(58 days)
The Stryker ENT Navigation System, of which the TGS Universal Headrest with Mounting Arm is an accessory, is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.
Example procedures include, but are not limited to the following ENT procedures:
- · Transsphenoidal access procedures:
- Intranasal procedures:
- · Sinus procedures, such as maxillary antrostomies; sphenoidotomies/sphenoid explorations, turbinate resections, and frontal sinusotomies:
- · ENT related anterior skull base procedures.
The TGS Universal Headrest with Mounting Arm is a reusable device intended to be used with the Stryker ENT Navigation System. It consists of three main components: a headrest, mounting arm and chair adapters. The mounting arm provides fixation for the field generator of the navigation system allowing it to be positioned in proximity to the patient creating an optimal electromagnetic field. The headrest provides support for the patient's head while undergoing navigation guided procedures. The chair adapters are fixed to the headrest to allow the headrest to various ENT procedure chairs
Here's an analysis of the acceptance criteria and study information for the TGS Universal Headrest with Mounting Arm, based on the provided FDA 510(k) summary:
This device is not an AI/ML device, therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable.
Acceptance Criteria and Reported Device Performance
The provided document describes the TGS Universal Headrest with Mounting Arm as a reusable accessory to the Stryker ENT Navigation System. The performance data focuses on demonstrating that the device meets its design specifications and functions as intended, rather than clinical efficacy metrics typically associated with diagnostic or therapeutic devices.
| Acceptance Criteria Category | Specific Criteria (Inferred from "Design Specifications" and "Intended Use") | Reported Device Performance |
|---|---|---|
| Dimensional Specifications | (Exact dimensions not provided, but implied to be within design limits) | Met |
| Functional Specifications | Ability to position the Field Generator. | Met |
| Ability to provide a resting surface for the patient's head. | Met | |
| Ability of mounting arm to provide fixation for field generator. | Met | |
| Ability to achieve different positions through locking mechanisms. | Met | |
| Simulated Use Performance | Performance during simulated typical ENT navigation procedures. | Performed as intended |
| Compatibility | Compatibility with the Stryker ENT Navigation System and various ENT procedure chairs (via adapters). | Compatible |
| Distribution Testing | Implied to ensure the device maintains integrity and functionality after shipping/handling. | Met |
| User Task Performance | Intended users (ENT physicians) can perform critical tasks related to use in a simulated environment. | Demonstrated as intended |
Study Information Table (if applicable, N/A otherwise)
| Category | Details |
|---|---|
| 1. Acceptance Criteria and Reported Performance | See table above. The document states "Bench testing was performed to demonstrate that the TGS Universal Headrest with Mounting Arm performs as intended and meets the design specifications. The testing included dimensional, functional, simulated use, compatibility and distribution testing." It also states "Design validation involved ENT physicians familiar with image guided sinus surgery and was conducted to demonstrate that the intended users could perform the critical tasks related to use of the TGS Universal Headrest with Mounting Arm in its expected use environment." |
| 2. Sample size and data provenance (test set) | Not applicable for this type of device. The "test set" here refers to the device prototypes/production units subjected to bench testing and simulated use. There is no patient data involved in this specific device's clearance. |
| 3. Number of experts and qualifications | "ENT physicians familiar with image guided sinus surgery" were involved in the design validation to demonstrate user task performance. The specific number of physicians and their exact years of experience are not provided. These experts were involved in design validation rather than establishing a ground truth for a diagnostic output. |
| 4. Adjudication method | Not applicable. This is for a mechanical accessory, not a diagnostic or AI device requiring ground truth adjudication. |
| 5. MRMC Comparative Effectiveness Study | Not applicable. This is not a diagnostic AI device. |
| 6. Standalone performance | Not applicable in the context of AI/ML algorithms. The device's "standalone" performance is its bench performance and functional testing as described. |
| 7. Type of ground truth used | Not applicable for a mechanical accessory. The "ground truth" for this device is the engineering specifications and intended function. |
| 8. Sample size for the training set | Not applicable. This is not an AI/ML device. |
| 9. How training set ground truth was established | Not applicable. This is not an AI/ML device. |
Summary and Key Takeaways for this Device:
The TGS Universal Headrest with Mounting Arm is a mechanical accessory for an existing navigation system. Its clearance is based on demonstrating substantial equivalence to predicate devices and proving that it performs its intended ergonomic and functional roles. The "study" for this device primarily consisted of:
- Bench testing: Verifying that the device meets its dimensional, functional, compatibility, and distribution specifications.
- Simulated use testing: Confirming that the device operates as expected during mock procedures.
- Design validation with user feedback: Ensuring that ENT physicians (intended users) can successfully perform critical tasks with the device in its expected use environment.
This type of device does not involve complex clinical trials, statistical performance metrics for diagnostic accuracy, or AI/ML algorithm evaluation. Therefore, many of the detailed questions regarding expert adjudication, ground truth, and AI-specific study designs are not relevant.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).