Vertessa™ Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Description

Vertessa Lite Y-Mesh is designed to be used in women suffering from uterine or vaginal vault prolapse and is implanted or affixed using suture of the surgeon's choice. Vertessa Lite Y-Mesh is provided sterile and is comprised of non-absorbable macroporous monofilament polypropylene warp knit blue mesh in a y-shape design.

AI/ML Overview

The provided text is a 510(k) summary for the Vertessa Lite Y-Mesh device, which is a surgical mesh for treating vaginal vault prolapse. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with a detailed performance analysis as might be done for an AI/ML device.

Therefore, many of the requested elements are not applicable or cannot be extracted from this type of document. This document outlines bench and failure mode testing and biocompatibility testing to show substantial equivalence, but it does not describe a study involving human subjects or AI/ML performance.

Here's an attempt to address your points based on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a table format with corresponding "device performance" in the way one might expect for a clinical study with a primary endpoint. Instead, it lists various mesh characteristics that were assessed and states that the device "passed all testing requirements" or "demonstrates substantial equivalence."

Acceptance Criteria (Assessed Characteristics)	Reported Device Performance
Mesh thickness	Assessed, device demonstrates substantial equivalence
Mesh knit characteristics	Assessed, device demonstrates substantial equivalence
Pore size	Assessed, device demonstrates substantial equivalence
Mesh density	Assessed, device demonstrates substantial equivalence
Tensile strength	Assessed, device demonstrates substantial equivalence
Mesh stiffness	Assessed, device demonstrates substantial equivalence
Flexural rigidity	Assessed, device demonstrates substantial equivalence
Tear resistance	Assessed, device demonstrates substantial equivalence
Burst strength	Assessed, device demonstrates substantial equivalence
Suture pullout	Assessed, device demonstrates substantial equivalence
Pyrogen levels	Assessed, device demonstrates substantial equivalence
Biocompatibility (cytotoxicity, sensitization, irritation, etc.)	Passed all biocompatibility testing as per FDA guidance
Sterility, aging, shelf life, transportation, and sterilization	Passed all testing requirements as per FDA guidance and ASTM F-1980-07
Bench and failure mode testing performance	Demonstrates substantial equivalence to predicate devices

Study Description: Substantial Equivalence Evaluation

The study described is an evaluation to demonstrate substantial equivalence of the Vertessa Lite Y-Mesh to two predicate devices: Alyte Y-Mesh Graft (K101722) by C.R. Bard, Inc. and Restorelle Y-Mesh (K112322) by Coloplast A/S. This evaluation was based on non-clinical bench testing, simulated use, surgeon feedback, and validation testing, in accordance with FDA guidance documents for surgical mesh.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): Not specified. The document mentions "non-clinical bench, simulated use, surgeon feedback and validation testing," but does not provide specific sample quantities for these tests (e.g., number of mesh samples tested for tensile strength, number of surgeons providing feedback).
Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal to Caldera Medical or conducted by contracted labs validating performance against established standards and predicate devices. The study is non-clinical as it involves laboratory and bench testing, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified. "Surgeon feedback" is mentioned, but the number of surgeons, their qualifications, or how their feedback was used to establish a "ground truth" (as typically understood in AI/ML contexts) for performance metrics is not detailed.
Qualifications: "Surgeon" is the only qualification mentioned.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML product requiring diagnostic output adjudication. The evaluation involved testing physical and material characteristics against standards and predicate device performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done? No. This type of study is typically performed for diagnostic devices, especially those incorporating AI, to assess reader performance with and without AI assistance. The Vertessa™ Lite Y-Mesh is a surgical implant, not a diagnostic device.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done? Not applicable in the context of AI/ML algorithms. The device itself is the physical mesh. Its performance (e.g., tensile strength, biocompatibility) is evaluated directly, which could be considered "standalone" in the sense that its inherent properties are tested independent of user interaction during the test, but this is not analogous to an AI algorithm's standalone performance.

7. Type of Ground Truth Used

The "ground truth," in this context, is primarily derived from:

Established Mechanical and Material Specifications: Performance characteristics (e.g., tensile strength, pore size, stiffness) are compared against known properties of the predicate devices and general standards for surgical mesh.
Biological Safety Standards: Biocompatibility testing results are compared against established FDA guidance and ISO standards (e.g., ISO-10993).
Sterilization and Shelf Life Standards: Testing results are compared against FDA guidance and ASTM standards (e.g., ASTM F-1980-07).
Predicate Device Performance: The "truth" for demonstrating substantial equivalence is the existing, legally marketed predicate devices' performance and characteristics.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

{0}------------------------------------------------

510(k) Summary

APR 2 5 2013

Date of Summary:

April 24, 2013

Submitted by:

Submitter: Caldera Medical, Inc. Address: 5171 Clareton Drive Agoura Hills, CA 91301 Contact: Vicki Gail, Manager QA/RA Phone: (818) 879-6555 x 102 Fascimile: (818) 879-6556

Device Information:

Trade Name: Vertessa Lite Y-Mesh Classification: Class II, Product Code: OTO, Surgical Mesh, Gynecologic, 21 CFR 878.3300, General and Plastic Surgery Alyte Y-Mesh Graft (K101722), C.R. Bard, Inc. Predicates: Restorelle Y-Mesh (K112322), Coloplast A/S

Description of Device:

Intended Use of Device:

Vertessa Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Technological Characteristics

Vertessa Lite Y-Mesh a modification of the predicate mesh devices, Alyte Y-Mesh Graft (K101722) by C.R. Bard, Inc. and Restorelle Y-Mesh (K112322) by Coloplast A/S. The device design is a Y-shape configuration, which is similar to that of the predicate mesh devices, has a similar intended use as that of the predicate devices 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 non-clinical bench, simulated use, surgeon feedback and validation testing has shown the Vertessa Lite Y-Mesh device to be substantially equivalent to that of the predicate device in its intended use, function, technological characteristics and performance.

{1}------------------------------------------------

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 characteristics, pore size, mesh density, tensile strength, mesh stiffness, flexural rigidity, tear resistance, burst strength, suture pullout and Pyrogen levels.

Vertessa Lite Y-Mesh 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".

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 Lite Y-Mesh has passed all testing requirements in terms of aging, shelf life, transportation and sterilization.

Bench and failure mode testing demonstrates that the performance of Vertessa Lite Y-Mesh is substantially equivalent to that of the predicate devices, Alyte Y-Mesh Graft (K101722) by C.R. Bard and Restorelle Y-Mesh (K112322) by Coloplast A/S.

Summary of Substantial Equivalence

Vertessa Lite Y-Mesh has demonstrated that it is substantially equivalent to that of the predicate devices, Alyte Y-Mesh Graft, (K101722), a product of Bard Medical and Restorelle Y-Mesh (K112322) a product of Coloplast A/S.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

April 25, 2013

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

Re: K123028

Trade/Device Name: Vertessa™ Lite Y-Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: April 16, 2013 Received: April 18, 2013

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. 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.

{3}------------------------------------------------

Page 2 - Ms. Vicki Gail

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 (OS) 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P.Lerner -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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left, followed by the text "CALDERA MEDICAL" in all capital letters. The font appears to be sans-serif.

Statement of Indications For Use

Indications For Use

510 (k) Number (if known): #K123028

Device Name: Vertessa™ Lite Y-Mesh

Indications for Use:

Prescription Use _-- X--(Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use . (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert ஜூட்ஜோer -S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K123028 510(k) Number

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.