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The CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina.

The following Indications for Use are associated with each of the following pessary styles:

Milex® Shaatz Folding Pessaries:
Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele.

Milex® Gellhorn Pessaries:
Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia.

Milex® Ring Folding Pessaries:
Milex Ring Pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.

Milex® Pessaries are intended for adult women as Obstetrical and Gynecological medical devices. Milex® Pessaries are distributed in a non-sterile condition made from silicone. The Milex Pessaries are available in a variety of styles, each having a range of sizes that is inserted into the vagina to function as a supportive structure of the uterus, bladder and rectum. All pessaries are produced in a like fashion, utilizing injection molding of liquid silicone rubber. The Milex Pessaries are manufactured in pink for single patient use.

This submission includes the following designs of Milex Pessaries: Shaatz Pessary, Gellhorn Pessary (Short and Long Stem), and Ring Folding Pessaries (Ring without support, Ring with support, Ring with knob without support, Ring with knob with support).

Based on the provided FDA 510(k) Clearance Letter and 510(k) Summary for CooperSurgical Milex® Pessaries, it's clear that this submission is for a medical device (vaginal pessaries) and NOT an AI/software device.

Therefore, many of the questions related to acceptance criteria, MRMC studies, standalone algorithm performance, ground truth establishment, and training/test sets for AI models do not apply to this specific clearance.

The "acceptance criteria" for this physical device are primarily based on demonstrating substantial equivalence to a predicate device through:

• Identical/Similar Indications for Use: Showing that the new device is intended for the same medical purposes as the predicate.
• Similar Technological Characteristics: Demonstrating that the materials, design, and fundamental principle of operation are comparable or that any differences do not raise new questions of safety or effectiveness.
• Performance Data (Bench Testing/Biocompatibility): Providing evidence that the device performs as intended and is safe for its intended use, typically through non-clinical testing.

Here's how to address the questions given the nature of the device:

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

For a physical device like a pessary, "acceptance criteria" are typically defined by demonstrating substantial equivalence to a predicate device and meeting established performance and safety standards through non-clinical testing. The "reported device performance" refers to the results of these tests and the comparison to the predicate.

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

• Sample Size: The document does not specify a "sample size" for a clinical test set in the way one would for an AI model or a clinical trial. The performance data is based on biocompatibility testing of the device material, which involves laboratory tests with specific biological samples (e.g., cell cultures, animal models for implantation/toxicity studies) rather than patient data.
• Data Provenance: Not applicable in the context of clinical patient data for this type of device. The data provenance would refer to the testing laboratories and their adherence to ISO standards for biocompatibility. The summary states "testing performed by CooperSurgical" and references international ISO standards.

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. This device is a physical medical device, not an AI or imaging diagnostic tool that relies on expert interpretation for ground truth.

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

• Not applicable. As above, this is for a physical device, not an AI model requiring human adjudication of results.

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 for a physical device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or software.

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

• Ground truth for this device is established through adherence to international consensus standards for medical device biocompatibility (ISO 10993 series) and engineering performance standards for physical characteristics like dimensions, durability, and material properties. It's not based on clinical "outcomes data" or "expert consensus" in the diagnostic sense, but rather on meeting pre-defined safety and performance benchmarks.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

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

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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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The Yoni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

The Yoni.Fit® Bladder Support is a vaginal pessary prescribed by a physician for single patient use for the temporary management of stress urinary incontinence. The device is intended for a single 30-day duration per patient. It can be worn for up to 12 hours in a 24-hour period and is reusable after washing with warm water and mild. oil-free soap. The device is a single-patient. multi-use medical device that will be provided non-sterile and requires reprocessing prior its first and subsequent uses. The rim of the Yōni.Fit® Bladder Support applies pressure aqainst the urethra and bladder neck to support the bladder and urethra. The Yōni.Fit® Bladder Support is available in each of the following sizes: 34mm (Size 2), 42mm (Size 3), 42mm (Size 3), 45mm (Size 3.5), 48mm (Size 4), and 52mm (Size 5). The Yoni.Fit® Bladder Support is made of injection molded silicone (non-latex rubber) with no color additives.

Each package of the Yoni.Fit® Bladder Support comes with the following:

• 3 reusable Yōni.Fit® Bladder Supports for sizing .
• . Cleaning brush
• Storage case ●
• Instructions for Use ●

The provided text describes the 510(k) summary for the Yoni.Fit® Bladder Support, a vaginal pessary intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women. While it details clinical performance data, it does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, based on the provided information, we can extract the relevant details to construct a response.

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

The document does not explicitly state pre-defined acceptance criteria for the clinical study. Instead, it describes its primary effectiveness endpoint and the achieved results. We can infer the "acceptance criteria" from the goal of the study – to show a statistically significantly higher responder rate compared to the control.

