(132 days)
The Omni Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Omni Hysteroscope is a hysteroscope consisting of a (base) rigid hysteroscope with optics and lighting connections. The Omni Hysteroscope includes three compatible sheaths, one diagnostic and two operative, that attach to the base scope; Omni 3.7 mm Diagnostic Sheath, Omni 5.5 mm Operative Sheath, and Omni 6mm Operative Sheath. The Omni Hysteroscope also includes removable outflow channels for fluid drainage. The Omni Hysteroscope is supplied non-sterile and is designed for multiple use with the device being cleaned and sterilized prior to each use.
This document, K182006, describes the 510(k) premarket notification for the Omni Hysteroscope. It focuses on demonstrating substantial equivalence to predicate devices, rather than an AI-driven system. Therefore, much of the requested information regarding AI model performance, ground truth establishment, expert adjudication, MRMC studies, and training set details for AI-based devices is not applicable.
Here's the information that can be extracted relevant to the performance testing described for the Omni Hysteroscope:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines various design verification tests conducted to ensure the device meets its specifications. It does not provide specific numerical acceptance criteria (e.g., "Field of view must be X degrees") nor does it report precise numerical performance results (e.g., "Field of view was measured at Y degrees"). Instead, it states that the devices comply with design specifications and that test results demonstrate substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance (Compliance Statement) |
|---|---|
| Dimensional Verification | Complies with design specifications |
| Objective Lens Testing (Field of view, focal length, depth of field, direction of view) | Complies with design specifications |
| Level of Illumination | Complies with design specifications |
| Luminous Energy Transmission Ratio | Complies with design specifications |
| Magnification (eyepiece) | Complies with design specifications |
| Image Quality (Resolution, Distortion) | Complies with design specifications |
| Risk Management (ISO 14971:2007) | Risks are mitigated to an acceptable level; benefits outweigh residual risks |
| Biocompatibility (ANSI AAMI ISO 10993-1:2009) | Patient contacting materials are biocompatible and comply with requirements |
| Electrical Safety (ANSI AAMI ES 60601-1:2005/(R)2012 & A1:2012, C1:2009/R)2012 & A2:2010/(R)2012 and IEC 60601-2-18:2009) | Testing was performed and passed |
| Usability Testing (FDA Guidance, IEC 62366-1:2015) | Testing was conducted in accordance with guidance and standards |
| Cleaning Validation | Successfully performed |
| Sterilization (ISO 14937:2009/(R)2013, ANSI/AAMI/ISO 17665-1:2006/(R)2013) | Sterilizations were conducted in accordance with standards |
2. Sample Size Used for the Test Set and Data Provenance:
This document refers to "design verification testing" and "performance testing" of the physical device. It does not involve a "test set" in the context of an AI model using patient data. The provenance of the data is implicitly from Hologic, Inc.'s internal testing facilities. It is a prospective generation of test data based on the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a physical medical device (hysteroscope), not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance relates to engineering specifications and physical measurements.
4. Adjudication Method for the Test Set:
Not applicable. There is no adjudication in the context of this device. Performance is measured against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI algorithms that assist human readers. The Omni Hysteroscope is a tool for viewing and performing procedures.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The Omni Hysteroscope is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is based on engineering specifications and established regulatory and industry standards for medical devices (e.g., ISO, ANSI AAMI for biocompatibility, electrical safety, sterilization, etc.). For example, objective lens testing would have specific optical parameters as the ground truth.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
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.