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The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse.

The Reia pessary is a collapsible vaginal pessary for non-surgical treatment of pelvic organ prolapse. The Reia pessary is reusable by a single user and is intended for prescription home use following an in-office size fitting process performed by a healthcare professional using fitting pessaries.

The Reia pessary is placed in the vagina, similar to a tampon or diaphragm, and by supporting the vaginal wall, the pessary prevents the descending organs from dropping into the vaginal canal. Similar to currently available pessaries, the Reia pessary has been evaluated for continuous use; however, its collapsible design enables simpler insertion and removal.

The Reia pessary is made entirely of medical-grade silicone and is a single part. The geometry of the pessary and the flexible nature of the silicone allows the Reia pessary to collapse to facilitate easy, comfortable insertion and removal. In its supportive state, the Reia pessary is domed at the top with a stem at the bottom. The end of the stem has a large loop that allows the user to easily locate, grasp, and pull the pessary out for removal. The expandable and collapsible technology fits the user's anatomy during insertion, use, and removal.

The Reia pessary is designed for self-management and to be easily collapsed for insertion and removal by any user. To insert the pessary, a user (e.g., patient or practitioner) pinches the outside of the pessary to elongate it into a narrower shape, allowing for easier, more comfortable insertion. Once it is released in the vagina, the pessary naturally expands to return to its supportive state. To remove the user pulls on the loop to re-elongate the pessary allowing for easier, more comfortable removal.

The Reia pessary is manually cleaned with soap and water by the user in the home environment or a healthcare facility between periods of use. The Reia fitting pessaries are manually cleaned and sterilized at a healthcare facility between uses.

The provided text is a 510(k) summary for the Reia pessary. It describes the device, its intended use, comparison to a predicate device, and performance data from bench and clinical testing. However, it does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to an AI/ML device, nor does it detail a study proving an AI/ML device meets acceptance criteria. The Reia pessary is a physical medical device (a vaginal pessary), and the provided document is a regulatory submission for this physical device, not an AI/ML software.

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML device, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance, as this document pertains to a physical medical device and not AI/ML software.

The document discusses "effectiveness" in the context of a clinical study for the physical pessary, using the Pelvic Floor Distress Inventory - 20 (PFDI-20) scores as a primary effectiveness endpoint, showing equivalence to existing pessaries. This is a measure of the physical device's clinical efficacy, not an AI/ML algorithm's performance.

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Gynethotics pessaries are removable devices placed in the vaginal cavity to provide a nonsurgical alternative for the treatment of pelvic organ prolapse and to relieve the symptoms of pelvic relaxation with or without urinary incontinence in adults.

Gynethotics Ring Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse.

Gynethotics Ring with Support Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse.

Gynethotics Ring with Knob Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Ring with Support and Knob is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Incontinence Ring Pessary is indicated for use in cases of stress urinary incontinence.

Gynethotics Marland Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Marland with Support Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Gellhorn Pessary is indicated for use in cases of mild (Stage I) to severe (Stage III or procidentia) pelvic organ prolapse.

Gynethotics Cube Pessary is indicated for use in cases of moderate (Stage II) to severe (Stage III or procidentia) pelvic organ prolapse.

Gynethotics pessaries are vaginal pessaries made from silicone that are inserted into the vagina to function as a supportive structure of the vagina, uterus, bladder and/or rectum to manage and treat the symptoms of pelvic floor dysfunction, such as pelvic organ prolapse and incontinence. Gynethotics pessaries come in four general shapes, including: Ring, Gellhorn, Marland, and Cube. Each shape comes in a range of configurable features and dimensions.

The provided text is a 510(k) Summary for the Gynethotics™ Pessary, a medical device. It does not describe a study involving an AI or software device that classifies, diagnoses, or assists human readers with medical images or data. Therefore, I cannot extract the information required to populate the fields related to acceptance criteria and study designs typically associated with such devices (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment, etc.).

The document focuses on demonstrating substantial equivalence of the Gynethotics™ Pessary, a physical vaginal pessary, to predicate devices through:

• Indications for Use Comparison: Showing similar intended medical applications (pelvic organ prolapse, stress urinary incontinence).
• Technological Characteristics Comparison: Highlighting that the device is made of similar materials (silicone) and has comparable dimensions to predicates, with differences not raising new safety/effectiveness questions.
• Performance Data (Bench/Lab Testing): Including mechanical testing (folding, bend, cord detachment, etc.) and biocompatibility testing (cytotoxicity, sensitization, irritation, etc.), TSST-1 risk assessment, cleaning validation, and packaging validation.

Therefore, it is impossible to provide the requested information based on the provided text. The information pertains to the regulatory submission for a physical medical device, not a diagnostic AI/software tool.

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The Flexi Shelf Pessary is indicated for use as a removable structure placed in the support of a second to third degree prolapse or procidentia.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the Panpac Flexi Shelf Pessary, which concerns the regulatory approval of a medical device based on its substantial equivalence to a predicate device, not on specific performance acceptance criteria and associated studies.

Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study findings based on the provided text.

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Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.

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This document is an FDA 510(k) clearance letter for the "Panpac Disposable Pessary Fitting Set." It primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The core of the request asks for specific details about acceptance criteria and a study. Since this type of information is generally found in the 510(k) submission itself (which includes detailed test reports and performance data), and not in the clearance letter, I cannot fulfill the request directly from the provided text.

The closest relevant information from the document is the "Indications for Use" statement, which describes the intended medical application of the device:

• Device Name: Panpac Disposable Pessary Fitting Set
• Indications for Use: Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele, rectocele as well as stress urinary incontinence in women.

To answer your specific questions, I would need access to the actual 510(k) summary or the full submission documentation.