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

• Sample Size (Clinical Study):

  • Total participants enrolled and randomized: 58 (31 Yōni.Fit® and 27 control)
  • Participants completing treatment phase: 56
  • Participants continuing to open label phase: 54
  • Participants completing 30 days of safety follow-up: 42
  • Participants completing 6 weeks of safety follow-up: 38
  • Participants with completely missing efficacy data (considered non-responders for analysis): 4 (2 Yōni.Fit®, 2 control)

• Data Provenance:

  • Country of Origin: Three US sites.
  • Study Type: Prospective, randomized, comparator-controlled, single blinded, multicenter crossover study.

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)

The study evaluates the effectiveness of a medical device for stress urinary incontinence using patient-reported outcomes (questionnaires) and objective measurements (12-hour pad weights, voiding diaries). The "ground truth" for efficacy is based on objective measurement of urine leakage (pad weights) and patient-reported symptoms, not expert interpretation of diagnostic images or pathology. Therefore, there is no mention of experts establishing ground truth in the context of diagnostic interpretation. The study was conducted by medical professionals, and participants were diagnosed with SUI by both a cough supine test and a history of SUI.

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

The document does not describe an adjudication method for establishing ground truth, as the primary effectiveness endpoint was based on quantitative measurements (pad weights) and participant questionnaires. Medical staff and investigators would have managed data collection and study conduct, but there's no mention of a specific adjudication panel for results.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for AI/CADe (Computer-Aided Detection/Diagnosis) devices where human readers interpret medical images with and without AI assistance. The Yoni.Fit® Bladder Support is a physical medical device, not a software or AI diagnostic tool.

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

No, a standalone (algorithm only) performance study was not done. As mentioned, the Yoni.Fit® Bladder Support is a physical device inserted by the patient (after physician fitting/prescription) for direct therapeutic effect, not a standalone algorithm.

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

The ground truth for the clinical effectiveness study was based on:

• Outcomes Data: Primarily objective measurements of urine leakage (average 12-hour pad weights) and patient-reported outcomes from questionnaires.
• Clinical Diagnosis: Participants were diagnosed with SUI by a cough supine test and a history of SUI prior to enrollment.

8. The sample size for the training set

The document describes a clinical study to evaluate the safety and effectiveness of the device, which serves as a pivotal study for regulatory approval. It does not mention a "training set" in the context of machine learning, as this is a physical medical device and not an AI/ML algorithm.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable based on the provided document. The clinical study was designed to test the device's performance against a control, not to train an algorithm.

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The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence (involuntary urine loss, such as a pee leak that occurs when you cough, laugh, sneeze or with some physical tasks).

Uresta® is a bell-shaped vaginal bladder support that is intended to support the urethra to help reduce leaks caused by stress urinary incontinence. It has a tapered tip for insertion into the vaginal introitus and a handle end to enable placement and removal. It may also be used with a water-based lubricant for easier insertion. Uresta® is available in five (5) sizes, ranging from 34 mm (size 2) to 52 mm (size 6). It can be inserted in the morning and removed at bedtime every day or used just for specific activities such as exercise and removed after the activity. Uresta® is molded from non-latex thermoplastic rubber and is provided non-sterile for single patient use.

This document is a 510(k) summary for the Uresta® vaginal pessary, seeking an Over-The-Counter (OTC) indication in addition to its existing Prescription (Rx) indication. The core of the submission revolves around demonstrating that the device can be appropriately self-selected and used by a lay user population for OTC use.

Based on the provided text, the specific details regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" are focused on the usability study conducted to support the OTC claim.

Here's a breakdown of the requested information:

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

The document does not present a formal table of quantitative acceptance criteria and specific numerical performance results for the usability study. Instead, it states the overall conclusion.

(Implicitly, the performance was adequate to support the OTC claim, as the conclusion states patients can appropriately self-select.) |
| Labeling Usability & Independent Use: Intended users can understand the Instructions for Use (IFU) and independently insert and fit the device without guidance. | "Intended users then participated in a labeling usability simulated study in which they reviewed the Instructions for Use and independently inserted and fit the device without guidance."

"The results of the self-selection and usability study demonstrate that patients can self-select and use the device appropriately."

