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The Intimate Rose Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to <= 30 days) duration. The Intimate Rose Vaginal Dilators are comprised of 8 progressively larger and color-coded medical-grade silicone dilators.

The provided text describes the regulatory clearance (510(k)) for the Intimate Rose Vaginal Dilators, not a study proving device performance against acceptance criteria in the typical sense of a clinical trial for a novel AI/software medical device.

Therefore, many of the requested sections are not applicable to the information contained in the provided FDA 510(k) summary. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing raw performance data against specific acceptance criteria for a new device's functionality.

However, I can extract the relevant information from the document as follows:

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

This information is not provided in a performance-against-acceptance-criteria format. The submission relies on demonstrating substantial equivalence to predicate and reference devices, aligning indications for use, and leveraging a previous self-selection study. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) mentioned, as this is a physical medical device, not an AI or diagnostic software.

The "performance" described is the device's ability to fulfill its intended use and be safe and effective, which is primarily assessed through comparison to existing devices and appropriate labeling.

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

The document mentions leveraging a "self-selection study conducted for the predicate device."

• Sample Size: Not specified for the predicate device's self-selection study.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It notes that the study was "previously conducted."

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

Not applicable. The self-selection study for the predicate device likely assessed lay users' ability to understand labeling and determine if the device was appropriate for them, rather than requiring expert ground truth for medical outcomes.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described for the self-selection study.

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 vaginal dilator, not an AI/software medical device requiring MRMC studies.

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

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

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

The document refers to a "self-selection study." The "ground truth" for such a study would likely be the user's ability to correctly interpret the labeling and self-assess their indication for use, as determined by the study design and evaluation criteria. It is not expert consensus, pathology, or outcomes data in a direct medical sense for this type of device.

8. The sample size for the training set

Not applicable. This is a physical device; there is no "training set" in the context of an AI/ML algorithm.

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

Not applicable. There is no training set for this type of device.

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The Hope&Her Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

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I'm sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document appears to be an FDA 510(k) clearance letter for a medical device called "Hope&Her Vaginal Dilator (Various)".

The letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as general controls, additional controls for Class II/III devices, Quality System regulations, and reporting requirements. It also includes the official Indications for Use statement for the device.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or the number/qualifications of experts.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used or details about training set size and ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.

Hope&Her Vaginal Dilators is a series of reusable, non-sterile, single user vaginal dilators that are used by patients to provide passive distention of the vaginal tissues using various sized dilators. The subject device has various sized rigid dilators that range from 15 mm to 38 mm in diameter (15, 22, 26, 30, 34, and 38 mm) and a handle to hold the dilator. The subject device is prescription-only. The subject device is composed polyester and polyamide. The subject device is distributed in heat-seal plastic bags.

This document is a 510(k) Summary for the Hope&Her Vaginal Dilators. It describes the device, its indications for use, and a comparison to a predicate device, along with non-clinical performance testing. The document states that performance testing was conducted to demonstrate substantial equivalence, but it does not contain information about acceptance criteria, clinical studies, or AI/software performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text. The document focuses on physical properties, biocompatibility, and reprocessing validation, which are non-clinical aspects.

Here's why I cannot fulfill your request based on the provided text:

• No Clinical Study Data: The document explicitly states "Summary of Non-Clinical Performance Testing" and lists tests like Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity) and Physical Properties (appearance, diameter, tensile strength). There is no mention of clinical studies, human subject testing, or any performance metrics related to diagnostic accuracy or effectiveness in a clinical setting.
• No Acceptance Criteria for Clinical Performance: Since no clinical performance study is described, there are no acceptance criteria for such a study.
• No AI/Software Component: The device described is a physical medical device (vaginal dilators). There is no mention of any AI or software component, which would be necessary for "device performance" in the context of diagnostic accuracy, human reader improvement with AI assistance, or standalone algorithm performance.
• No Ground Truth Information: Ground truth establishment typically refers to clinical or diagnostic accuracy studies. As none are described, this information is not present.

The 510(k) process for a device like a vaginal dilator often relies on substantial equivalence based on technological characteristics and non-clinical performance (like biocompatibility and physical properties) rather than extensive clinical efficacy trials, especially if a well-established predicate device exists and the indications for use are similar.

In summary, the provided text does not contain the information requested about acceptance criteria and a study proving the device meets them in the context of clinical performance, diagnostic accuracy, or AI-assisted performance.

