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Ascend AC (anterior compartment) and Ascend PC (posterior compartment) are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.

The Ascend Pelvic Floor Repair System consists of macroporous, monofilament, polypropylene mesh implants and a set of reusable introducers to facilitate mesh implant placement. The reusable introducers are available separately.

The provided text is a 510(k) summary for the Ascend Surgical Mesh and does not include a study describing acceptance criteria and device performance in the way a clinical trial or algorithm validation study would.

Instead, the medical device (Ascend Surgical Mesh) demonstrates substantial equivalence to predicate devices (AMS Apogee Vault Suspension System K040537 and AMS Perigee System K040623) based on non-clinical testing.

Here's how this information maps to your requested points, highlighting what is not applicable for this type of submission:

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

   • Not Applicable in the provided text. The document states: "The mesh used in the Ascend device has been tested in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh and has been shown to be equivalent to the listed predicate devices. In addition, the other components have demonstrated substantial equivalence to the predicate devices in terms of mechanical testing and biocompatibility."
   • This implies that the acceptance criteria are regulatory guidelines and established equivalence to predicate devices through mechanical testing and biocompatibility, rather than performance metrics like sensitivity, specificity, or accuracy which would be reported for an AI device. No specific table or numerical performance metrics are given.

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

   • Not Applicable. This is a physical medical device (surgical mesh), not an AI/algorithm-based device, so there is no "test set" in the context of data. The "testing" refers to bench testing for mechanical properties and biocompatibility.

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

   • Not Applicable. No ground truth established by experts for a test set, as this is not an AI/diagnostic device.

4. Adjudication method for the test set

   • Not Applicable. No test set or human adjudication process.

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

   • Not Applicable. This is a surgical mesh, not an AI diagnostic tool.

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

   • Not Applicable. This device is not an algorithm.

7. The type of ground truth used

   • Not Applicable / Inferred: For a physical device like surgical mesh demonstrating equivalence, the "ground truth" for performance would be metrics derived from bench testing (mechanical properties, biocompatibility) and comparison to established predicate devices under regulatory guidelines.

8. The sample size for the training set

   • Not Applicable. This is not an AI/algorithm-based device using a "training set."

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

   • Not Applicable. This is not an AI/algorithm-based device.

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The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The AMS Pelvic Floor Repair System consists of needles and mesh used to repair the pelvic floor.

The provided text is a 510(k) summary for the AMS Pelvic Floor Repair System. Unfortunately, it does not contain the detailed information required to answer your specific questions about acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment.

The "Summary of Testing" section is very brief, stating only: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices."

This highlights a common characteristic of 510(k) summaries, which often focus on demonstrating substantial equivalence to a predicate device rather than providing extensive details about de novo performance studies against specific acceptance criteria. For devices cleared through the 510(k) process, the primary "acceptance criterion" is usually a finding of substantial equivalence to a legally marketed predicate.

Therefore, many of your questions cannot be answered from the provided document. Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Information (Based on the Provided Text)

Reported Device Performance: The document states: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices." No specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility results) are provided or compared against acceptance criteria. |
| 2. Sample Size for Test Set & Data Provenance | Not provided. The summary just generally mentions "testing" without detailing the nature of the tests (e.g., clinical, bench, animal) or the sample sizes involved. |
| 3. Number of Experts & Qualifications for Ground Truth | Not applicable/provided. This device is a surgical mesh; the "ground truth" would typically refer to clinical outcomes, mechanical properties, or biocompatibility, not expert interpretation of diagnostic images. |
| 4. Adjudication Method | Not applicable/provided. |
| 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | No. This device is a surgical mesh, not an AI-assisted diagnostic tool. |
| 6. Standalone Performance Study (Algorithm Only) | No. This device is a surgical mesh, not an algorithm. Performance would relate to its physical and biological properties. |
| 7. Type of Ground Truth Used | Not explicitly stated. For a surgical mesh, "ground truth" would likely involve:

• Bench testing results: Mechanical strength, pore size, material composition, etc.
• Biocompatibility testing: In vitro and/or in vivo studies.
• Animal studies: To assess in-vivo performance and host response.
• Clinical outcomes: From studies on the predicate devices or potentially early clinical use if available (though not detailed here). |
  | 8. Sample Size for Training Set | Not applicable/provided. This is not a machine learning device. |
  | 9. How Ground Truth for Training Set Was Established | Not applicable/provided. |

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The AMS collagen dermal matrix is intended for use in the treatment of hernias where the The AMS collagen ochharmania in to implantation to reinforce soft tissues where weakness Connective lissoc has ruptured of for implanations of this includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix are intended for the placement of a pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The AMS Perigee System with Pre-Connected Collagen Dermal Matrix is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior wall prolapse.

The AMS Apogee System with Pre-Connected Collagen Dermal Matrix is intended for use in vaginal vault suspension to treat pelvic organ prolapse.

The AMS collagen dermal matrix is decellularized porcine dermis that is lyophilized and terminally sterilized. The product is available in a range of sizes.

The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix consist of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis for use as a urethral sling.

The Perigee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the anterior vaginal wall.

The AMS Apoqee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the vaginal vault.

The provided text describes a 510(k) summary for the AMS Collagen Dermal Matrix. This is a premarket notification for a medical device seeking clearance based on substantial equivalence to predicate devices, not a study proving device meeting acceptance criteria as would typically be conducted for and reported for an AI/ML device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission. The submission focuses on demonstrating equivalence to existing surgical mesh products.

However, I can extract information related to the device's intended use and the general claim of meeting "requirements" for this type of device.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Acceptance Criteria" for a 510(k) of this nature:

For a 510(k) submission like this one (for a traditional medical device prior to the widespread use of AI/ML), "acceptance criteria" are not typically quantitative thresholds on metrics like accuracy or sensitivity. Instead, the primary acceptance criterion is substantial equivalence to a legally marketed predicate device. This is demonstrated by showing:

• Similar intended use.
• Similar technological characteristics (materials, design).
• Evidence that any differences in technological characteristics do not raise new questions of safety or effectiveness.

The "testing" mentioned typically involves biocompatibility, mechanical properties, sterilization validation, and often animal studies, which are compared to known properties of the predicate devices or established standards. The text does not provide granular details of these tests or their specific outcome values.

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

• Not Applicable. This is a 510(k) for a surgical mesh, not a data-driven AI/ML device. There is no "test set" in the context of an algorithm's performance on data. The "testing" refers to benchtop, possibly animal, and material property tests to establish equivalence.

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

• Not Applicable. See point 2.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

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/ML device, and no MRMC study was mentioned or would be relevant for this type of device.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Not Applicable. For a surgical mesh, "ground truth" relates to the performance and safety characteristics established through laboratory testing (e.g., tensile strength, biocompatibility, porosity) and potentially animal studies, compared against the known characteristics of predicate devices and general scientific principles for medical device design. It's not "ground truth" in the sense of expert-annotated data for an AI/ML model.

8. The sample size for the training set:

• Not Applicable. This is a traditional medical device, not an AI/ML device. There is no "training set" in this context.

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

• Not Applicable. See point 8.

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