(28 days)
The Myosure XL Rod Lens Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Myosure XL Rod Lens Hysteroscope is comprised of an oval 6.0 mm x 6.4mm OD x 184 mm long stainless steel tube containing a series of rod lenses and a 4.0 mm working channel. At the distal end of the tube, an "objective" lens captures the image of the "object". The series of "rod" lenses relays the image along the length of the tube. The image is directed by a 45° prism to an offset evepiece that also contains "rod" lenses which relay the image along the length of the eyepiece tube. At the proximal end of the eyepiece, an "ocular" lens forms the image for the human eye and/or camera. The hysteroscope features a 0° angle of view and an 80° field of view.
The Myosure XL Rod Lens Hysteroscope also incorporates an inflow channel with stopcock, glass fibers for illumination, a 4 mm working channel and a proximal seal.
Additionally, the Myosure XL Rod Lens Hysteroscope utilizes a removable 4.0 mm OD x 283 mm length outflow channel which may be inserted through the hysteroscope's working channel. The outflow channel includes a seal to prevent distension fluid leakage from its proximal end. The seal also provides an insertion pathway for handheld instruments or cautery probes.
The Myosure XL Rod Lens Hysteroscope is intended to be sterilized prior to use.
The provided text describes a 510(k) premarket notification for a medical device, the Myosure XL Rod Lens Hysteroscope. It focuses on demonstrating equivalence to an existing predicate device rather than presenting a study with acceptance criteria and device performance results in the way a clinical trial or AI algorithm validation would.
Therefore, many of the requested sections about study design, sample sizes, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of regulatory submission. The submission's goal is to show that the new device is substantially equivalent to a previously cleared device.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific device performance metrics in a tabular format. The submission focuses on demonstrating equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated as quantitative thresholds) | The Myosure XL Rod Lens Hysteroscope complies with the functional and performance characteristics of the predicate device including flow rate testing, and seal effectiveness associated with the use of the device. (Implies performance meets the predicate's) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document refers to "Performance Testing" but does not detail the nature of these tests, sample sizes, or data provenance. It's likely these were bench tests or engineering validations, not clinical studies in the typical sense.
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)
This information is not applicable/not provided. The document describes a physical medical device (hysteroscope), not an AI algorithm requiring expert-established ground truth for image interpretation or diagnostic performance. Performance testing likely involved engineering measurements and functional checks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are typically associated with expert review of diagnostic cases, which is not described here.
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
This information is not applicable. This is a physical medical device, not an AI algorithm. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable/not provided in the context of diagnostic ground truth. For a physical device, "ground truth" would refer to established engineering specifications or functional standards against which the device's physical performance (e.g., flow rate, seal effectiveness) is measured. The document states the device "complies with the functional and performance characteristics of the predicate device."
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
§ 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.