(118 days)
The Smith & Nephew TRUCLEAR Operative Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Smith & Nephew's TRUCLEAR Operative Hyteroscope is a rigid hysteroscope 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 inflow-channel.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Smith & Nephew TRUCLEAR Operative Hysteroscope:
This document is a 510(k) Summary of Safety and Effectiveness for a medical device seeking substantial equivalence to a predicate device, not a report on a clinical study for a novel AI or diagnostic device. Therefore, many of the requested fields (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone algorithm performance) are not applicable as the submission focuses on engineering and performance testing to demonstrate equivalence, rather than a clinical efficacy study with human interpretation of data.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests/Criteria | Reported Device Performance |
|---|---|---|
| Optical Performance | Brightness | Demonstrated substantial equivalence to predicate device. |
| Vignetting | Demonstrated substantial equivalence to predicate device. | |
| Resolution | Demonstrated substantial equivalence to predicate device. | |
| Near and Far Focus | Demonstrated substantial equivalence to predicate device. | |
| Image Run Out | Demonstrated substantial equivalence to predicate device. | |
| Depth of Field | Demonstrated substantial equivalence to predicate device. | |
| Image Distortion | Demonstrated substantial equivalence to predicate device. | |
| Mechanical/Physical | Sheath Force Testing | Performed comparably to predicate device under similar conditions. |
| Working Channel Instrument Compatibility Testing | Performed comparably to predicate device under similar conditions. | |
| Electrical Safety | Compliance with IEC 60601-2-18 and IEC 60601 standards | Complies with applicable portions of these standards. |
| Cleaning & Sterilization | Cleaning and Sterilization Validations | Successfully passed validations per AAMI TIR 30 and AAMI TIR 12. |
| Biocompatibility | Biocompatibility Requirements | All materials demonstrated to meet biocompatibility requirements according to FDA General Program Memorandum #G95-1, Use of International Standards ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". |
| Overall Conclusion | Safety and Effectiveness | Optical and performance testing demonstrates that the proposed device is as safe, effective and performs as well as or better than the predicate. |
The "study" that proves the device meets the acceptance criteria is the sum of these various performance, optical, electrical, and materials testing. The objective was to demonstrate substantial equivalence to the predicate device (Smith & Nephew Operative Hysteroscope cleared in K013870) based on these technical characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a 510(k) for a physical medical device. The "test set" would refer to the specific physical units of the TRUCLEAR Operative Hysteroscope that underwent the various performance, optical, mechanical, and safety tests. The document does not specify the number of units tested. This kind of submission typically involves engineering and bench testing rather than patient data.
- Data Provenance: Not applicable in the context of patient data. The testing was likely conducted in laboratories or facilities belonging to Smith & Nephew or a contracted testing organization, presumably in the USA given the company address. This is engineering/bench data, not clinical data from patients.
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)
- Not applicable. Establishing ground truth by experts is relevant for diagnostic devices that process clinical data (e.g., images, signals) and require human interpretation as a gold standard. For this physical hysteroscope, the "ground truth" for its performance is determined by objective measurements against established engineering, optical, and safety standards and comparison to the predicate device's known performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies where human readers or interpreters might disagree on an outcome. This document describes engineering and performance testing.
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 is not mentioned and is not relevant for a 510(k) submission of a physical hysteroscope which is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm or AI device. It is a physical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" used for this submission is based on engineering specifications, recognized national and international standards (e.g., IEC 60601, ISO 10993, AAMI TIR), and the established performance characteristics of the predicate device. The objective was to show that the new device met these objective criteria and performed comparably to the legally marketed predicate.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning 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.