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Ask a specific question about this device

Ask a specific question about this device

The UroMed CaverMap® Surgical Aid is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open prostatectomy and colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open prostatectomy and colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.

The UroMed CaverMap Surgical Aid combines the technologies of two devices into one contained unit. The CaverMap Surgical Aid incorporates a nerve stimulator and a penile rigidity (tumescence) monitor into a single unit. The device is designed for identifying exposed nerves during open prostatectorny and colorectal surgical procedures. The device aid's the surgeon in locating the cavernosal and sacral nerves, which both effect tumescence.

The provided 510(k) summary for the UroMed CaverMap® Surgical Aid does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

This document focuses on establishing substantial equivalence to a predicate device (K970971 UroMed CaverMap Surgical Aid) based on its intended use, indications for use, and a general description of its technological features. It also lists the standards achieved (e.g., FDA Quality Systems Regulation, ISO standards), which are related to manufacturing and design controls, but not directly to performance acceptance criteria for the device's function.

Therefore, for each of your requested points, the answer is that the information is not provided in the given text.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document states a general "Summary of Standards Achieved" related to quality systems and biological evaluation, not specific performance metrics.
2. Sample size used for the test set and the data provenance: No performance study is described, hence no test set or information about its size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No performance study is described, hence no ground truth establishment details.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No performance study 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 such study is mentioned. The device is a "Nerve Stimulator/Locator" and does not appear to involve AI or "human readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No performance study of this nature is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No performance study is described.
8. The sample size for the training set: No training set is mentioned as part of a performance study.
9. How the ground truth for the training set was established: No training set is mentioned.

In summary, the provided 510(k) pertains to substantial equivalence based on established regulatory standards and a predicate device, rather than a detailed performance study with specific acceptance criteria and results.

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The UroMed Brachytherapy Iodine-125 Sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.

The UroMed I-125 Radionuclide Brachytherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal, and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.

UroMed I-125 Sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5mm long and 0.8mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by a laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The marker will be composed of gold alloy or iridium.

Iodine seeds have a half-life of 59.6 days and are available in a range of activity levels. The UroMed I-125 Sources are provided non-sterile and must be sterilized prior to use.

The provided text describes the UroMed Brachytherapy Iodine-125 Sources, a medical device. However, it does not contain information about acceptance criteria for device performance, the results of a study demonstrating these criteria are met, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on:

• Regulatory information: 510(k) summary, device classification, predicate devices.
• Intended Use and Indications for Use: What the device is for.
• Device Description: Physical characteristics (size, material, radioactive component).
• Summary of Standards Achieved: This section lists compliance with various regulatory and industry standards for manufacturing, quality systems, biological evaluation, material specifications, and leak testing. These are a form of acceptance criteria (i.e., the device must meet these standards to be cleared), but they are not presented as performance metrics in the typical sense of a clinical or analytical study.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, or details about the study, sample sizes, experts, adjudication, MRMC, standalone performance, or ground truth, as that information is not present in the provided text.

The closest information related to "acceptance criteria" is the list of standards the device complies with, which are prerequisites for regulatory clearance. These are general manufacturing, safety, and material standards, not performance metrics derived from a study.

Information that could be extracted and partially answers some points (though not in the requested format):

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

• Acceptance Criteria (from "Summary of Standards Achieved"):
  • FDA Quality System Regulation 21 CFR Part 820 Good Manufacturing Practice.
  • ISO 46001: Quality System
  • ISO 10993-1: 1992 (E), "Biological Evaluation of Medical Devices".
  • ASTM Standard for Titanium: F136-96e; Titanium alloy ASTM Grade 5 6AI-4V ELI Electro low interstitial elements.
  • ANSI Standards for Brachytherapy: N44.1 - 1973: "Integrity and Testing Specifications for Selected Brachytherapy Sources."
  • N44.2 - 1973: "Leak Testing Radioactive Brachytherapy Sources."
  • ISO 9978: 1992(E), "Radiation protection - Sealed radioactive sources - Leakage test Methods".
  • AAMI document, "Recommended Practice for Determining Residual Ethylene Oxide in Medical Devices".
• Reported Device Performance: The document states, "Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness." This is a general statement of compliance, not specific performance data.

