(42 days)
The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
The AMS Large Pore Polypropylene Mesh is a knitted mesh of polypropylene fibers. The mesh can be cut to any desired shape or size and resists unraveling.
This document describes the AMS Large Pore Polypropylene Mesh, its intended use, and the basis for its substantial equivalence to predicate devices, but it contains limited information regarding a formal study with acceptance criteria and a detailed comparison of device performance against those criteria. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than presenting a full clinical trial or complex performance study with defined acceptance criteria in the way a medical AI device might.
Here's an analysis based on the available text, addressing your points where possible:
1. A table of acceptance criteria and the reported device performance
The provided text does not include a specific table of acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) in the way one would see for an AI diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to predicate devices, meaning it performs similarly in relevant aspects. The study mentioned is a mechanical characterization study.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated biocompatible |
| Mechanical Characteristics (for surgical mesh) | Tested for a variety of mechanical characteristics in accordance with FDA's Guidance for the Preparation of a Pre-market Notification for a Surgical Mesh. Reported to be equivalent to the listed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "a variety of mechanical characteristics" were tested. However, it does not specify the sample size for this testing, nor does it provide details on data provenance (country of origin, retrospective/prospective). This would typically involve laboratory testing of the mesh material itself, not human subject 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 product is a surgical mesh, a physical medical device, not a diagnostic or AI-driven tool that requires expert interpretation for ground truth establishment. Therefore, this question is not applicable to the provided document. The "ground truth" for mechanical characteristics would be established through standardized engineering and material science tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies, which is not relevant for a mechanical mesh device.
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. The device is a surgical mesh; it does not involve human readers, AI assistance, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would be based on standardized laboratory testing and measurements of the material's mechanical properties and biocompatibility.
8. The sample size for the training set
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
Not applicable. As there is no training set for a machine learning model, this question is not relevant.
Summary of the Study and Evidence provided:
The provided 510(k) summary explains that the AMS Large Pore Polypropylene Mesh underwent two primary evaluations to demonstrate substantial equivalence to predicate devices:
- Biocompatibility Testing: The material used in the mesh was "demonstrated to be biocompatible." The details of this testing (e.g., specific ISO standards followed, animal studies, in vitro tests) are not provided in this summary but would have been part of the full 510(k) submission.
- Mechanical Characterization: The mesh was "tested for a variety of mechanical characteristics in accordance with FDA's Guidance for the Preparation of a Pre-market Notification for a Surgical Mesh." The critical finding states that the device "has a reputation of equivalence to the listed predicate devices" (Gynemesh Prolene Soft Mesh, Ethicon Prolene Soft Mesh, AMS Sacral Colpopexy Sling). This implies that its mechanical properties (e.g., tensile strength, pore size, elasticity) were found to be within acceptable ranges and comparable to those of already approved meshes.
The acceptance criteria for this type of device are implicitly that its biocompatibility and mechanical properties are comparable to or better than those of the predicate devices, ensuring similar safety and effectiveness for its intended use as tissue reinforcement in pelvic floor prolapse. The study confirming this "equivalence" was likely a series of laboratory-based material characterization tests.
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K033636 P/2
DEC 3 1 2003
510(k) Summary AMS Large Pore Polypropylene Mesh
510(k) Number _
Date of Summary Preparation: November 17, 2003
Submitter/Contact Person:
Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343
Phone: (952) 930-6000 Fax: (952) 930-6496
Device Name and Classification:
Trade Name: AMS Large Pore Polypropylene Mesh Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh, polymeric Product Code: OTP, OTO Classification: Class II
Manufacturing Location:
American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343
Predicate Devices:
Gynemesh Prolene Soft Mesh - K013718 Ethicon Prolene Soft Mesh - K001122 AMS Sacral Colpopexy Sling - K010931
Indications for Use:
The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Device Description:
The AMS Large Pore Polypropylene Mesh is a knitted mesh of polypropylene fibers. The mesh can be cut to any desired shape or size and resists unraveling.
Summary of Testing
The material used in the AMS Large Pore Polypropylene Mesh has been demonstrated to be biocompatible.
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K033636
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In addition, the AMS Large Pore Polypropylene Mesh has been tested for a in addition, the AMG Largo Ford : crypt a coordance with FDA's Guidance for the vanety of mechaniour characteristication for a Surgical Mesh and has r repuration of a vemaintent to the listed predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing a bird, or possibly a bird in flight. The symbol is rendered in solid black, creating a strong contrast against the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Road, West MINNETONKA MN 55343
SEP 2 8 2012
Re: K033636 Trade/Device Name: AMS Large Pore Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, OTO Dated: November 17, 2003 Received: November 19, 2003
Dear Ms. Linke:
This letter corrects our substantially equivalent letter of December 31, 2003.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE ENCLOSURE
510(k) Number:
AMS Large Pore Polypropylene Mesh Device Name:
Indications for Use: The AMS Large Pore Polypropylene Mesh is indicated for midications for Ose. The Ame Eargo volte , byt it is cial structures of the pelvic tissue relimordement and long thems withing surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Prescription Use مكو (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
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510(k) Number K633636
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.