PivitAB™ is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitAB™ may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

Device Description

PivitAB™ is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PivitAB™ is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a biorsonable polyarylate coating on the mesh containing the antimicrobial agents, rifampir and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the nesh in order to facilitate interoperative handling during placement and act a carrier for the imicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a ermanent mesh incorporated into the tissue.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PivitAB™ surgical mesh. This document focuses on demonstrating the substantial equivalence of the PivitAB™ to legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through a study designed to meet those criteria.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) summarizes existing data to show equivalence, rather than detailing a de novo study to establish new performance metrics against pre-defined acceptance criteria.

Here's an attempt to address your request based on the provided text, with explanations for what cannot be found:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	(Implicitly, comparable to predicate devices and acceptable for human implantation as per FDA guidance for surgical mesh.)	"The PivitAB™ and the polyarylate polymer have been demonstrated to be biocompatible."
Tissue Ingrowth	(Implicitly, satisfactory and comparable to commercial surgical mesh, as per FDA guidance for surgical mesh.)	"animal testing demonstrated that PivitAB™ will achieve satisfactory tissue ingrowth compared to control as evidenced by histopathology."
Antimicrobial Effectiveness (In Vivo)	(Implicitly, significantly fewer colonized implants compared to a non-antimicrobial control mesh.)	"Result demonstrated that there were significantly fewer colonized implants with PivitAB (13%) than with the PROLENE Mesh control (43%)."
Mechanical Properties / Hernia Repair Performance	(Implicitly, "comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies" as per FDA guidance for surgical mesh.)	"Non-clinical laboratory testing was performed in accordance with the FDA guidance document 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh' demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies."

Explanation: The 510(k) submission doesn't explicitly state numerical acceptance criteria in the way a clinical trial protocol would. Instead, it relies on demonstrating comparability to predicate devices and adherence to relevant FDA guidance for surgical mesh. The "reported device performance" is a summary of findings from various non-clinical and animal tests designed to support this comparability and safety.

2. Sample size used for the test set and the data provenance

Test Set Sample Size:
- For the antimicrobial effectiveness study: The text states "PivitAB™ and a non-antimicrobial coated Control (PROLENE, Ethicon, Sommerville, NJ) were inoculated with 10^5 CFUs of S aureus and implanted into rabbits." While it provides the result (13% vs 43%), it does not specify the number of rabbits or implants used in this study.
- For tissue ingrowth and other non-clinical tests: Not specified.
Data Provenance: The studies mentioned are referred to as "Non-clinical laboratory testing" and "animal testing."
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: These would typically be prospective studies, especially the animal model for antimicrobial effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. "Histopathology" for tissue ingrowth implies expert review by pathologists, but details on their number or qualifications are absent. For the antimicrobial effectiveness, the "ground truth" was the percentage of colonized implants, likely determined through microbiological culture and counting, not expert consensus on an image or clinical observation.

4. Adjudication method for the test set

This information is not explicitly provided. For the antimicrobial effectiveness study, the method was likely objective measurement (microbial counts), not an adjudication process among human observers.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI for medical imaging) where human readers interpret data. The PivitAB™ is a surgical mesh; its effectiveness is assessed through physical, biological, and antimicrobial performance, not human interpretation of diagnostic output. Therefore, there's no "AI assistance" or "human reader improvement" to measure.

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

Not applicable. PivitAB™ is a physical surgical implant, not an algorithm. Its performance is inherent to the device itself (materials, design, antimicrobial properties).

7. The type of ground truth used

For Biocompatibility: Likely based on standardized assays and histopathological examination in animal models, comparing responses to established benign materials.
For Tissue Ingrowth: "Histopathology" is mentioned, indicating microscopic examination of tissue sections as the ground truth.
For Antimicrobial Effectiveness: The "ground truth" was the presence and extent of microbial colonization on the implants, quantified through microbiological methods (e.g., CFUs - Colony Forming Units) from the explanted devices. This is an objective, laboratory-derived ground truth.
For Mechanical Properties: Likely engineering tests and physical measurements according to standards.

8. The sample size for the training set

Not applicable as this is not an AI/ML device that requires a training set. The data presented are from pre-clinical studies and animal models.

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

Not applicable, as there is no training set for this type of medical device.

Summary

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crobial Mesh - Premarket Notification [510(k)] Submission (K053656)

Revised 510(K) Summary

July 11, 2006

i/2

2001 1 4 1 JUG

510(k) Summary (as required by 21 CFR 807.92)

Pursuant to Section 12, Part (a)(i)3A of the Safe Medical Devices Act of 1990. TVRx Pharma, Inc. is providing a summary of the safety and effectiveness information available for PivitAB™, as well as the substantial equivalence decision making process used for PivitAB™.

Sponsor/Applicant Name and Address: TyRx Pharma, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, NJ 08852 Registration Number: 3005619263

Sponsor Contact Information: Mason Diamond, IDDS Vice President, Clinical and Regulatory Affairs Phone: 732-246-8676 Fax: 732-246-8677 E-mail: mason(@tvrxpharma.com

Date of Preparaton of 510(k) Summary: December 29, 2005

New Device Trade/Proprietary Name: PivitABTM

Device Common/Classification Name: Polymeric Surgical Mesh

Predicate Devices Name and 510(k) Numbers:

TyRx Surgical Mesh (K052864)

AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InibiZone ™ (K042592) Spectrum® Central Venous Catheter with or without Hydrophilic Coating (K000343) GORE-TEX® DualMesh® PLUS Biomaterial (1 mm and 2 mm) (K000185)

Device Description:

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TyRx Pharma Inc.

TyRx Antimicrobial Mesh - Premarket Notification [510(k)] Submission (K053656)

July 11, 2006

commercial surgical mesh.

Intended Use:

VOS3616

Performance Data:

Non-clinical laboratory testing was performed in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The PivitABTM and the polyarylate polymer have been demonstrated to be biocompatible. In addition, animal testing demonstrated that PivitAB™ will achieve satisfactory tissue ingrowth compared to control as evidenced by histopathology. PivitAB™ has demonstrated effectiveness in an in vivo experiment in which PivitAB™ and a nonantimicrobial coated Control (PROLENE, Ethicon, Sommerville, NJ) were inoculated with 105 CFUs of S aureus and implanted into rabbits. Result demonstrated that there were significantly fewer colonized implants with PivitAB (13%) than with the PROLENE Mesh control (43%).

Conclusions:

Based on the 510(k) summaries (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food Drug and Cosmetic Act.

TE: KEY INFORMATION

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 2006

TyRx Pharma, Inc. % Mason W. Diamond, D.D.S. Vice President, Clinical and Regulatory Affairs 1 Deer Park Drive, Suite G Monmouth Junction, New Jersey 08852

Re: K053656 Trade/Device Name: PivitAB™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: May 15, 2006 Received: May 16, 2006

Dear Dr. Diamond:

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, 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

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Page 2 - Mason W. Diamond, D.D.S.

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. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Obobera Anichump

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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TyRx Pharma Inc. TyRx Antimicrobial Mesh - Premarket Notification {510(k)] Submission (K053656) May 15, 2006

(5650)

Attachment 2: Revised Indication For Use Statement

Indications for Use

510(k) Number (if known): _ _ K.053656

PivitAB™ Device Name: _____________________

Indications for Use:

Is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitAB™ may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bruhn

Division of General, Restorative. and Neurological Devices

Page of

510(k) Number K053654

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.