(176 days)
For use to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures in a MR or an interventional MR environment, not to exceed a 1.5 Tesla static magnetic field.
The Greatbatch Scientific MR Compatible Laparoscope and Operating Laparoscopes are available in standard and autoclavable 8.0mm, 10.0mm sizes, with 0°, 30° or 45° angles.
The acceptance criteria for the Greatbatch Scientific MR Compatible Laparoscope and Operating Laparoscope are focused on MR compatibility within a 1.5 Tesla static magnetic field. The study conducted to prove this compatibility involved testing an 8.0mm endoscope from Greatbatch Scientific in conjunction with a 1.5 Tesla GE Signa Magnet.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Magnetic Attraction & Torque: | |
| Static Field Strength ≤ 1.5 Tesla | 1.5 Tesla / GE Signa 64 MHz MR System |
| Acceptable Deflection | Very slight deflection observed |
| Acceptable Torque | 5 degrees torque observed |
| Artifact: | |
| Static Field Strength ≤ 1.5 Tesla | 1.5 Tesla / GE Signa 64 MHz MR System |
| Minimal Distortion (FSPGR sequence) | "++" distortion in axial and sagittal planes (indicates some distortion, but deemed acceptable within the context of the device being "MR Compatible" and not causing significant issues) |
| RF Heating: | |
| Static Field Strength ≤ 1.5 Tesla | 1.5 Tesla / GE Signa 64 MHz MR System |
| SAR applied (max) | 2.1 W/kg (applied for 60 minutes) |
| Maximum temperature rise | 0.5°C maximum temperature rise observed |
2. Sample size used for the test set and the data provenance:
- Sample Size: The test set included "A Greatbatch Scientific MR Compatible 8.0mm endoscope". This suggests a sample size of one device (an 8.0mm endoscope) for the tests described.
- Data Provenance: The testing was conducted in a laboratory setting using a 1.5 Tesla GE Signa Magnet. The report does not specify the country of origin but implies a controlled, non-clinical environment. The study is prospective as it involves direct testing of the device for its compatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information is not applicable (N/A) to this study. The tests performed are objective physical measurements of the device's interaction with an MR environment (magnetic attraction, torque, artifact, and heating). The "ground truth" is established by direct measurement of physical properties, not by expert interpretation.
4. Adjudication method for the test set:
Not applicable (N/A). As mentioned above, the tests are objective physical measurements. There is no expert adjudication involved in determining magnetic attraction, torque, artifact intensity, or temperature rise. These are measured values against predefined criteria.
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:
No. This study is not an MRMC comparative effectiveness study. It assesses the physical compatibility of a medical instrument with an MR environment, not the performance of an AI algorithm or its impact on human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This study is not related to an algorithm's performance. It evaluates a physical device (a laparoscope).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this study is based on objective physical measurements and established MR safety standards/guidelines. The measured values for magnetic attraction, torque, artifact generation, and temperature rise are directly assessed against thresholds considered safe and acceptable for an MR-compatible device.
8. The sample size for the training set:
Not applicable (N/A). This study describes the testing of a physical medical device for MR compatibility. There is no "training set" as there is no machine learning or AI component involved.
9. How the ground truth for the training set was established:
Not applicable (N/A). As there is no training set.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.