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Restorelle Y is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Restorelle Y is a mesh is constructed of knitted nonabsorbable monofilaments of polypropylene, a synthetic polymer. It is designed for the treatment of vaginal vault prolapse. The Y shape design allows the two Y - leg segments to be attached to the anterior and posterior vaginal walls. The base of the Y segment is designed to attach to the sacral ligament.

The provided text describes the Restorelle® Y surgical mesh and its 510(k) submission for an expanded indication for use.

Here's an analysis of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of numerical targets for clinical performance that the device had to meet to be cleared. Instead, it presents the results of a clinical study and concludes "The performance data and clinical data on similar mesh devices provided in this submission demonstrate that the Restorelle Y mesh is substantially equivalent to its predicate devices."

However, we can infer performance metrics from the reported clinical outcomes.

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

• Sample Size for Test Set: Not explicitly stated as a number of patients. The study is described as an "independent prospective cohort study." However, one of the referenced abstracts, "Prospective Cohort Study of Robotic Sacrocolpopexy using Lightweight Polypropylene Y Mesh," by Salamon et al., is the source of the clinical data. Without access to the full abstract, the exact number of patients in that specific study cannot be extracted directly from this 510(k) summary. The summary refers to the study's results after "twelve-month postoperative assessments," implying a follow-up period for the cohort.
• Data Provenance: The study was conducted by clinicians whose affiliations are not explicitly stated in the 510(k) summary, but the names (Christa Lewis DO, Charbel Salamon MD, etc.) are common in US medical practice. The abstracts were presented at the "AAGL 40th Global Congress of Minimally Invasive Gynecology (November 6-10, 2011 in Hollywood, FL)," suggesting a US or international context, but predominantly American names. It was a prospective cohort study.

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

The document does not provide details on how "ground truth" was established within the prospective cohort study, nor does it specify the number or qualifications of experts involved in data collection or assessment for objective or clinical cure rates. The measurements of POP-Q stages and subjective measures would typically be performed by trained medical professionals (e.g., gynecologists or urogynecologists) involved in the study.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes reported in the prospective cohort study.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a surgical mesh, not an AI-powered diagnostic or assistive tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No, a standalone (algorithm only) performance study was not done. This is a physical medical device (surgical mesh), not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established through a combination of:

• Objective anatomical assessment: Specifically, POP-Q (Pelvic Organ Prolapse Quantification) Stage 0 or 1 for anatomical cure. This is a standardized clinical measurement.
• Subjective measures: These would have been patient-reported outcomes or clinician assessments of symptoms, as indicated by "simultaneously considering POP-Q points and subjective measures" for clinical cure rate. This also included patient-reported dyspareunia (painful intercourse) and sexual activity.

8. The Sample Size for the Training Set

This question is not applicable in the context of this device. A "training set" typically refers to data used to train an artificial intelligence or machine learning model. The Restorelle Y is a physical surgical mesh, not an AI algorithm. Its development would involve engineering and material science, not a data-driven training set in the AI sense.

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

This question is not applicable for the reasons stated above (see point 8).

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