Vertessa™ may be used for the repair of uterine or vaginal vault prolapse that requires support material. It may be used in open or laparoscopic abdominal procedures.

Device Description

Vertessa™ is designed to be used in the inpatient or outpatient surgery setting in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa™ mesh will be provided sterile and is comprised of macroporous monofilament polypropylene warp knit clear mesh.

AI/ML Overview

The document provided details for a 510(k) premarket notification for the "Vertessa™" surgical mesh. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.

Therefore, the requested information elements related to specific acceptance criteria, a standalone study with performance metrics, MRMC studies, ground truth establishment, sample sizes for training/test sets, and expert adjudication are not applicable to this 510(k) summary. The study conducted here is a bench and validation testing to demonstrate substantial equivalence against predicate devices for various characteristics.

Here's the information that can be extracted or inferred from the provided text, structured to address your request as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicitly stated numerical "acceptance criteria" for performance that the device must meet independently. Instead, the "acceptance criterion" is generally "demonstrates substantial equivalence" to the predicate devices in the assessed characteristics.

Characteristic Assessed	Reported Device Performance (vs. Predicate)
Mesh thickness	Substantial equivalence to Ascend® Blue
Mesh knit characteristics	Substantial equivalence to Ascend® Blue
Pore size	Substantial equivalence to Ascend® Blue
Mesh density	Substantial equivalence to Ascend® Blue
Tensile strength	Substantial equivalence to Ascend® Blue
Mesh stiffness	Substantial equivalence to Ascend® Blue
Flexural rigidity	Substantial equivalence to Ascend® Blue
Tear resistance	Substantial equivalence to Ascend® Blue
Burst strength	Substantial equivalence to Ascend® Blue
Suture pullout	Substantial equivalence to Ascend® Blue
Pyrogen levels	Substantial equivalence to Ascend® Blue
Biocompatibility	Substantial equivalence to Ascend® Blue
Aging	Passed testing requirements (shelf life)
Shelf life	Passed testing requirements (shelf life)
Transportation	Passed testing requirements
Sterilization	Passed testing requirements
Mechanical bench and validation testing	Equivalent device function to Ascend® Blue and POPMesh™

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

Sample size for test set: Not specified in the provided text. The testing conducted included "bench, simulated use, surgeon feedback and validation testing," for which specific sample sizes are not detailed.
Data provenance: Not explicitly stated, but assumed to be internal testing conducted by Caldera Medical, Inc. The document does not indicate the country of origin of data or if it was retrospective or prospective in the medical sense (e.g., patient data). It refers to laboratory/bench testing.

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

This information is not applicable and not provided. The substantial equivalence argument relies on direct comparison of physical and mechanical properties of the device (Vertessa™) to a predicate device (Ascend® Blue) and passing of various standard tests (biocompatibility, sterility, etc.), rather than expert-established ground truth in a diagnostic or clinical context. "Surgeon feedback" is mentioned, but its role in "ground truth" or a defined test set is not detailed.

4. Adjudication method for the test set

Not applicable and not provided. As explained above, the assessment is based on physical and mechanical properties and standard compliance, not on expert adjudication of diagnostic outcomes.

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 is not an AI-enabled diagnostic device.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance here relates to the physical and mechanical properties of the mesh itself, which were tested against established standards and compared to a predicate device.

7. The type of ground truth used

Again, the concept of "ground truth" in the diagnostic sense (e.g., pathology, outcomes data) does not directly apply here. For the physical and mechanical properties, the "ground truth" or reference point is the performance of the predicate device (Ascend® Blue) and established industry standards and FDA guidance documents for testing methods and acceptable ranges (e.g., ISO-10993 for biocompatibility, ASTM F-1980-07 for accelerated aging).

8. The sample size for the training set

Not applicable. This is not a machine learning device.

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

Not applicable. This is not a machine learning device.

In summary: The provided document is a 510(k) summary for a surgical mesh, which aims to demonstrate substantial equivalence to existing predicate devices. The "studies" conducted are primarily bench and validation tests conforming to FDA guidance and industry standards, comparing physical and material properties, and biological safety. The detailed elements requested are typically associated with performance studies for diagnostic devices, especially those involving AI or human interpretation, which is not the case for this product.

