(184 days)
The TruClear Elite Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.
TruClear™ Elite Hysteroscopes are reusable instruments for use in visualizing the uterine cavity and performing diagnostic and operative procedures. The TruClear™ Elite Hysteroscopes are stainless steel instruments designed with a rod-lens optical channel for visualization, optical fibers for illumination, and a working channel to permit introduction of instrumentation.
The subject Truclear™ Elite Hysteroscopes Plus (7.25mm) and Mini (6mm) are modifications to the previously cleared Smith & Nephew Operative Hysteroscopes 8.0 (K013870) and 5C (K152143). Both the Truclear™ Elite Plus and Mini Hysteroscopes are rigid hysteroscopes with a slanted distal tip, rod lens optics and disposable proximal fluid seal.
The TruClear™ Elite Hysteroscopes are composed of the working channel insert and the hysteroscope body. The device is designed to be disassembled for access to interior lumens during cleaning and sterilization. Like the predicate devices, the subject devices have an inflow and outflow channel to provide continuous flow during the clinical procedure. The inflow channel passes through the hysteroscope body and provides operative fluid from a fluid management system or pressurized saline bag to distend the uterine cavity. The outflow channel which is contained within the working channel insert, clears the uterine cavity to maintain visualization. The outflow channel also acts as the instrument channel through which the tissue removal device is inserted.
This document describes the TruClear™ Elite Hysteroscopes, a medical device designed for viewing the cervical canal and uterine cavity for diagnostic and operative procedures. It is a reusable instrument with a rod-lens optical channel, optical fibers for illumination, and a working channel.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/ML device submissions. Instead, it demonstrates substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical performance testing.
The document lists various non-clinical bench tests performed to support substantial equivalence. For optical characteristics, some performance metrics are provided in comparison to the predicate devices.
| Metric (Acceptance Criteria Implicitly Compared to Predicate) | Predicate K013870 (Smith & Nephew Operative Hysteroscope 8.0) | Predicate K152143 (Smith & Nephew TRUCLEAR Operative Hysteroscope 5C) | TruClear™ Elite Hysteroscope Plus (K180496) (Reported Performance) | TruClear™ Elite Hysteroscope Mini (K180496) (Reported Performance) |
|---|---|---|---|---|
| Indications for Use Statement | "used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures" | "used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." | "is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures" | "is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures" |
| Material of Construction | Stainless Steel, PEEK, Sapphire, Optical Glass | Stainless Steel, PEEK, Sapphire, Optical Glass | Stainless Steel, PEEK, Sapphire, Optical Glass | Stainless Steel, PEEK, Sapphire, Optical Glass |
| Working Length (mm) | 191.5 (scope), 168 (sheath) | 219 (scope), 205 (sheath) | 201.1 | 201.1 |
| Outer Diameter (mm) | 8.5 | 5.25 | 7.25 | 6 |
| Working Channel Diameter (mm) | D shaped 5.5 by 5.4 | D shaped 5.5 by 5.4 | 4.2 | 3.1 |
| Distal Tip Shape | Flat | Slanted | Slanted | Slanted |
| Working Channel Closure | Stopcock | Stopcock | Seal | Seal |
| Recommended Light Source | Metal Halide and Xenon (≤ 300 W) | Metal Halide and Xenon (≤ 300 W) | Metal Halide and Xenon (≤ 300 W) | Metal Halide and Xenon (≤ 300 W) |
| Focal Length (mm) | 1.3 | 0.6 | 1.02 | 1.02 |
| Working Distance (mm) | 30 | 10 | 30 | 30 |
| Field of View (Degrees) | 80 | 85 | 80 | 80 |
| Direction of view (Degrees) | 0 | 0 | 0 | 0 |
| Optics (Image Transmission System) | Rod lens | Fiber optic (Image bundle) | Rod lens | Rod lens |
| Ratio of Luminous Energy Transmitted to Energy Delivered | 23.5% (12%) | 15.6% (12.8%) | 23.5% | 23.5% |
| Eyepiece Magnification | 21x | 37x | 19.4x | 19.4x |
| Resolution @ 30 mm Working Distance (lp/mm) | 8.5 | 3 | 8 | 8 |
| Distortion | -26% barrel | -23% barrel | -22% barrel | -22% barrel |
Note: The "acceptance criteria" here are implicitly that the new devices perform comparably to, or demonstrate equivalent safety and effectiveness as, the predicate devices. The document explicitly states: "The subject and predicate devices have different technological characteristics, including dimensions, device design, and optical characteristics. These differences do not raise different questions of safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The provided document details non-clinical bench testing. It does not mention a "test set" in the context of patient data or clinical imagery. Therefore, information regarding:
- Sample size used for a test set (clinical data),
- Data provenance (country of origin, retrospective or prospective),
is not applicable to this submission as it focuses on physical device performance and equivalence to a predicate, not AI/ML algorithm evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since this is a submission for a physical medical device (hysteroscope) and not an AI/ML algorithm requiring image interpretation or diagnostic accuracy assessment, there is no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
As there is no mention of a clinical "test set" requiring expert interpretation or ground truth establishment, an adjudication method is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this document. This type of study is typically performed to evaluate the impact of AI assistance on human reader performance, which is not relevant for this physical device submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. The device is an optical instrument (hysteroscope) which is used by a human operator for direct visualization. It is not an AI/ML algorithm.
7. The Type of Ground Truth Used
For the non-clinical bench testing, the "ground truth" would be established by engineering standards, physical measurements, and validated testing protocols for device performance characteristics (e.g., resolution measured by optical equipment, flow rates measured by flow meters, material properties, sterility validation). In a regulatory context, the "ground truth" for substantial equivalence is defined by demonstrating that the new device is as safe and effective as the predicate device(s) for its intended use, supported by these engineering and performance tests.
8. The Sample Size for the Training Set
As this is a submission for a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned or applicable for this device, the method for establishing its ground truth is not applicable.
§ 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.