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The Gynecare TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device.

The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.

The Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant. The Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly.

The Winged Guide is a stainless steel accessory instrument that facilitates consistent passage of the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly through the dissection tract.

The provided document is a 510(k) summary for surgical instrumentation and describes performance testing for those instruments, not for an AI/ML device. Therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance.

The document discusses the following types of performance testing for the GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide:

• Sterilization validation: To demonstrate the devices are sterile to an SAL of 10^-6.
• Package integrity: To ensure the sterility of the packaged devices.
• Dimensional and mechanical performance: To confirm the instruments meet design specifications and can withstand intended use.
• Biocompatibility: Including cytotoxicity, sensitization, and irritation tests to ensure the materials are safe for patient contact.
• Shelf life: To validate the stability and performance of the devices over their intended storage period.

The document concludes that the subject devices are substantially equivalent to their predicate devices and meet the special controls outlined in 21 CFR 884.4910.

Since this document does not pertain to an AI/ML device, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML performance.

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The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.

The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitation of the urethra and bladder neck during the placement of the GYNECARE TVT Device and GYNECARE TVT EXACT Continence System.

The GYNECARE TVT EXACT™ Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically.

The subject devices include the following components:

GYNECARE TVT™ Reusable Introducer
GYNECARE TVTTM Reusable Rigid Catheter Guide
GYNECARE TVT EXACT™ Continence System Trocar

The subject devices are intended to be used with the GYNECARE TVT™ Device and GYNECARE TVT EXACT™ Continence System intended to treat stress urinary incontinence.

GYNECARE TVT™ Reusable Introducer
The GYNECARE TVT™ Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT™ Device from the vagina to the abdominal skin. It is connected and fixed to the threaded end of the shaft, prior to inserting the needle with the tape.

GYNECARE TVT™ Reusable Rigid Catheter Guide
The GYNECARE TVT™ Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Folev catheter (recommended size 18 French) positioned in the urethra. To facilitate insertion, it can be lubricated with gel.

GYNECARE TVT EXACT™ Continence System Trocar
The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic Trocar Handle. The Trocar Shaft is designed to fit inside the white Trocar Sheaths on the GYNECARE TVT EXACT™ Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence System Implant in the patient from a vaginal incision up through the abdominal wall.

This document describes a 510(k) premarket notification for reusable surgical instruments (GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide) and a single-use instrument (GYNECARE TVT EXACT™ Continence System Trocar), which are accessories for urogynecologic surgical mesh systems. The submission asserts substantial equivalence to predicate devices (K974098 and K132054).

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for performance. Instead, it lists the types of performance tests conducted and concludes that the devices meet the requirements, implying that the results of these tests were considered acceptable.

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

The document does not specify the sample sizes used for any of the performance tests (e.g., how many devices were tested for mechanical performance, sterilization, or reprocessing).

The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These were likely conducted in a controlled laboratory environment by the manufacturer.

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

This type of information is not applicable to the performance characteristics studied for these medical instruments. The "ground truth" for mechanical performance, sterility, or biocompatibility is established through objective laboratory testing and industry standards, not through expert consensus on interpretation, as might be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set:

This is not applicable as the tests relate to objective engineering and biological performance characteristics, not subjective clinical interpretations.

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

No, an MRMC comparative effectiveness study was not done. These devices are surgical instruments, not diagnostic tools that would directly assist human readers in interpreting images or data. Therefore, the concept of "effect size of how much human readers improve with AI vs. without AI assistance" is not relevant here.

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

No, a standalone performance study in the context of an algorithm is not applicable. These are physical medical devices, not software algorithms.

7. The type of ground truth used:

The "ground truth" for these tests would be established by:

• Sterilization Validation: Demonstrated sterility to a specified Sterility Assurance Level (SAL) through objective microbiological testing.
• Mechanical Performance: Adherence to engineering specifications and relevant industry standards for strength, durability, and dimensional accuracy, measured objectively.
• Biocompatibility: Compliance with ISO 10993 standards, assessed through laboratory tests (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation).
• Reprocessing Validation: Demonstrated effectiveness of cleaning, disinfection/sterilization, and functional integrity after multiple reprocessing cycles, verified through objective testing.
• Package Integrity: Objective tests to ensure sterile barrier integrity.
• Shelf Life: Stability and functional integrity over time, verified through accelerated aging or real-time shelf-life studies.

8. The Sample Size for the Training Set:

This concept is not applicable. These are physical medical instruments and do not involve machine learning algorithms that require training data.

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

This concept is not applicable for the same reason as above (no machine learning involved).

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The GYNECARE TVT™ Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT™ device when placed in a top-down retropubic fashion (also known as an abdominal approach).

The GYNECARE TVT™ Reusable Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT™ device retropubically.

The GYNECARE TVT™ Reusable Rigid Catheter Guide is a reusable device intended to facilitation of the urethra and bladder neck during the placement of the GYNECARE TVT™ device.

The subject devices included the following components:

GYNECARE TVT™ Reusable Introducer

GYNECARE TVT™ Reusable Rigid Catheter Guide

GYNECARE TVT™ Abdominal Guides and Couplers

The subject devices are intended to be used with the GYNECARE TVT™ sling intended to treat stress urinary incontinence.

