The Kelyniam Custom Skull Implant (CSI) is designed individually for each patient to correct defects in cranial bone. The Kelyniam Custom Skull Implant (CSI) is individually sized and shaped implantable prosthetic cranioplasty plates intended to fill defects in a specific patient's cranial skeleton. The implants are composed of PEEK-OPTIMA, and are fabricated using the patient's CT imaging data. The implants are provided with .125" diameter pressure relief holes, equally spaced over the contour of the implant with .625″ centerline spacing and a minimum of .500″ edge margin. The devices are provided non-sterile for sterilization prior to implantation and are attached to the native bone with commercially available cranioplasty fasteners. This product is a single use device.

AI/ML Overview

The provided text is a 510(k) summary for the Kelyniam Custom Skull Implant (CSI) and discusses substantial equivalence to predicate devices, but it does not describe acceptance criteria or a study that specifically proves the device meets acceptance criteria in the manner typically expected for AI/software-based medical devices (e.g., performance metrics against a clinical ground truth).

Instead, the submission appears to be focused on demonstrating substantial equivalence to existing legally marketed devices based on intended use, material, technical specifications, and sterilization. The "study" mentioned directly relates to a biocompatibility test (Toxicity), not a performance study in the context of diagnostic accuracy or a human-AI comparison.

Therefore, many of the requested sections will be answered as "Not Applicable" or "Not Provided" based on the content of the document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Statement
Material	Composed of PEEK-OPTIMA or equivalent polymers.	Meets: "The implants are composed of PEEK-OPTIMA..." and the comparison table shows "PEEK-OPTIMA LT1" for Kelyniam CSI.
Form/Design	Individually sized and shaped; pressure relief holes (.125" dia, .625" centerline spacing, .500" edge margin).	Meets: "The Kelyniam Custom Skull Implant (CSI) is designed individually for each patient..." and "The implants are provided with .125" diameter pressure relief holes, equally spaced over the contour of the implant with .625″ centerline spacing and a minimum of .500″ edge margin."
Sterilization	Provided non-sterile for sterilization prior to implantation.	Meets: "The devices are provided non-sterile for sterilization prior to implantation..." and the comparison table confirms "Non-sterile."
Single Use	Single use device.	Meets: "This product is a single use device."
Biocompatibility (Toxicity)	Endotoxin levels lower than minimum requirements for medical devices in contact with cerebrospinal fluid (per LAL test).	Meets: "In these test, the Kelyniam Custom Skull Implants detected endotoxin levels were lower than the minimum requirements for medical devices in contact with cerebrospinal fluid."
Intended Use Equivalence	Intended to replace bony voids in the cranial skeleton, equivalent to predicate devices.	Meets: The "Substantial Equivalence Chart" directly compares the Kelyniam CSI's intended use ("Correction of defects in cranial bone") with predicate devices, all of which involve replacing bony voids or correcting defects in cranial/craniofacial bone. The 510(k) summary explicitly states equivalence based on this and other factors to multiple predicate devices (Synthes PSCI K053199, OsteoSymbionics K072601, KLS Martin K072707). The "Indications for Use Statement" confirms the intended use as "replacement of bony voids in the cranial skeleton."

Study Information (Based on provided document)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Provided / Not Applicable: The document describes a biocompatibility (Toxicity) test using Limulus Amebocyte Lysate (LAL). This is a laboratory test on the device material, not a clinical study involving a "test set" of patient data or cases. The sample size would refer to the number of devices tested or the replicates of the LAL test, which is not specified but is typically much smaller than a clinical sample size. No country of origin or retrospective/prospective status is relevant or provided for this type of test.
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 / Not Provided: Ground truth in the context of clinical performance (e.g., diagnostic accuracy) is not relevant to the LAL toxicity test. The "ground truth" for the LAL test is the regulatory standard for endotoxin levels.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / None: No adjudication method is relevant for a biocompatibility test.
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: No MRMC study was done, as this device is a physical implant, not an AI-assisted diagnostic tool.
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.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Regulatory Standard for Endotoxin Levels: For the toxicity test, the "ground truth" is the established regulatory limit for endotoxin levels in medical devices in contact with cerebrospinal fluid.
The sample size for the training set
- Not Applicable: This is a physical medical device, not a machine learning algorithm that requires a training set. The device is custom-manufactured for each patient based on their CT imaging data, but "training set" is not relevant here.
How the ground truth for the training set was established
- Not Applicable: As there is no training set for an algorithm, this question is not relevant.

