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The PelvX Incontinence Dish Vaginal Pessary is intended for treatment of stress urinary incontinence combined with a mild 1st or 2nd degree uterine prolapse and/or a mild cystocele.

The PelvX Incontinence Dish Vaginal Pessary is a pessary intended for the treatment of stress urinary incontinence. It is made of medical grade silicone and is shaped like a dish to surround and support the cervical area and bladder areas. Holes in the dish allow drainage of vaginal fluids. It features a bulbous portion at one location on its circumference designed to support and elevate the bladder neck, thereby providing improved urethral sphincter control.

The provided 510(k) summary for the PelvX Incontinence Dish does not contain information about specific acceptance criteria related to a performance study for the device's intended use (treating stress urinary incontinence and mild prolapse/cystocele).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Milex Incontinence Dish) and safety testing of the materials used in the device. This type of 510(k) submission typically does not include a clinical performance study with acceptance criteria in the same way modern AI/software-as-a-medical-device (SaMD) submissions do. For a physical device like a pessary, substantial equivalence is often based on design, materials, and intended use comparison.

Therefore, I cannot populate the requested table and sections with specific acceptance criteria and a performance study demonstrating the device meets those criteria, as that information is not present in the provided document.

However, I can extract information related to the safety testing and the comparison to the predicate device, which serves as the basis for marketing clearance in this context.

Summary of Available Information (Not a Performance Study against Acceptance Criteria):

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria for Performance: Not explicitly stated as this device's clearance relied on substantial equivalence, not a direct performance study against a predefined efficacy metric.
• Reported Device Performance (Implicit): The device is considered substantially equivalent to the Milex Incontinence Dish, which implies it performs similarly for its intended use. No specific efficacy rates (e.g., reduction in incontinence episodes) are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Clinical Performance Study: No clinical performance study data provided.
• Safety Testing: Material testing was performed by NamSA, without specifying a "sample size" in the context of device performance on patients. It refers to testing on the silicone material itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no clinical performance study involving expert assessment or ground truth establishment for patient outcomes was conducted or reported.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no clinical performance study involving expert assessment or adjudication was conducted or reported.

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 is a physical medical device, not an AI/software device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable; this is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable as no clinical performance study requiring ground truth was conducted or reported. The "ground truth" for clearance in this case is the established safety and efficacy of the predicate device.

8. The sample size for the training set

• Not applicable as there is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established

• Not applicable as there is no mention of a training set for an algorithm.

Information on Safety Testing (as provided in the document):

The submission highlights material safety testing conducted on the medical-grade silicone used in the device. This testing regime was compared to requirements in "General Purpose Memorandum G95-1 Use of International Standard ISO-10993" for devices in contact with mucosal membranes for between 24 hours and 30 days.

• Tests Performed:

  • Acute Systemic Toxicity
  • Cytotoxicity
  • Muscle Implantation (1 week)
  • Muscle Implantation (4 weeks)
  • Muscle Implantation (12 weeks)
  • ISO Sensitization Study
  • Pyrogenicity
  • Vaginal Irritation (14 days)

• Conclusion: The test results supported the position that this material is substantially equivalent to other materials used for similar purposes (specifically, the material in DesChutes Donut Pessary (510(k) #974117)).

In summary, for K990593, the acceptance criteria for market clearance were primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Milex Incontinence Dish) in terms of intended use, materials, design, and contraindications, along with demonstrating the safety of the specific materials used. There was no clinical performance study reported in this 510(k) summary that established specific performance acceptance criteria for treating stress urinary incontinence or prolapse directly for this device.

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