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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.

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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.

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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

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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.

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