(Similar to self-selection, the performance was deemed appropriate.) |

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not explicitly state the numerical sample size for the usability study. It refers to "women who were naïve to the device" and "intended users."
• Data Provenance: The document does not specify the country of origin. Given the context of a 510(k) submission to the FDA, it's highly implied to be a study relevant to the U.S. patient population. The study was prospective as it involved active participation of individuals in a simulated usability environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: The document mentions "clinical diagnosis" for confirming self-selection, implying healthcare professionals were involved in verifying eligibility. However, it does not specify the number of experts or their qualifications (e.g., specific medical specialties or years of experience).
• Qualifications: "Clinical diagnosis" suggests a qualified medical professional, but specific qualifications are not provided.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the usability study. The "clinical diagnosis" for confirming self-selection suggests a direct clinical assessment rather than a multi-reader, multi-case review.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or relevant in this submission. This is a medical device (vaginal pessary), not an AI/software-as-a-medical-device (SaMD) that assists human readers in interpreting medical images or data.

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

This question is not applicable as the device is a physical medical device (vaginal pessary), not an algorithm or AI system.

7. The type of ground truth used

The ground truth for the usability study essentially revolved around:

• Clinical Diagnosis: To confirm whether participants met the medical criteria for stress urinary incontinence after they self-selected based on packaging information.
• Observed Performance: Direct observation of participants' ability to interpret the Instructions for Use and successfully insert/fit the device independently.

8. The sample size for the training set

This question is not applicable. The "training set" concept is relevant for machine learning algorithms. This submission describes usability testing of a physical medical device, not an algorithm.

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

This question is not applicable for the same reason as point 8.

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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 ProVate Vaginal Support is indicated for the temporary, nonsurgical management of Pelvic Organ Prolapse in females.

The ProVate Vaginal Support is a vaginal ring pessary intended for the conservative nonsurgical, temporary management of Pelvic Organ Prolapse (POP) in females. The ProVate is a disposable, single use device intended to use for up to seven (7) days. The ProVate device is intended for prescription home use following a size fitting process performed by a health care professional. The device is supplied in its compact mode, within a disposable Applicator intended for the insertion of the device is expanded into its circular ring shape using the Applicator Plunger when inserting the device into the vagina. At the end of its use (up to 7 days), the patient pulls the Removal String which collapses the device into its compact configuration, facilitating easy removal. The device is then thrown away, and a new device can be inserted by the patient as needed. The ProVate includes additional components to facilitate insertion and removal of the device. The ProVate device is constructed to allow insertion into the vagina by the patient while the device is in a compact mode contained within a single use applicator. The ProVate device is expanded to its circular shape using the applicator when inserted into the vagina. Once inserted, the circular shape of the ProVate is comparable to that of the predicate device and the ring provides support to the prolapsed organs. To remove the device, the ProVate includes a removal string. Pulling on the string collapses the device to its compact state allowing for easier and more comfortable removal.

The ConTIPI Medical Ltd. ProVate Vaginal Support is a vaginal pessary intended for the temporary, nonsurgical management of Pelvic Organ Prolapse (POP) in females. The device's safety and effectiveness were evaluated through a series of bench tests and two clinical studies.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" against which specific device performance metrics are directly reported in a comparative format. However, the document outlines various tests conducted and their successful outcomes, indicating that the device met the performance and safety requirements. The performance data section provides indirect evidence of fulfilling acceptance criteria.

2. Sample Sizes and Data Provenance

The document describes two clinical studies:

• Prospective Safety Clinical Study:
  • Sample Size: Not explicitly stated but described as "statistically powered."
  • Data Provenance: Multicenter, randomized, cross-over study. The country of origin is not explicitly stated, but the manufacturer is based in Israel and the submission is to the U.S. FDA, suggesting potential international or U.S.-based study sites. The study design is prospective.
• Prospective Clinical Study to Evaluate Safety and Effectiveness:
  • Sample Size: Not explicitly stated but described as "statistically powered."
  • Data Provenance: One arm, multi-clinic prospective study. Country of origin not explicitly stated.

3. Number of Experts and Qualifications (for Ground Truth)

The document does not detail the number of experts or their specific qualifications for establishing ground truth within the clinical studies. For the clinical studies, vaginal examinations were conducted by physicians, who would serve as experts in assessing prolapse stages and adverse events. Specific qualifications (e.g., years of experience, specialization) are not provided.

• In the "Prospective Clinical Study to Evaluate Safety and Effectiveness," a "fitting process performed by a physician" is mentioned, indicating the involvement of medical professionals in determining appropriate device sizing and assessment.
• "Vaginal examinations and microbial evaluations were performed at the beginning and at the end of each usage phase" in the safety study, again implying medical expert assessment.

4. Adjudication Method

The document does not specify an adjudication method for the test set data (e.g., 2+1, 3+1 for resolving discrepancies). It is implied that clinical assessments were made by individual clinicians or study investigators.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The clinical studies focused on the performance of the device itself, either in comparison to a control device (for microflora) or against a baseline (for prolapse improvement), rather than on the impact of AI assistance on human readers.

