Search Results

GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.

GIMMI ALPHA Endoscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

Laparoscopic and urological-gastroenterologic and related accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Needle holders and other Class I devices included in the endoscopic catalogs may be onepiece. The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).

Minimally Invasive Gl and GU Devices are design specific for short term use in diagnostic and/or therapeutic procedures

This document is a 510(k) premarket notification for the GIMMI ALPHA® Endoscopic Instruments & Accessories. It establishes substantial equivalence to various predicate devices and describes the general characteristics of the device. However, it does not contain a detailed study with specific acceptance criteria and performance results directly comparable to those criteria in a quantitative manner.

Instead, the document states general compliance and conformance without providing numerical performance metrics or detailed study designs.

Therefore, many of the requested sections regarding specific acceptance criteria, performance data, sample sizes, ground truth establishment, and expert involvement cannot be extracted from this document based on the provided text.

Here's what can be inferred and what cannot:

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

• Acceptance Criteria: Not explicitly stated with quantifiable thresholds in the provided text. The document broadly states "safety, effectiveness, and reliability."
• Reported Device Performance: Not reported numerically. The document states, "All results were in conformance with the cited harmonized device standards" and "The results of design validation raise no new issues of safety and effectiveness."

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely from GIMMI GmbH's internal testing.

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

• This information is not provided as the document does not detail specific clinical or performance studies involving "ground truth" established by experts. The "ground truth" in this context would typically refer to definitive diagnoses or outcomes for a clinical study comparing the device's output to reality, which is not described.

4. Adjudication method for the test set

• Not applicable/not provided, as no expert-adjudicated test set 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

• This is not applicable. The device is described as "Endoscopic Instruments & Accessories" and devices "for minimally invasive GI, GU, and laparoscopic diagnostic and/or therapeutic indications." It is a physical medical device, not an AI-powered diagnostic tool, and therefore, an MRMC study with AI assistance is not relevant to this submission.

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

• This is not applicable as the device is a physical instrument, not a standalone algorithm.

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

• Not applicable/not specified for a clinical performance study involving "ground truth." The "performance and physical tests" would likely rely on engineering standards and measurements rather than medical ground truth.

8. The sample size for the training set

• Not applicable, as this is a physical medical device, not a machine learning algorithm requiring a "training set."

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

• Not applicable for the same reason as above.

Summary based on the provided text:

The document serves as a regulatory submission confirming that the GIMMI ALPHA® Endoscopic Instruments & Accessories are "substantially equivalent" to predicate devices. It states that:

• The devices have the same intended use.
• They are made of the same materials.
• They are produced to the same international and FDA-recognized standards.
• "All materials used... were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices."
• "All results were in conformance with the cited harmonized device standards."
• "The results of design validation raise no new issues of safety and effectiveness."

However, it refrains from providing detailed study protocols, quantitative performance data, or specific acceptance criteria with reported numerical results. The substantiation relies on adherence to general standards and comparison to existing, cleared predicate devices rather than a new, detailed clinical performance study with defined acceptance criteria.

Ask a specific question about this device

The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.

Restore Female Continence device is a simple, noninvasive suction cup which fits over the urinary meatus. Air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via suction. If inadequate suction occurs. Aquaphor or a petroleum based ointment can be applied to the outside rim of the device to enhance suction. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and, therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intraabdominal and intravesical pressure during valsalva, thereby decreasing or preventing leakage.

Here's an analysis of the NEBL Restore Female Incontinence Device's acceptance criteria and the study used to prove it, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for NEBL Restore Female Incontinence Device

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't explicitly state pre-defined acceptance criteria with numerical targets in the same way a device specification document might. Instead, the "acceptance criteria" are implied by the clinical study's objectives: to demonstrate a statistically significant improvement in objective and subjective efficacy measures, and to show the device is safe and well-tolerated.

Here's a table summarizing the reported device performance against these implied criteria:

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

• Sample Size for Test Set: 100 women
• Data Provenance: The study was conducted in the U.S. across 8 Investigational Sites. It is a prospective clinical study as women used the device during a 12-week device usage period, with baseline (Control) measurements taken before device use and follow-up measurements at Week 12.