GYNECARE TVT™ Reusable Introducer: The GYNECARE TVT Introducer is provided non-sterile and is reusable. The Introducer is made of stainless steel. It consists of two parts, a handle and an inserted threaded metal shaft. The Introducer is intended to facilitate the passage of the GYNECARE TVT Device from the vagina to the abdominal skin. It is connected and fixed to the needle, via the threaded end of the shaft, prior to inserting the needle with the tape.

GYNECARE TVT™ Reusable Rigid Catheter Guide: The GYNECARE TVT Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identification of the urethra and the bladder neck during the surgical procedure. It is inserted into a Foley catheter (recommended size 18 French) positioned in the bladder via the urethra. To facilitate insertion, it can be lubricated with gel.

GYNECARE TVT™ Abdominal Guide: The GYNECARE TVT abdominal guide is a sterile disposable instrument intended to facilitate passage of the GYNECARE TVT device. Two abdominal guides are included in each kit with the GYNECARE TVT couplers.

GYNECARE TVT™ Coupler: The GYNECARE TVT coupler is a sterile disposable polypropylene connector used to connect the GYNECARE TVT abdominal quide to the GYNECARE TVT needle. Two couplers are included in each kit with abdominal quides.

The provided text is a 510(k) summary for medical devices, specifically instrumental accessories for urogynecologic surgical mesh. It does not describe an AI device or a study involving AI performance. Therefore, I cannot extract the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, or human reader effectiveness with AI.

The document discusses the following:

• Device Names: GYNECARE TVT™ Abdominal Guides and Couplers, GYNECARE TVT™ Reusable Introducer, GYNECARE TVT™ Reusable Rigid Catheter Guide.
• Intended Use: These are instrumental accessories used to facilitate the placement of the GYNECARE TVT™ device (a surgical mesh for stress urinary incontinence).
• Predicate Device: GYNECARE TVT™ (K012628), which is the surgical mesh system itself.
• Performance Testing: Sterilization validation, reprocessing validation, package integrity, dimensional and mechanical performance, biocompatibility (cytotoxicity, sensitization, irritation), and shelf life.
• Conclusion: The subject devices are substantially equivalent to the predicate device and meet special controls for urogynecologic surgical mesh instrumentation.

This document clearly focuses on the safety and effectiveness of conventional surgical instruments, not on the performance of an AI-powered diagnostic or assistive tool.

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The Caldera Medical surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence.

Caldera Medical Outside-In introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL), Desara® Blue SS (CAL-DS01BS)

Caldera Medical Inside-Out introducers may be used with or without the Winged Guide Accessory with the following Desara implants:

Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® SL (CAL-DS01SL)

Caldera Medical Suprapubic introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV), Desara® Blue SS (CAL-DS01BS)

Caldera Medical Transvaginal introducers may be used with the following Desara implants: Desara® (CAL-DS01), Desara® Blue (CAL-DS01B), Desara® Blue OV (CAL-DS01BOV)

Desara® TV (CAL-DS01TV), Desara® Blue TV (CAL-DS01BTV) implants may only be used with Caldera Medical Transvaginal introducers, CAL-TV32

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for Caldera Medical Surgical Mesh Instruments. It does not contain any information about acceptance criteria, device performance metrics, clinical study design, sample sizes, expert qualifications, ground truth establishment, or any details related to an AI/algorithm-based medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document is strictly administrative in nature, confirming the substantial equivalence of the surgical instruments to previously marketed predicate devices.

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The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures.

The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures.

The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures.

The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures.

The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.

The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.

The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.

The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.

The subject devices are not sold individually and are only offered packaged as part of a surgical mesh system. Device descriptions specific to each delivery device are italicized below within each existing system description.

Advantage™ System and Advantage Fit™ System: The disposable delivery device consists of a handle with a curved needle, and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for transvaginal placement.

Lynx™ System: The disposable delivery device consists of a handle with a curved needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.

Solyx™ SIS System: The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle.

Obtryx™ System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.

Obtryx™ II System (Curved & Halo): The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent as per your request.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table format for a diagnostic or AI device. Instead, it details that the device met "applicable design and performance requirements" and various "special controls."

However, we can infer the types of performance aspects that were evaluated:

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

The document does not provide information on specific sample sizes for test sets, nor does it detail the data provenance (e.g., country of origin, retrospective/prospective) for any performance data. The tests described are related to device engineering and material performance, not clinical data or diagnostic accuracy.

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

This information is not applicable and not provided as the submission is for a surgical delivery device, not a diagnostic device requiring expert interpretation for ground truth establishment. The "performance testing" described is for mechanical, material, and sterility validation.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided as the device is a surgical delivery tool, not an AI-assisted diagnostic or interpretation system.

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

This information is not applicable and not provided as the device is a physical surgical delivery tool, not an algorithm.

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

The concept of "ground truth" in the context of diagnostic or AI performance is not applicable here. For the engineering and biocompatibility tests, the "truth" is established by adherence to recognized standards, test methodologies, and objective measurements (e.g., sterility validation protocols, mechanical stress limits, chemical analysis for biocompatibility).

8. The sample size for the training set

This information is not applicable and not provided as the device is a physical surgical instrument and does not involve AI or machine learning models that require a "training set."

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

This information is not applicable and not provided for the reasons stated in point 8.

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