(30 days)
The Instrument Clamp Electromagnetic Sphere and Instrument Clamp Electromagnetic Universal are accessories to the Electromagnetic Navigation Unit and are intended for navigating conventional surgical instruments.
The Stryker ENT Navigation System 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 the 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:
-
Transphenoidal access procedures:
-
Intranasal procedures;
-
Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies;
-
ENT related anterior skull based procedures.
The Instrument Clamps Electromagnetic are part of the Stryker ENT Navigation System. The basic principle of this system is the generation of an electromagnetic (EM) field with an EMemitter (Field Generator). The EM devices have sensor coils that transform the detected EM field into an analogue signal is transmitted via cable to the Electromagnetic Navigation Unit. The signal is then evaluated, and the tracking data is transmitted to the platform. This technology allows tracking instruments without a line-of-sight requirement.
The Instrument Clamps Electromagnetic are to be used for localizing surgical instruments in a dedicated working volume. They are intended to be mounted on suitable surgical rigid instruments. The body of the clamp incorporates the required sensor coils, which enables tracking of conventional instruments. For accurate navigation, the instrument with the attached electromagnetic clamp needs to be calibrated prior to use.
Two electromagnetic clamps are in scope of this submission:
- Instrument Clamp Electromagnetic Sphere: Clamping interface optimized for tracking instruments with a circular cross-section between 2.0 mm and 4.6 mm in diameter (inclusive)
- . Instrument Clamp Electromagnetic Universal: Clamping interface optimized for tracking instruments with angular cross-section (e.g. forceps) between 3.0 mm and 6.0 mm in diameter (inclusive)
The subject devices are not intended to have patient contact. Their bodies are made of PEEK and the clamps and screws are manufactured from titanium.
They are reusable devices that need to be reprocessed prior to first use. They are limited to 10 uses.
The provided text describes the 510(k) premarket notification for the "Instrument Clamps Electromagnetic" by Stryker Corporation. The document focuses on establishing substantial equivalence to a predicate device (Scopis Extended Instrument Set EM, K171661) rather than presenting a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial. However, it does outline performance testing related to accuracy, reprocessing, and electrical safety.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the performance testing for accuracy was conducted according to ASTM F2554. It indicates that "The devices meet state-of-the-art acceptance criteria for point accuracy, precision and distance accuracy." However, the specific numerical acceptance criteria or the reported device performance metrics (e.g., actual point accuracy values, precision values, or distance accuracy values) are not provided in the text.
| Acceptance Criteria Category | Acceptance Criteria (Specifics not provided in the document) | Reported Device Performance (Specifics not provided in the document) |
|---|---|---|
| Performance - Accuracy | Meets state-of-the-art acceptance criteria for point accuracy, precision, and distance accuracy as per ASTM F2554. | Achieved "state-of-the-art acceptance criteria" for point accuracy, precision, and distance accuracy. (No specific numerical results given) |
| Reprocessing | Validated in compliance with FDA guidance and TIRs; steam sterilization compliant with ISO 17665-1 and ANSI/AAMI ST79. | Validated in compliance. Instructions follow ISO 17664. |
| Electrical Safety | Certified for compliance with ANSI/AAMI ES 60601-1 as accessories to ME Equipment. | Certified for compliance. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of a clinical study with patients or data. The testing described is bench testing. Therefore, information regarding sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable to the type of testing presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Ground truth establishment by experts is typically relevant for clinical studies or image-based AI studies. Since the testing described is bench testing of physical device characteristics (accuracy, reprocessing, electrical safety), this information is not applicable.
4. Adjudication Method for the Test Set:
As no expert- Adjudicated test set is described, the adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No clinical studies, and specifically no MRMC comparative effectiveness studies involving human readers, were performed or are described in the provided text. The document explicitly states: "No clinical testing was deemed necessary for this 510(k) submission." Therefore, information on effect size of human readers with/without AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance:
The device is a physical instrument clamp for surgical navigation, not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable. The accuracy testing refers to the physical tracking performance of the instrument, not an AI algorithm.
7. Type of Ground Truth Used:
For the bench testing described:
- Accuracy: The ground truth would typically be established by a highly precise measurement system against which the device's tracking performance is compared. The specifics of this ground truth measurement system are not detailed beyond "state-of-the-art acceptance criteria for point accuracy, precision and distance accuracy."
- Reprocessing: The ground truth for successful reprocessing would be the absence of contaminants and maintenance of device functionality after the specified reprocessing cycles, confirmed by established laboratory methods and standards.
- Electrical Safety: Compliance with ANSI/AAMI ES 60601-1 is the ground truth.
8. Sample Size for the Training Set:
The device is a physical medical instrument, not an AI model requiring a "training set" of data. Therefore, this information is not applicable.
9. How Ground Truth for the Training Set Was Established:
As there is no training set, this information is not applicable.
Summary of Key Findings from the Document:
The 510(k) submission for the Instrument Clamps Electromagnetic relies on bench testing to demonstrate substantial equivalence to a predicate device.
- Accuracy testing was performed according to ASTM F2554, and the devices reportedly met "state-of-the-art acceptance criteria," but specific numerical performance values are not disclosed.
- Reprocessing validation complied with FDA guidance, TIRs, ISO 17665-1, and ANSI/AAMI ST79.
- Electrical safety compliance was certified to ANSI/AAMI ES 60601-1.
- No clinical testing was deemed necessary.
- The device is a physical instrument, not an AI/software product, so concepts like "test set sample size (for data)," "experts for ground truth," "adjudication," "MRMC studies," "standalone algorithm performance," and "training set" are not directly applicable in the context of the information provided.
§ 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).