OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with or with or with or without duraplasty.

Device Description

OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

AI/ML Overview

The provided document is a 510(k) summary for the OSSDSIGN Cranial PSI device. It includes information about acceptance criteria and mechanical/biocompatibility testing comparing it to a predicate device, but it does not describe studies involving human performance or assessment by experts. Therefore, many of the requested fields cannot be answered from this document.

Here's the information that can be extracted:

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

Test Method and Relevance Summary	Acceptance Criteria	OSSDSIGN Cranial PSI Performance	KLS Martin - PCI Titanium Mesh (Predicate) Performance
Dynamical Load Test: To verify that the Cranial PSI supports the forces exerted onto the implant from sleeping during the device lifetime. Method: orbital shaker, 125 rpm, 60 hours. Relevance: test simulates changed head position every 20 minutes during 8 hours sleep for 50 years.	No deformation	No deformation	No deformation
Max Force [N]: To establish the maximum force that can be applied to the device before failure. Method: Universal testing machine at 1 mm/min. Relevance: protection from falling objects and blunt trauma.	>100 N	461 N	383 N
Energy absorption [mJ]: To establish the maximum energy the device can absorb before failure. Method: Universal testing machine at 1 mm/min. Relevance: protection from falling objects and blunt trauma.	>1000 mJ	2260 mJ	3760 mJ
Resistance to Deformation [mm]: To establish device resistance to deformation before device failure. Method: Universal testing machine at 1 mm/min to 100 N applied force. Relevance: Both the subject device and predicate passed the test.	<6 mm	0.5 mm	1.1 mm

Biocompatibility Acceptance Criteria and Results:

Test	Test Method Summary	Acceptance Criteria (Implied by results)	Results for OSSDSIGN Cranial PSI
Cytotoxicity	ISO 10993-5 Method: L-929 mouse fibroblast cells	Not cytotoxic; No evidence of causing cell lysis or toxicity	Not cytotoxic; No evidence of causing cell lysis or toxicity
Sensitization	ISO 10993-10 Method: guinea pig maximization test	Non-sensitizer; No evidence of causing delayed dermal contact sensitization	Non-sensitizer; All test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
Sensitivity, Irritation	ISO 10993-6 Method: polar and non-polar test article extracts intracutaneously injected into five separate sites on the right side of the back of three rabbits. Observations for erythema and edema at 24, 48, and 72 hours.	Non-irritant; Difference between test and control mean scores <1.0	Non-irritant; Difference between the test and the control mean scores <1.0, confirming the device is a non-irritant
Systemic (acute) toxicity	ISO 10993-11 Method: 20 mice observed at 4, 24, 48 and 72 hours.	Non-toxic; No mortality or evidence of systemic toxicity	Non-toxic; No mortality or evidence of systemic toxicity
Genotoxicity	ISO 10993-3 Method: mouse lymphoma forward gene mutation assay.	Not mutagenic; <2-fold increase in mean mutant frequency	Not mutagenic; <2-fold increase in mean mutant frequency of the L5178Y/TK cell line.
Mutagenicity	ISO-10993-3 Method: bacterial reverse mutation study	Non-mutagenic; <2-fold increase in mutagenic frequency	Non-mutagenic; <2-fold increase in mutagenic frequency.
Implantation	ISO 10993-6 Test for local effects after implantation, 2- and 6-week subcutaneous implantations in rabbits.	Non-irritant compared to control	Non-irritant; Non-irritant compared to control.
Analytical Extractable Chemical Analysis	ISO 10993-12 Analysis by GC-MS, ICP-MS, LC-MS and HPLC-ELSD	Non-hazardous; No hazardous materials detected in various extractions	Non-hazardous in all results, including extractions in polar, non-polar and mid-polar solvents. No hazardous materials detected.
Indirect Hemolysis	ISO 10993-4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood	Hemolytic index within acceptable criteria (implied by "All samples passed the acceptance criteria")	The hemolytic index for the test article extract was 3.8% and the test article extract was slightly hemolytic. All samples passed the acceptance criteria.
Material Mediated Pyrogenicity	ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity, Pyrogen Test	Total rise of temperatures during the 3 hour observation period within acceptable limits; Nonpyrogenic (implied by results)	The total rise of temperatures during the 3 hour observation period was within acceptable limits. The test article was judged as nonpyrogenic. All samples passed the acceptance criteria.

