Cook® Biodesign® Surgisis® Anterior Pelvic Floor Graft is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of anterior and anterior/apical vaginal vault prolapse.

Cook® Biodesign® Surgisis® Posterior Pelvic Floor Graft is indicated for tissue reinforcement in women with pelvic organ prolapse, for transvaginal repair of posterior and posterior/apical vaginal vault prolapse.

Device Description

The Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are non-synthetic, non-woven, resorbable layered sheets of natural Extracellular Matrix (ECM) collagen that are pre-configured and can be cut and further shaped by a surgeon to the desired size and shape. The grafts are manufactured from multiple layers of porcine Small Intestinal Submucosa (SIS), an acellular collagenous ECM material derived from porcine small intestine where the serosal. mucosal and muscle lavers have been removed. The collagenous material is not cross-linked and is designed to be eventually replaced by the patient's tissue. The shapes of the Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are specifically designed to meet the clinical needs associated with the device's intended use. The Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts consist of 3 individual grafts: J-PF-ANT-USL, J-PF-ANT-SSL and J-PF-4-POST. J-PF-ANT-USL and J-PF-ANT-SSL are indicated for anterior prolapse repair and J-PF-4-POST is indicated for posterior prolapse repair. The Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are all supplied sterile and are intended for one time use.

AI/ML Overview

The provided text is a 510(k) Summary for the Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts. This document details the regulatory submission for a medical device and primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the information required for a study that proves the device meets specific acceptance criteria (as would be typical for an AI/software device or a novel device requiring efficacy demonstration) is largely not present in the provided text. The submission is for a surgical mesh, and its approval hinges on demonstrating it is as safe and effective as a legally marketed predicate device, not on meeting predefined performance metrics from a study with acceptance criteria.

However, I can extract the available information and highlight what is missing based on your request:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not list specific numerical acceptance criteria for a "device performance" metric in the way an AI algorithm's sensitivity/specificity would be evaluated. Instead, the "performance" here refers to physical and biological properties being comparable to predicate devices. The acceptance criteria for this type of device are generally qualitative in demonstrating substantial equivalence in the specified tests.

Acceptance Criteria Category	Specific Test	Acceptance Criteria (Qualitative, inferred)	Reported Device Performance (as stated)
Biocompatibility	Cytotoxicity	Pass	"undergone and passed all relevant biocompatibility testing"
	Sensitization	Pass	"undergone and passed all relevant biocompatibility testing"
	Acute Intracutaneous Reactivity	Pass	"undergone and passed all relevant biocompatibility testing"
	Acute Systemic Toxicity	Pass	"undergone and passed all relevant biocompatibility testing"
	Subchronic Toxicity	Pass	"undergone and passed all relevant biocompatibility testing"
Mechanical Performance	Suture Retention Strength	Comparable to predicate	"passed all relevant...performance testing"
	Probe Burst Strength	Comparable to predicate	"passed all relevant...performance testing"
	Tensile Strength	Comparable to predicate	"passed all relevant...performance testing"
	Stiffness	Comparable to predicate	"passed all relevant...performance testing"
	Tear Resistance	Comparable to predicate	"passed all relevant...performance testing"
	Delamination	Comparable to predicate	"passed all relevant...performance testing"
Material/Processing	Impurities Removal	No adverse effect	"additional processing to remove impurities from the SIS material" (implication is successful)
	Delamination Prevention	Successful	"include resorbable suture to improve handling and prevent delamination" (implication is successful)
Shelf Life	Maintain properties over time	Successful	"shelf life testing was also completed to support substantial equivalence."
Clinical Equivalence	Safety and Effectiveness in Use	Equivalent to predicate	"clinical evidence including published clinical data, reinforces the conclusion that the Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are substantially equivalent to the predicate devices."

Study Information (Based on the provided text)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: The text refers to "clinical evidence including published clinical data" and "performance data." This implies a compilation of existing data rather than a single, dedicated randomized control trial or a specific "test set" for a novel algorithm. The country of origin is not specified, and it appears to be retrospective ("published clinical data").
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. Given the nature of a surgical mesh submission based on substantial equivalence, "ground truth" in the context of expert consensus similar to an AI study wouldn't typically apply. The "ground truth" here is the established safety and effectiveness of the existing predicate devices and the physical/biological properties measured.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided and is not applicable to the type of device and study described (demonstration of substantial equivalence to a physical predicate device).
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those involving human interpretation of images with AI assistance. This device is a surgical implant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical mesh, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth," in a broad sense for this submission, appears to be:
  - Biocompatibility Standards: Established regulatory standards for biocompatibility.
  - Mechanical Property Measurement Standards: ASTM/ISO standards for testing material strength, etc.
  - Clinical Outcomes/Safety Profiles of Predicate Devices: The established safety and effectiveness of the Surgisis Sling™ (K992159) and Surgisis (K062696) in relevant clinical applications, informed by "published clinical data."
The sample size for the training set:
- Not applicable. This device is a surgical mesh, not an AI algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm is involved.

Summary of Study Context:

This 510(k) submission primarily relies on non-clinical performance testing (biocompatibility, mechanical tests, shelf life) and reference to existing clinical data (published clinical data) related to the predicate devices and similar materials (SIS). The purpose is to demonstrate that the new device, despite some technological differences (pre-configured shape, perforations, resorbable suture), is substantially equivalent in safety and effectiveness to the legally marketed predicate devices. It is not a study designed to validate a novel performance claim against specific, pre-defined numerical acceptance criteria through a prospective clinical trial.

