FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

Device Description

FortaGen consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 5 x 5 cm to 12 x 36 cm in sterile double layer peelable packaging.

AI/ML Overview

The provided text describes a medical device called FortaGen™ Surgical Mesh and its clearance by the FDA based on substantial equivalence to predicate devices. However, the information provided does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance data against specific metrics.

The document states:

"FortaGen was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests." This is a general statement that tests were conducted and passed, but no specific criteria, results, or study details are provided.
The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which implies that it meets the safety and efficacy standards demonstrated by those predicates. However, it doesn't detail what specific performance metrics constitute substantial equivalence or how FortaGen™'s performance was directly compared against them in a structured study report.

Therefore, I cannot populate the requested table or answer most of the specific questions about the study design as the information is not present in the provided text.

Based on the available information, here's what can be extracted:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility requirements	Device passed all tests
Integrity requirements	Device passed all tests
Performance requirements	Device passed all tests
Substantial Equivalence to predicate devices (GraftPatch (K970561) and Surgisis (K980431))	Determined to be substantially equivalent by FDA

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "FortaGen was subjected to a panel of tests."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe a process involving experts establishing ground truth for a test set. This type of information is typically relevant for diagnostic devices or AI-assisted systems, which this surgical mesh is not.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods are typically used in clinical studies with human interpretation, which is not described here for the device's technical assessment.
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 device is a surgical mesh, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with/without AI assistance would not be performed for this product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical mesh, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the device's performance tests (biocompatibility, integrity, performance), the ground truth would be established by validated test methods and established standards/specifications for medical devices, rather than expert consensus on diagnostic images or pathology. The document does not specify the exact methods or standards used for these tests.
The sample size for the training set:
- Not applicable. This is a physical surgical mesh, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is a physical surgical mesh, not an AI model.

In summary, the provided text indicates that the FortaGen™ Surgical Mesh passed a panel of tests for biocompatibility, integrity, and performance and was deemed substantially equivalent to predicate devices by the FDA. However, it does not offer the granular detail requested about specific acceptance criteria values, study designs, sample sizes, or methods for establishing ground truth, which are more typically provided for diagnostic devices or those involving interpretation of data.

Summary

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MAY 1 0 2002

02 1105

Submitted by:

Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021

Contact

Michael L. Sabolinski Telephone: (781) 575-0775 Facsimile: (781) 575-0440

April 25, 2002 Date:

Device:

Trade Name: Common/Usual Name: Classification Name: Regulatory Class:

FortaGen™ Surgical Mesh, Tissue Repair Biomaterial Surgical Mesh (79FTM, 878.3300) Class II

Predicate Device:

The device is similar to predicate collagen-based Surgical Mesh devices previously cleared for commercial distribution. The relevant predicate devices include GraftPatch (K970561) manufactured by Organogenesis Inc. and Surgisis (K980431) manufactured by Cook Biotech, Incorporated.

Statement of Substantial Equivalence:

FortaGen is substantially equivalent to the predicate devices, having similar intended use, technological characteristics, materials, physical construction and performance.

Intended Use:

FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suturc-line reinforcement and reconstructive procedures. The device is intended for one-time use.

Device Description:

Performance Data:

FortaGen was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2002

Mr. Michael L. Sabolinski, M.D. Executive Vice President Medical and Regulatory Affairs Organogenesis, Inc. 150 Dan Road Canton, MA 02021

Re: K021105

Trade/Device Name: FortaGen™ Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: April 4, 2002 Received: April 5, 2002

Dear Dr. Sabolinski:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & no review 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 associated in the 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 - Mr. Michael L. Sabolinski, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,

Muriam C. Provost

for Celia 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 STATEMENT

Applicant: Organogenesis Inc.

021105 510(k) Number (if known):

Device Name: FortaGen™

Indications For Use:

The device is intended for one-time use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Muriam C. Provost

(Optional Format 1-2-96)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K021105 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Organogenesis Inc., Amendment to 510(k) Premarket Notification April 25, 2002

Page 2

Regulation Number and Section

§ 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.