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

Sample Size: The document does not specify a distinct "test set" sample size in the context of human data or image analysis. The tests mentioned are mechanical and biocompatibility tests performed on the device itself or in animal models/in vitro assays.
- For the mechanical tests, the "size" of the device tested was 197 cm² for both the subject device and the predicate. The number of individual samples tested is not stated.
- For biocompatibility:
  - Cytotoxicity: L-929 mouse fibroblast cells (number of cells/replicates not specified).
  - Sensitization: Guinea pigs (number not specified).
  - Irritation: 3 rabbits.
  - Systemic toxicity: 20 mice.
  - Genotoxicity: Mouse lymphoma cell line (L5178Y/TK).
  - Mutagenicity: Bacterial strains (not specified).
  - Implantation: Rabbits (number not specified) for 2- and 6-week implantation.
Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective) as it relates to clinical or imaging data, which are not part of this 510(k) summary. The company is based in Uppsala, Sweden.

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)

This information is not applicable as the document describes mechanical and biocompatibility testing of a physical device, not a diagnostic algorithm requiring ground truth established by human experts.

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

This information is not applicable as the document describes mechanical and biocompatibility testing of a physical device, not a diagnostic algorithm requiring adjudication of human expert interpretations.

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

This information is not applicable. No MRMC comparative effectiveness study involving human readers or AI assistance is mentioned in this 510(k) summary. The study is a non-clinical comparison of a device's physical properties with a predicate device.

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

This information is not applicable. This document evaluates a physical medical device (a cranial implant), not a standalone algorithm.

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

For the mechanical tests, the "ground truth" is defined by the objective performance measurements against pre-defined engineering requirements (e.g., no deformation, >100 N max force, <6 mm deformation).
For biocompatibility tests, the "ground truth" is established by the results of standardized biological assays (e.g., looking for cell lysis, sensitization, irritation, toxicity, mutagenicity, pyrogenicity) as per ISO standards. These are objective measures based on biological reactions.

8. The sample size for the training set

This information is not applicable. The device is a physical implant, not an AI algorithm that requires a training set. The term "training set" is not relevant to the described testing.

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

This information is not applicable for the reasons stated in point 8.

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 features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a thick, black line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

January 19, 2017

OSSDSIGN AB % David Weissburg Principal Weissburg Associates 808 Williamson Street, Suite 402 Madison, Wisconsin 53703

Re: K161090

Trade/Device Name: OSSDSIGN Cranial PSI Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PJN Dated: December 13, 2016 Received: December 14, 2016

Dear Mr. Weissburg:

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

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the quality systems (OS) 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 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,

Michael J. Hoffmann -S

for

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) K161090

Device Name OSSDSIGN Cranial PSI

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

K161090

1. 510(k) Owner Name and Address: OSSDSIGN AB Virdings Alle 2, SE 754 50, Uppsala Sweden Telephone: +46 (0) 18-55 39 93 Email: ub@ossdsign.com Contact: Ulrik Birgersson
1. Contact Person: David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA
1. Date prepared: January 18, 2017
1. Trade Name: OSSDSIGN Cranial PSI
Regulation Description: Preformed Non-alterable Cranioplasty Plate 5.
Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 6. 882.5330, Product code: PJN)
1. Class: 2
1. Substantially equivalent to: KLS Martin - Patient Contoured Mesh (K062570)
Device Description: OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that 9. replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient's unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.
1. Indications for Use: OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.
1. Comparison of Technological Characteristics with the Predicate Device :

	OSSDSIGNCranial PSI (K161090, subject device)	KLS MartinPatient Contoured Mesh(K062570, predicate)
Indications For Use	OSSDSIGN Cranial PSI is intended for the reconstruction of cranial defects. It is indicated for non-load bearing applications for patients in whom cranial growth is complete and for use with an intact dura, with or without duraplasty.	Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.
Materials	Ti grade 23, proprietary calcium phosphate ceramic	CP Titanium

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	OSSDSIGNCranial PSI (K161090, subject device)	KLS MartinPatient Contoured Mesh (K062570, predicate)
Titaniumthickness	0.4 – 1.6 mm	0.6 – 1.0 mm
Max size	200 cm²	200 cm²
Provided form	Titanium and CeramicCeramic mixed and cured in manufacturer's facility	Titanium only
Sterility on delivery	Sterile	Non-sterile

