(101 days)
The TGS Guidewire 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:
- · 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 Guidewire is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for use with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System during balloon sinus dilation procedures.
The Scopis ENT Software is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.
The Scopis ENT Software with TGS (Target Guided Surgery) is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.
The TGS Guidewire is a single use, sterile, disposable instrument intended to be used with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System. The instrument is an electromagnetically navigated device which consists of a sensor in a protective sheath that can be inserted into the working lumen of the XprESS device, a bayonet connector to secure the device to the XprESS luer and a cable and plug to connect the device to the navigation system. The navigation system displays the position of the instrument in the preoperative scans.
The Scopis ENT Software is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.
The Scopis ENT Software with TGS (Target Guided Surgery) is an accessory to the Electromagnetic Navigation Unit and intended for controlling of the hardware of the navigation unit.
The provided text describes a 510(k) premarket notification for the TGS Guidewire and updated Scopis Software. It details the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about an AI/ML component, a clinical study with a test set, ground truth establishmet, expert review, or MRMC studies. The document primarily focuses on demonstrating the substantial equivalence of the TGS Guidewire and updated Scopis Software to existing predicate devices through performance testing, rather than an AI/ML algorithm's performance against specific acceptance criteria in a robust clinical study.
Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable based on the provided text.
Here is a breakdown of the available and missing information based on your request:
1. A table of acceptance criteria and the reported device performance
The document mentions "Navigation accuracy" as a key performance metric for the TGS Guidewire. While it reports the device's performance, it does not explicitly state an acceptance criterion for this navigation accuracy. It implicitly uses the predicate device's performance as a benchmark for substantial equivalence.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Navigation Accuracy | Not explicitly stated (implied to be comparable or better than predicate) | 0.75 ± 0.27mm |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not mentioned. The performance data discussed is from "bench testing," not a clinical test set involving patient data.
- Data Provenance: Not applicable/Not mentioned for a clinical test set. The data is from internal bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for navigation accuracy in bench testing would likely be based on precise measurement instruments, not expert human review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication.
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. There is no mention of a multi-reader multi-case study, nor an AI component where human readers would interact with AI. The device is a "Stereotaxic Instrument" and software for navigation, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a hardware guidewire used in conjunction with a navigation system and software, implying human interaction, not a standalone algorithm performing a task without human intervention. The "navigation accuracy" measured is for the combined system's ability to locate anatomical structures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the navigation accuracy, the "ground truth" would be established by the precise measurement setup and instrumentation used in the bench testing. No clinical ground truth methods like expert consensus, pathology, or outcomes data are mentioned.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device that requires machine learning training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.
§ 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).