The provided 510(k) summary for the GraftPatch® device does not contain specific acceptance criteria or a detailed study description in the way one might expect for a diagnostic or AI-driven device. This submission focuses on establishing substantial equivalence to predicate surgical meshes.

Therefore, many of the requested data points (such as acceptance criteria tables, sample sizes, expert qualifications, and AI-specific study details) are not explicitly present in the provided text.

Here's an attempt to answer the questions based on the available information:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Material Composition	Not explicitly stated (e.g., tensile strength, pore size, degradation rate)	Composed of heat-laminated layers of crosslinked porcine collagen. Similar to predicate devices.	The submission implies that the material characteristics are equivalent to predicate devices, but specific quantitative criteria are not listed.
Functionality	Functionality in soft tissue reinforcement (e.g., in hernia repairs)	Animal implant studies were performed to confirm the functionality. Results demonstrated suitability for intended use.	Specific functional tests, quantitative outcomes, or pass/fail criteria from animal studies are not provided. The statement is qualitative.
Biocompatibility	Conformance with Tripartite and ISO 10993 recommendations	Biocompatibility testing was conducted. Results demonstrated suitability for intended use.	Specific biocompatibility tests performed (e.g., cytotoxicity, sensitization, irritation) and their pass/fail criteria are not detailed. The statement highlights compliance with standards.
Design Similarity	Similar design to predicate surgical meshes.	"GraftPatch® is similar in design...to other surgical meshes."	No specific design parameters (e.g., dimensions, weave pattern) are compared against explicit criteria. This is a descriptive comparison.
Intended Use Similarity	Intended use aligns with predicate surgical meshes for soft tissue reinforcement.	"GraftPatch® is similar in...intended use to other surgical meshes."	The stated indication for use matches that of typical surgical meshes.

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

The submission mentions "Animal implant studies" and "Biocompatibility testing." However:

Sample Size: Not specified for any of the studies mentioned.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be pre-market internal testing.
Retrospective or Prospective: These would likely be considered prospective studies designed to support the 510(k).

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)

Not applicable. This device is a surgical mesh, not an diagnostic imaging device. "Ground truth" in the context of expert consensus for diagnostic interpretation is irrelevant here. The studies involved animal model evaluations and material biocompatibility testing. The "experts" would be the scientists and veterinarians conducting and evaluating these technical studies. Their specific number and qualifications are not listed in the 510(k) summary.

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

Not applicable. This concept is typically relevant for studies involving human interpretation (e.g., radiology reads) where discrepancies need to be resolved. For animal implant and biocompatibility studies, the evaluation would follow established scientific and regulatory protocols for data collection and interpretation.

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 device is a surgical mesh and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study is not relevant.

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

Not applicable. This device does not involve any algorithm or AI.

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

For the studies mentioned:

Animal Implant Studies: The "ground truth" would be determined by direct observation in the animal models, potentially histology/pathology of explanted tissues, and clinical signs of the animals over time.
Biocompatibility Testing: The "ground truth" for biocompatibility is established by the results of standardized tests conforming to Tripartite and ISO 10993 recommendations (e.g., cell viability, irritation scores, immunological responses).

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

Summary

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K970561

510(k) SUMMARY Organogenesis Inc. GraftPatch®

AUG - I 1997

1. DATE PREPARED

January 23, 1997

2. SUBMITTER

Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021

3. CONTACT

Joel T. Cademartori, P.E. Vice President of Regulatory Affairs, Quality Assurance and Control Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021

(617) 575-0775 Telephone: (617) 575-0440 Facsimile:

4. DEVICE NAME

GraftPatch®

DEVICE CLASSIFICATION ડ.

Class II (21 CFR 878.3300) Product Code: 79 FTM

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6. DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS

GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists, e.g., hernia repairs. The device is composed of heat-laminated layers of crosslinked porcine collagen. GraftPatch® is similar in design, materials, function, and intended use to other surgical meshes which are currently in U.S. commercial distribution. Examples of other surgical meshes which have been cleared for commercial distribution include the Supple Periguard® by Bio-Vascular, Inc. (K923657), and Vicryl surgical mesh by Ethicon, Inc. (K810218).

Determination of substantial equivalence for this product was based on descriptive information about the design, materials, and intended use of the device. Animal implant studies were performed to confirm the functionality of the device. Biocompatibility testing was conducted on the device material in conformance with Tripartite and ISO 10993 recommendations. Results of all testing demonstrated that GraftPatch® Surgical Mesh is both suitable for its intended use and substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel T. Cademartori. P.E. Vice President of Regulatory Affairs Organogenesis Inc ... 150 Dan Road Canton, Massachusetts 02021

Re: K970561 Trade Name: GraftPatch® Regulatory Class: II Product Code: FTL Dated: June 23, 1997 Received: Jun 25, 1997
AUG - 1 1997

Dear Mr. Cademartori:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Joel T. Cademartori, P.E.

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Wilson, Ph.D., M.P.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: _ GraftPatch®

Indications For Use:

The GraftPatch® is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

9703

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

colle

(Division Sign-Off) Division of General Restorative Device 510(k) Number

Prescription Use
(Per 2.1 CFR 801.109)

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Organogenesis Inc. - GraftPatch® 510(k)

1123/97

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.