6. Standalone Performance Study (Algorithm Only)

This device is a physical medical device (vaginal pessary), not a software or AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted.

7. Type of Ground Truth Used

The ground truth for the clinical studies was based on:

• Clinical Assessments: Vaginal examinations performed by physicians to assess prolapse stage (e.g., improvement by at least one stage, starting from stage 2 or 3 to stage 0 or 1).
• Microbial Evaluations: Laboratory analysis of vaginal microflora.
• Adverse Event Reporting: Clinical evaluation and reporting of adverse events.

This constitutes a combination of expert clinical assessment and laboratory data.

8. Sample Size for the Training Set

This question is not applicable. The ProVate Vaginal Support is a physical medical device, not an AI or machine learning model that requires a training set. The "training" in this context refers to the development and iterative testing of the device, which is informed by engineering principles, bench testing, and clinical feedback, rather than a data training set for an algorithm.

9. How Ground Truth for the Training Set was Established

This question is not applicable for the same reason as point 8. The device development process involves engineering specifications and preclinical/clinical data gathering, not the establishment of ground truth for an algorithmic training set.

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The Revive bladder support is intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

The Revive bladder support reduces bladder leaks in women who are suffering from SUI by preventing or reducing unwanted urinary leakage. Use of the device is applicable for women who experience leakage when laughing, coughing, exercising, sneezing, etc. The device is not intended to treat women with urge incontinence. The shape of the Revive bladder support is designed to fit in the vaginal tract, and there is no sizing required. The device fits most users. The device can be worn daily for up to 12 hours. The Revive bladder support can be reused (and cleaned) for up to 31 times. Each packaged Revive bladder support device comes with the following:

• · 1 Reusable Bladder Support
• · 1 Reusable Applicator
• · 1 Month Strings Supply
• · Travel Case
• · Instructions for Use

The provided document describes the Revive™ Reusable Bladder Support, intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women aged 18 and older. While the document details the device's characteristics, non-clinical tests, and a clinical study, it does not explicitly state quantified acceptance criteria for device performance. Instead, it reports observed performance outcomes from a clinical study and states that the device was effective, well-tolerated, and safe.

Therefore, for the acceptance criteria table, I will use clinically meaningful improvements reported in the study as the "acceptance criteria" based on the reported "met" performance.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Test Set (Clinical Study): The exact number of participants is not explicitly stated, but it refers to "participants" throughout the clinical study summary. Based on the percentages provided for efficacy results (53% of participants, 71% of participants), an N value for the clinical study is not given.
• Data Provenance: The study was a "multicenter study," implying data from multiple locations, but specific countries are not mentioned. It was an "interventional" study, indicating a prospective design where participants underwent a baseline phase and a treatment phase with the investigational product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• The document states that "All adverse events were reviewed by a third-party adjudicator for consistent reporting and classification using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0."
• The number and qualifications of this "third-party adjudicator" or any other experts establishing ground truth for efficacy measures are not specified in the provided text.

4. Adjudication method for the test set

• For adverse events, a "third-party adjudicator" reviewed events for consistent reporting and classification. No specific adjudication method like "2+1" or "3+1" is mentioned, just that a single (implied) third-party individual or entity performed the review.
• For efficacy outcomes (pad weight gain, leakage episodes, quality of life), no adjudication method is described.

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

• No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. The device is a physical medical device (bladder support), not an AI algorithm. The closest comparison is the statement: "The percentage of responders is greater as compared to the predicate device," but this is a direct comparison of the device's performance against historical data/reports of a predicate device, not an MRMC study.

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

• Not applicable. This device is a physical medical device, not an algorithm.

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

• Clinical Outcomes Data: The ground truth for efficacy was based on direct clinical measurements and patient-reported outcomes from the intervention:
  • Pad weight gain reduction (quantitative measure).
  • Leakage reduction (number of leakage episodes per day, quantitative measure).
  • Improvement in quality of life analysis (patient-reported outcome).
• Safety Data: Adverse events, vaginal swabs, and urinalysis results served as ground truth for safety.
• Laboratory Testing: Biocompatibility data (cytotoxicity, sensitization, irritation, pyrogenicity, genotoxicity, chemical characterization) and Staphylococcus aureus growth/TSST-1 production tests provided ground truth for material safety.
• Engineering/Mechanical Test Data: Removal string retention, pessary extraction, string tensile strength, and pessary removal retraction forces provided ground truth for physical performance.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI/machine learning algorithm that requires a training set. The clinical study was for evaluation of the device as a whole.

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

• Not applicable. As above, there was no "training set" in the context of an AI/ML algorithm.

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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.

Not Found

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.

Not Found

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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