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Desara TV EZ and Desara Blue TV EZ are intended to be used in females to position a mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The 3.0mm or 2.7mm surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara TV EZ and Desara Blue TV EZ surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Desara TV EZ and Desara Blue TV EZ Systems are comprised of sterile, single-use midurethral slings used to provide support in the pelvic region to treat female stress urinary or mixed incontinence and a stainless steel disposable introducer in either a 3.0mm or 2.7mm diameter. The devices are intended to be used in females, via the transvaginal surgical approach in the in-patient or out-patient clinical setting.

Desara TV EZ and Desara Blue TV EZ slings are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices include mesh placement aides consisting of: integral sleeves over the mesh, a removable EZ tab midline indicator and dilator tubes at each end of the device which attach to the 3.0mm or 2.7mm transvaqinal surqical introducer for placement of the mesh. All placement aids are removed after the device is positioned and only the mesh portion of the device remains as a permanent implant.

The provided text describes a 510(k) premarket notification for a medical device called the Desara TV EZ and Desara Blue TV EZ Systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

As such, the document details bench testing and validation of the device's physical and performance characteristics, biocompatibility, shelf life, packaging, and sterilization, primarily to show that the new device performs equivalently to the predicate devices. It does not present a study proving the device meets specific acceptance criteria related to a human subject study, nor does it involve AI assistance or human reader performance evaluation.

Therefore, I cannot extract the information required for the requested table and study details. The document does not contain any data on:

• Device performance in a clinical setting (e.g., accuracy, sensitivity, specificity).
• Sample sizes for test sets in human studies.
• Data provenance (retrospective/prospective, country of origin) related to clinical outcomes.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance or human-in-the-loop studies.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size or how its ground truth was established.

The document primarily focuses on demonstrating equivalence through non-clinical testing.

Here's what can be extracted regarding acceptance criteria and performance, but it pertains to the device's material and mechanical properties, not clinical outcomes:

1. Table of Acceptance Criteria and Reported Device Performance (for non-clinical characteristics):

The document states that the testing "met all pre-defined acceptance criteria and regulatory requirements" but does not numerically list the specific acceptance criteria or the measured performance values for each characteristic. It only lists the types of tests conducted.

The study described here is purely for regulatory clearance based on substantial equivalence to predicate devices, focusing on engineering and material performance, not clinical efficacy or AI performance.

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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 Digitex Delivery Device is a single-use device intended for use as an aid in suturing transvaginal pelvic organ prolapse procedures with surgical mesh.

The Digitex® Suture Delivery System is composed of a delivery device and suture cartridge and is designed for use by the physician to facilitate the consistent placement of suture when direct visualization is not possible and/or the anatomical location is difficult to reach. The shaft of the device has been designed to allow for adjusting the angle of the needle housing to further facilitate suture placement in the desired location.

This document (K173527) is a 510(k) Premarket Notification for the Digitex Delivery Device, a specialized surgical instrument. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria for an AI/algorithm.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, and MRMC studies for an AI device is NOT available in this document. The document describes non-clinical performance testing for a physical medical device.

However, I can extract the information relevant to the device's non-clinical performance testing and its acceptance (as stated in the document), though it's not structured in the way you asked for an AI/algorithm study.

Here's what can be extracted based on the provided text, rephrased to fit your prompt as much as possible, while clarifying that this is for a physical device, not an AI:

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

The document mentions that "The results of all performance testing met pre-defined acceptance criteria as applicable and are acceptable." However, the specific quantitative acceptance criteria or the raw performance data for each test are not detailed in this summary. It only states that the results met the criteria.

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

This document describes non-clinical physical device testing. Sample sizes for these engineering tests and data provenance in terms of country of origin or retrospective/prospective nature are not specified in this 510(k) summary. These types of details would typically be found in the full test reports submitted to the FDA, not in the public 510(k) 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 non-clinical physical device testing described. The "ground truth" for these tests relates to engineering specifications and material standards, not expert medical consensus on diagnostic images.

