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

Device Description

Vertessa® Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa® Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa "Lite will be available in a rectangular flat sheet mesh and rectangular strip mesh designs.

The flat sheet mesh designs are available in the following sizes: 8 x 16 cm, 8 x 18 cm, 8 x 20 cm, 8 x 22 cm, 8 x 24 cm, 8 x 26 cm, 10 x 16 cm, 10 x 18 cm, 10 x 20 cm, 10 x 22 cm, 10 x 24 cm, 10 x 26 cm, and 11 x 30 cm.

The strip mesh designs are available in the following sizes: 4 x 16 cm, 4 x 18 cm, 4 x 20 cm, 4 x 22 cm, 4 x 24 cm, 4 x 26 cm, 5 x 18 cm, 5 x 20 cm, 5 x 20 cm, 5 x 22 cm, 5 x 24 cm, 5 x 26 cm, and 6 x 30 cm.

AI/ML Overview

This document is a 510(k) premarket notification for the Vertessa® Lite surgical mesh by Caldera Medical, Inc. It aims to demonstrate substantial equivalence to a predicate device, not to establish new safety and effectiveness through a traditional clinical study with acceptance criteria in the way a diagnostic AI device would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI device are not applicable or not present in this document. This submission primarily focuses on physical and material characteristics and demonstrates comparability to an existing device.

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not:

1. A table of acceptance criteria and the reported device performance

This document does not present acceptance criteria for a diagnostic performance metric (like sensitivity, specificity, or AUC) as expected for an AI device. Instead, it compares the physical and mechanical properties of the new Vertessa® Lite to its predicate device. The "acceptance criteria" here are implied to be "comparable to the predicate device" for the listed mesh characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Comparable mesh thickness	Demonstrated comparability to predicate Vertessa® Lite (K123337)
Comparable mesh knit characteristics	Demonstrated comparability to predicate Vertessa® Lite (K123337)
Comparable pore size	Demonstrated comparability to predicate Vertessa® Lite (K123337)
Comparable mesh density	Demonstrated comparability to predicate Vertessa® Lite (K123337)
Comparable tensile strength	Demonstrated comparability to predicate Vertessa® Lite (K123337)
Comparable mesh stiffness (tensile and bending)	Demonstrated comparability to predicate Vertessa® Lite (K123337)
Comparable tear resistance	Demonstrated comparability to predicate Vertessa® Lite (K123337)
Comparable suture pullout strength	Demonstrated comparability to predicate Vertessa® Lite (K123337)
Biocompatibility	Demonstrated per FDA guidance (ISO-10993)
Sterilization validation & Shelf life	Demonstrated per FDA guidance (K90-1, ASTM F-1980-07) for a three-year shelf life

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

Sample size for test set: Not explicitly stated in terms of number of mesh samples tested for each characteristic. This kind of detail is typically in the test reports, which are summarized here.
Data provenance: Not specified in the provided text. The studies would have been conducted internally or by a contracted lab.

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 submission does not involve human expert interpretation for "ground truth" establishment in the context of a diagnostic AI device. The ground truth refers to the physical and chemical properties measured by standard test methods.

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

Not applicable. There is no "adjudication" necessary as this is not a diagnostic interpretation study.

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 device, and therefore no MRMC study was conducted or is relevant.

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

Not applicable. This is not an AI algorithm; it's a medical device (surgical mesh).

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

The "ground truth" or reference for the performance evaluation consists of established physical, mechanical, and biological testing standards and methods for surgical mesh materials. For example, tensile strength is measured against established engineering principles, and biocompatibility is assessed against ISO 10993 standards. The comparative aspect is against the properties of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

In summary: K150016 is a 510(k) premarket notification for a Class II surgical mesh. Approval is based on demonstrating substantial equivalence to a previously cleared predicate device (Vertessa® Lite, K123337) by showing comparable physical, mechanical, and biocompatibility characteristics, rather than meeting specific diagnostic performance acceptance criteria typical for an AI/CADe device. The "study" involves physical and biological testing of the mesh and comparison to the predicate, as outlined in FDA guidance for surgical mesh.

Summary

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

April 6, 2015

Caldera Medical, Inc. Vicki Gail Manager QA/RA 5171 Clareton Drive Agoura Hills, CA 91301

Re: K150016

Trade/Device Name: Vertessa® Lite Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: December 29, 2014 Received: January 6, 2015

Dear Vicki 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

for

Sincerely yours,

Herbert P. Lerner -S

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): K150016

Device Name: Vertessa® Lite

Indications for Use:

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

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)

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Image /page/3/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 green and gray. The word "CALDERA" is in green, while the word "MEDICAL" is in gray.

510(k) Summary K150016

Date of Summary: April 6, 2015

Submitted by:

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

Device Information:

Vertessa® Lite Trade Name:

Classification:	Class IIOTO (mesh, surgical, gynecologic, for apical vaginalprolapse, transabdominally placed)21 CFR 878.3300 (surgical mesh)
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Vertessa®Lite (K123337), Caldera Medical, Inc. Predicates:

Description of Device:

Intended Use of Device:

Vertessa® Lite devices 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.

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Image /page/4/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left and the text "CALDERA MEDICAL" on the right. The word "CALDERA" is in green, while the word "MEDICAL" is in gray.

Technological Characteristics:

Vertessa® Lite devices submitted herein are a modification of the predicate mesh device, Vertessa® Lite (K123337). The modifications include available sizes, configuration (pre-cut strips), and a larger pore size. Vertessa® Lite devices submitted herein are comprised of the same blue mesh and the same mesh knit pattern as the predicate device. Vertessa® Lite submitted herein has the same intended use and same technological characteristics as that of its predicate device, Vertessa® Lite (K123337).

Performance Summary:

In accordance with the FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the following mesh characteristics were assessed: mesh thickness, mesh knit characteristics, pore size, mesh density, tensile strength, mesh stiffness (tensile and bending), tear resistance, and suture pullout strength. The results demonstrate that the Vertessa® Lite has comparative mechanical performance to the predicate device. Vertessa® Lite (K123337).

Vertessa® Lite has demonstrated biocompatibility as indicated per the FDA guidance document, 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 document, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry, FDA and the FDA consensus standard, ASTM F-1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, Vertessa® Lite has demonstrated appropriate sterilization validation and information to support a three-year shelf life.

Summary of Substantial Equivalence:

The performance data demonstrate that the Vertessa® Lite devices submitted herein are substantially equivalent to the predicate device, Vertessa" Lite (K123337) also a product of Caldera Medical, Inc.

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.