Search Results

The Contour Profile Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The CPX™4 Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

In order to provide these tissue expanders with elasticity and integrity, the shells are made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the devices have integral, silicone elastomer, magnetically detected, injection ports and incorporate a BUFFERZONE® area with self-sealing technology that is attached to the inside of the anterior surface of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The textured shell provides a disruptive surface for collagen interface.

Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

Suture fixation tabs are incorporated into some models of the MENTOR® CPX™4 Tissue Expanders to give surgeons the option to attach the device to surrounding tissue for enhanced device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

This document is a 510(k) summary for the Mentor CPX™4 Tissue Expander, a physical medical device, not an AI/ML powered software product. Therefore, many of the requested categories in your prompt, which are typically relevant for AI/ML device studies, are not applicable.

Here's an attempt to extract and frame the information based on the provided document, addressing the prompt's specific points where possible, and indicating "N/A" where the information is not relevant or available for a physical device submission:

Acceptance Criteria and Device Performance for Mentor CPX™4 Tissue Expander

This 510(k) summary describes modifications to an existing physical medical device, the Mentor Contour Profile Tissue Expander. The "studies" conducted are non-clinical performance tests to demonstrate substantial equivalence to the predicate device, not clinical trials or AI/ML model performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria:
The document states, "All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device performs as well as or better than the predicate device." The specific numerical or qualitative thresholds for these criteria are not detailed in this 510(k) summary. The overarching acceptance criterion for the submission is demonstrating "substantial equivalence" to the predicate device.

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

• Sample Size: Not explicitly stated as "test set" in the context of an AI/ML model. For non-clinical performance testing of a physical device, this would typically refer to the number of units tested per parameter. This information is not detailed in the 510(k) summary.
• Data Provenance: N/A for AI/ML data provenance. The testing was non-clinical performance testing conducted by the manufacturer, MENTOR Worldwide LLC.

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

N/A. This concept is not applicable to the non-clinical performance testing of a physical product where "ground truth" typically refers to physical measurements and adherence to engineering specifications, rather than expert interpretation of data.

4. Adjudication method for the test set

N/A. Adjudication methods (e.g., 2+1) are common in clinical studies or AI/ML ground truth establishment. For non-clinical performance testing, results are typically determined by adherence to pre-defined specification limits.

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

N/A. This is a physical medical device, not an AI/ML system, so MRMC studies involving human readers and AI assistance are not relevant.

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

N/A. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

For physical device testing, "ground truth" refers to established engineering specifications, performance standards, and the physical properties of the device. The non-clinical testing was based on meeting pre-determined acceptance criteria for parameters like joint strength and leak performance, likely against internal specifications and potentially relevant industry standards.

8. The sample size for the training set

N/A. There is no AI/ML model or "training set" for this physical device.

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

N/A. There is no AI/ML model or "training set" for this physical device. The "ground truth" for physical device manufacturing and testing would be based on validated design specifications and quality control procedures.

Ask a specific question about this device

The Mentor Resterilizable Gel Breast Implant Sizer is indicated for temporary insertion intraoperatively to evaluate the size and shape of the MemoryGel™ breast implant to be implanted.

The Mentor Resterilizable Gel Breast Implant Sizer (Sizer) is a silicone elastomer device, filled with silicone gel, that is designed for temporary intraoperative placement in the surgically prepared breast pocket. The Sizer is used to evaluate the appropriate MemoryGel™ breast implant size and shape for each patient prior to implantation of a breast implant. It is provided non-sterile and must be sterilized prior to use. The Sizer should not be sterilized more than ten times.

This document describes the validation of the Mentor Resterilizable Gel Breast Implant Sizer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set in the material biocompatibility or physical properties testing. It mentions "materials being used" and "the Sizers."

The data provenance is prospective, as these tests were conducted specifically for the device's clearance. The country of origin is USA, as the manufacturer is Mentor Corporation, located in Santa Barbara, CA and Irving, TX.

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

This information is not provided in the document. The studies described are technical performance tests (biocompatibility, physical integrity, sterilization effectiveness) which typically rely on standardized laboratory testing protocols rather than expert medical interpretation of results for "ground truth."

