(127 days)
The TRUCLEAR™ Incisor® Plus Blade 2.9 is intended for use in gynecological procedures by trained professional gynecologists to resect and remove endometrial tissue for the following indications, submucous myomas and endometrial polyps. The TRUCLEAR™ Incisor Plus Blade 2.9 is used specifically with the TRUCLEAR Hysteroscopic Morcellator.
The TRUCLEAR Hysteroscopic Morcellator includes:
- TRUCLEAR Control Unit .
- . TRUCLEAR Footswitch
- . TRUCLEAR Handpiece
The TRUCLEAR™ Incisor Plus Blade 2.9 consists of an inner and outer stainless steel tube. Both tubes have a molded hub on the proximal end and a cutting window with symmetrical teeth on the distal end. The inner tube fits into the outer tube and is snapped and locked in place into a motor drive unit, which rotates the inner tube of the device. Tissue is simultaneously shaved and suctioned through the cutting window of the disposable blade.
Here's an analysis of the provided text regarding the TRUCLEAR™ Incisor® Plus Blade 2.9, focusing on acceptance criteria and supporting studies:
A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Shed Test: Visual aid ranking scheme met. | Demonstrated that after 6 minutes of continuous use in water, the TRUCLEAR™ Incisor Plus Blade 2.9 met the established criteria of the visual aid ranking scheme. |
| Cutting Performance Test: No seizing or mechanical failure. | Demonstrated that after running the blade for 15 minutes under simulated use conditions, there was no seizing or mechanical failure of the blade. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The tests refer to "6 minutes of continuous use" for the Material Shed Test and "15 minutes under simulated use conditions" for the Cutting Performance Test. These durations likely refer to the operational time for a single blade or a set of blades, but the total number of blades or test repetitions is not specified.
- Data Provenance: The study was conducted by Smith & Nephew, Inc., a medical device manufacturer based in Andover, MA, USA. The data would be considered prospective as it involves performance testing newly designed devices. There is no information regarding country of origin of the data beyond the manufacturer's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For the Material Shed Test, a "visual aid ranking scheme" was used, implying some form of assessment, but the number or qualifications of individuals involved are not detailed. For the Cutting Performance Test, the criterion is "no seizing or mechanical failure," which is an objective measurement rather than an expert ground truth.
4. Adjudication method for the test set:
- This information is not provided. The nature of the tests (material shed, cutting performance) suggests objective measurements and observations rather than a need for complex adjudication methods typical for subjective assessments or image-based diagnostics.
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, an MRMC comparative effectiveness study was not done. This document describes performance testing for a surgical tool (hysteroscope blade), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical surgical tool. It does not involve an algorithm or AI.
7. The type of ground truth used:
- Material Shed Test: The ground truth was based on an "established criteria of the visual aid ranking scheme." This implies a pre-defined standard for acceptable material shedding, likely involving visual inspection and comparison.
- Cutting Performance Test: The ground truth was based on objective mechanical performance: "no seizing or mechanical failure of the blade." This is a physical observation.
8. The sample size for the training set:
- Not applicable / Not provided. This device is a mechanical tool. There is no "training set" in the context of machine learning or algorithms. The design and manufacturing processes are refined through engineering principles and iterative testing, not through a data-driven training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it. The ground truth for the performance tests (material shed and cutting) are described above.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.