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

The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). For objective tests like Pad Weight Test and Provocative Stress Test, the "ground truth" is inherently quantitative measurement. For subjective measures like the Incontinence Impact Questionnaire and Satisfaction Survey, the patients' own responses constitute the "ground truth." Clinical assessments (physical exams, urine cultures) would have been performed by medical professionals at the investigational sites, but their specific roles or the number involved in establishing a "ground truth" consensus are not detailed.

4. Adjudication Method for the Test Set

The document does not mention a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Given that the efficacy parameters were statistically analyzed using paired t-test, repeated-measures analysis, and Wilcoxon signed-rank testing, it implies direct measurement and patient reporting rather than a consensus-based adjudication process for the primary endpoints. Clinical safety assessments would have been part of standard clinical practice at each site.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a single-arm, pre-post comparison of device performance in a cohort of patients. It does not involve multiple human readers evaluating cases or comparing human performance with and without AI assistance.

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

This question is not applicable as the NEBL Restore device is a physical medical device (a suction cup) worn by patients, not an AI algorithm. Therefore, there is no "algorithm-only" performance to describe.

7. The Type of Ground Truth Used

The ground truth used for the test set was a combination of:

• Objective Measurements:
  • Pad Weight Test (PdWt): Direct measurement of urine leakage in grams.
  • Provocative Stress Test (PST): A score representing the severity of leakage during specific maneuvers.
  • Urine Cultures: Laboratory results for the presence of bacteriuria.
• Subjective Patient-Reported Outcomes:
  • Voiding Diary: Patient-reported number of incontinence episodes per day (IEPD).
  • Incontinence Impact Questionnaire (I-QOL): Patient-reported quality of life scores.
  • Satisfaction Survey: Patient-reported satisfaction with ease of placement/removal, performance, comfort, and tolerability (e.g., vaginal irritation).
• Clinical Observations:
  • Physical Examinations: Observations by medical professionals regarding adverse events.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device development. This term is primarily relevant for machine learning algorithms. For a physical medical device like the Restore, the "training" typically refers to engineering design iterations and perhaps pilot or feasibility studies. The clinical study of 100 women serves as the primary evaluation of the final device design.

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

As there is no "training set" described for an AI algorithm, this question is not applicable. For the physical device, the "ground truth" during its development phases would have been established through a combination of engineering testing, user feedback on prototypes, and nonclinical studies (e.g., biocompatibility) to refine the design before formal clinical efficacy trials.

Ask a specific question about this device

The C3® External Male Bladder Control Device is intended to be used for the management of urinary incontinence in males.

The C3® External Male Bladder Control Device is a disposable, externally applied occlusive device intended to manage urinary incontinence in males. The male urethra is occluded by applying an external force on the base of the dorsal side of the penile shaft by means of a clamp.

The provided text describes a 510(k) premarket notification for a medical device, the C3® External Male Bladder Control Device. However, it explicitly states that no functional or safety testing was repeated for this device because it is identical to a previously marketed prescription device (K885323). The submission relies on the substantial equivalence of the new Over-The-Counter (OTC) device to this predicate and to other unclassified OTC penile constriction rings.

Therefore, the input text does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria for the K974040 submission. It merely asserts that the device is identical to a previously cleared device, with the only difference being the labeling for OTC use.

Based on the provided text, here's what can be stated about the acceptance criteria and the study that "proves" the device meets acceptance criteria (which, in this case, is a claim of substantial equivalence without new testing for this specific submission):

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or defined within the provided text for the K974040 submission. The core "acceptance criterion" for this 510(k) is substantial equivalence to existing predicate devices, implying that the safety and efficacy demonstrated by those predicates are met.
• Reported Device Performance: No new performance data is reported as no functional or safety testing was repeated for this 510(k) submission. The device performance is presumed to be identical to the predicate device K885323.

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

• Sample Size: Not applicable, as no new test set or functional/safety testing was conducted for this 510(k) submission (K974040).
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable, as no new test set requiring expert ground truth was established for this 510(k) submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable, as no new test set requiring adjudication was conducted for this 510(k) submission (K974040).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done for this 510(k) submission. The device is a physical bladder control device, not an AI-assisted diagnostic or imaging system where MRMC studies are typically performed.
• Effect Size of Human Readers with/without AI: Not applicable.