4. Adjudication Method:

The document does not describe an adjudication method as it's not relevant for the types of technical performance tests conducted.

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

An MRMC comparative effectiveness study was not performed or described. The device is a physical breast implant sizer, not an AI or imaging diagnostic tool that would typically involve human reader performance comparisons.

6. Standalone Performance:

Standalone performance for the device was performed. The studies focused on the intrinsic properties and performance of the Sizer itself (biocompatibility, physical durability, sterilization effectiveness) without human interaction as part of the primary measurement.

7. Type of Ground Truth Used:

The ground truth used for these studies was based on:

• Standardized laboratory testing protocols and established thresholds: For biocompatibility (ISO 10993), physical properties (design specifications and defined acceptance criteria in a protocol), and sterilization effectiveness (achieving a minimum SAL of 10⁻⁶). This is a form of empirical measurement against defined standards.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device validation. Training sets are typically used for machine learning algorithms. This device is a physical medical device, and its validation relies on engineering and biological safety testing, not AI model training.

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

As there is no training set for a physical device, this question is not applicable.

Ask a specific question about this device

The Mentor NovaSilk Mesh is indicated for tissuc reinforcement and long-lasting rne Memor of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, cither as mechanical support or bridging matcrial for the fascial defect.

NovaSilk is a permanent, synthetic knitted polypropylenc mesh that is square in shape. It is a sterile, single use device which will be available in quantitics of three.

The provided text describes a medical device, the Mentor NovaSilk™ Mesh, and its clearance process through the FDA 510(k) pathway. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than explicit performance against predefined acceptance criteria for AI/ML devices or diagnostic accuracy. Therefore, much of the requested information for an AI/ML device is not applicable or not present in this document.

Here's an analysis based on the information provided and what is typically sought for AI/ML device evaluations:

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

For this device (surgical mesh), the "acceptance criteria" are not reported in terms of specific performance metrics like sensitivity, specificity, accuracy, or AUC that would be relevant for an AI/ML diagnostic or predictive device. Instead, acceptance for 510(k) clearance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device and meeting general safety and effectiveness requirements through various tests.

The document lists the following characteristics assessed for NovaSilk:

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. The testing described appears to be bench testing for material characteristics and biocompatibility, not a clinical study with patient "test sets" in the context of AI/ML evaluation.

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. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for ground truth.

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

This is not applicable. The device is a surgical mesh, not a diagnostic tool requiring adjudication of interpretations.

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 a surgical mesh, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a surgical mesh, not an algorithm.

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

This is not applicable. The "ground truth" for this device would be its physical and biological properties conforming to established standards and demonstrating safety. The biocompatibility tests for pyrogenicity and cytotoxicity provide a form of "ground truth" regarding its biological safety.

8. The sample size for the training set

This is not applicable. The device is a manufactured medical product, not an AI/ML model that requires a training set.

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

This is not applicable.

Ask a specific question about this device

The Mentor Aris Suprapubic Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Mentor Aris Suprapubic Surgical Kit consists of two components: the Mentor Aris Sling and a set of Introducers. The Mentor Aris Sling is an implantable, suburcthral, support tape made from knitted monofilament polypropylene fibers. Two sterile, disposable flat curved Introducers necessary for implantation of the sling are also included in the Surgical Kit. The Introducers consist of a stainless steel needle with a plastic handle.

The Mentor Aris™ Suprapubic Surgical Kit is a medical device for the surgical treatment of stress urinary incontinence. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a standalone study report.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for the testing described for the Aris Introducers. It generally states that "testing was performed."

The data provenance is not explicitly mentioned but typically in 510(k) submissions, testing is performed by the manufacturer or contracted labs. The studies listed are laboratory-based performance and biocompatibility tests, not clinical studies with human subjects.

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

This information is not applicable. The "ground truth" here refers to established standards (e.g., ISO guidelines for biocompatibility, engineering specifications for mechanical performance), not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" are relevant for clinical studies or evaluations involving human interpretation. The testing described is objective laboratory testing against predetermined specifications.

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

No, an MRMC comparative effectiveness study was not done. The device is a surgical kit, not an AI software or diagnostic tool that would involve human readers or image interpretation.

