The Caldera Polypropylene Mesh is a mesh sling implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

Device Description

The Caldera Polypropylene Mesh is made of monofilament polypropylene mesh. The Caldera Polypropylene Mesh is a sterile, single-use mesh used to provide additional support to weak muscle in specific urological, gynecological, or gastroenterological procedures.

It is provided in a variety of pre-formed sizes and shapes as well as a large size that can be cut to size by the physician.

The Caldera Polypropylene Mesh is available as the mesh only, without accessory items.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Caldera Large Pore Monofilament Polypropylene Mesh. This submission is for a medical device and not an AI or algorithm-driven system. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this document.

The document discusses the regulatory approval process for a surgical mesh, focusing on its substantial equivalence to a legally marketed predicate device. The information provided is characteristic of a traditional medical device approval, not a study evaluating an algorithm's diagnostic or predictive performance.

Here's the relevant information that can be extracted or deduced from the provided text:

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

The document summarizes the basis for regulatory approval, which is "substantial equivalence" to a predicate device. This means the new device is as safe and effective as a device already on the market. Specific performance metrics are not given in an acceptance criteria table because the submission relies on similarity to an existing device rather than novel performance claims from a dedicated clinical study for this specific mesh.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to legally marketed predicate devices	Deemed substantially equivalent to predicate devices.
Biocompatibility	Testing performed and found appropriate.
Appropriate Physical Testing (as per FDA Guidance "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh")	Testing performed and found appropriate.
Sterility	The device is sterile (stated in Device Description).
Single-use	The device is single-use (stated in Device Description).

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

Not applicable. This is a 510(k) submission for a non-AI medical device based on substantial equivalence to a predicate device, not a performance study against a specific test set.

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. Ground truth establishment for a test set is not described as this is not a study assessing diagnostic performance.

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

Not applicable. No test set adjudication is mentioned.

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 a non-AI medical device; therefore, MRMC studies related to AI assistance are irrelevant.

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

Not applicable. This is a physical mesh device, not an algorithm.

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

Not applicable in the context of an algorithm's performance. For a medical device like surgical mesh, the "ground truth" for safety and effectiveness is established through adherence to recognized standards for biocompatibility and physical properties, and by demonstrating substantial equivalence to similar devices with a history of safe and effective use.

8. The sample size for the training set:

Not applicable. This is a non-AI medical device; there is no "training set" in the context of machine learning.

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

Not applicable. As above, there is no training set mentioned for this type of device submission.

Summary

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(A)

FEB 2 2 2006

Caldera Medical, Inc. Caldera Large Pore Monofilament Polypropylene Mesh K060004

510(k) Summary of Safety & Effectiveness

Date of Application:	December 30, 2005
Applicant:	Bryon L. Merade, CEOCaldera Medical, Inc.28632 Roadside Drive, Suite 260Agoura Hills, CA 91301Tel: (866) 422-5337 Fax: (818) 879-6556
Contact:	Marla KengenCaldera Medical, Inc.28632 Roadside Drive, Suite 260Agoura Hills, CA 91301Tel: (866) 422-5337 Fax: (818) 879-6556marla@calderamedical.com
Device Name:	Surgical Mesh (878.3300)
Trade Name:	Caldera Large Pore Monofilament PolypropyleneMesh
Common Name:	Surgical Mesh
Classification:	Class II
Registration Number:	9054589
Manufacturing Site:	Herniamesh s.r.l.Via Cirie 22/ASan Mauro TorineseTorino, Italy 10099Tel: +39 100 8227300Fax: +39 011 8221396
Sterilization Site:	Bioster S.p.a.Via Cà Bertoncina 29Seriate (BG), Italy 24068Tel: +39 35 302729Fax: +39 35 302515

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Caldera Medical, Inc. Caldera Large Pore Monofilament Polypropylene Mesh K060004

510(k) Summary of Safety & Effectiveness

Device Description

It is provided in a variety of pre-formed sizes and shapes as well as a large size that can be cut to size by the physician.

The Caldera Polypropylene Mesh is available as the mesh only, without accessory items.

Statement of Indications for Use

Testing

Testing has been performed on the Caldera Polypropylenc Mesh 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

. .

Public Health Service

FEB 2 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060004

Trade/Device Name: Caldera Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 27, 2006 Received: January 30, 2006

Dear Ms. Kengen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed 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 ass sured in the encreases 776, the enactment date of the Medical Device Amendments, or to conninered pror to that 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic recry the to nevice, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general volta on profitering practice, 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 your device is elaborired (dis anal 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 ean or found in the overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loase be actised that i Drivination that your device complies with other requirements of the Act that I DA has Intact a and regulations administered by other Federal agencies. You must or any I cactar stutures and registeries sincluding, but not limited to: registration and listing (21 Comply with an the Not of except 801); good manufacturing practice requirements as set Circle rate 607); accems (21 CFR Part 820); and if applicable, the electronic form in the quand by by and 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 his letter will anow you to oegin maneeting your and equivalence of your device to a legally premarket notification: "The PDT Interlassification 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 acrise is. J at (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Comphalled at (21 ) == Part 807.97). You may obtain Misolanumg by Telefone to premainer notificantonews the Act from the Division of Small other general information on your respense Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consultip://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Malkerson

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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Additional Information Requested: K060004 Caldera Large Porc Monofilament Polypropylene Mesh

(A) - Revised

Indications for Use Form

510(k) Number: KO60004

Device Name: Caldera Mesh

Indications For Use:

The Caldera Polypropylene Mesh is a mesh sling implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISID and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

Prescription Use - X (per 21 CFR 801 109)

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Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Of ice of Device Evaluation (ODE)

elame

Division of General, Restoral and Neurological Devices

510(k) Numbe K060004

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.