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The Intimate Rose Vaginal Dilators are tools intended to dilate the vagina in controlled stages to help relieve symptoms of vaginismus.

The Intimate Rose Vaginal Dilators are intended to treat women suffering from vaginismus (including related dyspareunia). Vaginismus is the involuntary spasm of the muscles in the vaginal wall which then inhibits sexual intercourse by making it painful or impossible. Dyspareunia is the pain experienced during sexual intercourse caused by physical and/or emotional problems. The device is used as a tool to dilate the vagina in controlled stages. It is a reusable device that comes into contact with the vaginal mucosal membrane for a prolonged (> 24 hours to ≤ 30 days) duration. The Intimate Rose Vaginal Dilators are comprised of 8 progressively larger and color-coded medical-grade silicone dilators.

The provided document is a 510(k) summary for the Intimate Rose Vaginal Dilators. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study that typically involves human readers or an AI algorithm’s performance.

This document describes a device approval process based on non-clinical performance testing for a physical medical device (vaginal dilators), not an AI/ML-driven device. Therefore, the requested information regarding acceptance criteria, human reader studies, AI assistance, ground truth, and training set details for AI/ML performance is not present in the provided text.

Based on the document, I can only provide information related to the device's physical and biological properties.

Here's what can be extracted from the document regarding the device's evaluation, focusing on the non-clinical tests performed:

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

The document doesn't explicitly state "acceptance criteria" for each performance test in a quantitative manner. Instead, it states that the tests demonstrate the device is "acceptable" or "non-" (e.g., non-cytotoxic). The reported performance is the "test results" and the conclusion.

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

• Sample size: The document states that "all 8 colors of the subject device" were tested for biocompatibility and physical properties. It does not provide a specific number of individual dilator units tested for each characteristic.
• Data provenance: Not explicitly stated as "country of origin" or "retrospective/prospective." The testing was non-clinical laboratory testing performed to international and FDA guidance 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):

This question is not applicable. The device is a physical medical device, not an AI/ML diagnostic or interpretive tool that requires expert-established ground truth on clinical data for performance evaluation in the context of this 510(k) submission. The "ground truth" for these tests would be the established biological or physical standards.

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

This question is not applicable. Adjudication methods are typically for subjective clinical assessments or image interpretations, which are not part of this device's non-clinical performance testing.

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:

This question is not applicable. This is not an AI-assisted device.

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

This question is not applicable. This is not an AI device.

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

For the non-clinical tests described:

• Biocompatibility: The "ground truth" is defined by the international standards (ISO 10993 series) for toxicity, sensitization, irritation, and systemic effects.
• Physical Properties: The "ground truth" for physical characteristics like diameter, hardness, compression, and density would be the device's design specifications and material properties, compared against measured values.

8. The sample size for the training set:

This question is not applicable. This is not an AI/ML device, so there is no "training set."

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

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

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The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.

The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy for vaginal tightness through stretching of the vaginal tissue under electromechanical expansion, one millimeter at a time. The Milli Vaginal Dilator expands electronically in increments of 1mm from a baseline of 15mm to 40mm in diameter. Dilation and contraction of the Milli Vaginal Dilator is at the control of the user with a simple button push of either the + or - buttons. The Milli Vaginal Dilator is a single vaginal dilator tool that encompasses the diameter range of many commercially available dilator sets, allowing the user to increase the diameter in smaller increments while the device remains inserted, eliminating the need for removal and insertion of larger sizes. The dilation setting is provided on the user interface to allow the user to easily track dilation progress. The Milli Vaginal Dilator also incorporates a vibration feature that may be used as desired to promote relaxation. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The subject device is intended to be sold over the counter (OTC), to be purchased online without the support of a healthcare provider.

The Milli Vaginal Dilator (K220035) does not meet the specified input requirement of being an AI/ML device, as it is a physical medical device. Therefore, a comprehensive analysis of AI/ML-specific acceptance criteria, test sets, ground truth establishment, and comparative effectiveness against human readers is not applicable.

However, based on the provided text, I can extract the following information regarding the device's performance assessment and criteria for its clearance:

The device, Milli Vaginal Dilator, is intended for "controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex." The current 510(k) submission (K220035) is for Over-The-Counter (OTC) use, whereas its predicate (K211959) was for Prescription (Rx) use. The primary study presented aims to demonstrate that users can self-select appropriately for the OTC version.

