(115 days)
EM ENT Instruments are indicated for use in navigated ENT procedures to locate points on a CT-based or MR-based digital model and to remove fluids, semi-fluid substances, tissue, and bone dust. EM ENT Instruments are indicated for use with Medtronic computer-assisted surgery systems. The EM ENT instruments are indicated for use in ENT procedures such as:
·CSF leak repairs related to ENT procedure
- •Intranasal procedures
- ·Orbital decompression procedures
- •Polyposis procedures
- ·Endoscopic dacryocystorhinostomy
- ·Sinus procedures, such as maxillary antrostomies
- · Ethmoidectomies
- ·Sphenoidotomies/sphenoid explorations
- ·Turbinate resections and frontal sinusotomies
The EM ENT instruments can also be used in the ENT surgical approach for the following procedures:
•Pituitary tumor removal
·Skull base procedures
·Transsphenoidal procedures
·Optic nerve decompression procedures
•Encephalocele procedures
The Electromagnetic Ear Nose & Throat (EM ENT) Navigated Suctions are electromagnetically tracked, handheld, re-usable instruments intended to be used with EM ENT Instrument Trackers and ENT software on a Medtronic computer-assisted surgery system. The EM ENT Instrument Tracker is attached to the EM ENT Navigated Suction to track its position. The navigation system's mobile emitter generates a lowenergy magnetic field to locate the tracker mounted on the instrument. Then, the software displays the location of the instrument's tip within multiple patient image planes and other anatomical renderings.
The provided text describes the Medtronic EM ENT Navigated Suctions device, focusing on its substantial equivalence to predicate devices rather than a standalone performance study with detailed acceptance criteria and ground truth. However, some information can be extracted and inferred from the "Discussion of the Performance Testing" and "Summary of the Technological Characteristics" sections to partially answer your request.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
Based on the "Summary of the Technological Characteristics" section, a key performance metric for the navigation aspect is system accuracy.
| Acceptance Criteria (Inferred from "System or Instrument Accuracy Requirements" of Predicate Device) | Reported Device Performance (Subject Device: EM ENT Navigated Suctions) |
|---|---|
| Equivalent to StealthStation® System GoldenEye™ Micro-Magnetic Tracking System and StealthStation® System Update regarding accuracy. | Within a standard controlled environment: navigated peg errors of 1.54 mm at 95% confidence and 99% reliability |
| Within a simulated surgical environment: navigated peg errors of 1.73 mm at 95% confidence and 99% reliability (Note: The document states "5% confidence" but this is highly likely a typo and should be 95% confidence to align with standard statistical reporting and the prior statement. Assuming 95% confidence for consistency, otherwise, a 5% confidence level would be unusual and indicate a low level of certainty). | |
| Suction functionality (Inferred from comparison to Medtronic Manual Suctions) | Yes (Substantially Equivalent to predicate) |
| Instrument Tip Configurations, Materials, Instrument Shaft Configurations, Reusability | Substantially equivalent/same as predicate devices (details are comparative, not absolute performance metrics with specific values) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the accuracy tests (e.g., how many pegs were measured, how many trials). It also does not explicitly state the data provenance (country of origin, retrospective/prospective). The testing appears to be prospective bench testing conducted by the manufacturer, Medtronic Navigation, Inc., in the USA (Louisville, Colorado is listed as the company address).
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)
The document does not mention the involvement of experts for establishing ground truth for the test set. The accuracy testing described (navigated peg errors) implies a more objective, measurement-based ground truth established by physical reference points or precise measurement tools, not subjective expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. Given the nature of the accuracy testing (quantitative measurements), adjudication by expert readers would not be applicable.
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
A MRMC comparative effectiveness study was not conducted. This device is a surgical navigation instrument, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The closest comparison is its utility in guiding surgeons, but this is not typically assessed through an MRMC study as described for AI in image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The provided text focuses on the device's accuracy in navigation. The "algorithm only" performance is implicitly tested through the reported navigated peg errors. This reflects the system's ability to accurately determine the instrument's position relative to the digital model. There is no separate "human-in-the-loop" performance described in terms of diagnostic effectiveness or reading improvement. The human-in-the-loop component is the surgeon using the navigation system during a procedure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the accuracy testing, the ground truth was based on physical, objective measurements of "navigated peg errors." This implies the use of precise reference points and measurement systems to determine the true position of the pegs, against which the device's reported position was compared. It is not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
The document does not mention a training set. Surgical navigation systems like this are typically developed based on engineering principles and tested for accuracy, rather than "trained" on large datasets like machine learning models. Therefore, the concept of a training set as it applies to AI/ML is not relevant here.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The device's operation relies on electromagnetic tracking and digital modeling, not on a trained algorithm with a ground truth established in the same manner as a diagnostic AI.
§ 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).