OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

Device Description

OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the OSSDSIGN Cranioplug.

Upon reviewing the provided FDA 510(k) summary, it's important to note that this document describes a medical device (a burr hole cover) and its non-clinical testing, not a diagnostic AI/ML device. Therefore, many of the requested categories, such as data provenance, expert adjudication, MRMC studies, standalone performance with ground truth for AI, etc., are not applicable as this is not an AI/ML product.

The document focuses on demonstrating the substantial equivalence of the "OSSDSIGN Cranioplug" (subject device) to a legally marketed predicate device ("OSSDSIGN Cranioplug") through bench and biological performance testing.

Acceptance Criteria and Device Performance for OSSDSIGN Cranioplug

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied/Direct)	Reported Device Performance (OSSDSIGN Cranioplug003)
Energy absorption, flap reattachment	Sustained deformation energy comparable to predicate device.	Sustained deformation energy of 0.06 J (same as predicate).
Flap Fixation Dynamic Load	No flap deformation after simulating 50 years of sleep with hourly repositioning, comparable to predicate device.	No flap deformation. All Cranioplug models tested.
Cytotoxicity	No evidence of causing cell lysis or toxicity (ISO 10993-5 compliant).	No evidence of causing cell lysis or toxicity.
In vivo implantation (Biocompatibility)	Biocompatibility, adequate resorption rate, and osteoconduction (ISO 10993-6 compliant).	In vivo studies show biocompatibility, adequate resorption rate and osteoconduction.
Mechanical Performance	Meet mechanical performance for safety and efficacy (implicitly comparable to predicate).	The device provides mechanical performance for safety and efficacy.
Biologic Performance	Meet biologic performance for safety and efficacy (implicitly comparable to predicate).	The device provides biologic performance for safety and efficacy.

Note: The acceptance criteria are largely implied based on establishing substantial equivalence to the predicate device. The goal is to demonstrate that the new device performs as safely and effectively as the predicate.

Regarding AI/ML Specific Questions (Not Applicable to this Device):

The following questions are not applicable to the OSSDSIGN Cranioplug as it is a physical medical implant (burr hole cover), not an AI/ML diagnostic or assistive device.

2. Sample size used for the test set and the data provenance: Not applicable. This involves physical device testing, not data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI device involves expert annotations; for this physical device, "ground truth" is established by physical measurements and biological assays.
4. Adjudication method for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, "ground truth" is derived from standardized physical testing methods (e.g., universal testing machine, dynamic load simulation) and biological assays (cytotoxicity, in vivo implantation results/histology).
8. The sample size for the training set: Not applicable. This device does not have a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study (Non-Clinical for a Physical Device):

The study described is a non-clinical evaluation to demonstrate the substantial equivalence of the OSSDSIGN Cranioplug (subject device) to its predicate device (an earlier version of the Cranioplug, K140309).

Key aspects of the study:

Objective: To show that the subject device is as safe and effective as the predicate device, despite minor differences in materials (Titanium grade) and dimensions (titanium thickness, additional size).
Methodology: Bench testing and biological performance testing.
- Bench Testing:
  - Energy absorption, flap reattachment: Devices installed in an anatomical model and tested in a Universal Testing Machine to a 2mm displacement to determine deformation energy.
  - Flap Fixation Dynamic Load: Three Cranioplugs fixating a flap in an anatomical model, tested with an 8.5 kg head weight simulating 50 years of sleep with hourly repositioning.
- Biological Performance:
  - Cytotoxicity: ISO elution method (ISO 10993-5) using extracts in IX MEM at 37°C for 24 hours.
  - In vivo implantation: A 52-week sheep implantation study, compliant with ISO 10993-6.
Results: The subject device met the performance standards demonstrated by the predicate device in all tests.
- Energy absorption was identical to the predicate (0.06 J).
- No flap deformation observed under dynamic loading.
- No evidence of cytotoxicity.
- Biocompatibility, adequate resorption rate, and osteoconduction were observed in vivo.
Conclusion: Nonclinical tests demonstrate that OSSDSIGN Cranioplug003 is as safe and effective as its legally marketed predicate device.