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

• Standalone Performance Study: No, a standalone performance study was not done for this 510(k) submission. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable for the K974040 submission, as no new performance data or ground truth establishment was described. The submission relies on the established safety and efficacy of the predicate devices.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable. This device is a physical medical device, not an AI/ML algorithm.

Ask a specific question about this device

The UroMed Patch is indicated for the prevention or decrease of urine leakage in women with stress urinary incontinence.

The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.

The UroMed Patch is a single use, disposable foam pad that is coated on one side with an adhesive gel. The patch is worn over the urethra between times of unination. The product is intended to prevent unine form escaping the environs of the urethra, and is replaced each time the patient urinates.

The UroMed Patch is a single-use, disposable foam pad with an adhesive gel coating used to prevent or decrease urine leakage in women with stress urinary incontinence.

Here's an analysis of its acceptance criteria and the study proving its effectiveness:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly state acceptance criteria in terms of specific thresholds for improvement or statistical significance for each performance parameter. However, the study results, all achieving a p-value of 0.0001, strongly suggest that the observed improvements were considered statistically significant and indicative of efficacy. The improvements themselves can be interpreted as the de-facto acceptance criteria for clinical effectiveness.

*Note: The submission mentions an average improvement of 60% when reviewing leakage episodes at weeks 9, 13, and 17, compared to the initially reported 65.5% at 12 weeks. Both are substantial improvements.

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

The document does not explicitly state the sample size (number of participants) for the clinical testing. It only states that the UroMed Patch has been "extensively tested for its safety and efficacy."

The data provenance (country of origin, retrospective/prospective) is not explicitly stated. However, given the context of a 510(k) submission to the FDA, it is highly likely that the data was collected in a prospective clinical study, most likely within the United States, or at least following good clinical practice (GCP) guidelines.

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

This information is not provided in the submission. The clinical study focused on patient-reported outcomes (leakage episodes, perceived severity, quality of life) and objective measurements (leakage in grams/hour). These do not typically involve experts establishing a "ground truth" in the same way an imaging device might (e.g., radiologist consensus).

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided, as the study does not involve image interpretation or similar tasks requiring expert adjudication. The primary data points were quantitative measurements and patient self-assessment collected during a standard clinical trial.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The UroMed Patch is a therapeutic device for incontinence, and its efficacy is measured by objective physiological parameters and patient-reported outcomes, not by human interpretation of diagnostic cases. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

The concept of "standalone performance" (algorithm only) is not applicable to the UroMed Patch. This device is a physical product directly used by patients, not a diagnostic algorithm. Its performance is assessed through its direct physical effect on reducing urine leakage and its impact on the user.

7. Type of Ground Truth Used:

The ground truth for the clinical study was established using a combination of:

• Objective Physiological Measurements: Leakage measured in grams per hour.
• Patient-Reported Outcomes (PROs):
  • Mean number of leakage episodes per week (self-reported).
  • Perceived severity of leakage (patient-rated scale).
  • Impact on Quality of Life (patient-rated scale).

These measures collectively served as the "ground truth" for assessing the device's efficacy.

8. Sample Size for the Training Set:

This information is not applicable as the UroMed Patch is a physical medical device, not an AI/ML algorithm that requires a "training set." Its development would involve engineering, material science, and possibly in-vitro testing, but not an algorithmic training set in the AI sense.

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

This information is not applicable as there is no "training set" in the context of this physical device. The "ground truth" for its development would involve established engineering standards, material properties, and biocompatibility testing criteria (e.g., ISO 10993 for biocompatibility), rather than a statistically derived ground truth for an algorithm.

Ask a specific question about this device

The INSIGHT Medical FemAssist™ Flexible is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).

