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Endospeculum used only to expand the scope of routine gynecological examinations. Fenestrated blades and finger rings bend outwards in opposite directions permitting thorough examination of the urethra and cervix. Compresses cervical tissue to allow direct visualization of the walls of the cervical os and interior of the uterus.

The Gynex Endospeculums are made of 300 series instrument grade stainless steel. There are two styles, plain handle and ratchet handle. Both have "gold" plate handles. Tip sizes are 3mm and 4mm for both handle types. Overall length of both types is 270mm (approx. 10 in.). The device is essentially identical to the Kogan endospeculum listed above. The blade tips are spring closed and pressing the handles together opens spreads the tips to compress the cervical wall and expand the cervical os or urethra for inspection.

Here's an analysis of the provided text regarding the Gynex Endospeculum, focusing on acceptance criteria and supporting studies:

It's important to note that the provided documents are a 510(k) premarket notification for a Class II medical device. For such devices, particularly those like manual surgical instruments, the "acceptance criteria" and "study" for performance are often centered around demonstrating substantial equivalence to a legally marketed predicate device and adherence to manufacturing and materials standards, rather than clinical trials with statistical endpoints for AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

For the Gynex Endospeculum, the acceptance criteria are not explicitly stated in numerical performance metrics as might be seen for software or diagnostic devices. Instead, they are implicit in the comparison to the predicate device and adherence to industry standards, ensuring the device is safe and effective for its intended use.

Explanation of "Acceptance Criteria":
In this context, the acceptance criteria are largely met by demonstrating that the Gynex Endospeculum is substantially equivalent to the predicate device ("Kogan Endospeculum, Gynecology, Obstetrics, V. Mueller, The Surgical Armamentarium, 1973"). This means it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The comparison table directly addresses this by showing similarities in design, materials, and sizes. Additionally, compliance with various quality and manufacturing standards serves as a form of acceptance criteria for ensuring safe and reliable production.

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

This is not applicable in the traditional sense of a "test set" for an AI algorithm or a clinical trial with patient data.

• Sample Size: Not applicable. The device is a manual surgical instrument. Its "performance" study is primarily a comparison of its physical and functional characteristics to a predicate device.
• Data Provenance: Not applicable for a "test set." The comparison is based on the characteristics of the predicate device (Kogan Endospeculum) which is a historical preamendment device. The design specifications and materials of the Gynex Endospeculum itself are the "data" being presented.

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

Not applicable. There is no concept of "ground truth" or expert review of a "test set" in the context of this 510(k) submission for a manual surgical instrument. The evaluation is focused on substantial equivalence to an existing device and adherence to manufacturing specifications.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of AI performance or clinical study adjudication. The FDA's review process itself can be seen as an adjudication of substantial equivalence based on the provided information, but it's not a method applied to a dataset for device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices, imaging systems, or AI-powered tools where human interpretation is involved. The Gynex Endospeculum is a manual surgical instrument.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. This concept is relevant for AI algorithms. The Gynex Endospeculum is a physical, manual instrument and does not have an "algorithm-only" mode. Its performance is inherent in its physical properties, design, and manufacturing quality, and how it is used by a healthcare professional.

7. The Type of Ground Truth Used

Not applicable. "Ground truth" (e.g., pathology, outcomes data) is typically used for diagnostic or AI-driven devices to validate accuracy. For a manual surgical instrument like the Gynex Endospeculum, the "truth" is established by its physical and functional characteristics matching the predicate device and meeting manufacturing standards, ensuring it performs its intended mechanical function safely and effectively.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for a manual surgical instrument. This concept is exclusive to machine learning and AI algorithms.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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