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EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women

The subject device is a silicone vaqinal pessary. The submission includes the following designs: cube, dish, donut, marland, oval, gellhorn, gellhorn short, shaatz, and ring.

The provided document is a 510(k) premarket notification decision letter from the FDA for a device named "Pessary" manufactured by EIS Corporation. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The essential nature of a 510(k) submission, particularly for a device like a vaginal pessary, means that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to demonstrating substantial equivalence to a predicate device, rather than proving novel clinical efficacy or diagnostic performance. Therefore, the "acceptance criteria" in this context refer to showing that the new device shares fundamental technological characteristics and intended use with the predicate, and does not raise new questions of safety or effectiveness. The "study" refers to non-clinical performance testing confirming that these characteristics are maintained.

Based on the provided text, here's the information broken down:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) for a physical medical device like a pessary, the acceptance criteria are not typically expressed in terms of diagnostic metrics like accuracy or sensitivity. Instead, they relate to material properties, safety assessments, and functional comparison to a predicate.

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

This document describes a 510(k) for a physical device, not an AI/ML diagnostic or prognostic device. The "test set" in this context would refer to samples used for non-clinical performance testing (e.g., material testing, biocompatibility).

• Sample size: Not specified. Standard practice for biocompatibility and shelf-life testing involves a sufficient number of samples to achieve statistical confidence or meet regulatory requirements, but the exact number isn't in this summary.
• Data provenance: Not explicitly stated regarding country of origin for the non-clinical tests. The manufacturer is based in Korea. The studies are "non-clinical study performance," meaning laboratory-based rather than human clinical trials. Thus, the data is prospective within the lab setting.

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

Not applicable. For a physical device 510(k), experts are typically involved in designing and interpreting the non-clinical tests (e.g., toxicologists for biocompatibility, engineers for material properties), but their "ground truth establishment" is not in the same vein as expert consensus for diagnostic interpretation. The "ground truth" for these tests would be objective measurements against established scientific standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1) are relevant for reconciling differing expert opinions in diagnostic studies. For non-clinical material and performance testing, results are typically objective measurements or observations against predetermined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical studies (biocompatibility, shelf life) would be:

• Established scientific standards and regulatory guidelines: For biocompatibility, this refers to the criteria outlined in ISO 10993-1, where specific chemical, biological, and physical parameters are measured and compared against acceptable thresholds.
• Material specifications: For physical properties, performance is compared against predefined engineering specifications for the silicone material.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The "training" for such a device is in its manufacturing and material selection process.

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

Not applicable. See #8.

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Ask a specific question about this device

Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele as well as stress urinary incontinence in women.

Not Found

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Panpac Vaginal Pessaries". It indicates the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

However, this document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

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This device is for use in adult women, over 18 years of age, who experience involuntary urine loss with physical activity (stress urinary incontinence).

The uresta™ Pessary has been modified to be manufactured using an alternate non-latex thermoplastic elastomer rubber. No other changes have been made to the device.

The EastMed Inc. uresta™ Pessary (K083769) is a vaginal pessary designed for adult women experiencing stress urinary incontinence. This 510(k) pertains to a modified version of the device, where the only change is the manufacturing material (an alternate non-latex thermoplastic elastomer rubber).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not provide details on sample size, test set, or data provenance (e.g., country of origin, retrospective/prospective) for any specific study. The 510(k) focuses on demonstrating substantial equivalence based on a material change to an already cleared device.

3. Number of Experts and Qualifications:

The document does not mention the use of experts to establish ground truth for any test set. Given the nature of the submission (material change), such an assessment might not have been deemed necessary.

4. Adjudication Method:

The document does not describe any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a physical medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance:

The concept of "standalone performance" for an algorithm is not applicable here, as the uresta™ Pessary is a physical device, not an algorithm.

7. Type of Ground Truth Used:

The document implies that the ground truth for establishing safety of the new material was based on biocompatibility testing standards and results. No other form of "ground truth" (like pathology or outcome data) is mentioned in relation to the material change.

8. Sample Size for Training Set:

The document does not provide any information regarding a training set sample size. As a physical medical device, the concept of a "training set" in the context of an algorithm or machine learning model is not relevant.

9. How Ground Truth for Training Set Was Established:

The document does not address how ground truth for a training set was established, as there is no mention of a training set or an algorithm in this 510(k) submission.

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This device is for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence).

The uresta™ Pessary is designed for adult women who experience involuntary urine loss from the most common type of incontinence; stress incontinence, from physical activity such as coughing, laughing and/or exercising. uresta™ Pessary is a bell-shaped vaginal pessary with a handle at its base for easy insertion and removal. uresta™ Pessary stops leaking from the bladder by supporting the urethra. The narrow tip allows for easy insertion into the vaginal introitus. It is inserted directly into the vagina like a tampon and seats itself so that the wide base provides support to the urethra. It is made of medical grade injection moulded Santoprene (non-latex thermoplastic rubber). uresta™ Pessary is available individually in sizes1 (30 mm), 2 (34 mm), 3 (38 mm), 4 (43 mm), 5 (48 mm), 6 (52 mm). The products are sold individually, and as a kit including one each of sizes 3, 4, 5, the most commonly used sizes.

This looks like a 510(k) premarket notification for a medical device (uresta™ Pessary) and does not contain information about acceptance criteria or a study proving the device meets them.

The provided text is primarily administrative, detailing the device's manufacturer, contact information, classification, predicate devices, a brief description of the device and its intended use, and the official FDA clearance letter.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This information would typically be found in a clinical study report or a more detailed technical report submitted as part of the 510(k) application, but it is not present in the provided summary documents.

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