The INSIGHT Medical FemAssist™ device consists of a small, flexible, cylindrical, non-sterile device with a short profile which is manufactured from soft silicone material. The FemAssist™ fits over the external female urethral opening, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ is placed directly over the urettral opening where it is held in place by its own mild vacuum action, supporting and reinforcing the natural action of the muscles that control wine output and preventing accidental urine loss. Aquaphor oinment is applied to the device flange area prior to placing it over the urethral opening to help achieve a good seal. The flange area of the FemAssist™ Flexible device is thimer than that of the standard FemAssist™ cleared in K963858 for increased patient comfort.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FemAssist™ Flexible device:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary for the INSIGHT Medical Corp. FemAssist™ Flexible describes a device intended to manage stress urinary incontinence (SUI) in women. The acceptance criteria and supporting studies focus on physical characteristics, safety, and a limited clinical evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define quantitative acceptance criteria for the clinical performance, but rather focuses on equivalence to a predicate device and positive patient feedback. For physical characteristics, the acceptance criterion is equivalence to the predicate device.

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

• Sample Size (Clinical Test Set): 14 women.
• Data Provenance: Retrospective (early 1997) market evaluation conducted at the Peakhurst Community Health Centre, Peakhurst, New South Wales, Australia.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test set. The clinical evaluation primarily relies on quantitative 1-hour pad weight testing and patient self-reporting for subjective feedback.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method beyond the quantitative pad weight testing and subjective patient reports. There's no mention of expert consensus or arbitration for ambiguous cases.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The evaluation was a clinical market evaluation with patients.

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical medical device, not an algorithm or AI. Therefore, a standalone (algorithm only) performance study was not applicable and not performed.

7. Type of Ground Truth Used (Clinical Test Set)

The ground truth for the clinical test set was a combination of:

• Quantitative Outcome Data: Reduction in urine leakage measured by 1-hour pad weight testing.
• Patient-Reported Outcomes (PROs): Subjective feedback on comfort, liking the device, and perceived effectiveness in controlling urine loss.

8. Sample Size for the Training Set

The document does not mention a separate "training set" in the context of device development or clinical evaluation. The initial "standard" FemAssist™ device (K963858) would have undergone its own development and testing, which might be considered an ancestral "training" for the modified Flexible version, but no specific data is provided. This device is a physical product, not an AI/ML algorithm that typically uses training datasets.

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

As there is no mention of a training set in the context of AI/ML, this question is not applicable to the information provided for this medical device. The "ground truth" for the predicate standard FemAssist™ would have been established via its own development and clinical evaluation processes, which are not detailed in this submission for the modified Flexible device.

Ask a specific question about this device

The Restore Continence Device is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence. Although it can help control urinary incontinence, it will not correct the underlying cause of the condition.

The Restore Female Continence device is a simple, non invasive suction cup device which fits over the urinary meatus. Similar to a suction cup, air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via self-suction. If inadequate suction occurs, Aquaphor or an equivalent ointment can be applied to the outside rim of the device to enhance adhesion. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intra-abdominal and intravesical pressure during valsalva thereby decreasing or preventing leakage.

The NEBL Restore Female Continence Cap is a device designed to manage urinary leakage in women suffering from stress urinary incontinence.

Here's an analysis of its acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

Ask a specific question about this device

The FemAssist™ is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).

The FemAssist™ device is a small (3.5cm in diameter) cylindrical device with a short profile (2.0cm in height) designed and constructed (molded) to fit over the female urethra, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ supports and reinforces the natural action of the muscles that control urine output and prevents accidental urine loss. The female urethra is located between the vagina and the clitoris, in the center of the area about 3cm in diameter. The FemAssist™ product is place by it's own mild vacuum action.

Here's a breakdown of the acceptance criteria and study information for the FemAssist™ Urinary Incontinence Device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Clinical Efficacy Test Set: Data from 73 women from one clinical site.
   • Clinical Safety Test Set: 222 women initially enrolled. 138 patients were followed for at least 30 days. Data was collected at three (3) US sites.
   • Data Provenance: United States (US sites), prospective clinical study.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study. The effectiveness measure (pad weight test) and adverse event reporting would likely have involved clinical personnel (doctors, nurses) at the study sites, but their specific roles in "ground truth establishment" are not detailed.

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

   • The document does not describe any specific adjudication method for the clinical test set data. Adverse events were "obtained from voiding diaries and physician visits," and pad weight tests are objective measurements.

4. 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 was not an AI-based device, nor was it a multi-reader, multi-case study. It's a medical device for urinary incontinence.