Summary

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200 Myrtle Street, 2nd Floor, New Britain, CT 06053, 1-800-280-8192, FAX 501-641-2000

510(k) Summary Kelyniam Custom Skull Implant

APR 1 4 2011

510(k) Submitter Kelyniam Global, Inc. 200 Myrtle Street, 2nd Floor New Britain, CT 06053 (800) 280-8192
Contact Person: James Ketner President/CEO (800) 280-8192 (860) 832-9331, Ext 223 (501) 641-2000, Fax

Date of Summary: 25 October 2010

Proprietary Name: Kelyniam Custom Skull Implant (CSI) Device Name: Common Name: Patient-specific cranial implant Classification Name: "plate, cranioplasty, preformed, nonalterable,' a class II device in accordance with 21 CRF §882.5330

Panel: Neurology

Product Code: GXN

Device Description:

Indications for use:

The Kelyniam Custom Skull Patient Specific Cranial implant is intended to replace bony voids in the cranial skeleton.

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Toxicity

A series of Limulus Amebocyte Lysate (LAL) test were performed. In these test, the Kelyniam Custom Skull Implants detected endotoxin levels were lower than the minimum requirements for medical devices in contact with cerebrospinal fluid.

Substantial Equivalence:

The Kelyniam Custom Skull Implants (CSI) are substantially equivalent to the Synthes Patient Specific Cranial Implant (PSCI) (K053199), OsteoSymbionics Patient-Specific Cranial Implant (K072601) and KLS Martin Patient Contoured Mesh (K072707). Like these other devices, the Kelyniam Custom Skull Implant (CSI) is manufactured from PEEK or equivalent polymers, sold non-sterile and is customized to each patient.

	KelyniamCustom SkullImplant (CSI)	Synthes PatientSpecificCranial/CraniofacialImplant (PSCI)(K053199)	OsteoSymbionicsPatient-SpecificCranial Implant(K072601)	KLS MartinPatientContouredMesh(K072707)
Intended Use	Correction ofdefects incranial bone	Replace bony voidsin thecranial/craniofacialskeleton	Correct defectsin craniofacialbone	Replacebony voidsin the cranialand/orcraniofacialskeleton
Material	PEEK-OPTIMALT1	PEEK Optima-LT1	PolymethylMethacrylate(PMMA)	PEEK (PCM-P)
TechnicalSpecifications	Plate - Customsized to eachpatient usingCT data	Custom sized toeach patient	Plate - Customsized to eachpatient	Mesh -Customsized to eachpatient
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile

Substantial Equivalence Chart

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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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Mr. James Ketner President/CEO/Chairman Kelyniam Global. Inc. 200 Myrtle Street, 2nd Floor New Britain. CT 06053

APR 1 4 2011

Re: K103582

Trade Name: Kelyniam Custom Skull Implant (CSI) Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: II Product Code: GXN Dated: October 25, 2010 Received: January 25, 2011

Dear Mr. Ketner:

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. Ilsting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

for

Sincerely yours,

Keoia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Kelyniam Custom Skull Implant (CSI)

Indications for Use: Patient Specific Cranial implants are intended for the replacement of bony voids in the cranial skeleton.

Prescription Use Yes(Part 21 CFR 801 Subpart D)	Over-The-Counter Use No(21 CFR 801 Subpart C)
AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rusanau

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103582

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).