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

This is not applicable. The device is a physical surgical kit, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the testing described is based on:

• International Standards: Specifically, ISO 10993-5 (cytotoxicity) and ISO 10993-10 (intracutaneous reactivity) for biocompatibility.
• Engineering Specifications/Performance Characteristic Specifications: For the mechanical and physical properties of the Introducers (e.g., sling pull-out force, torque, tensile performance, flexure, stiffness). These specifications are set by the manufacturer to ensure the device performs as intended.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This is not applicable as there is no training set for this device.

Overall Study Information:

The "study" presented in this 510(k) summary is a set of tests designed to demonstrate that the Mentor Aris Suprapubic Surgical Kit (specifically the Introducers, as the Sling was previously cleared) meets established safety and performance requirements and is substantially equivalent to predicate devices. These tests include:

• Biocompatibility Testing of Aris Introducers: Cytotoxicity per ISO 10993-5 and intracutaneous reactivity per ISO 10993-10. These tests determine if the device materials are harmful to biological systems.
• Performance Testing of Aris Introducers: This involved evaluating the mechanical integrity and functionality of the Introducers, including:
  • Sling pull-out force from the eyelet
  • Torque and tensile performance of the handle/needle interface
  • Needle flexure characterization
  • Needle stiffness characterization

The results of these tests confirmed the Introducers are "non-toxic and non-irritants" and "meet the required performance characteristic specifications for the intended use of the instruments," supporting the claim of substantial equivalence. The document does not provide raw data, specific numerical thresholds for "acceptance criteria," or detailed test methodologies beyond the standard names mentioned.

Ask a specific question about this device

The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.

The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.

The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.

The provided text describes a medical device, the Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter, and its 510(k) submission for substantial equivalence. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot fulfill the request as it pertains to AI/ML device testing and acceptance criteria based on the provided input.

The document details:

• Device Description and Indications for Use: What the catheter is and its intended purpose.
• Substantial Equivalence Claim: The manufacturer's claim that the device is substantially equivalent to previously cleared devices (Mentor Self-Cath Plus Catheter and Mentor Self-Cath Closed System).
• Summary of Testing (Biocompatibility): This section describes the tests performed to ensure the device is safe for biological contact. These are standard biocompatibility tests, not performance studies as would be conducted for an AI/ML algorithm.

The biocompatibility testing results essentially serve as the "acceptance criteria" and "reported performance" in this context, demonstrating that the materials are safe for their intended use.

Here's how I would present the available information if forced to apply the request's structure, while highlighting the mismatch:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.

The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.

The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.

The provided text describes a medical device, the Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter, and its path to FDA clearance via a 510(k) submission (K050008). However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar measures typically used for diagnostic or AI-based devices.

This submission focuses on substantial equivalence to predicate devices and biocompatibility testing rather than performance in terms of diagnostic effectiveness or clinical outcome improvement through a P-value or specific statistical analysis commonly found in clinical trials. As such, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the given information:

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

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

• Sample Size for Test Set: Not specified for biocompatibility tests (e.g., number of units tested, number of animals). This information is usually detailed in the full test reports, which are not included in this summary.
• Data Provenance: Not specified. The tests are general biocompatibility tests, not clinical studies in humans or specific geographical data.

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

• Not applicable. This submission concerns the biocompatibility and substantial equivalence of a physical medical device, not a diagnostic algorithm requiring expert-established ground truth.

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

• Not applicable. This type of adjudication is typically used for image-based diagnostics or clinical studies where subjective interpretation is involved.

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 study was done. This is not an AI-assisted device.

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

• Not applicable. This is not an algorithm.

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

• For biocompatibility, the "ground truth" is established by the results of standardized biological tests (e.g., observation of cellular reactions, animal responses to extracts, genotoxicity assays) and comparison against acceptance criteria defined by relevant ISO standards or regulatory guidelines.
• For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

Ask a specific question about this device

The Mentor Aris Trans-obturator Surgical Kit consists of the Mentor Aris Trans-obturator Tape, an implantable, suburethral, support tape, plus introducers. The Tape and the Surgical Kit are indicated for the surgical treatment of all types of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Mentor Aris Trans-obturator Kit consists of two components: the Mentor Aris Transobturator Tape and a set of introducer needles.