5. 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, external medical device and not an algorithm or AI system. Its performance is tested entirely standalone (device only) as it's designed to be used by the patient without the need for human intervention or interpretation beyond initial fitment and instructions.

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

   • Clinical Effectiveness: Objective measurements - urine leakage measured by the change in pad weight (standardized one-hour pad weight test) and patient self-reported dryness days from voiding diaries.
   • Clinical Safety: Patient self-reported adverse events (from voiding diaries) and physician observations during visits.
   • Biocompatibility/Benchtop: Pass/fail criteria established by recognized standards (NAmSA, USP) for laboratory tests.

7. The sample size for the training set:

   • The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning model.

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

   • Not applicable (see point 7).

Ask a specific question about this device

The UroMed ABC device is intended to prevent or reduce episodes of male urinary incontinence.
The UroMed ABC device is indicated to prevent or reduce episodes of male urinary incontinence.

The UroMed ABC device is a urological clamp designed to significantly reduce the leakage of urine by occluding the urethra. The ABC device is clamped on the glans of the penis to provide less compression, yet the same continence as those urological clamps that are placed on the shaft of the penis.

This K971992 document describes the UroMed Alternative Bladder Control Continence Device (ABC), a Class I urological clamp. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined endpoints.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the provided document. The 510(k) submission for the UroMed ABC device does not articulate specific acceptance criteria for performance metrics (such as efficacy in preventing urine leakage or comfort levels) nor does it report device performance against such criteria. The submission primarily relies on demonstrating substantial equivalence to existing predicate devices.

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

This information is not provided for efficacy or clinical performance. The document only mentions "Bench tests were conducted to evaluate the tack force and the peel force of the ABC device adhesive." It does not specify the sample size for these bench tests, nor does it provide details on data provenance beyond stating "on human skin" for the peel force. There is no information about a test set for clinical performance.

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

This information is not applicable/not provided. There is no mention of a clinical test set requiring expert-established ground truth for the UroMed ABC device. The submission relies on bench testing and substantial equivalence to market approval.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. No clinical test set requiring adjudication is described in the document.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the provided document. The submission focuses on substantial equivalence based on device design and intended use, not on comparing human reader performance with and without AI assistance. The device is a physical medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable/not provided. The UroMed ABC is a physical medical device and does not involve an algorithm or AI. Therefore, a standalone performance study in the context of AI algorithms is not relevant.

7. Type of Ground Truth Used

For the bench tests on adhesive performance, the "ground truth" would be the direct measurements of tack force and peel force. However, for the overall effectiveness of the device in preventing urinary incontinence, the document does not refer to any specific ground truth method applied to a clinical study. Instead, it relies on the established safety and effectiveness of its predicate devices through the substantial equivalence pathway.

8. Sample Size for the Training Set

This information is not applicable/not provided. The UroMed ABC device is not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As the device is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.

In Summary:

The K971992 submission for the UroMed ABC device is a Class I 510(k) submission, which typically relies on demonstrating substantial equivalence to legally marketed predicate devices. This type of submission generally does not require extensive clinical trials with detailed performance acceptance criteria, test sets, or ground truth establishment in the same manner as novel, higher-risk devices or AI/ML-driven diagnostics. The provided document details the device's design, intended use, and a summary of bench tests for adhesive properties, with the primary argument being substantial equivalence to existing penile clamps.

Ask a specific question about this device

The Miniguard is an external female continence device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence occurs when intraabdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who experience urine leakage under conditions of physical stress.

The Miniguard female continence device consists of a small pad that is coated on one side with a biocompatible polymer adhesive. The Miniguard is an external management device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence. The Miniguard's function is to provide occlusion of the urinary opening by creating a seal over the urinary opening. The foam pad backing is intended to facilitate application and removal and for user comfort.

The Advanced Surgical Intervention (ASI) Miniguard Female Continence Device was evaluated for its safety and efficacy in decreasing urinary leakage episodes and improving quality of life in women with stress incontinence.

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a pass/fail format per se, but rather presents the statistically significant improvements as the measure of effectiveness. I've re-framed the reported performance as meeting implied criteria for significant improvement.

Ask a specific question about this device