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The ASPIVIX v1.1 Cervical Suction Tenaculum is indicated to snare, grasp, hold and manipulate cervical tissue.

ASPIVIX v1.1 is a sterile, single-use, one-piece device that consists of four non-removable parts: a reloadable vacuum reserve embedded inside the main body, an activation / deactivation slider ring, a sliding tube to generate vacuum in the main body and an anatomic suction pad to put in contact with the cervix.

This document describes a 510(k) premarket notification for the ASPIVIX v1.1 Cervical Suction Tenaculum. It details the device's indications for use, comparison to a predicate device, and performance data provided to support substantial equivalence.

Based on the provided text, the device itself is a manual instrument, not an AI device. Therefore, many of the requested elements pertaining to AI device validation (e.g., sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission. The 510(k) summary focuses on demonstrating that the new manual device is as safe and effective as a legally marketed predicate device.

However, I can extract the information relevant to the performance data and acceptance criteria as described for this manual device.

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "All test results were in accordance with the test acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria for each test. Instead, it lists the types of performance tests conducted and the general conclusion.

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

This information is not provided in the given text. The document refers to "testing" but does not specify the number of units or samples used for each test, nor the provenance (country of origin, retrospective/prospective) of any clinical data, as this is a physical medical device clearance, not an AI/software as a medical device (SaMD) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not provided. As this is a manual medical device, there is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The testing involves physical and biological properties.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typical for human reader studies with AI, which are not relevant for this manual device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable and not provided. MRMC studies are used to evaluate diagnostic performance of AI or human readers, which is not the type of claim being made or evaluated for this manual device.

6. Standalone Performance (Algorithm Only)

This information is not applicable and not provided. This is a manual physical device, not an algorithm or software.

7. Type of Ground Truth Used

This information is not applicable in the AI/diagnostic sense. For this manual device, the "ground truth" or reference standards are the established performance metrics and biocompatibility standards (e.g., ISO standards for cytotoxicity, sensitization, irritation; mechanical testing standards for traction and bend strength).

8. Sample Size for the Training Set

This information is not applicable and not provided. This device does not involve machine learning or AI models with training sets.

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

This information is not applicable and not provided. As above, there is no training set as this is not an AI device.

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