(68 days)
The ACell UBM Surgical Mesh ML and MLPlus are intended for implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hernia and body wall repair, and esophageal repair. By providing pubourethral support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.
The ACell UBM Surgical Mesh ML and MLPlus are composed of porcine collagen and are supplied sterile in sizes ranging from 16 cm² to 14x20 cm.
The provided text describes a 510(k) premarket notification for the ACell UBM Surgical Mesh ML and MLPlus. This document focuses on the regulatory clearance process for a medical device and does not contain information about a study proving device performance against specific acceptance criteria in the way you've outlined for an AI/ML medical device.
The main points from the document regarding "tests" are:
- Discussion of tests and test results: "The ACell Surgical Mesh ML and MLPlus were subjected to a number of tests to assess the biocompatibility and the performance of the materials. They passed the requirements of all tests and were shown to be safe and effective as surgical mesh devices as indicated."
This is a very general statement and does not provide specific acceptance criteria, reported performance metrics, or details of a study design that would fit the questions about AI/ML device performance.
Therefore, I cannot populate the requested table and answer many of your specific questions because the provided text is about a traditional medical device (surgical mesh) and its 510(k) clearance, not an AI/ML device and its performance study.
Here's why the questions cannot be answered from the provided text:
- Table of acceptance criteria and reported device performance: The document states "passed the requirements of all tests" but does not detail what those tests were, what their specific acceptance criteria were, or the quantitative performance metrics achieved by the device.
- Sample size, data provenance: Not applicable as no such studies demonstrating AI/ML performance are described.
- Number of experts, qualifications: Not applicable. The "tests" likely refer to material science, biocompatibility, and mechanical property tests, not expert-reviewed output.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable. This device is a surgical mesh, not an AI assisting human readers.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
In summary, the provided document is a 510(k) summary for a physical surgical mesh product. It details regulatory information, intended use, and general statements about passing safety and performance tests, but it does not contain the kind of detailed study information (especially concerning AI/ML performance, ground truth, expert review, sample sizes, etc.) that your questions are designed to extract.
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R41140
ACell UBM Surgical Mesh ML and MLPLus Abbreviated 510(k) Premarket Notification
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Submitter: ACell, Inc.
| JUL - 7 2004 | Section 9.0510(k) SUMMARY |
|---|---|
| ACell UBM Surgical Mesh ML and MLPlus | |
| Submitter Name: | ACell, Incorporated |
| Submitter Address: | 10555 Guilford RoadSuite 113Jessup, Maryland 20790 |
| Contact Person: | James R. DeFrancescoChief Executive Officer |
| Phone Number: | 410-715-1700 |
| Fax Number: | 410-715-4511 |
| Date Prepared: | April 30, 2004 |
| Device Trade Name: | ACell UBM Surgical Mesh ML and MLPlus |
| Device CommonName: | Surgical mesh |
| Classification Name: | Mesh, Surgical (FTM; 21 CFR 878.3300) |
| Predicate Devices: | K040621; ACell, Inc., ACell UBM Surgical MeshK992159; Cook Biotech, Inc., Surgisis™ Sling |
| Device Description: | The ACell UBM Surgical Mesh ML and MLPlus are composed of |
f porcine collagen and are supplied sterile in sizes ranging from 16 cm² to 14x20 cm.
The ACell UBM Surgical Mesh ML & MLPLus are intended for Intended Use: implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hernia and body wall repair, and esophageal repair. By providing pubourethrai support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.
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Submitter:
ACell, Inc.
2/2
| Discussion of testsand test results: | The ACell Surgical Mesh ML and MLPlus were subjected to a number oftests to assess the biocompatibility and the performance of thematerials. They passed the requirements of all tests and were shown tobe safe and effective as surgical mesh devices as indicated. |
|---|---|
| Conclusion: | These devices, with respect to material composition, devicecharacteristics and intended use, are substantially equivalent to thepredicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three abstract shapes, possibly representing human figures or wings, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 7 2004
ACell, Inc. c/o Ms. Patsy J. Trisler, J.D., RAC 5610 Wisconsin Avenue, #304 Chevy Chase, Maryland 20815
Re: K041140
Trade/Device Name: ACell UBM Surgical Mesh ML and MLPlus Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: April 30, 2004 Received: April 30, 2004
Dear Ms. Trisler:
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 for answer or 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 application (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 such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 - Ms. Patsy J. Trisler, J.D., RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mailing of substantial equivalence of your device to a legally premarket notification: "The PDF intrallegsification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at novier Joss (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Commarket notification" (21CFR Part 807.97). You may obtain Misoranding of reference to prenessonsibilities under the Act from the Division of Small other general information and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
KO41140
Indications for Use:
The ACell UBM Surgical Mesh ML and MLPlus are intended for implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following gastronomical and support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hemia and body wall repair, and esophageal repair, Sacroonpourethral support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.
Over-The-Counter Use × Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
(Posted November 13, 2003)
..............................................................................................................................................................................
510(k) Number_K 64 // 40
Page 1 of 1
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.