(268 days)
The Stryker ESSx with Navigation Mount is to be utilized for Functional Endoscopic Sinus Surgery (FESS) for the incision of soft and osseous tissue in the sinus cavities, open plastic, reconstructive and aesthetic surgery of the Head and Neck. When used in conjunction with the Stryker Navigation/Tracker System, the device will enhance the surgeon's ability to localize anatomical landmarks (intraoperatively).
The Stryker ESSx with Navigation Mount is an electric, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories. The handpiece will operate with FDA cleared Stryker Navigation Systems. The Navigation feature will serve as a secondary verification to the tips position which is obtained through visual means typically with use of an endoscope.
The provided document describes a 510(k) Summary for a medical device called the "Stryker ESSx with Navigation Mount." This type of submission to the FDA is for demonstrating substantial equivalence to pre-existing legally marketed devices, not for proving a device meets specific performance acceptance criteria through clinical studies in the same way a PMA (Pre-Market Approval) or de novo device might.
Therefore, many of the detailed questions regarding acceptance criteria, specific study designs, sample sizes, ground truth establishment, and MRMC studies are not applicable to this 510(k) submission. The FDA approval here is based on a comparison to predicate devices, not on a detailed performance study against specific acceptance criteria.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated for this 510(k)) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Specific performance metrics (e.g., accuracy, precision, speed, safety in randomized trials) are not provided in this 510(k) summary. | The Stryker ESSx with Navigation Mount has the same intended use, technological characteristics, and navigated operating mechanism as the predicate devices: Diego Powered Dissector Handpiece with Starlink Image Guided Adapter Mounting Interface (K030343) and Xomed XPS 3000 System (K041523). It also has the same intended use as the Stryker Hummer IV MicroDebrider System (K011381). |
| Numerical acceptance criteria (ee.g., X% accuracy, Y-second speed) are not part of a substantial equivalence claim. | The device is considered substantially equivalent to legally marketed devices based on this comparison. |
Reasoning for Absence: 510(k) submissions primarily focus on demonstrating substantial equivalence to legally marketed predicate devices. They typically do not require the rigorous, pre-defined performance acceptance criteria and associated clinical study data that would be found in a De Novo submission or a PMA for a novel device. The "acceptance criteria" in this context are implicitly met if the device is found to be substantially equivalent to predicates that have already demonstrated safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable / Not explicitly stated. This 510(k) summary relies on a comparison to predicate devices, not on a new clinical study with a "test set" in the traditional sense. The data provenance would be the existing documentation for the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No new "test set" requiring ground truth establishment by experts is described in this 510(k) summary. The document does mention that the "Navigation feature will serve as a secondary verification to the tips position which is obtained through visual means typically with use of an endoscope." This implies existing clinical practice and expertise, but not a specific set of experts for a new study's ground truth.
4. Adjudication Method for the Test Set
- Not applicable. No new "test set" requiring an adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. Such studies are typically part of more extensive clinical evaluations, not standard for an equivalence claim.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable / Not explicitly stated. The device is an "electric, high-speed instrument system" and not an AI algorithm. Its navigation feature works "in conjunction with the Stryker Navigation/Tracker System" to "enhance the surgeon's ability to localize anatomical landmarks." This inherently involves a human-in-the-loop (the surgeon) performing the procedure. A "standalone" performance for an instrument with a navigation mount doesn't fit the typical definition of an algorithm's standalone performance.
7. The Type of Ground Truth Used
- Implicitly, the established safety and effectiveness of the predicate devices. For the specific function of the navigation feature, the document states it "will serve as a secondary verification to the tips position which is obtained through visual means typically with use of an endoscope." This suggests that the "ground truth" for tip position during surgical use relies on the surgeon's visual assessment, often aided by an endoscope. However, this is for real-world surgical application, not a controlled study's ground truth.
8. The Sample Size for the Training Set
- Not applicable. This device is an instrument system, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set is involved for this type of device.
Summary of the 510(k) Approach:
The Stryker ESSx with Navigation Mount received FDA clearance based on substantial equivalence to existing, legally marketed predicate devices. This means that the FDA determined the device is safe and effective because it has the same or very similar intended use and technological characteristics to devices already on the market. The justification for equivalence is presented by comparing the new device's features and intended use to those of three predicate devices. This regulatory pathway bypasses the need for extensive new clinical trials with pre-defined acceptance criteria, explicit sample sizes, or ground truth establishment for a novel study, as these aspects were already addressed (or deemed not necessary) for the predicate devices.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.