2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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, as this is a physical brachytherapy source, not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided. This would relate to performance studies, which are not detailed.
8. The sample size for the training set: Not applicable (not an AI device, no training set).
9. How the ground truth for the training set was established: Not applicable.

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The UroMed Sling Kit is intended to be used in a suburethral sling procedure for the alleviation of involuntary leakage of urine due to urinary incontinence in adult women.

The UroMed Sling Kit is indicated for use by the surgeon for placing a urethral sling. The kit provides instruments to help the surgeon place the sling beneath the urethra. The kit will be used in suburethral sling procedures for female urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.

The UroMed Sling Kit is a single use, manual surgical kit for use during suburethral sling procedures. The kit will be used to place a sling (autograph, allograph, or synthetic) beneath the urethra in suburethral sling procedures.

The kit is comprised of two needles, two sheaths and two loops.

The kit components are constructed out of the following materials:

Needle: Surgical Stainless Steel, meeting ASTM Specification F899-84, with a handle constructed of Polyethylene Terephthalate (PET-P).

Sheath: Polyethylene

Loop: Surgical Stainless Steel, meeting ASTM Specification F899-84, with Polyethylene shaft

The provided text describes a 510(k) submission for the UroMed Sling Kit, a surgical instrument kit. It explicitly states that the device is determined to be substantially equivalent to legally marketed predicate devices, rather than establishing acceptance criteria through a specific study with defined performance metrics and a test set.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable in this context. The basis for clearance is demonstrating substantial equivalence to existing devices, not meeting novel performance criteria through a dedicated study.

Here's a breakdown of why each point is not applicable based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices, not on setting new performance acceptance criteria for the UroMed Sling Kit itself.
2. Sample sized used for the test set and the data provenance: Not applicable. No specific test set or clinical study data is presented to demonstrate performance against acceptance criteria. The clearance is based on comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for a test set is part of a performance study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication 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: Not applicable. This is a surgical instrument kit, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical instrument kit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No performance study is detailed that would require ground truth establishment.
8. The sample size for the training set: Not applicable. No training set for an algorithm is relevant for this medical device submission.
9. How the ground truth for the training set was established: Not applicable. No training set for an algorithm is relevant for this medical device submission.

Summary based on the provided text:

The UroMed Sling Kit's acceptance was based on demonstrating substantial equivalence to existing, legally marketed predicate devices (Cook Loop Retriever, Cook Stamey Needle, Cook Fascial Dilator, Acufex Suture Retriever). This equivalence was established by comparing the device's intended use, indications for use, and materials to those of the predicate devices. The submission also cited compliance with relevant standards such as ASTM F899-84 for surgical stainless steel and ISO 10993-1 for biological evaluation of medical devices. No new clinical performance data or studies defining specific acceptance criteria for the UroMed Sling Kit were presented or required for its 510(k) clearance.

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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.

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The UroMed Needle Grasper is intended to be used during endoscopic/laparoscopic surgical procedures to hold a suture needle allowing for suture passing.

The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.

The UroMed Needle Grasper is a single use, manual surgical instrument for use during endoscopic/laparoscopic surgical procedures. The Needle Grasper will be used through an endoscopic/laparoscopic operating channel or under open surgical procedures. The instrument will be used to place and pass suture in bladder neck suspension procedures (urethropexy).

The device is constructed out of Surgical Stainless Steel with a handle constructed of medical grade polymers.

The provided 510(k) summary for the UroMed® Needle Grasper does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study particulars. The document focuses on demonstrating substantial equivalence to predicate devices based on design and material standards, rather than presenting a performance study with specific acceptance criteria that would typically be found in direct performance assessment.

Here's a breakdown of what can and cannot be answered from the provided text:

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

No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission relies on "Summary of Standards Achieved" for materials and biocompatibility to establish equivalence.

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

Not applicable. The document does not describe a performance test set or clinical study to assess device performance in the way implied by this question.

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. No ground truth establishment for a test set is described.

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

Not applicable. No test set 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

Not applicable. This device is a manual surgical instrument and does not involve AI or human "readers" in the context of diagnostic interpretation.

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

Not applicable. This device is a manual surgical instrument and does not involve an algorithm.