The Mentor Aris Trans-obturator Tape is an implantable, suburethral, support tape made from knitted monofilament polypropylene fibers. This structure gives the Aris Tape resistance to traction, allows tissue colonization and facilitates positioning during surgery.

A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Surgical Kit.

The provided text describes a 510(k) submission for a medical device called the Mentor Aris Trans-obturator Tape and Surgical Kit. However, it does not contain any information about acceptance criteria, device performance metrics, or any specific studies with sample sizes, expert involvement, or adjudication methods.

The key information from the document related to "proving" the device meets acceptance criteria is simply a claim of substantial equivalence to previously cleared devices.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about a study, because that information is not present in the provided text.

The document primarily focuses on:

• Device Identification: Proprietary and common name, classification, product code.
• Device Description: Components (tape and introducer needles), material of the tape (knitted monofilament polypropylene).
• Substantial Equivalence Claim: Stating it is equivalent to Mentor ObTape Trans-Obturator Tape (cleared under K031767 and K042851) and other similar products.
• Indications for Use: Surgical treatment of all types of stress urinary incontinence.
• Summary of Testing (General): A very broad statement that "All mechanical, biological, and chemical testing specifications comply with established ISO, USP, EN and/or NF standards." This statement indicates that some testing was done to meet general standards, but provides no specific results or acceptance criteria.
• FDA Communication: The FDA's letter of acknowledgment and substantial equivalence determination.

To answer your questions fully, the 510(k) summary would need to include a section detailing performance testing, clinical studies, or engineering studies, which is absent here.

Ask a specific question about this device

The Mentor ObTape Trans-obturator Surgical Kit consists of an implantable, suburethral support tape and introducers. It is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or sphincter deficiency.

The Mentor ObTape Trans-obturator Surgical Kit consists of two components: the Mentor ObTape Trans-obturator Tape and a set of Introducer Needles.

The Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The tape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, allows tissue colonization and facilitates positioning during surgery.

A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Kit.

The provided text describes a 510(k) submission for the Mentor ObTape™ Trans-obturator Surgical Kit. This is a medical device clearance process, not a study evaluating an AI algorithm, and therefore many of the requested elements (like sample size for test sets, number of experts, MRMC studies, standalone performance of an algorithm, and training set details) are not applicable to this type of regulatory submission.

The "study" in this context refers to the pre-clinical and mechanical testing performed to demonstrate that the device is substantially equivalent to a previously cleared predicate device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Additional Information (Not applicable for AI algorithms)

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

• Not applicable. This submission focuses on the substantial equivalence of a physical medical device (surgical tape and introducers), not an AI algorithm. The testing involved mechanical and biocompatibility assessments of the physical components, not a "test set" of data in the AI sense. The text does not provide sample sizes for these tests. Data provenance in this context would refer to the origin of the materials and manufacturing standards, which are not detailed in the summary.

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

• Not applicable. There is no "ground truth" establishment in the AI sense for this device. The tape component's equivalence is based on it being identical to a previously cleared device. The introducers' performance is based on mechanical and biocompatibility testing against predefined standards, likely conducted by qualified engineers and toxicologists/biologists, but not "experts" establishing a "ground truth" for a test set.

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

• Not applicable. No adjudication method is relevant as there is no "test set" or human interpretation of data in the AI context.

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 not an AI-assisted device.

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

• Not applicable. This is not an AI device.

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

• Not applicable. For the tape, the "ground truth" is that it is identical to a predicate device already deemed safe and effective. For the introducers, the "ground truth" is adherence to established mechanical performance specifications and demonstrated biocompatibility as per relevant standards. These are not "ground truths" in the diagnostic AI sense.

8. The sample size for the training set:

• Not applicable. This is not an AI device with a training set.

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

• Not applicable. This is not an AI device.

