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Omni hysteroscope:
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.

Omni Lok cervical seal:
The Omni Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.

The Omni Hysteroscope is used to provide viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative 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.
The Omni hysteroscope can be used with the Omni Lok cervical seal accessory. The Omni Lok cervical seal accessory slides over the operative sheath of the Omni hysteroscope. The Omni Lok cervical seal accessory is intended to be used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix.
The Omni Lok cervical seal is a sterile, single - use accessory for hysteroscopic procedures. The Omni Lok cervical seal remains seated at the opening of the cervix and remains flush against the cervical opening throughout the duration of the procedure to create a seal. This seal minimizes fluid leakage from the cervix.

The provided text describes a 510(k) premarket notification for the Omni Hysteroscope and Omni Lok cervical seal. It details the device's technical characteristics, indications for use, and performance testing conducted to demonstrate substantial equivalence to a previously cleared predicate device.

Here's the information extracted and organized according to your request, with a crucial caveat: The document does not describe a study involving "human readers" or "AI assistance." The "device" in question is a physical medical instrument (hysteroscope and cervical seal accessory), not an AI algorithm or diagnostic software.

Therefore, questions related to MRMC studies, AI performance, training sets, and expert adjudication for establishing ground truth in the context of diagnostic interpretation are not applicable to this submission. The "ground truth" for this medical device is its physical performance and safety, as demonstrated through bench, simulated use, and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

For the Omni Hysteroscope, the submission states:
"There have been no changes to the Omni hysteroscope performance as a result of this submission. The testing submitted in the predicate K182006 showed the device complies with all design specifications." This implies the acceptance criteria for the hysteroscope itself are tied to the prior clearance (K182006) and its established design specifications.

For the Omni Lok cervical seal accessory, the acceptance criteria and performance are as follows:

The overall conclusion states: "The verification test results demonstrate the device functions as intended; i.e., the device specifications are met, the device adequately attaches to the hysteroscope, has appropriate mechanical properties, and reduces leakage from a model cervix/uterus when utilized with a hysteroscope."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state numerical "sample sizes" in terms of a specific number of units for each bench test. The testing described is typical for physical medical devices—e.g., "shelf life testing," "biocompatibility testing," "design verification testing." These usually involve a statistically appropriate number of units or replicates for each specific test, but the exact numbers are not detailed in this summary.

• Data Provenance: The studies are described as "non-clinical bench testing and simulated use testing." This indicates the data is from laboratory settings, not from human subjects. As such, concepts like "country of origin of the data" (in terms of patient demographics) are not applicable. It's prospective testing conducted to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

N/A. This is not an AI/diagnostic imaging device. The "ground truth" is established through engineering specifications, scientific standards (e.g., ISO, ASTM standards), and validated test methods. The design verification and biocompatibility testing are performed by qualified engineers, technicians, and specialized labs following established protocols.

4. Adjudication Method for the Test Set

N/A. Not applicable to a physical device performance and safety study of this nature. "Adjudication" in this context would typically refer to expert review of diagnostic interpretations, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A. This is a physical medical device, not an AI or diagnostic tool requiring human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A. This is a physical medical device. The "performance testing" detailed (e.g., leak testing, spring compression) represents its "standalone" performance without human interaction regarding diagnostic interpretation, but this is not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the Omni Lok cervical seal is based on:

• Engineering specifications and design requirements: Ensuring the device meets its intended physical and mechanical properties (e.g., friction fit, spring compression, leak reduction).
• International and national standards: Adherence to standards like ASTM, ISO, and IEC for shelf life, biocompatibility, sterilization, usability, and packaging integrity.
• Simulated use testing: Performance in a "model cervix/uterus" to demonstrate its function as intended.

8. The Sample Size for the Training Set

N/A. There is no training set for a physical device. This isn't an AI/machine learning product.

9. How the Ground Truth for the Training Set was Established

N/A. There is no training set.

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