The Patient Contoured Implant – PEEK (PCI-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.
The purpose of this premarket notification is to offer the implants sterile.

AI/ML Overview

This document is a 510(k) premarket notification for the KLS Martin L.P. Patient Contoured Implant - PEEK (PCI-PEEK). However, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Patient Contoured Mesh - PEEK (PCM-P) [K072707]). This means the submission argues that the new device is as safe and effective as the predicate device because it shares similar characteristics and intended use.

Here's a breakdown of the information provided, specifically addressing your request:

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

Not provided. This document does not specify performance acceptance criteria in terms of metrics like accuracy, reliability, or specific functional outputs. The focus is on demonstrating equivalence in design, 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 for performance testing. There is no "test set" in the context of typical AI/software performance evaluation. The substantial equivalence argument relies on comparing the characteristics of the new device to the predicate.
Biocompatibility testing: The document mentions LAL endotoxin testing. While a "sample size" isn't explicitly stated for this, it's typically performed on batches of devices. Data provenance is not specified beyond "LAL endotoxin testing demonstrates...".

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 "test set" requiring ground truth established by experts for performance evaluation in this type of submission.

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

Not applicable. See point 3.

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

No. This is a hardware implant, not an AI or software device. Therefore, no MRMC study or AI-related effectiveness study was conducted or is applicable.

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

No. This is a hardware implant, not an algorithm.

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

Not applicable. See point 3. The "ground truth" for this submission revolves around established safety and effectiveness of the predicate device, and the biocompatibility of the material.

8. The sample size for the training set

Not applicable. This is a hardware implant, not an AI/machine learning model that requires a training set.

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

Not applicable. See point 8.

Information provided related to "acceptance criteria" and "study" (in the context of substantial equivalence):

The document primarily discusses biocompatibility testing as the relevant "study" for the new device.

Biocompatibility Testing:
- The evaluation was conducted in accordance with FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1.
- The patient-contacting material (PEEK) is the same as the predicate device (K072707), with identical chemical composition, manufacturing processes, and permanent body contact duration.
- Specific performance finding: LAL endotoxin testing demonstrated that the sterile PEEK implant conforms to the required < 2.15 EU/device endotoxin lot release specification. This is the closest thing to an "acceptance criterion" and "reported performance" for the sterile aspect of the device.
Clinical Studies:
- "Clinical testing was not necessary for the determination of substantial equivalence." This explicitly states that no clinical studies were performed for this submission.

Conclusion from the document:

The KLS Martin L.P. Patient Contoured Implant - PEEK (PCI-PEEK) is deemed substantially equivalent to its predicate because it has the same intended use, design, function, and material composition. The only difference is that the new device will be offered in sterile packaging. The manufacturer argues that these similarities do not raise new safety or effectiveness issues.

Summary

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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

November 9, 2015

KLS Martin L.P. Ms. Jennifer Damato Director of Quality MGT & Regulatory Affairs P.O. Box 16369 Jacksonville, Florida 32245-6369

Re: K151382

Trade/Device Name: Patient Contoured Implant - PEEK (PCI-PEEK) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: October 7, 2015 Received: October 8, 2015

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. 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. 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Carlos L. Pena -S/A

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151382

Device Name

Patient Contoured Implant - PEEK (PCI-PEEK)

Indications for Use (Describe) The Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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KIST

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 • Fax 904-641-7378 www.klsmartinnorthamerica.com

510(k) Summary Section 21 CFR 807.92

Submitter:	KLS-MARTIN L.P.
	11201 Saint Johns Industrial Pkwy S
	Jacksonville, FL 32246
Contact Person:	Jennifer DamatoDirector of Quality MGT & Regulatory AffairsPhone: 800-625-1557Fax: 904-641-7378
Date Prepared:	November 4, 2015
Trade Name:	Patient Contoured Implant - PEEK (PCI-PEEK)
Common Name:	Preformed Plate
Classification:	Plate, Cranioplasty, Preformed, Non-alterableClass II, 21 CFR 882.5330, Product Code GXN
Predicate Devices:	Patient Contoured Mesh – PEEK (PCM-P) [K072707]
	No reference devices were used in this submission.

Device Description:

The purpose of this premarket notification is to offer the implants sterile.

Indications for Use:

The Patient Contoured Implant – PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.

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KLS martın LP.

Technological Characteristics / Substantial Equivalence:

	Patient Contoured Implant – PEEK (PCI-PEEK)(Subject Device)	Patient Contoured Mesh – PEEK (PCM-P)(Predicate: K072707)
Indications for Use	The Patient Contoured Implant – PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.	Patient Contoured Mesh – PEEK (PCM-P) is intended to replace bony voids in the crania and/or craniofacial skeleton.
Anatomical Sites	Cranial	Craniomaxillofacial
Material	PEEK	PEEK
Style	Solid or solid with holes	Solid or solid with holes
Sterilization	Provided Sterile (Gamma)	Provided Non-sterile (Steam)
Method of Fixation	Titanium Screws and Titanium Plates	Titanium Screws and Titanium Plates
Where used (hospital, home, ambulance, etc)	Health Care Facilities / Hospitals	Health Care Facilities / Hospitals

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Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The letters "KLS" are in red, while "martin" is in gray. The letters "L.P." are in black and are slightly smaller than the other letters in the logo.

Performance Data:

Biocompatibility Testing

The biocompatibility evaluation for the Patient Contoured Implant - PEEK (PCI-PEEK) was conducted in accordance with the FDA Blue Book Memorandum #G95-1, "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process,' as recognized by FDA.

The patient-contacting material PEEK (Polyether ether ketone) used for the Patient Contoured Implant – PEEK (PCI-PEEK) is previously cleared in K072707. The implant has identical chemical composition, undergoes identical manufacturing processes, and has the same permanent body contact duration as the predicate, K072707.

LAL endotoxin testing demonstrates that the sterile PEEK implant conforms to the required < 2.15 EU/device endotoxin lot release specification.

Clinical Studies

Clinical testing was not necessary for the determination of substantial equivalence.

Substantial Equivalence Conclusion:

The subject device, Patient Contoured Implant - PEEK (PCI-PEEK), has the same intended use, design, function, and is composed of the same material as the predicate, Patient Contoured Mesh - PEEK (PCM-P). The subject device differs from the predicate in that it will be offered in sterile packaging. The similarities in technological characteristics do not raise new issues of safety or effectiveness and demonstrate substantial equivalence to the predicate device.

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).