Summary

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510 K Summary

APR 5 2013

Perry Guinn, VP of Quality Assurance and Regulatory Submitted By: Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 807-1942 December 31, 2012

Name of Device:

Trade/Proprietary Name:	Biodesign® Surgisis® Anterior and Posterior Pelvic FloorGrafts
Common/Usual Name:	Surgical Mesh
Classification Name:	Mesh, surgical, non-synthetic, urogynecologic, for pelvicorgan prolapse, transvaginally placed
Product Code:	PAI
Classification Number:	21 CFR §878.3300
Device Class:	Class II

Predicate Devices:

Surgisis Sling™ (K992159) manufactured by Cook Biotech Incorporated Surgisis (K062696) manufactured by Cook Biotech Incorporated

Intended Use:

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K130006

Device Description:

Discussion of Tests and Test Results:

The Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts have undergone and passed all relevant biocompatibility testing (cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, subchronic toxicity); and performance testing (suture retention strength testing, probe burst strength testing, tensile strength testing, stiffness testing, tear resistance testing and delamination testing). These data support a conclusion that the device is substantially equivalent to the predicate devices. In addition, shelf life testing was also completed to support substantial equivalence. Furthermore, clinical evidence including published clinical data, reinforces the conclusion that the Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts are substantially equivalent to the predicate devices.

Substantial Equivalence:

The subject and predicate device do not have the same Indications for Use statement. The predicate device has a general Indications for Use statement and encompasses a number of different procedures over range of medical disciplines, including vaginal prolapse repair. The subject device is only indicated for transvaginal pelvic organ prolapse repair in specific vaginal compartments. The differences between the Indications for Use statements of the subject and predicate device do not alter the intended therapeutic effect of the device because both the subject and predicate device are used to reinforce soft tissue. Therefore, the subject and predicate device have the same intended use.

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The subject and predicate device do not have the same technological characteristics. The new technological characteristics of the subject device include the following:

. The Biodesign Surgisis Grafts are pre-configured to treat specific types of pelvic organ prolapse transvaginally. The Surgisis Sling is rectangular shaped; and therefore, surgeons must modify the Surgisis Sling themselves based the type of repair and a patient's anatomy.
. The Biodesign Surgisis Grafts contain perforations to allow fluid movement through the graft. The Surgisis Sling does not have perforations. The perforations were added to the Biodesign Surgisis Grafts to reduce the risk of seroma formation.
The Biodesign Surgisis Grafts include resorbable suture to improve handling and . prevent delamination. The Surgisis Sling does not include sutures.
The Biodesign Surgisis Grafts are manufactured differently than the Surgisis . Sling. Specifically, the Biodesign Surgisis Grafts undergo additional processing to remove impurities from the SIS material and utilize a different layering technique.

The new characteristics of the subject device could affect safety and effectiveness. Specifically, in regards to safety, the addition of resorbable suture could affect local tissue response. With regard to effectiveness, there is a question of whether the preconfigured mesh is appropriate for its target prolapse repair procedure.

Cook Biotech provided sufficient performance data to assess the effects of the new technological characteristics, including biocompatibility, mechanical performance, and clinical testing, and the performance data demonstrate substantial equivalence of the Surgisis Biodesign Pelvic Floor Grafts to its proposed predicate device.

A substantial equivalence table comparing the Biodesign Surgisis Anterior and Posterior Pelvic Floor Grafts and its predicates is provided on the following page.

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Device	Biodesign® Surgisis®Anterior and PosteriorPelvic Floor Grafts	Surgisis™ Sling	Surgisis
Manufacturer	Cook Biotech	Cook Biotech	Cook Biotech
510 (k)Number	K130006	K992159	K062696
Intended Use	Cook® Biodesign®Surgisis® AnteriorPelvic Floor Graft isindicated for tissuereinforcement in womenwith pelvic organprolapse, fortransvaginal repair ofanterior andanterior/apical vaginalvault prolapse.Cook® Biodesign®Surgisis® PosteriorPelvic Floor Graft isindicated for tissuereinforcement in womenwith pelvic organprolapse, fortransvaginal repair ofposterior andposterior/apical vaginalvault prolapse.	For implantation toreinforce soft tissueswhere weakness exists inthe urological,gynecological andgastroenterologicalanatomy including butnot limited to thefollowing procedures:pubourethral support,urethral and vaginalprolapse repair, colonand rectal prolapserepair, reconstruction ofthe pelvic floor, bladdersupport, tissue repair andsacrocolposuspension.By providingpubourethral support, thesling may be used for thetreatment of urinaryincontinence resultingfrom urethralhypermobility orintrinsic sphincterdeficiency	Surgisis is intended forimplantation to reinforcesoft tissue. The device isintended for one-timeuse.
Product Code	PAI	FTM	FTM
Material	SIS	SIS	SIS
Thickness	70µm to 600µm(nominal)	70µm to 600µm(nominal)	0.1 to 2.0mm
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
One-time Use	Yes	Yes	Yes

Table. Substantial Equivalence Information

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Image /page/4/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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2013

Cook Biotech Incorporated % Mr. Nick X. Wang Regulatory Specialist 1425 Innovation Place WEST LAFAYETTE IN 47906

Re: K130006

Trade/Device Name: Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAI Dated: January 24, 2013 Received: January 29, 2013

Dear Mr. Wang:

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 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); 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/CDRHQffices/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" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Herbert P. Verner -S

for

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 Statement

510(k) Number (if known): K130006

Device Name: Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Herbert P. Lerner -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K130006

Regulation Number and Section

§ 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.