(30 days)
The Smith & Nephew TRUCLEAR Operative Hysteroscope 5C and Sheath 5C are used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The subject TRUCLEAR Operative Hysteroscope 5C and TRUCLEAR Sheath 5C are modifications to the TRUCLEAR Operative Hysteroscope 5.0 and TRUCLEAR Sheath 5.6 previously cleared in K112134. The TRUCLEAR Operative Hysteroscope 5C is a rigid hysteroscope with a slanted distal tip that is intended for use in office based, hospital and ambulatory surgical centers. The operative hysteroscope incorporates an optical fiber bundle design in order to reduce the overall diameter of the needle portion of the hysteroscope and still provide adequate space in the working channel for instrumentation. The Smith & Nephew TRUCLEAR Operative Hysteroscope internal design consists of a "D" shaped working channel into the needle portion of the hysteroscope. The working channel also acts as an inflowchannel.
This document is a 510(k) premarket notification for a medical device called the TRUCLEAR Operative Hysteroscope 5C and Sheath 5C. This type of submission does not typically include an acceptance criteria table or a detailed study proving the device meets specific performance metrics in the way a clinical trial for a new drug or novel AI algorithm would. Instead, it focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, AI-related studies) are not applicable to this type of regulatory submission for this particular device.
Here's an analysis based on the provided text, addressing the applicable points:
1. A table of acceptance criteria and the reported device performance
This document does not provide a formal table of acceptance criteria with specific numerical thresholds for performance. The "acceptance criteria" are implied by the demonstration of "substantial equivalence" to the predicate device and success in the non-clinical bench testing. The reported "performance" is qualitative, showing that the device meets drawing dimensions, achieves clear vision within a certain time, and has reduced insertion force.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet drawing dimensions for physical specifications. | All devices met drawing dimensions. |
| Allow for assembly of scopes with sheaths. | All scopes could be assembled with all sheaths. |
| Achieve clear vision during flow and visualization testing within an acceptable timeframe. | Average time to attain clear vision was 14.2 seconds. |
| Exhibit comparable or improved insertion force compared to predicate device. | Showed an average 29% reduction in insertion force compared to the predicate devices. |
| Maintain integrity and functionality after packaging/shipping. | Product will not be damaged during shipping and will function properly post-shipping. |
| Function similarly to predicate devices regarding intended use and indications for use. | Substantially equivalent to predicate devices regarding intended use, indications for use, and performance characteristics. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify the exact sample size for the individual non-clinical tests (e.g., how many hysteroscopes and sheaths were tested for dimensional inspection, flow and visualization, or insertion force). It refers to "all devices" in some instances but doesn't provide a number.
- Data Provenance: The testing was "non-clinical bench testing," meaning it was conducted in a lab setting, not on human subjects. The country of origin of the data is not specified, but the applicant (Smith & Nephew, Inc.) is based in Andover, MA, USA, and the submission is to the US FDA, so it's likely conducted or overseen in the USA. The data is prospective for the purpose of this submission (i.e., new testing was performed for this modified device).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a bench study on a physical medical device, not an AI algorithm requiring expert consensus for ground truth on clinical images or data. The "ground truth" for these tests comes from objective measurements against engineering specifications and comparisons to the predicate device.
4. Adjudication method for the test set
Not applicable. There was no expert adjudication needed for these non-clinical bench tests. The tests involve objective measurements and observations.
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. This submission is for a physical medical device (hysteroscope and sheath), not an AI-powered diagnostic tool. MRMC studies are typically relevant for evaluating the impact of AI algorithms on human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was based on:
- Engineering specifications and drawing dimensions (for dimensional inspection).
- Objective measurements (e.g., time to clear vision, insertion force measurements).
- Comparison to the performance of the legally marketed predicate device (for substantial equivalence).
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical medical device.
§ 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.