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

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

• Sample Size for Clinical (Self-Selection) Study: 25 subjects.
• Data Provenance: Prospective, multi-center study. The text does not specify the country of origin, but generally, FDA submissions involve studies conducted in the US unless otherwise stated.

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

• Number of Experts: The ground truth for the self-selection study was established by one healthcare professional (HCP) for each subject.
• Qualifications of Experts: The text refers to them generally as "healthcare professional," but does not provide specific qualifications (e.g., "radiologist with 10 years of experience"). However, for a vaginal dilator, it would typically imply a gynecologist, family physician, or similar medical practitioner.

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

• Adjudication Method: The study used a comparison method where each subject's "unaided self-assessment" was compared against "the assessment by the healthcare professional, after an in-person evaluation of the subject and blinded to the subject's prior self-assessment." This is a direct comparison against a single blinded expert's assessment for each subject, rather than a multi-expert consensus or adjudication model.

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 MRMC comparative effectiveness study was done. This device is a physical medical device, not an AI/ML diagnostic tool meant to assist human readers. Therefore, this question is not applicable.

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

• No standalone (algorithm-only) performance study was done. This is a physical device, not an algorithm. The "standalone" performance closest to this concept would be the device's technical performance (e.g., dilation accuracy, reliability), which was assessed through nonclinical testing.

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

• For the self-selection clinical study, the ground truth for appropriate candidacy was the assessment by a healthcare professional (HCP) after an in-person evaluation.

8. The sample size for the training set:

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

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

• Not applicable. As the "training set" concept is not relevant for this physical device.

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The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia.

The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion. The device is intended for use for adult women (>=18 years) who need controlled vaginal dilation for an examination, in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus and related dyspareunia. The Milli Vaginal Dilator expands electronically in increments of 1mm from a baseline of 15mm to 40mm in diameter. Dilation and contraction of the Milli Vaginal Dilator are completed by the user with a simple button push of either the + or - buttons. The Milli Vaginal Dilator is a single vaginal dilator tool that encompasses the diameter range of many commercially available dilator sets, allowing the user to increase the diameter in smaller increments while the device remains inserted. The dilation setting is provided on the user interface to allow the user to easily track dilation progress. The Milli Vaginal Dilator also incorporates a vibration feature that may be used as desired. The Milli Vaginal Dilator is battery powered and provided with a storing/charging case and a USB/adaptor to facilitate charging. The Milli Vaginal Dilator is intended for use in a home or healthcare environment. The device is intended for prescription (Rx) use, and the treatment duration, frequency, and length are specified in the Instructions for Use and/or at the discretion of the physician.

The provided text does not contain acceptance criteria or a study that proves the device meets acceptance criteria in the way typically expected for a medical device.

This document is a 510(k) Premarket Notification for the Milli Vaginal Dilator, which is a process to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific performance criteria against a predefined standard in a clinical setting.

Here's a breakdown of why the requested information is largely absent and what is provided:

1. A table of acceptance criteria and the reported device performance:
   The document extensively compares the Milli Vaginal Dilator to two predicate devices (Panpac Vaginal Dilator and Amielle Vaginal Dilator) in "Table 1: Substantial Equivalence Table" (page 6). This table highlights similarities and differences in:

   • Classification, Product Code, Indications for Use, Single Use, Prescription/OTC, Primary Mode of Action, Design, Dilation Size (Outer Diameter), Dilation Jumps, Energy Source, Software, Environment for Use, Sterility.
   • For performance, it lists various nonclinical bench testing performed for the Milli Vaginal Dilator:
     • Shelf Life Storage and Packaging (Transit) Testing
     • Biocompatibility Testing
     • Software Verification Testing
     • Electromagnetic Compatibility and Electrical Safety Testing
     • Size and Dilation Design Verification
     • Charging/Cleaning Verification
     • Reliability Testing
     • Engineering Evaluation
   • Crucially, it states for each of these nonclinical tests that "All Nonclinical Bench Performance Testing performed for the Milli Vaginal Dilator passed the prespecified acceptance criteria/design inputs."
   • However, the specific acceptance criteria values (e.g., what constitutes a pass for "Size and Dilation Design Verification") are not provided nor are the quantitative results of these tests. The table only states that the tests were performed and passed.

