(381 days)
The Greatbatch Scientific MR Compatible Laryngoscope is intended for use in endoscopic visualization and surgery on the trachea, pharynx and larynx in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
The Greatbatch Scientific MR Compatible Laryngoscope is available in standard and autoclavable 8.0mm, 70° angle.
The provided text describes the Greatbatch Scientific MR Compatible Laryngoscope and its MR safety testing.
Here's an analysis of the acceptance criteria and study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test / Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| MR Compatibility | Static Field Strength | Applicable for 1.5 Tesla MR Systems | 1.5 Tesla / GE Signa 64 MHz MR System |
| Magnetic Attraction | Minimal deflection/attraction | "Very slight" deflection | |
| Magnetic Torque | Minimal torque | 5 degrees | |
| Artifact | Acceptable level of distortion | "artifact same as the device ++" (indicating comparable to predicate) | |
| RF Heating | Temperature rise within safe limits | 1.1°C temperature rise | |
| Gradient Induced Voltage | Not explicitly stated/tested (See "Gradient Induced Voltage 4.") | No phantom tests conducted |
Note on Implied Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for magnetic attraction, torque, or artifact. However, the FDA's clearance implies that the reported performance was deemed "acceptable" for MR compatibility. For RF heating, a 1.1°C rise is reported, which is generally considered a safe and acceptable level for medical devices in an MR environment. The "artifact same as the device ++" implies that the new device's artifact profile is comparable to, and thus acceptable relative to, the predicate device.
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- The document describes a single device being tested for MR compatibility. It's not a study with a "test set" in the typical sense of evaluating diagnostic performance with multiple patient cases. Instead, it's a physical device testing to ensure safety and compatibility in an MR environment. Therefore, the "sample size" is 1 device.
- Data Provenance:
- The testing was performed directly on the Greatbatch Scientific MR Compatible Laryngoscope.
- The location of the testing is implied by the "GE Signa 64 MHz MR System," suggesting a controlled laboratory or clinical setting where such equipment is available. No specific country of origin for the data is mentioned, but the submitter is based in New York, USA.
- The study is prospective in the sense that the new device was subjected to specific MR compatibility tests.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This submission is for device safety and compatibility testing, not for diagnostic performance evaluation or establishing a "ground truth" for clinical outcomes or interpretations. The "truth" in this context is the physical behavior of the device in an MR environment. The experts involved would be engineers and physicists conducting and interpreting the MR safety tests according to established standards.
4. Adjudication Method
- Not applicable. This study is not a clinical performance study requiring adjudication of expert interpretations. The results are objective measurements of physical properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic performance of AI or imaging interpretation by human readers, which is not the purpose of this submission.
6. Standalone Performance (Algorithm Only without Human-in-the-loop)
- Yes, in spirit. The MR compatibility tests performed are akin to a "standalone" evaluation of the device's physical properties without human interaction influencing the measurements. The device itself (the laryngoscope) is the subject of the performance evaluation in the MR environment. There is no algorithm involved.
7. Type of Ground Truth Used
- The "ground truth" for this study is based on objective physical measurements and established MR safety standards/guidelines. For example, magnetic attraction is measured by string deflection and torque, artifact by visual inspection of images, and RF heating by temperature sensors. There isn't a "pathology" or "outcomes data" ground truth in this context.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set." The device is a physical instrument.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set involved, this question is not relevant.
§ 868.5540 Rigid laryngoscope.
(a)
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9