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

Not applicable. This is not a study involving human readers or expert adjudication of medical cases.

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 document is for a physical surgical device, not an AI or imaging diagnostic tool. No MRMC study was performed or is relevant.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for the non-clinical performance tests is based on engineering specifications, material standards (e.g., ISO 10993-1 for biocompatibility), and pre-defined acceptance criteria for physical device performance (e.g., sterilization efficacy, package integrity, mechanical strength).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device. No training set was used.

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

Not applicable.

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The Meridian VPS is a single-use device intended to assist in the position and manipulation of the vagina during gynecologic surgical procedures such as sacrocolpopexy.

The Meridian® Vaginal Positioning System (VPS) is a single-use vaginal positioning device comprised of multiple polymers with an ergonomic handle and adjustable head for positioning. The head of the device consists of four main parts: a support body, a kick-out door, an adjustable cervical pin and an adjustable rib feature. The handle of the device consists of three main parts: two handle halves and an actuator knob. The Meridian Vaginal Positioning System is placed in the vagina to stabilize and aid in the identification of vaginal structures including anterior, posterior, apex, fornices and sulci during surgical procedures such as sacrocolpopexy.

This document is a 510(k) summary for the Meridian Vaginal Positioning System (VPS), a medical device. It describes the device, its intended use, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

No acceptance criteria and device performance table can be generated from the provided text. The document lists the types of non-clinical performance tests performed (e.g., biocompatibility, sterilization validation, mechanical testing) but does not provide specific quantitative acceptance criteria values or the reported performance data for these tests. It only states that "The results of the performance testing described above demonstrate that the Meridian Vaginal Positioning System is as safe and effective as the predicate device and supports a determination of substantial equivalence."

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria as one might find in a clinical trial report for an AI/ML diagnostic device.

Here's what can be extracted regarding the study, with explanations for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, this information is not present in the provided 510(k) summary. The document lists the types of tests performed (e.g., Cytotoxicity, Sensitization, Irritation, Functional testing, Maximum force for head, etc.) but does not provide numerical acceptance criteria or the specific results obtained for each test. The summary only states that the performance testing results "demonstrate that the Meridian Vaginal Positioning System is as safe and effective."

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

The document describes non-clinical performance testing (e.g., biocompatibility, mechanical testing, sterilization validation). It does not involve a "test set" in the context of patient data or clinical images. Therefore:

• Sample size for the test set: Not applicable, as this was non-clinical testing of the device itself, not a clinical study involving patient data. The document would typically refer to the number of devices or test units used for each test (e.g., n=5 for bend testing), but these specific numbers are not provided.
• Data provenance (country of origin, retrospective/prospective): Not applicable for non-clinical device testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This was non-clinical performance testing of a physical medical device (Vaginal Positioning System), not a study involving the interpretation of data where expert ground truth would be established (e.g., image annotation for an AI algorithm).

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

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

• No. This document describes the non-clinical performance testing of a physical surgical instrument. An MRMC study is typically performed for diagnostic devices (especially AI/ML-driven ones) to assess the impact of the device on human reader performance.

6. Standalone (Algorithm Only) Performance:

• No. This device is a physical surgical instrument, not an algorithm. Standalone performance is relevant to AI/ML algorithms that provide an output without human intervention.

7. Type of Ground Truth Used:

• Not applicable. For physical device testing, "ground truth" refers to established material properties, mechanical specifications, and biological safety limits, as defined by standards like ISO 10993-1. The "ground truth" for these tests would be the established limits and specifications against which the device's performance is measured. The document states that tests were performed "per the special controls listed in 21 CFR 884.4910" and according to standards like ISO 10993-1.

8. Sample Size for the Training Set:

• Not applicable. This document is not describing an AI/ML device that requires a training set. The "device" is a physical instrument.

