(207 days)
Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.
A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending.
The provided text describes the 510(k) summary for the Portex Ring Pessary, which is a medical device. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert adjudication, or MRMC comparative effectiveness studies.
The document primarily focuses on:
- Device Identification: Applicant, name, classification, predicate device.
- Device Description and Intended Use: What it is, what it's for, contraindications, and warnings.
- Technical Characteristics: Mentions that "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device(s) for its intended use" and lists "Visual and Dimensional" tests.
- Data Submitted (Safety): States that a biological safety assessment was performed in accordance with ISO 10993, Part 1:1994.
Therefore, I cannot provide the requested table and study details as the information is not present in the given text.
Summary of what can be extracted (and what cannot):
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated. The document mentions "tests have been developed which are considered sufficient to ensure the efficacy and safety of the device" including "Visual and Dimensional" tests, and biological safety per ISO 10993. No specific quantifiable criteria or pass/fail thresholds are given.
- Reported Device Performance: No specific performance metrics or results (e.g., success rate in preventing prolapse, reduction in stress incontinence) are provided.
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not mentioned for any performance or efficacy testing.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned. The document relies on pre-clinical testing and comparison to a predicate device, not clinical studies with expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned, as there is no described test set requiring adjudication in the context of clinical performance or diagnostic accuracy.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a pessary, not an AI-assisted diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical pessary, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biological safety, the ground truth would be established by the ISO 10993 standards and associated laboratory tests.
- For physical characteristics (visual and dimensional), the ground truth would be engineering specifications and quality control measurements.
- No "ground truth" equivalent to what would be used for a diagnostic device (e.g., pathology for cancer detection) is described for this product.
8. The sample size for the training set:
- Not applicable/Not mentioned. There is no "training set" as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).