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The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.

The ReFlex Treatment System is a comprehensive, behavioraliy-based program designed for independent use by incontinent people in their own home. The product kit includes a personal training device, an informational video, instructional journal, and direct clinical support via phone and internet. At the program's core is the pneumatically-based ReFlex Trainer, a handheld device which when connected to the vaginal sensor displays the magnitude of pelvic muscle contractions.

The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.

Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative format as would typically be seen for a medical device seeking to demonstrate specific performance metrics (e.g., sensitivity, specificity, accuracy). However, the overall goal of the clinical study was to demonstrate the safety and efficacy of the device for its intended use and its ability to be used without licensed practitioner supervision. The reported performance is based on the outcomes of this clinical study.

Specific outcomes:

• 43% of participants were completely cured of their symptoms of incontinence.
• 36% had over 50% improvement of their symptoms.
• This results in an overall improvement rate of 79%. |
  | Safety of the device, particularly regarding biocompatibility and electrical safety. | Biocompatibility: "Extensive biocompatibility and safety testing of the silicone material used in the balloon sensors was performed... test results from all tests support the position that this material is substantially equivalent to the material used in the predicate device and indicate that the material is biocompatible, non-toxic and well tolerated by mucosal membranes." (Tests included Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity, Pyrogen, and Muscle Implantation Studies).

Electrical Safety: The device was designed and tested to meet UL2601-1, 2nd Edition, and EN 60601-1-2:1993, indicating adherence to relevant electrical safety standards. |
| Ability to be used independently by incontinent individuals in their own home (without licensed supervision). | "clinical testing of the product demonstrated that the device can be used outside the supervision of a licensed practitioner, and adequate directions for use have been prepared." |

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

• Sample Size: The document does not specify the exact number of participants in the clinical study. It generally refers to "all study participants who completed the study," "self-selected healthy women of a wide age-range," and percentages of "participants."
• Data Provenance: The document does not explicitly state the country of origin. The sponsor, DesChutes Medical Products, Inc., is based in Bend, OR, USA, suggesting the study was likely conducted in the US. The study is described as "clinical testing," implying a prospective nature where data was collected specifically for this evaluation.

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

This section is not applicable as the study evaluates the effectiveness of a treatment system directly on patient symptoms and outcomes, rather than requiring expert assessment to establish a "ground truth" for diagnostic accuracy. The ground truth, in this context, is the reported improvement or cure of incontinence symptoms by the patients themselves, likely supported by other clinical assessments, though details are not provided.

4. Adjudication Method for the Test Set:

Not applicable. This was a clinical efficacy study for a treatment device, not a diagnostic accuracy study requiring adjudication of expert readings. Patient self-reporting of symptoms and/or clinical assessments (e.g., severity index) would have formed the basis of outcome measurement.

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. The ReFlex Treatment System is a biofeedback device for pelvic muscle exercises, not an AI-powered diagnostic tool requiring human reader interpretation or assessment. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The ReFlex Treatment System is a treatment device used by individuals, not an algorithm. Its performance is inherent in its design and the patient's interaction with it, not a standalone algorithmic output.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the clinical performance data appears to be based on patient-reported outcomes (symptom improvement/cure) and potentially objective clinical assessments of symptom severity. The summary states, "All study participants who completed the study saw some degree of symptom improvement" and refers to "improve their symptoms and lower their severity index." This points towards outcomes data as the primary ground truth.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" for the ReFlex Treatment System. It is a physical treatment device, not a machine learning model that requires training data. The "training" that occurs is for the patient learning to use the device.

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

Not applicable, as there is no training set mentioned for the device itself.

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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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The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse.

The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the PelvX Ring Vaginal Pessary and PelvX Ring with Support Vaginal Pessary, indicating that the device has been found substantially equivalent to predicate devices. It outlines the regulatory classification, indications for use, and general responsibilities but does not detail performance criteria or associated studies.

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The PelvX Incontinence Ring Vaginal Pessary is a vaginal pessary intended for treatment of of a sourinary incontinence.

PelvX Incontinence Ring Vaginal Pessary

The provided document is an FDA 510(k) clearance letter for the PelvX Incontinence Ring Vaginal Pessary. It confirms substantial equivalence to a predicate device for the treatment of urinary incontinence. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and the study that proves it meets them based on the text provided. This letter is a regulatory approval, not a scientific study report.

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The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse.

The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or cystocele.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the PelvX Donut and PelvX Cube Vaginal Pessaries. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is related to regulatory approval based on demonstrating substantial equivalence to a predicate device, not performance testing of an AI/ML device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or training sets from this document. The questions you've asked are typically relevant to the evaluation of AI/ML-driven diagnostic or assistive devices, which is not what this document describes.

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