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

• Not applicable. See point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device, the Meridian Vaginal Positioning System (VPS). It details non-clinical performance testing to establish substantial equivalence. It does not contain information about acceptance criteria values, reported performance data, clinical study sample sizes, expert adjudication, or AI/ML-specific testing methodologies (like MRMC studies or training set details). The "proof" of meeting safety and effectiveness criteria relies on demonstrating compliance with recognized standards and pre-defined specifications through the listed non-clinical tests, which include biocompatibility, sterilization validation, package integrity, dimensional analysis, and various mechanical tests.

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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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The Capio™ SLIM Suture Capturing Device is intended for use in general suturing applications during surgery to assist in the placement of suture material in tissues at the operative site. The Capio™ SLIM Suture Capturing Device is to be used with sensory and/or direct visual control.

The Capio SLIM Suture Capturing Device is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures.

The Capio™ SLIM Suture Capturing Device is urogynecologic mesh instrumentation used with urogynecologic surgical mesh. The subject device is also intended for use in general suturing applications during surgery to assist in placement of suture material in tissues, and assist in insertion or anchoring of surgical mesh for transabdominal pelvic organ prolapse repair.

The Capio™ SLIM Suture Capturing Device is a sterile, single use device and is designed to be used by the physician to facilitate the placement of sutures in difficult to access locations during open surgical procedures. The Capio™ SLIM device is also designed to throw, catch and retrieve sutures in one step. The device consists of a one-handactivated plunger at the proximal end, a tubular shaft and a curved needle driver at the distal end. Depressing the plunger actuates the carrier and drives the suture/dart through the tissue. The needle is automatically caught by the device's needle catch mechanism for easy suture tying, or the device may be re-loaded for additional suture throws.

This document is a 510(k) summary for a medical device (Capio™ SLIM Suture Capturing Device) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study that proves the device meets specific acceptance criteria in the way a clinical or performance study of an AI/imaging device would.

Based on the provided text, here is an analysis regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria":

This document does NOT describe the acceptance criteria or a study proving device performance in the context of an AI/imaging diagnostic device.

Instead, it describes the non-clinical performance tests conducted to demonstrate that the device meets applicable design and performance requirements and supports substantial equivalence to a predicate device. The "acceptance criteria" in this context refer to the successful completion and passing of these engineering and safety tests.

Here's how to interpret the request with the provided information:

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

The document lists various non-clinical performance tests. For each test, the "reported device performance" is implicitly that the device passed or met the requirements, thus demonstrating sufficient performance for its intended use and compliance with special controls. Specific numerical criteria or results are not provided for each test in this summary.

2. Sample sized 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 document. The tests described are primarily engineering, mechanical, and biological tests on device prototypes or manufactured units, not on a "test set" of patient data.

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 information is not applicable and therefore not provided. The ground truth for these non-clinical tests is based on established engineering standards, material science, and biological testing protocols, not expert medical opinion on patient data.

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

This information is not applicable and therefore not provided. Adjudication methods are relevant for studies involving human interpretation or uncertain diagnoses, which is not the case for these non-clinical device tests.

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

There was no MRMC comparative effectiveness study done. This device is a physical surgical instrument, not an AI or imaging device that assists human readers.

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

There was no standalone (algorithm only) performance study done. This device is a physical surgical instrument, not an algorithm.

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

As explained previously, for the non-clinical tests, the "ground truth" is based on:

• Engineering standards and specifications: For dimensional, functional, compression, tensile, deflection, needle retention, catch pull, and actuation tests.
• Established protocols for sterilization and packaging integrity: For sterilization validation, package integrity, and distribution challenge tests.
• Standardized biocompatibility test methods: For cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.
• Industry standards for accelerated and real-time aging: For shelf-life testing.

8. The sample size for the training set

This is not applicable as this is not an AI/machine learning device.

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

This is not applicable as this is not an AI/machine learning device.

In summary, the provided document describes the engineering, mechanical, sterility, packaging, and biocompatibility performance data for a physical surgical device, demonstrating that it meets design requirements and supports substantial equivalence. It does not contain information typically associated with clinical studies or AI device performance evaluation.

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