Patient Contoured Mesh (PCM) is a custom shaped titanium panel that is pre-shaped to fit the anatomy of the patient using a CT based model of the patient. Patient Contoured Mesh (PCM) is fixated using standard KLS Martin's 1.5mm titanium screws (K971297)

AI/ML Overview

The provided text is a 510(k) summary for the KLS-Martin Patient Contoured Mesh (PCM) device, focusing on its substantial equivalence to predicate devices rather than a detailed study demonstrating quantitative performance against specific acceptance criteria. Therefore, most of the requested information cannot be found in the provided document.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Information

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

Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., strength, fit accuracy in a numerical range). The approval is based on "substantial equivalence" to predicate devices regarding materials and intended use.
Reported Device Performance: No specific quantitative performance data (e.g., mechanical test results, clinical outcomes data with specific metrics) is provided. The document highlights similarities in materials and intended use.

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 based on substantial equivalence, not a clinical trial or performance study with a test set of data.

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. There is no mention of a test set with ground truth established by experts.

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

Not applicable.

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 device is not an AI/software device, and no MRMC study or AI assistance is mentioned.

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

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

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

Not applicable.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning device.

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

Not applicable.

Summary of what is available from the document:

Device Name: Patient Contoured Mesh (PCM)
Intended Use: To replace bony voids in mandibular, maxillofacial or craniofacial skeleton.
Basis for Approval: Substantial equivalence to predicate devices (K052871, K053199, K033868, K944565, K971297).
Technological Characteristics (Similarities):
- Manufactured from titanium (similar to Stryker Custom TI Implant, Synthes Patient Specific Cranial/Craniofacial Implant).
- Materials and intended use for reconstructive procedures of the mandibular, maxillofacial or craniofacial skeleton (identical to KLS-Martin Micro Osteosynthesis System).
Technological Characteristics (Differences):
- PCM is manufactured from CP Titanium, whereas some predicate devices (Synthes Patient Specific Cranial/Craniofacial Implant) are manufactured from titanium and PEEK.

Summary

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kts martin,L.P.

K662570

510(K) SUMMARY

OCT 3 1 2006

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Submitter:	KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378
Contact Person:	Jennifer DamatoDirector RA/QA
Date of Summary:	18 August 2006
Device Name:	Patient Contoured Mesh (PCM)
Trade Name:	PCM
Common Name:	Titanium Panel
Classification Name and Number:	Plate, Cranioplasty, Preformed, Non-Alterable(CFR 882.5330)
Regulatory Class:	II
Predicate Devices:	Stryker Custom TI Implant (K052871)Synthes Patient Specific Cranial/CraniofacialImplant (PSCI) (K053199)Synthes (USA) Patient SpecificCranial/Craniofacial Implant (K033868)KLS-Martin Micro Osteosynthesis System(1.5 mm) (K944565)Centre-Drive Drill Free Screws (DFS)(K971297)
Intended Use:	Patient Contoured Mesh (PCM) is intended toreplace bony voids in mandibular, maxillofacialor craniofacial skeleton.
Device Description:	Patient Contoured Mesh (PCM) is a customshaped titanium panel that is pre-shaped to fitthe anatomy of the patient using a CT basedmodel of the patient. Patient Contoured Mesh

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K662570 4/2

(PCM) is fixated using standard KLS Martin's 1.5mm titanium screws (K971297)

Technological Characteristics:

Similarities to Predicate

Patient Contoured Mesh (PCM) and Stryker Custom TI Implant (K052871), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868) are patient specific implants that are manufactured from titanium.

Patient Contoured Mesh and KLS-Martin Micro Osteosynthesis System (1.5 mm) (K944565) are identical in materials and in the intended use for reconstructive procedures of the mandibular, maxillofacial or craniofacial skeleton.

Differences to Predicate

Patient Contoured Mesh (PCM) is manufactured from CP Titanium and Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868) are manufactured from titanium and PEEK

Substantial Equivalence:

Patient Contoured Mesh (PCM) is substantially equivalent in materials and patient specificity to the Stryker Custom TI Implant (K052871), Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) (K053199) and Synthes (USA) Patient Specific Cranial/Craniofacial Implant (K033868)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

OCT 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KLS-Martin L.P. % Ms. Jennifer Damato Director RA/QA 11239 St. Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K062570

Trade/Device Name: Patient Contoured Mesh Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: August 18, 2006 Received: August 31, 2006

Dear Ms. Damato:

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.

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 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); 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.

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Page 2 – Ms. Jennifer Damato

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Mark N. Melkerson

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

Enclosure

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Indications for Use

Kd2590

510(k) Number (if known):

Device Name: Patient Contoured Mesh (PCM)

Indications For Use:

Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.

Prescription Use S (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)
(Division Sign-Off)
Division of General, Resto and Neurological Devices
Page 1 of 1
510(k) Number	K062570

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).