Cranial PSI Accessories are indicated for use as accessories to the OSSDSIGN Cranial PSI for the reconstruction of cranial defects. They are 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.

Device Description

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set.
Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile.
Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "OSSDSIGN Cranial PSI Accessories." This document focuses on demonstrating substantial equivalence to a predicate device and includes details on biocompatibility and performance testing of the accessories. However, it does NOT describe an AI/ML medical device, nor does it contain information about acceptance criteria or a study proving that an AI/ML device meets those criteria.

The document primarily focuses on physical, non-AI medical device accessories. Therefore, I cannot extract the requested information in the format of an AI/ML device study.

Here's why the prompt cannot be fulfilled from the provided text:

No mention of AI/ML: The document does not refer to any artificial intelligence, machine learning, algorithms, or software intended for automated analysis or diagnosis.
Device type: The described devices are physical accessories (Anatomical Model, Plastic Drawing Guide, Cranial Implant Trial) made from PA2200 polyamide, designed to aid in the implantation of a cranioplasty plate.
Testing methods: The performance tests detailed are related to physical properties like deformation, particle generation, and dimensional integrity, not algorithmic accuracy or clinical outcome prediction by an AI model.
Ground Truth/Experts: The concepts of "ground truth," "expert consensus," "human readers," "training set," or "test set" in the context of data used for AI model development or validation are absent.

Therefore, I must state that the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

OSSDSIGN AB % David Weissburg Principal Weissburg Associates 300 2nd Avenue SE. #14 St. Petersburg, Florida 33701

Re: K190523

Trade/Device Name: OSSDSIGN Cranial PSI Accessories Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: PJN Dated: September 9, 2019 Received: September 10, 2019

Dear David 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions 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

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801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190523

Device Name OSSDSIGN Cranial PSI Accessories

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

K190523

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 300 2ND Avenue SE, Suite 14 St. Petersburg, FL 33701 USA
1. Date prepared: October 10, 2019
1. Trade Name: OSSDSIGN Cranial PSI Accessories
Requlation Description: Preformed Non-alterable Cranioplasty Plate 5.
1. Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code: PJN)
1. Class: 2
1. Substantially equivalent to: OSSDSIGN Cranial PSI (Parent Device, K161090)
1. Device Description: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient's unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set.
- Anatomical Model Original supports OSSDSIGN Cranial PSI by facilitating visual and tactile orientation for the physician of the patient's anatomy. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
- Anatomical Model Modified supports OSSDSIGN Cranial PSI by facilitating visual ● and tactile orientation for the physician after removal of physician-specified regions. It is provided non-sterile, is not intended to be sterilized and is not to be brought into contact with Cranial PSI, Plastic Drawing Guide or the Cranial Implant Trial.
- Plastic Drawing Guide supports accurate placement and fitting of OSSDSIGN Cranial PSI by assisting physicians in marking of bone intended for removal. Provided sterile.
- Cranial Implant Trial supports placement and fitting of OSSDSIGN Cranial PSI by . assisting physicians in confirming OSSDSIGN Cranial PSI fit, fixation point positions and soft tissue coverage. Provided sterile.

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10. Indications for Use:

	OSSDSIGNCranial PSI Accessories (subject device)	OSSDSIGNCranial PSI (K161090) withoutCranial PSI Accessories
IndicationsFor Use	Cranial PSI Accessories areindicated for use as accessories tothe OSSDSIGN Cranial PSI for thereconstruction of cranial defects.They are indicated for non-loadbearing applications for patients inwhom cranial growth is completeand for use with an intact dura,with or without duraplasty.	OSSDSIGN Cranial PSI isintended for the reconstruction ofcranial defects. It is indicated fornon-load bearing applications forpatients in whom cranial growth iscomplete and for use with an intactdura, with or without duraplasty.
Materials	PA2200	Ti grade 23, proprietary calciumphosphate ceramic
Max size	200 cm²	200 cm²
Provided form	Formed PA2200	Titanium and CeramicCeramic mixed and cured inmanufacturer's facility
Sterility	Anatomical Model Original:provided non-sterileAnatomical Model Modified:provided non-sterilePlastic Drawing Guide: providedsterileCranial Implant Trial: providedsterile	Cranial PSI: provided sterile

11. Comparison of Technological Characteristics with the Predicate Device:

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		12. Biocompatibility of Cranial PSI Accessories:
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Test	Test Method Summary	Results
Cytotoxicity	ISO 10993-5Method:L-929 mouse fibroblast cells	Not cytotoxic.The test article extract showed nocytotoxic potential to L-929 mousefibroblast cells.
Systemic (acute)toxicity	ISO 10993-11Method: 20 mice observed at 4, 24,48 and 72 hours	No systemic toxicity.There was no mortality or evidenceof systemic toxicity from theextracts injected into mice.
SensitizationStudy	ISO 10993-10Method: Guinea Pig Maximizationscored at 24 and 48 hours	Not a sensitizer.No evidence of delayed dermalcontact sensitization.
Irritation Study	ISO 10993-10Method: Intracutaneous study inrabbits scored at 24, 48 and 72hours	Not an irritant.No evidence of irritation.
Pyrogen Study	USP 40-NF 35Method: IV injection in 3 rabbits	Non-pyrogenic.No rabbit showed a temperaturerise >0.5°C.
Hemolysis Study	ISO 10993-4Method: human blood	Non-hemolytic.The mean hemolytic index for thetest article extract was of 0.1%.
AnalyticalExtractableChemicalAnalysis	ISO 10993-18Method: extracts analyzed by FTIR,GC-MS, UPLC-MS, ICP-MS andGC-MS	Non-hazardous in all results.No leachables were detected inpotentially toxic concentrationsfrom a worst-case deviceconfiguration.

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Test Method and Relevance Summary	Results
Deformation Test:Resistance to deformation simulating aclinician pressing hard with a surgical markeragainst the Plastic Drawing Guide.Requirement: <1mm deviationMethod: test article supporting 200g weight	<1mm deformationin all cases
Simulated Clinical Use Study:Plastic Drawing Guide (PDG) evaluated for worstcase friction and generation of particles.Requirement: no visible particles generated duringthe test or clinically acceptable particles.Method: 10X 360° screw rotations and 2 cm droptest, 10X magnification and visual inspectionRelevance: there is slight friction associated withplacement and removal of PDG into itscorresponding anatomical location. This studysimulates normal placement with a 5X worst-casebias.	No visible particlesgenerated during thetest.
Dimensional Integrity Test:Verification of dimensional integrity and fit.Requirement: no dimensional changes to anydevices.Method: qualitative evaluation of fit after transport.Relevance: conforming manufacturing controlsand packaging and shipping system.	No dimensionalchanges to anydevices.

13. Performance Testing:

Conclusions: Nonclinical tests demonstrate that the Cranial PSI Accessories which are intended to be used with the Cranial PSI are substantially equivalent to the Cranial PSI.

Cranial PSI Accessories demonstrate biocompatibility consistent with current ● consensus standards.
Plastic Drawing Guide demonstrates resistance to deformation in excess of loading . applied in clinical use.

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).