POPmesh™ may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Device Description

POPmeshTM is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. POPmeshTM is constructed using a warp- knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. It maintains excellent isotropic properties arising from its knitted construction. POPmeshTM has the necessary strength, flexibility, durability and surgical adaptability. These properties permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.

AI/ML Overview

This 510(k) summary for the Caldera Medical, Inc. POPmesh does not provide acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for an AI/software-as-a-medical-device (SaMD) submission. This is a submission for a physical surgical mesh, and as such, the regulatory requirements and "proof" of meeting acceptance criteria differ significantly.

Instead, the submission focuses on substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly related to the safety and effectiveness profile demonstrated by the predicate devices and the performance of the new device relative to those predicates through specific testing.

Here's how we can frame the available information in the context of your request, while acknowledging that many of your specific categories are not directly applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical device, "acceptance criteria" relate to material properties, biocompatibility, and intended use as compared to existing, legally marketed devices.

Acceptance Criteria Category	Reported Device Performance (Summary from Submission)
Biocompatibility	Patient contact materials are the "same materials as the predicate detailed." Polypropylene has a "long history of biocompatibility." Testing was performed as outlined in FDA Guidance.
Physical Performance (Strength, Flexibility, Durability)	POPmesh™ has "necessary strength, flexibility, durability and surgical adaptability." It maintains "excellent isotropic properties" from its knitted construction. Testing was performed as outlined in FDA Guidance.
Sterility	The device is supplied sterile. (Implicitly meets sterility standards. No specific test results detailed in summary.)
Intended Use Equivalence	POPmesh™ "has the same indications as its predicate device, Minimesh, Mpathy Corp." (K041362).
Design/Manufacturability	Constructed from knitted monofilaments using a warp-knit process to a "unique design that permits the mesh to be cut into any desired shape or size without unraveling."

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

This is not applicable in the typical sense for an AI/SaMD. The "test set" here would refer to the samples of the physical mesh produced and subjected to various physical and biocompatibility tests.

Sample Size: Not specified in the provided summary. Testing samples would have been representative of the manufactured product.
Data Provenance: Not explicitly stated, but it would be from in-house laboratory testing, potentially by external contract labs for specialized tests (e.g., biocompatibility), all conducted according to internal protocols and FDA guidance. This is not "retrospective or prospective" data in the clinical trial sense.

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

This concept is not applicable. For a physical medical device like surgical mesh, "ground truth" is established through:

Standardized Material Testing: Adherence to recognized ASTM, ISO, or other industry standards for material properties. The "experts" are the engineers and scientists conducting these tests and interpreting the results against established specifications.
Biocompatibility Standards: Testing against a battery of ISO 10993 standards, interpreted by toxicologists and biocompatibility specialists.
Clinical Experience with Predicate Devices: The long history of safe and effective use of the predicate devices (polypropylene mesh) serves as a form of "ground truth" for the material and design principles.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert opinions in image reading or clinical diagnoses. For physical device testing, results are typically quantitative and compared against predefined specifications, not adjudicated expert opinions.

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

Not applicable. MRMC studies are designed to assess the performance of diagnostic tools (often imaging-based) by comparing human reader performance with and without AI assistance across a set of cases. This device is a physical surgical mesh, not a diagnostic AI tool.

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

Not applicable. This is a physical product, not an algorithm.

7. Type of Ground Truth Used

For this device, the "ground truth" is multifaceted and based on:

Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) and historical data on polypropylene's biological response.
Material Science Specifications: Engineering specifications for properties like tensile strength, pore size, flexibility, and elasticity, derived from clinical needs and predicate device characteristics.
Historical Clinical Use: The long and established safe and effective use of polypropylene surgical mesh, particularly the predicate devices.

8. Sample Size for the Training Set

Not applicable. This device is not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no AI model or training set involved.

Summary of the 510(k) Submission for Caldera Medical, Inc. POPmesh:

The submission for the POPmesh primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, specifically Minimesh® Polypropylene Mesh (K041362).