1. Testing vs. predicate:

	Results
Test Method and Relevance Summary	OSSDSIGN CranialPSI	KLS Martin - PCITitanium Mesh(K062570)
	Size: 197 cm²	Size: 197 cm2
Dynamical Load Test:To verify that the Cranial PSI supports the forcesexerted onto the implant from sleeping during thedevice lifetime.Requirement: no deformationMethod: orbital shaker, 125 rpm, 60 hours.Relevance: test simulates changed head positionevery 20 minutes during 8 hours sleep for 50years. Both the subject device and predicatepassed the test.	No deformation	No deformation
Max Force [N]To establish the maximum force that can beapplied to the device before failure.Requirement: >100 NMethod: Universal testing machine at 1 mm/minRelevance: protection from falling objects andblunt trauma. Both the subject device andpredicate passed the test. The subject deviceprovided moderately better performance than thepredicate.	461	383
Energy absorption [mJ]To establish the maximum energy the device canabsorb before failure.Requirement: >1000 mJMethod: Universal testing machine at 1 mm/minRelevance: protection from falling objects andblunt trauma. Both the subject device andblunt trauma. Both the subject device and	2260	3760

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predicate passed the test.
Resistance to Deformation [mm]To establish device resistance to deformationbefore device failure.Requirement: <6 mmMethod: Universal testing machine at 1 mm/min to100 N applied forceRelevance: Both the subject device and predicatepassed the test.	0.5 mm	1.1 mm

13. Biocompatibility:

Test	Test Method Summary	Results
Cytotoxicity	ISO 10993-5Method:L-929 mouse fibroblast cells	Not cytotoxicNo evidence of causing cell lysis ortoxicity
Sensitization	ISO 10993-10Method: guinea pig maximizationtest	Non-sensitizerAll test article extracts showed noevidence of causing delayeddermal contact sensitization in theguinea pig.
Sensitivity,Irritation	ISO 10993-6Method: polar and non-polar testarticle extracts intracutaneouslyinjected into five separate sites onthe right side of the back of threerabbits. Observations for erythemaand edema were conducted at 24,48, and 72 hours.	Non-irritantDifference between the test andthe control mean scores <1.0,confirming the device is a non-irritant
Systemic (acute)toxicity	ISO 10993-11Method: 20 mice observed at 4, 24,48 and 72 hours.	Non-toxicNo mortality or evidence ofsystemic toxicity
Genotoxicity	ISO 10993-3Method: mouse lymphoma forwardgene mutation assay.	Not mutagenic<2-fold increase in mean mutantfrequency of the L5178Y/TK cellline.
Mutagenicity	ISO-10993-3Method: bacterial reverse mutationstudy	Non-mutagenic<2-fold increase in mutagenicfrequency.
Implantation	ISO 10993-6Test for local effects afterimplantation, 2- and 6-weeksubcutaneous implantations inrabbits.	Non-irritantNon-irritant compared to control.
AnalyticalExtractableChemicalAnalysis	ISO 10993-12Analysis by GC-MS, ICP-MS, LC-MSand HPLC-ELSD	Non-hazardous in all results,including extractions in polar, non-polar and mid-polar solvents.No hazardous materials detected.
IndirectHemolysis	ISO 10993-4Biological evaluation of medicaldevices - Part 4: Selection of testsfor interactions with blood	The hemolytic index for the testarticle extract was 3.8% and thetest article extract was slightlyhemolytic.All samples passed theacceptance criteria.
Material MediatedPyrogenicity	ISO 10993-11Biological evaluation of medicaldevices - Part 11: Tests for systemictoxicity, Pyrogen Test	The total rise of temperaturesduring the 3 hour observationperiod was within acceptablelimits.The test article was judged asnonpyrogenic.All samples passed theacceptance criteria

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14. Conclusions:

Nonclinical tests demonstrate that Cranial PSI is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified in this summary.

Cranial PSI mechanical performance in a battery of life-style emulating test scenarios . shows substantial equivalence in mechanical effectiveness compared to the predicate device
. Cranial PSI demonstrated biocompatibility per current consensus standards

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).