Summary

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October 12, 2018

OssDsign AB % David Weissburg Prinicpal Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin 53703

Re: K181539

Trade/Device Name: OSSDSIGN Cranioplug Regulation Number: 21 CFR 882.5250 Regulation Name: Burr Hole Cover Regulatory Class: Class II Product Code: GXR Dated: September 10, 2018 Received: September 11, 2018

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. 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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Matthew C. Krueger -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) K181539

Device Name OSSDSIGN Cranioplug

Indications for Use (Describe)

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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510(k) SUMMARY

K181539

1. 510(k) Owner Name and Address: OssDsign AB Virdings Allé 2 SE 754 50, Uppsala Sweden Telephone: +46 (0) 18-55 39 93 Email: info@ossdsign.com Contact: Ulrik Birgersson
1. Contact Person: David Weissburg Weissburg Associates 808 Williamson St., Suite 402 Madison, Wisconsin, 53703 USA
ന് Date prepared: October 10, 2018
Trade Name: OSSDSIGN® Cranioplug 4.
1. Regulation Description: Burr Hole Cover
Classification Name: Cover, Burr Hole (21 CFR 882.5250, Product Code GXR) 6.
1. Class: 2
1. Predicate: K140309, Cranioplug, OssDsign
Device Description: OSSDSIGN Craniopluq003 is an osteoconductive calcium phosphate 9. ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators.
1. Intended Use / Indications For Use: OSSDSIGN Cranioplug is an implant intended to cover and plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery. These osseous defects are surgically created and are not intrinsic to the stability of the bony structure. The ceramic component of Craniopluq resorbs and is replaced with bone during the healing process. Cranioplug is indicated for use in adults and adolescents age 12 and older.

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		11. Comparison of Technological Characteristics with the Predicate Device:

	OSSDSIGN Cranioplug003(subject device)	OSSDSIGN Cranioplug001(Predicate, K140309)
Intended Use	OSSDSIGN Cranioplug isan implant intended to coverand plug holes drilled intothe skull during surgery andto reattach cranial boneremoved during surgery.These osseous defects aresurgically created and arenot intrinsic to the stabilityof the bony structure. Theceramic component ofCranioplug resorbs and isreplaced with bone duringthe healing process.Cranioplug is indicated foruse in adults andadolescents age 12 andolder.	OSSDSIGN Cranioplug isintended to cover and plugholes drilled into the skullduring surgery and to reattachcranial bone removed duringsurgery. It is cleared for use fornon-weight bearingapplications in adults andadolescents age 12 and older.
Materials	Ti grade 2,proprietary calcium phosphateformulation (same aspredicate)	Ti grade 3,proprietary calcium phosphateformulation
Re-sterilizable	No	No
Titanium thickness	0.4mm	0.5mm
Sizes (diameter)	11mm and 14mm	14mm
Ceramic hardening	Cured in manufacturer's facility	Cured in manufacturer's facility
Sterility on delivery	Sterile	Sterile
Shelf life	24 months	18 months

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1. Testing vs. predicate: Cranioplug003 and its predicate were tested for bench performance characteristics and biologic performance. Direct comparison of performance, safety and effectiveness of Cranioplug003 and its predicate demonstrates that Cranioplug003 is substantially equivalent to its predicate in all characteristics. The table below provides a summary of some of the tests completed.

Test	Test Method Summary	Results
Energyabsorption, flapreattachment	Device and predicate installed inanatomical model. Tested inUniversal Testing Machine to 2mmdisplacement to determinedeformation energy.	Subject device and predicate sustaineddeformation energy of 0.06 J.
Flap FixationDynamic Load	Flap fixated with 3 Cranioplugsinstalled in anatomic model. 8.5 kghead weight tested to simulate 50years of sleep with hourlyrepositioning.	No flap deformation. All Cranioplugmodels tested.
Cytotoxicity	ISO elution method, ISO 10993-5,extracted in IX MEM at 37°C for 24hours	No evidence of causing cell lysis ortoxicity.
in vivoimplantation	52-week sheep implantation study,ISO 10993-6	in vivo studies show biocompatibility,adequate resorption rate andosteoconduction.

1. Conclusions: Nonclinical tests demonstrate that Cranioplug003 is as safe and effective as its legally marketed predicate device.

Regulation Number and Section

§ 882.5250 Burr hole cover.

(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).