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 lagaroscopic 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 two rectangular flat sheet mesh designs.

AI/ML Overview

The provided text is a 510(k) summary for the Vertessa™ Lite surgical mesh. It describes the device, its intended use, technological characteristics, and demonstrates substantial equivalence to a predicate device through performance testing. However, it does not describe a study involving an AI/CADe device or any sort of "device performance" in terms of clinical outcomes, diagnostic accuracy, or human reader improvement with AI.

Therefore, I cannot directly answer your prompt's specific questions regarding acceptance criteria and a study proving device performance in the context of an AI/CADe device. The document is for a medical device (surgical mesh), not an AI system.

However, I can extract the information related to the acceptance criteria and performance summary for the surgical mesh itself, as described in the 510(k) summary. I will present this information in a way that aligns with your prompt structure, while noting the difference in device type.

Device Type: Surgical Mesh (Vertessa™ Lite) - NOT an AI/CADe device.
Premarket Submission Number: K123337

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vertessa™ Lite surgical mesh were based on demonstrating substantial equivalence to its predicate device, Vertessa™ (K120327). This was achieved by assessing various mesh characteristics against established standards and guidelines.

Acceptance Criteria Category	Specific Characteristics Assessed	Reported Device Performance
Mechanical Properties	Mesh thickness	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Mesh knit characteristics	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Pore size	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Mesh density	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Tensile strength	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Mesh stiffness	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Flexural rigidity	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Tear resistance	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Burst strength	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
	Suture pullout	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
Material Safety	Pyrogen levels	"Results from testing demonstrate substantial equivalence to the predicate device, Vertessa™."
Biocompatibility	General Biocompatibility	Supported by reference device (Ascend® Blue, K101462) made of same material, which "passed all biocompatibility as indicated per the FDA guidance documents."
Sterility	Sterility	"Tested in accordance with the FDA Guidance...and met all requirements."
Shelf Life/Aging	Aging and Shelf Life	"Passed all testing requirements in terms of aging and shelf life in accordance with the FDA guidance."

Study Proving Device Meets Acceptance Criteria:

The study referenced is a series of "mechanical bench and validation testing" and other compliance tests (biocompatibility, sterility, accelerated aging) conducted on the Vertessa™ Lite device. This testing was performed to demonstrate "function equivalence based upon key device characteristics and its intended use to the predicate device, Vertessa™."

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

Sample Size: Not explicitly stated in terms of a specific number of units for each test. The summary indicates "results from testing," implying that a sufficient number of samples were tested to demonstrate equivalence.
Data Provenance: The tests were conducted by Caldera Medical, Inc. (the manufacturer). This is internal testing data. The country of origin of the data is implicitly the United States, as Caldera Medical, Inc. is located in Agoura Hills, CA. The nature of the data is prospective, as it involves newly manufactured devices undergoing specific tests.

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

Not Applicable: This is a physical medical device (surgical mesh), not a diagnostic or AI device that requires expert ground truth for its performance assessment. The "ground truth" for these tests is based on objective measurements against established engineering standards and regulations, and comparison to the predicate device.

4. Adjudication method for the test set

Not Applicable: As this is primarily bench testing against objective physical/chemical properties and regulatory standards, an adjudication method for a "test set" (in the sense of a clinical or image-based study) is not relevant.

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-assisted diagnostic device. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or mentioned.

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

Not Applicable: This device is a surgical mesh; it does not involve algorithms or AI.

7. The type of ground truth used

The "ground truth" for the performance evaluation of the surgical mesh was based on:
- Objective physical and mechanical properties: Measured values (e.g., tensile strength, pore size, thickness) compared against the predicate device and potentially industry standards.
- Regulatory standards and guidance: Compliance with FDA guidance for surgical mesh characteristics, biocompatibility (ISO-10993), sterility (FDA Guidance K90-1), and accelerated aging (ASTM F-1980-07).
- Predicate device characteristics: The characteristics of the legally marketed predicate device, Vertessa™ (K120327), served as the benchmark for demonstrating "substantial equivalence."

8. The sample size for the training set

Not Applicable: This is not an AI/ML device where a "training set" in the computational sense would be used.

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

Not Applicable: See point 8.

Summary

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K123337
PAGE 1 OF 2

510(k) Summary

Date of Summary: February 20, 2013

FEB 2 1 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:

Vertessa™ Lite Device Trade Name:

Classification: Class II, Product Code: OTO, Surgical Mesh, Gynecologic, 21 CFR 878.3300, General and Plastic Surgery

Predicate: Vertessa™ (K120327), Caldera Medical, Inc.

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.

Technological Characteristics

Vertessa™ Lite devices are a modification of the predicate mesh device, Vertessa™ in knit pattern and mesh resin colorant. In addition, Vertessa™ Lite is available in two sizes. Vertessa™ Lite has the same intended use as that of its predicate, Vertessa™ and does not change the fundamental scientific technology of the predicate device.

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 on Vertessa™ Lite: mesh thickness, mesh knit characteristics, pore size, mesh density, tensile strength, mesh stiffness, flexural rigidity, tear resistance, burst strength, suture pullout and pyrogen levels. The results from testing demonstrate substantial equivalence to the predicate device, Vertessa™.

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K123337
PAGE 2 of 2

Results of mechanical bench and validation testing demonstrate Vertessa™ Lite device function equivalence based upon key device characteristics and its intended use to the predicate device, Vertessa™.

A reference device which is also a product of Caldera Medical, Ascend® Blue (K101462), was used as support for Vertessa™ Lite biocompatibility since both are comprised of the same polypropylene mesh resin with colorant. Ascend® Blue has passed all biocompatibility 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", " .

Sterility of Vertessa™ Lite devices was tested in accordance with the FDA Guidance, Updated 510(k) Sterility Review Guidance K90-1 and met all requirements.

Vertessa™ Lite devices have passed all testing requirements in terms of aging and shelf life in accordance with the FDA quidance, 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.

Summary of Substantial Equivalence

The conclusions drawn from non-clinical testing, demonstrate that Vertessa™ Lite is safe and effective for its intended use and is substantially equivalent to the predicate device, Vertessa™, also a product of Caldera Medical, in its intended use, performance and technological characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

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

February 21, 2013

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

Re: K123337

Trade/Device Name: Vertessa™ Lite Regulation Number: 21 CFR& 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: January 24, 2013 Received: February 1, 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, 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.

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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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/6 description: The image shows the name "Benjamin R. Fisher -S". The name is written in a simple, sans-serif font. The letters "R.F." are stylized with a geometric pattern.

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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Image /page/4/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a stylized image to the left of the company name. The company name, "CALDERA MEDICAL", is written in all capital letters.

Statement of Indications For Use

Indications For Use

510 (k) Number (if known): __K123337

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 lagaroscopic abdominal procedures.

Prescription Use ----------(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 T NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off ctive, Gastro-Renal, and K123337

Benjar -05'00'

Vertessa™ Lite 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.