OSSDSIGN Cranial PSI is an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in patients in whom cranial growth is complete and for use with an intact dura, 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 component of Cranial PSI resorbs and is replaced with bone during the healing process. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called OSSDSIGN Cranial PSI. It outlines the device's characteristics and its substantial equivalence to a predicate device. However, it does not include the detailed information about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies that would be necessary to fully answer your request.

The document states that "Nonclinical tests demonstrate that Cranial PSI is as safe and effective as its legally marketed predicate device," and mentions "in vivo studies show biocompatibility, adequate resorption rate and osteoconduction." but doesn't provide the acceptance criteria for these.

Based on the provided text, I can only provide the following information:

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

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility	In vivo studies show biocompatibility
Adequate Resorption Rate	In vivo studies show adequate resorption rate
Osteoconduction	In vivo studies show osteoconduction
Safety and Effectiveness	Nonclinical tests demonstrate as safe and effective as predicate device

Note: The document implies these as critical performance aspects, but does not explicitly state quantitative acceptance criteria or detailed performance metrics.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: 52-week sheep implantation study. The exact number of sheep is not specified.
Data Provenance: In vivo (animal study - sheep). The country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The study mentioned is an in vivo implantation study, which typically relies on pathological analysis rather than expert human interpretation of imaging.

4. Adjudication method for the test set:

This information is not provided in the document.

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 provided in the document. The device, OSSDSIGN Cranial PSI, is a patient-specific implant for cranial reconstruction, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable.

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

This information is not provided in the document. As mentioned, the device is an implant, not an algorithm.

7. The type of ground truth used:

For the in vivo implantation study, the ground truth would typically be established through histopathological analysis of tissue samples from the implanted area to assess biocompatibility, resorption, and osteoconduction.

8. The sample size for the training set:

This information is not provided in the document. The device is a physical implant, not a machine learning algorithm that requires a training set.

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

This information is not provided in the document, as it's not relevant to this type of device.

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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 1, 2021

OssDsign AB % David Weissburg Weissburg Associates 411 Walnut Street #16642 Green Cove Springs, Florida 32043-3443

Re: K212414

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: July 30, 2021 Received: August 3, 2021

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 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 of medical device-related adverse events) (21 CFR 803) for

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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-device-safety/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 Advice (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,

Adam D. Pierce, Ph.D. 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) K212414

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

K212414

1. 510(k) Owner Name and Address: OSSDSIGN AB Rapsgatan 23A SE 754 50, Uppsala Sweden Telephone: +46 (0) 18-55 39 93 Email: ia@ossdsign.com Contact: Jonas Åberg
1. Contact Person: David Weissburg Weissburg Associates 411 Walnut Street #16642 Green Cove Springs, FL 32043-3443 USA
1. Date prepared: October 1, 2021
1. Trade Name: OSSDSIGN Cranial PSI
1. Regulation Description: Preformed Non-alterable Cranioplasty Plate
1. Classification Name: Plate, Preformed Non-alterable Cranioplasty Plate (21 CFR 882.5330, Product code: PJN)
1. Class: 2
1. Predicate Device: OSSDSIGN Cranial PSI (K161090)
1. 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 component of Cranial PSI resorbs and is replaced with bone during the healing process. 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 an implant intended for the reconstruction of cranial defects. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The ceramic component of Cranial PSI resorbs and is replaced with bone during the healing process. Cranial PSI is indicated for use in 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: The subject device is identical to cleared predicate device OssDsign Cranial PSI K161090 in every way except the proposed labeling change.

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	OSSDSIGNCranial PSI (K212414, subjectdevice)	OSSDSIGNCranial PSI (K161090, predicate)
IndicationsFor Use	OSSDSIGN Cranial PSI is animplant intended for thereconstruction of cranial defects.These osseous defects aresurgically created or the result oftraumatic injury to the bone andare not intrinsic to the stability ofthe bony structure. The ceramiccomponent of Cranial PSI resorbsand is replaced with bone duringthe healing process. Cranial PSI isindicated for use in 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.
	the healing process. Cranial PSI isindicated for use in patients inwhom cranial growth is completeand for use with an intact dura,with or without duraplasty.
Materials	Ti grade 23, proprietary calciumphosphate ceramic	Ti grade 23, proprietary calciumphosphate ceramic
Titaniumthickness	0.4 – 1.6 mm	0.4 – 1.6 mm
Max size	200 cm²	200 cm²
Provided form	Titanium and CeramicCeramic mixed and cured inmanufacturer's facility	Titanium and CeramicCeramic mixed and cured inmanufacturer's facility
Sterility ondelivery	Sterile	Sterile

12. Performance Testing:

Test	Test Method Summary	Results
in vivoimplantation	52-week sheep implantation study,ISO 10993-6	in vivo studies showbiocompatibility, adequateresorption rate andosteoconduction.

13. Conclusion:

Nonclinical tests demonstrate that Cranial PSI is as safe and effective as its legally marketed 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).