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

   • No clinical "test set" in the context of human subjects is mentioned for performance evaluation. The testing described is primarily nonclinical bench testing.
   • For bench testing, the sample sizes of units tested are not provided.
   • The "data provenance" (country of origin, retrospective/prospective) is not applicable or provided for the bench tests.

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):

   • This is not applicable as no clinical study with "ground truth" established by experts for performance evaluation was conducted or presented in this 510(k). The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device." (page 5).

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

   • Not applicable, as no clinical performance "test set" requiring adjudication by experts was presented.

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 Milli Vaginal Dilator is a physical medical 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, as this is not an AI algorithm.

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

   • For the nonclinical bench testing, the "ground truth" would be the device's own design specifications and engineering standards. The document states that tests passed "prespecified acceptance criteria/design inputs." The specifics of these are not detailed.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" for an algorithm.

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

   • Not applicable.

In summary:

The document describes a 510(k) submission, where the primary goal is a finding of "substantial equivalence" to existing predicate devices. This typically relies heavily on nonclinical (bench) performance testing to show that any differences in technological characteristics do not raise different questions of safety or effectiveness.

The document indicates that all necessary bench testing was conducted, and the results "passed the prespecified acceptance criteria/design inputs." However, the specific quantitative acceptance criteria and the detailed results of these tests that would demonstrate "device performance" in terms of those criteria are not provided in this summary document. The "study" itself is the battery of nonclinical bench tests listed, which collectively demonstrated that the device meets its established specifications, allowing the FDA to conclude substantial equivalence.

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The Allura™ Vaginal Stent is indicated to maintain the vaginal canal following radiological treatment or surgical procedures to restore, enlarge or create a vagina.

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I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text is a 510(k) clearance letter for the Allura™ Vaginal Stent and does not contain information about acceptance criteria or supporting studies. It merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

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Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus.

Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "Panpac Vaginal Dilators." This type of document is usually a regulatory approval and does not contain or describe a study on the device's technical performance or acceptance criteria in the way you've outlined.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details. The document primarily focuses on:

• Device Identification: Panpac Vaginal Dilators
• Regulation Number/Name: 21 CFR § 884.3900, Vaginal stent
• Regulatory Class: II
• Product Code: HDX
• Applicant: Panpac Medical Corporation
• FDA Determination: Substantially equivalent to legally marketed predicate devices.
• Indications for Use: Vaginal dilation for examination, surgical procedure, or relief of vaginismus.
• General Controls: Mentions requirements for registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

There is no mention of performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert reviews in this regulatory clearance letter.

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The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons in women with congenital absence of the vagina who have failed first-line non-surgical treatment with conventional vaginal dilators. The set is used in conjunction with a laparoscopic surgical procedure to create and enlarge the vaginal cavity via continuous traction between the abdomen and vulva, and to maintain the vaginal canal after surgery.

The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons to be placed in the vagina to enlarge the vaginal cavity and maintain the vaginal canal after laparoscopic-assisted creation of a neo-vagina.

This is a 510(k) premarket notification for a medical device, which is an application seeking substantial equivalence to a legally marketed predicate device. This type of submission generally does not include detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as would be found in a De Novo or PMA submission. The focus of a 510(k) is to demonstrate that the new device is as safe and effective as (substantially equivalent to) an existing device.

Therefore, many of the requested details about acceptance criteria and specific study designs are typically not found within a 510(k) summary. I will extract the information that is present and note where the requested information is not available due to the nature of a 510(k) submission.

Here's the breakdown of the information provided in the document:

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

• Acceptance Criteria: A 510(k) does not typically define explicit acceptance criteria in the same way a clinical trial or performance study for a novel device would. Instead, the "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has "similar basic features, design, and intended uses" and that "minor differences...raise no new issues of safety and effectiveness."
• Reported Device Performance: The document states: "The KSEA Neo-vagina Surgery Set and Accessories is substantially equivalent to the predicate device since the basic features, design, and intended uses are similar. The minor differences between the KSEA Neo-vagina Surgery Set and Accessories and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function, or intended use of the devices."

