shears without Adaptive Tissue Technology are identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized." The tests performed (biocompatibility, reprocessing validation, sterilization, function tests, packaging validation) aim to demonstrate that the reprocessed device achieves this equivalence.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned or implied.
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