Summary

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MAY 1 0 2012

510(k) Summary

Date of Summary:

Mav 4, 2012

Submitted by:

Submitter: Address: Contact: Phone:
Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 Vicki Gail. Manager QA/RA (818) 879-6555 x 102

Device Name:

Device	Surgical Mesh (878.3300)
Trade Name:	Vertessa™
Common Name:	Surgical Mesh
Classification:	Class II, Product Code: OTO - Surgical Mesh, Gynecolgic, 21CFR 878.3300, General And Plastic Surgery
Predicate Device:	Ascend® Blue (K101462), Caldera Medical Inc.POPMesh™ (K053424), Caldera Medical, Inc.

Description of Device:

Intended Use of Device:

Vertessa™ may be used for the repair of uterine or vaginal vault prolapse that requires support material. It may be used in open or laparoscopic abdominal procedures.

Technological Characteristics

Vertessa™ is a modification of the predicate mesh device, Ascend® Blue, which is comprised of the same knit pattern. Vertessand has a specific intended use from the predicate device, POPMesh™, and does not change the fundamental scientific technology of the predicate devices.

Performance Summary

In accordance with the FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)'s the results of bench, simulated use, surgeon feedback and validation testing has shown Vertessa ™ to be substantially equivalent to the predicate devices in its intended use, technological characteristics and performance.

Vertessa M is comprised of the same mesh as the predicate device. Ascend® Blue, FDA 510(k) #K101462, also a product of Caldera Medical. In accordance with the FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh. the following mesh characteristics were assessed: mesh thickness, mesh knit

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characteristics, pore size, mesh density, tensile strength, mesh stiffness, flexural rigidity, tear resistance, burst strength, suture pullout and pyrogen levels. Vertessa™ mesh demonstrates substantial equivalence to the predicate device, Ascend® Blue.

Vertessa™ has passed all biocompatibility testing as indicated per the FDA guidance documents, FDA Device Advice, Guidance Documents (Medical Device and Radiation Emitting Product), 3. Biocompatibility and FDA Blue Book Memorandum #G95-1 Entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices
Part-1: Evaluation and Testing". Vertessa™ demonstrates substantial equivalence to the predicate device, Ascend® Blue.

In accordance with the FDA Guidance, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry, FDA, FDA Device Advice, Guidance Documents (Medical Device and Radiation Emitting Product), 4. Labeling and FDA Consensus standard, ASTM F-1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, Vertessa™ has passed all testing requirements in terms of aging, shelf life: transportation and sterilization and has demonstrated substantial equivalence to the predicate device, Ascend® Blue.

Results of mechanical bench and validation testing demonstrate equivalent device function based upon its intended use to the predicate devices, POPMesh™ and Ascend® Blue.

The performance of Vertessa'" demonstrates that the device is as safe, and as effective, and performs at least as safely and effectively as the predicate devices, Ascend® Blue and POPMesh™.

Summary of Substantial Equivalence

Vertessa™ is safe and effective for its intended use and is substantially equivalent to the predicate devices, Ascend® Blue and POPmesh™, also products of Caldera Medical.

Confidential

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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 stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

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

Ms. Vicki Gail Manager, QA/RA Caldera Medical, Inc. 5171 Clareton Drive AGOURA HILLS CA 91301

MAY 1 0 2012

Re: K120327

Trade/Device Name: VertessaTM Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: March 15, 2012 Received: March 15, 2012

Dear Ms. Gail:

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. 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. 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

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Page 2 -

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/CDRHOffices/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,

Benjamin K. Evanko

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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Statement of Indications For Use

Indications For Use

510 (k) Number (if known): K120327

Device Name: Vertessa™

Indications for Use:

Vertessa™ may be used for the repair of uterine or vaginal vault prolapse that requires support material. It may be used in open or laparoscopic abdominal procedures.

Prescription Use -- X-

AND/OR

Over the Counter Use_ (Part 21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Graine Bupt for Bergfisher

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120327

Vertessa (formerly CentraSoft) #K120328 Caldera Medical, Inc.

Page 31

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.