Table of (Implied) Acceptance Criteria and Performance:

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

• This information is not provided in a 510(k) summary. A 510(k) application focuses on demonstrating equivalence to existing devices, often through comparative analysis of device specifications, materials, and intended use, rather than a clinical trial with a "test set" in the context of an AI/algorithm.

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)

• This information is not applicable/not provided. Ground truth establishment by experts is typically part of studies for novel devices or AI algorithms. This 510(k) is for a surgical instrument set.

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

• This information is not applicable/not provided. Adjudication methods are relevant for studies where expert consensus on interpretations (e.g., from images) is needed.

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

• This information is not applicable/not provided. MRMC studies are specific to evaluating diagnostic devices, especially those incorporating AI, and are not part of a 510(k) for a surgical instrument set. The device described is a set of physical surgical instruments, not an AI or diagnostic tool.

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

• This information is not applicable/not provided. There is no algorithm or AI component in this device.

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

• This information is not applicable/not provided. As this is a surgical instrument set and not a diagnostic or AI device, the concept of "ground truth" for performance evaluation in a structured study is not directly relevant in the 510(k) summary provided.

8. The sample size for the training set

• This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.

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

• This information is not applicable/not provided. There is no "training set" or "ground truth" in the context of an AI/ML device for this submission.

Summary of the Study (Implied by 510(k) Process):

The "study" in a 510(k) context is a comparative analysis of the new device against a legally marketed predicate device(s).

• Design: The submission performs a comparison of the KSEA Neo-vagina Surgery Set and Accessories against two predicate devices: Bioteque America, Inc. (K003380) and Specialities REMEEX International, S.L. (K033310).
• Objective: To demonstrate that the new device is "substantially equivalent" to these predicates in terms of basic features, design, intended use, and technological characteristics, and that any differences do not raise new issues of safety and effectiveness.
• Methodology: The summary states that the devices are compared based on their design, intended uses, and technological characteristics (removable, reusable, biocompatible, autoclavable materials, range of sizes).
• Outcome: The conclusion is that the KSEA Neo-vagina Surgery Set and Accessories is substantially equivalent to the predicate devices.

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The GYNECARE PROSIMA* Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH* PS Nonabsorbable PROLENE Soft Mesh, are indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor, either as mechanical support or bridging material for the fascial defect. The Systems provide maintenance of the vaginal canal during the period of healing following surgical repair of vaginal wall prolapse, while supporting the position of the Mesh Implants.

The GYNECARE PROSIMA Anterior, Posterior, and Combined Pelvic Floor Repair Systems consist of pre-cut GYNECARE GYNEMESH PS Mesh Implant(s), and instruments to facilitate Mesh Implant placement and postoperative support.

The provided document is a 510(k) premarket notification for the GYNECARE PROSIMA Pelvic Floor Repair Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics for a novel technology like AI/ML.

Therefore, many of the requested categories are not applicable to this kind of regulatory submission. The document explicitly states that the approval is "Based on the similarities to the predicate devices identified in this submission," rather than a study against a pre-defined performance criterion for the new device.

Here's an attempt to address the request based on the provided text, indicating where information is not applicable:

Acceptance Criteria and Study Analysis for GYNECARE PROSIMA Pelvic Floor Repair Systems

This 510(k) submission for the GYNECARE PROSIMA Pelvic Floor Repair Systems establishes substantial equivalence to predicate devices, rather than demonstrating performance against pre-defined acceptance criteria for a novel device through a clinical study. The "performance data" section focuses on material biocompatibility and functional bench/cadaver testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a clinical "test set" with human subjects in the context of an AI/ML algorithm evaluation. The testing mentioned is "bench and cadaver testing." No specific sample sizes for these tests are provided, nor is data provenance in terms of country of origin or retrospective/prospective status for clinical data, as it's not a clinical study.

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

Not applicable. There is no mention of "experts" establishing ground truth for a test set in the context of this 510(k) summary. The evaluation focuses on material properties and functional tests, not diagnostics or interpretations requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method is mentioned as there is no diagnostic test set requiring human consensus for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is not a study involving human readers or AI assistance.

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

For the biological reactivity, the "ground truth" (or standard of acceptability) was established by ISO Standard 10993-1. For functional performance, the "ground truth" was whether the device "meets or exceeds all functional requirements," which would be defined by internal engineering specifications or industry standards for mechanical performance. No pathology, outcomes data, or expert consensus serving as ground truth for clinical performance is described.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable.

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