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

Not applicable. No ground truth for performance evaluation is described. The "ground truth" for the submission is the regulatory acceptance of predicate devices and adherence to material standards.

8. The sample size for the training set

Not applicable. The document does not describe a training set for an algorithm or a performance study.

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

Not applicable. The document does not describe a training set or its ground truth establishment.

Summary of available information regarding compliance/study:

The 510(k) submission for the UroMed® Needle Grasper primarily demonstrates substantial equivalence through adherence to recognized standards and comparison to legally marketed predicate devices.

• Study Type: This is not a performance study with "acceptance criteria" in the sense of effectiveness or diagnostic accuracy. It's a regulatory submission demonstrating substantial equivalence primarily through design comparison and material compliance evaluations.
• Compliance to Standards: The device's "performance" is implicitly demonstrated through its construction from materials that meet established standards for surgical instruments and biocompatibility:
  • ASTM F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments.
  • USP Class VI Biocompatibility.
• Equivalence to Predicate Devices: The core of the justification is that the UroMed Needle Grasper is "substantially equivalent to legally marketed devices" (Cook Endoscopic Grasping Forceps, Laurus Medical Suture Placement System) in terms of its intended use, indications for use, and basic function. The text states: "Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness."

In conclusion, the 510(k) summary provided does not contain the information requested for a detailed performance study with specific acceptance criteria and ground truth establishment, as it focuses on demonstrating substantial equivalence through design, materials, and intended use alignment with existing predicate devices and adherence to specific material standards.

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The Urovations Nerve Stimulator is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

The Urovations Nerve Stimulator is indicated for use in the stimulation of the cavernosal nerves during open prostatectomy (surgical) procedures, aiding the surgeon in locating these nerves. The device is designed as an adjunct to current open prostatectomy procedures in which a nerve sparing technique is used. The Nerve Stimulator is not designed to replace the surgeon's expertise in mapping out the vascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.

The Urovations Nerve Stimulator is a electrical Nerve Stimulator designed for use during open prostatectomy (surgical) procedures. The stimulator provides a biphasic current pulse with variable amplitude between 1 - 20mA, a constant pulse width of 800usec/phase, and a constant frequency of 16Hz. The stimulation is applied to the body by the surgeon in order to locate and test the excitability of the cavernosal nerves.

Here's an analysis of the provided text regarding the Urovations Nerve Stimulator, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against pre-defined acceptance criteria in the same way a de novo or PMA submission might. Therefore, the "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate devices and general safety/effectiveness standards for the device type.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not explicitly stated in the provided text. The clinical study is mentioned in the singular, implying a single cohort, but the number of patients/procedures is not given.
   • Data Provenance: The document is a 510(k) summary submitted to the FDA in the USA, so the study was likely conducted in the USA. It is a prospective clinical study, as it "was conducted to determine if the Urovations Nerve Stimulator provides electrical stimulation..."

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

   • This information is not provided. The study focused on the device's ability to stimulate nerves and elicit a response, which would likely be observed intra-operatively by the operating surgeon. The "ground truth" here is the physical response to electrical stimulation rather than an interpretation of an image or signal by an expert off-line.

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

   • This information is not provided. Given the nature of observing a direct physiological response during surgery, formal adjudication methods like 2+1 or 3+1 are typically not applicable. The surgeon observing the response acts as the primary "interpreter."

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a nerve stimulator, not an AI-powered diagnostic tool, so "human readers" and "AI assistance" are not relevant concepts in this context. The study focused on the device's ability to directly stimulate nerves and elicit a physiological response during surgery.

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

   • Yes, the clinical study essentially functions as a standalone performance assessment of the device (not an algorithm) in its intended use. The device directly stimulates nerves, and its performance is measured by its ability to achieve this and elicit a response. While a surgeon operates the device, the study aims to show the device's inherent capability to perform its function.

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

   • The ground truth was based on direct physiological response/observation during surgery. The text states the study indicated the device "provides an electrical charge to stimulate the cavernosal nerves and elicits a visible and measurable response in tumescence." This visible and measurable response serves as the ground truth for successful nerve stimulation.

7. The sample size for the training set:

   • This device is an electromechanical nerve stimulator, not an AI/machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

   • As there is no AI/machine learning component, there is no training set ground truth to establish.

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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.

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