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The Meridian VPS is a single-use device intended to assist in the position and manipulation of the vagina during gynecologic surgical procedures such as sacrocolpopexy.

The Meridian® Vaginal Positioning System (VPS) is a single-use vaginal positioning device comprised of multiple polymers with an ergonomic handle and adjustable head for positioning. The head of the device consists of four main parts: a support body, a kick-out door, an adjustable cervical pin and an adjustable rib feature. The handle of the device consists of three main parts: two handle halves and an actuator knob. The Meridian Vaginal Positioning System is placed in the vagina to stabilize and aid in the identification of vaginal structures including anterior, posterior, apex, fornices and sulci during surgical procedures such as sacrocolpopexy.

This document is a 510(k) summary for the Meridian Vaginal Positioning System (VPS), a medical device. It describes the device, its intended use, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

No acceptance criteria and device performance table can be generated from the provided text. The document lists the types of non-clinical performance tests performed (e.g., biocompatibility, sterilization validation, mechanical testing) but does not provide specific quantitative acceptance criteria values or the reported performance data for these tests. It only states that "The results of the performance testing described above demonstrate that the Meridian Vaginal Positioning System is as safe and effective as the predicate device and supports a determination of substantial equivalence."

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria as one might find in a clinical trial report for an AI/ML diagnostic device.

Here's what can be extracted regarding the study, with explanations for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, this information is not present in the provided 510(k) summary. The document lists the types of tests performed (e.g., Cytotoxicity, Sensitization, Irritation, Functional testing, Maximum force for head, etc.) but does not provide numerical acceptance criteria or the specific results obtained for each test. The summary only states that the performance testing results "demonstrate that the Meridian Vaginal Positioning System is as safe and effective."

2. Sample Sizes Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing (e.g., biocompatibility, mechanical testing, sterilization validation). It does not involve a "test set" in the context of patient data or clinical images. Therefore:

• Sample size for the test set: Not applicable, as this was non-clinical testing of the device itself, not a clinical study involving patient data. The document would typically refer to the number of devices or test units used for each test (e.g., n=5 for bend testing), but these specific numbers are not provided.
• Data provenance (country of origin, retrospective/prospective): Not applicable for non-clinical device testing.

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

• Not applicable. This was non-clinical performance testing of a physical medical device (Vaginal Positioning System), not a study involving the interpretation of data where expert ground truth would be established (e.g., image annotation for an AI algorithm).

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

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

• No. This document describes the non-clinical performance testing of a physical surgical instrument. An MRMC study is typically performed for diagnostic devices (especially AI/ML-driven ones) to assess the impact of the device on human reader performance.

6. Standalone (Algorithm Only) Performance:

• No. This device is a physical surgical instrument, not an algorithm. Standalone performance is relevant to AI/ML algorithms that provide an output without human intervention.

7. Type of Ground Truth Used:

• Not applicable. For physical device testing, "ground truth" refers to established material properties, mechanical specifications, and biological safety limits, as defined by standards like ISO 10993-1. The "ground truth" for these tests would be the established limits and specifications against which the device's performance is measured. The document states that tests were performed "per the special controls listed in 21 CFR 884.4910" and according to standards like ISO 10993-1.

8. Sample Size for the Training Set:

• Not applicable. This document is not describing an AI/ML device that requires a training set. The "device" is a physical instrument.

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

• Not applicable. See point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device, the Meridian Vaginal Positioning System (VPS). It details non-clinical performance testing to establish substantial equivalence. It does not contain information about acceptance criteria values, reported performance data, clinical study sample sizes, expert adjudication, or AI/ML-specific testing methodologies (like MRMC studies or training set details). The "proof" of meeting safety and effectiveness criteria relies on demonstrating compliance with recognized standards and pre-defined specifications through the listed non-clinical tests, which include biocompatibility, sterilization validation, package integrity, dimensional analysis, and various mechanical tests.

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