The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Device Description

The Desara Mesh Sling is a sterile, single-use pubourethral sling used to provide support in the pelvic region to treat stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has integral sleeves and sutures to assist the surgeon in placement of the device. The sleeves and sutures are removed after placement of the device.

AI/ML Overview

The provided text describes a 510(k) summary for the Desara Mesh Sling, a surgical mesh device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way one might expect for a diagnostic or AI-driven device.

Here's a breakdown based on the information provided, highlighting what is not available in the given text:

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

This information is not explicitly provided in the given text in a tabular format as you've requested. The document states:

"The biocompatibility tests conducted for the new Desara mesh were selected in accordance to ISO 10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing standards and all test results were passing."

And, "In accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the results of bench, cadaver lab and validation testing has shown the new Desara Mesh device to be substantially equivalent to the predicate device."

This indicates that acceptance criteria would have been defined by ISO 10993 for biocompatibility and specific unstated criteria for bench, cadaver lab, and validation testing, with the general reported performance being "passing" and "substantially equivalent." No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or defined physical properties with numerical targets) are given.

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

This information is not provided in the document. The text mentions "bench, cadaver lab and validation testing," but no details on sample sizes for these tests are given.

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):

This information is not applicable/provided. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for ground truth establishment. The testing mentioned (biocompatibility, bench, cadaver lab, validation) would involve engineering and biological assessments, not expert image/data review.

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

This information is not applicable/provided. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the primary focus of this device's performance evaluation for 510(k) submission.

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:

This information is not applicable. The Desara Mesh Sling is a surgical implant, not an AI-driven diagnostic device. Therefore, no MRMC study or AI-assisted human reader improvement analysis would be relevant or performed.

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

This information is not applicable. As stated above, this is a surgical mesh, not an algorithm, so standalone performance is not relevant.

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

For biocompatibility, the ground truth would be established by standardized biological responses as defined by ISO 10993. For bench and cadaver lab testing, the "ground truth" would relate to physical properties, mechanical performance, and surgical handling characteristics compared against engineering specifications and potentially against the predicate device. Outcomes data would typically come from clinical trials, which are not detailed here beyond the general statement of substantial equivalence.

8. The sample size for the training set:

This information is not applicable/provided. This is not an AI/machine learning device that requires a training set.

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

This information is not applicable/provided, as there is no training set for this type of device.

Summary of available information regarding acceptance criteria and study:

The provided document details a 510(k) submission for the Desara Mesh Sling. The core of its performance data revolves around demonstrating substantial equivalence to a predicate device.

Acceptance Criteria (Implicit):
- Biocompatibility: Meet ISO 10993 standards.
- Bench Testing: Meet unstated physical and mechanical property specifications, and demonstrate equivalence to the predicate device.
- Cadaver Lab Testing: Demonstrate equivalence in handling and placement characteristics in a simulated surgical environment.
- Validation Testing: General phrase indicating further testing to confirm design outputs meet design inputs, likely encompassing performance and safety benchmarks comparable to the predicate.
Reported Device Performance:
- "all [biocompatibility] test results were passing."
- "the results of bench, cadaver lab and validation testing has shown the new Desara Mesh device to be substantially equivalent to the predicate device."

The document lacks the specific quantitative metrics, detailed study parameters, and expert-based evaluations that would be present for a diagnostic or AI-driven medical device. Its focus is on demonstrating that the modified surgical mesh is as safe and effective as its predecessor through a series of engineering and biological tests.

Summary

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510(k) Summarv

Date of Summary:	July 29, 2013
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Submitted by:

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

Device Name:

Device Name:	Surgical Mesh (878.3300)
Trade Name:	Desara Mesh Sling
Common Name:	Surgical Mesh
Device Class:	Class II, Product Code OTN, 21 CFR 878.3300,Gynecologic, For Stress Urinary Incontinence, Female,Obstetrics/Gynecology Panel
Predicate Device:	Desara Mesh Sling. K072456. Caldera Medical. Inc.

Description of Device:

Intended Use of Device:

The Desara Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Technological Characteristics

The new Desara Mesh is a modification of the predicate mesh device, with the same intended use and does not change the fundamental scientific technology as the predicate device.

Performance Data Summary

The biocompatibility tests conducted for the new Desara mesh were selected in accordance to ISO 10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing standards and all test results were passing.

Confidential

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In accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the results of bench, cadaver lab and validation testing has shown the new Desara Mesh device to be substantially equivalent to the predicate device.

Summary of Substantial Equivalence

The new Desara mesh is safe and effective for its intended use and is substantially equivalent to the predicate device, Desara mesh, also a product of Caldera Medical.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a person with outstretched arms. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

September 13, 2013

Caldera Medical, Inc. % Vicki Gail Quality and Operations Manager 28632 Roadside Drive. Suite 260 Agoura Hills, CA 91301

K101169 Re: Trade/Device Name: Desara® Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE ltr): April 23, 2010 Received (Date on orig SE Itr): April 26, 2010

Dear Vicki Gail,

This letter corrects our substantially equivalent letter of May 20, 2010.

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

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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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

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

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Indications for Use

510(k) Number (if known): K101169

Device Name: Desara® Mesh

Indications for Use:

Image /page/4/Picture/5 description: The image shows the text "Prescription Use (21 CFR 801 Subpart D)" with a box next to it that has been marked with an "X". The text indicates that the product is intended for prescription use and is subject to the regulations outlined in Title 21, Code of Federal Regulations, Part 801, Subpart D. The presence of the "X" in the box suggests that this option has been selected or indicated.

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2013.09.13 13:31:56 -04/00'

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Desara Mesh 510(k) #K101169 Add To File

Confidential

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.