(275 days)
The KOLPEXIN™ Sphere is a vaginal pessary that is indicated for the conservative management of vaginal prolapse and pelvic floor muscular weakness.
The KOLPEXIN* Sphere is symmetrically circular shaped with an attached nylon string for device removal. The device is made from medical grade polycarbonate, LEXAN 144R-111, GE Plastics, and is available in six sizes; 44mm, 42mm, 39mm, 36mm, 32mm and 28mm.
Here's an analysis of the provided text regarding the KOLPEXIN* Sphere, focusing on the acceptance criteria and the study conducted.
It's important to note that the provided documents are a 510(k) summary and a 510(k) clearance letter. These documents typically provide high-level summaries of studies, but not the detailed study protocols, full results, or comprehensive acceptance criteria that would be found in a complete clinical study report or a peer-reviewed publication. Therefore, some of the requested information may not be explicitly present in these specific documents.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicit or Implied from Indications) | Reported Device Performance (from "Clinical Study" section) |
|---|---|
| Safety: Device is non-sensitizing, non-irritating, and suitable for intended use. | "materials manufacturer safety tests demonstrate that the KOLPEXIN* Sphere is non-sensitizing, non-irritating and suitable for its intended use." (Biocompatibility Testing) |
| "The study concluded the KOLPEXIN* Sphere is a safe and effective device..." (Clinical Study) | |
| Efficacy: Effective for conservative management of vaginal prolapse. | "The study concluded the KOLPEXIN* Sphere is a safe and effective device for the conservative management of vaginal prolapse..." (Clinical Study) |
| Efficacy: Effective for management of pelvic floor muscular weakness. | "The study concluded the KOLPEXIN* Sphere is a safe and effective device... for pelvic floor muscular weakness." (Clinical Study) |
| Functionality: Operates as intended (symmetrically circular shaped, attached nylon string for removal, available in six sizes). | No explicit performance metric is given for functionality from the clinical study, but the physical description details these aspects. The study states "A multicenter study to confirm the safety, efficacy, and functionality... was performed." implying functionality was confirmed. |
Missing Information:
- Specific quantitative acceptance criteria (e.g., minimum percentage reduction in prolapse grade, minimum strength increase, specific thresholds for adverse events).
- Detailed quantitative performance data from the clinical study. The provided text only states that the device was found "safe and effective."
2. Sample Size Used for the Test Set and Data Provenance
- Sample size: Not explicitly stated in the provided text for the clinical study. It is referred to as "A multicenter study," implying multiple sites and likely more than a handful of participants, but no specific number is given.
- Data provenance (country of origin, retrospective/prospective): Not explicitly stated. The submitter is ADAMED Ltd. from Poland, and the contact is in the USA. The study is described as "A multicenter study," suggesting a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the 510(k) summary. Given the nature of a medical device for vaginal prolapse and pelvic floor weakness, the "ground truth" (i.e., diagnosis, assessment of change, etc.) would typically be established by physicians specializing in gynecology or urogynecology. However, the document doesn't detail this.
4. Adjudication Method for the Test Set
- This information is not provided in the 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The device in question is a physical medical device (a pessary/training aid), not an AI algorithm that assists human readers in interpreting medical images or data. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, this is not applicable. The KOLPEXIN* Sphere is a physical device, not an algorithm. Its performance is directly observed in patients, not through standalone algorithmic processing.
7. Type of Ground Truth Used
- Based on the indication "conservative management of vaginal prolapse and pelvic floor muscular weakness," the ground truth would likely be based on:
- Clinical Assessments: Physical examinations by medical professionals (e.g., POP-Q staging for prolapse, palpation for muscle strength).
- Patient-Reported Outcomes (PROs): Questionnaires related to symptoms, quality of life, and satisfaction.
- The document does not detail the specific ground truth methods or metrics used in the clinical study.
8. Sample Size for the Training Set
- This concept is not applicable here. The KOLPEXIN* Sphere is a physical medical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "clinical study" evaluates its performance in actual patients.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable, as there is no "training set" in the context of this device. The clinical study for this device is the primary evaluation of its safety and efficacy.
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).