Ask a specific question about this device

The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

The Genesis Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence). The Prosthesis (used in pairs) is inserted into the corpora cavernosa. Each Prosthesis consists of a r roothed in panel in panel is a silver wire coil and silver wire coil and silver wire core in the flexible center section and a trimmable proximal section. The distal end is shaped to provide an anatomical fit under the glans penis. The silver wire coil and core in the flexible center section anatelinear in antost the gost into an erect position for intercourse, and then moved into a lowered position for concealment under clothing. Placed within the corpus cavernosum and crus of the penis, the Prosthesis will fit firmly at the ischial tuberosity. The ends fit the proximal culde-sacs of the cavernosa and provide support to the Prosthesis.

All components of the Genesis Penile Prosthesis incorporate a hydrophilic coating on all external surfaces.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary for a penile prosthesis and not an AI/ML device. Therefore, many standard AI/ML study components will not be present.

Device: Mentor Genesis™ Penile Prosthesis

Device Type: Penile Rigidity Implant (not an AI/ML device)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the sample sizes (number of units/samples) used for each physical, mechanical, or biocompatibility test. It only states that "Physical and Mechanical testing" and "Biocompatibility testing" were conducted.
• Data Provenance: Not applicable in the context of this device. The testing describes lab-based performance verification, not data from human subjects or clinical populations.

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

• Not applicable. The "ground truth" here refers to the pre-defined engineering specifications and biocompatibility standards that the device had to meet. The determination of whether a test result "met all specifications" would typically be done by qualified testing personnel and reviewed by engineering/quality control teams, not "experts establishing ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not applicable. Performance was assessed against pre-defined specifications for each test, not by adjudication of different evaluations.

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

• No, a MRMC comparative effectiveness study was not done. This is a physical medical device (penile prosthesis), not a diagnostic algorithm or AI system. Such studies are not relevant for this type of product.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Engineering Specifications and Biocompatibility Standards: The "ground truth" for this device's performance was established by internal engineering design specifications for physical and mechanical properties (e.g., specific thresholds for column strength, desired lubrication properties) and recognized international standards for biocompatibility (ISO 10993-5).

8. Sample Size for the Training Set

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

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

• Not applicable. As above, no training set was used.

Ask a specific question about this device

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

ObTape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, tissue colonization and facilitates positioning during surgery. Disposable and re-usable Introducer Needles necessary for the implantation are also available with the device.

The provided text is a 510(k) summary for a medical device (Mentor ObTape Trans-obturator Tape and Introducers). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a detailed performance evaluation in the way an AI/software device would.

Therefore, many of the requested categories for a study proving device acceptance against specific criteria are not applicable or cannot be extracted from this document, as it describes a physical surgical mesh and its introducers.

Here's an attempt to answer the questions based on the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. A table of acceptance criteria and the reported device 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 the 510(k) summary. The document describes tests against established standards for materials and biocompatibility, but it does not detail the specific sample sizes used for these tests, nor the data provenance in terms of country of origin or whether the tests were retrospective/prospective. This type of detail is typically part of the underlying test reports, not the summary.

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 to the type of device and testing described. The "ground truth" for this device is determined by physical and biological testing against recognized industry standards (EDANA, USP, ISO, EN), not by expert interpretation of clinical data in the same way an AI device would require.

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

This is not applicable to the type of testing described. Adjudication methods are typically used when interpreting subjective data (like medical images), which is not the case for mechanical properties or biocompatibility testing. The compliance is determined by objective measurements against predefined thresholds within the standards.

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. An MRMC study is relevant for evaluating the clinical performance of diagnostic or assistive AI technologies. This submission is for a surgical implant (mesh), not an AI-powered diagnostic tool.

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

This is not applicable. The device is a physical surgical implant, not an algorithm.

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

The "ground truth" is based on established industry and regulatory standards for material properties and biocompatibility.

• For mechanical testing: The ground truth for compliance is whether the measured Tear Strength, Tensile Strength, and Elongation meet the specified values within the EDANA standards.
• For biocompatibility: The ground truth for compliance is whether the results of tests for Cytotoxicity, Genotoxicity, Hemolysis, Implantation, Pyrogenicity, Intracutaneous Reactivity, Sensitization, and Systemic Toxicity adhere to the requirements of USP, ISO 10993, or EN standards.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This is not applicable. As there is no training set for a physical device, this question is irrelevant.

Ask a specific question about this device