The "study" or evidence provided to show this equivalence includes:

Material Equivalence: Stating that the patient contact materials (polypropylene) are the "same materials as the predicate detailed" and highlighting polypropylene's "long history of biocompatibility."
Biocompatibility Testing: Performance of "testing... for biocompatibility as well as appropriate physical testing as outlined in the FDA Guidance Document 'Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh'." While no specific results are detailed in the summary, this indicates that standard tests were conducted and presumably met relevant criteria (e.g., ISO 10993 standards).
Physical Performance Claims: Describing the device's inherent properties (strength, flexibility, durability, isotropic properties, ability to be cut without unraveling) which are implicitly compared to the performance characteristics of predicate devices and general requirements for surgical mesh.
Indications for Use Equivalence: Explicitly stating that POPmesh™ "has the same indications as its predicate device, Minimesh, Mpathy Corp." (K041362).

The FDA's letter (K053424) confirms that based on this submission, the device was found to be substantially equivalent for its stated indications for use. This means the FDA concluded that the device is as safe and effective as the predicate device(s) and does not raise different questions of safety and effectiveness.

Summary

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Caldera Medical, Inc. POPmesh 510(K)

K05 3424
Page 1 of 2

FEB 2 2 2006

510(k) SUMMARY OF SAFETY & EFFECTIVENESS

SUBMITTED BY:	Caldera Medical, Inc.28632 Roadside Drive, Suite 260Agoura Hills, CA 91301
CONTACT PERSON:	Marla Kengen
DATE PREPARED:	October 12, 2005
CLASSIFICATION:	Polymeric Surgical Mesh (Product Code FTL) is a Class IIdevice per 21 CFR 878.3300
COMMON NAME:	Polymeric Surgical Mesh
PROPRIETARY NAME:	POPmeshTM
PREDICATE DEVICES:	K041362 Minimesh® Polyproylene Mesh(Mpathy Medical Devices Limited)K001122 Prolene® (Ethicon , Inc.)K002672 Vypro® II (Ethicon, Inc.)
DEVICEDESCRIPTION:	POPmeshTM is a non-absorbable polypropylene meshconstructed from knitted monofilaments of extrudedpolypropylene.
	POPmeshTM is constructed using a warp- knit process to aunique design that permits the mesh to be cut into any desiredshape or size without unraveling.
	It maintains excellent isotropic properties arising from itsknitted construction.
	POPmeshTM has the necessary strength, flexibility, durabilityand surgical adaptability. These properties permit the correctadaptation to the various stresses encountered in the body.
	The device is supplied sterile.

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Caldera Medical, Inc. POPmesh 510(K)

510(k)

K053424
page 2 of 2

510(k) SUMMARY OF SAFETY & EFFECTIVENESS cont.

POPmesh™ may be used for the repair of abdominal wall hernia, INTENDED USE: including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

POPmesh™ is a prescriptive device and should only be used by a licensed physician.

POPmesh™ has the same indications as its predicate device, Minimesh, Mpathy Corp.

The patient contact materials used in this device are the same TESTING: materials as the predicate detailed. Polypropylene has a long history of biocompatibility.

Testing has been performed on the POPmesh™ for biocompatibility as well as appropriate physical testing as outlined in the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

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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 features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2006

Caldera Medical, Inc. c/o Ms. Marla Kengen Project Leader 28632 Roadside Drive, Suite 260 Agoura Hills, California 91301

Re: K053424

Trade/Device Name: Caldera Medical, Inc. POPmesh™M Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 27, 2006 Received: January 31, 2006

Dear Ms. Kengen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreate) to ttg ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . conninered prior to may 20, 2011 accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrolore, mains of the Act include requirements for annual registration. listing of general controll provisive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may be sucjoet to basil 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 i least of advised that I Drivisation that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any it ederal statutes and regarments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITC Fatt 6075, accems (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.

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Page 2 - Ms. Kengen

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to organ maining of substantial equivalence of your device to a legally promative notification."> > results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrice for your 240) 276-0115. Also, please note the regulation entitled, Comact the Office of Complains and (E+) notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Caldera Medical, Inc. POPmesh 510(K)

Indications for Use

510(k) Number: K053424

Device Name: Caldera Medical, Inc. POPmesh™

Indications for Use:

POPmesh™ may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional uterovaginal prolapse and other fascial deficiencies that require temoral, and the sional decrovagnial processo and consection of procedures of for repair by the vaginal route.

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

()ver-The-Counter Use (21 CFR 807 Subpart C )

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

Device Evaluation (ODE) Concurrence of C

(Division Sign-Division of General, Restorative, and Neurological Devices

510(k) Number	K053424
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Page 28

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.