The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

Device Description

The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is a preformed non-alterable cranioplasty plate that cannot be altered or reshaped at the time of surgery and is designed to be implanted in a patient to repair a skull defect.
The subject device is composed of commercially pure (CP) Grade 2 titanium per ASTM F67. The manufacturing process is subtractive manufacturing (CNC milled) from models created and developed from patient specific CT Scan Data. The software used in this process is identical to the software used in the predicate device (K110684). The device is designed to have, as requested by the physician, drainage holes over the defect void area, fixation holes over an onlay area, and retractions and other features that fall within the approved design envelope. All designs must be approved by the physician prior to manufacture.

AI/ML Overview

The provided document describes the MedCAD AccuShape Titanium Patient-Specific Cranial Implant and its substantial equivalence to a predicate device (MedCAD AccuShape PEEK Patient Specific Cranial Implant) based on non-clinical performance testing.

It is important to note that this document does not describe an AI/ML-driven device or study parameters typical for such devices (e.g., ground truth establishment for a training set, human reader studies, or expert consensus on clinical data). The device described is a physical cranial implant, and the study referenced in the document is a series of non-clinical performance tests designed to assess the physical and mechanical properties of the implant, not its diagnostic or predictive accuracy in an AI context.

Therefore, many of the requested bullet points, particularly those pertaining to AI/ML device evaluation (like sample size for test/training sets of data, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to the information provided in this document.

However, I can extract information relevant to the device's acceptance criteria and the non-clinical performance testing performed for this physical device.

Here's an interpretation of the "acceptance criteria" and "study" as presented for a physical medical device, rather than an AI/ML diagnostic:

Device: MedCAD AccuShape Titanium Patient-Specific Cranial Implant (K220357)

Purpose of the "Study" (Non-Clinical Performance Testing): To demonstrate the substantial equivalence of the MedCAD AccuShape Titanium Patient-Specific Cranial Implant to its predicate device (MedCAD AccuShape PEEK Patient Specific Cranial Implant, K110684) by evaluating its physical and mechanical properties.

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

Test	Acceptance Criteria (Inferred from "Results" and "Test Method Summary")	Reported Device Performance (Results)
MR Compatibility Testing	To characterize the device's behavior in a Magnetic Resonance Environment per ASTM F2503-20. The acceptance is a clear designation regarding MR compatibility (e.g., safe, unsafe, conditional).	The subject device was characterized to be MR Unsafe. This designation is noted in the labeling.
Screw Fixation Testing	Verification that fixation retention of the implant at the point of fixation of the screw is at least as strong as the axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model.	PASS: The fixation retention of the implant at the point of fixation of the screw is at least as strong as the axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model.
Evaluation of Fit Testing	Manufactured implant, based on worst-case CT data (1.25mm scan thickness) from historical cases, must optically align with the 3D model and must fit over the corresponding defect in a representative anatomical model when evaluated by qualified inspectors. Predetermined acceptance criteria must be met.	PASS: All samples met the predetermined acceptance criteria.
Comparative Strength	The subject device must demonstrate substantial equivalence in strength to the predicate device (K110684 AccuShape PEEK) when subjected to a load/displacement test until failure, ensuring similar mechanical performance for the same defect geometry and fixation.	PASS: The subject device was substantially equivalent to the predicate device. (Implies that the load/displacement curves and failure points demonstrated comparable mechanical performance to the predicate when tested under identical conditions).

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

Sample Size for Test Set:
- Evaluation of Fit Testing: "3 large defect predicate historical cases (K110684)" were used to generate "worst case CT data". The number of manufactured implants tested is implied to be at least 3 (one for each case). The phrase "All samples" in the result suggests a specific number of manufactured implants were produced and tested, but the exact number isn't quantified beyond the 3 cases used for input data.
- Comparative Strength: "Identical subject and predicate devices" were used, implying at least one (and likely more for statistical significance, though not stated) of each type (titanium and PEEK) for comparative testing.
- Screw Fixation: Not explicitly stated, but implies multiple tests to determine "at least as strong as" criteria.
- MR Compatibility: At least one device (or representative sample) would be tested.
Data Provenance: The "worst case CT data" for the Evaluation of Fit testing came from "3 large defect predicate historical cases (K110684)". This suggests a retrospective use of previously acquired clinical data (CT scans) from actual patients. The country of origin is not specified but is implicitly USA, given this is an FDA submission.

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

This concept is not directly applicable in the context of this device's non-clinical testing. The "ground truth" (or reference standard) is based on engineering specifications, material properties, and established test methodologies (e.g., ASTM standards, previous FDA-cleared device performance).
For the "Evaluation of Fit Testing," "qualified inspectors" performed the evaluation. Their qualifications (e.g., years of experience, specific certifications) are not detailed beyond "qualified".

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

Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers interpreting medical images, where discrepancies need to be resolved. This document describes physical, non-clinical tests.

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. This device is a physical implant, not an AI/ML diagnostic tool, and no human reader study was performed.

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

Not applicable. This is not an AI algorithm. The manufacturing software is mentioned (same as predicate device), but its performance in terms of design output is assessed through the physical device tests (e.g., Evaluation of Fit), not as a standalone AI model.

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

The "ground truth" for these tests is based on:
- Engineering Specifications/Standards: e.g., ASTM F2503-20 for MR compatibility.
- Predicate Device Performance: For comparative strength, the performance of the legally marketed predicate device (K110684 PEEK implant) served as the benchmark.
- Established Biomechanical Principles: For screw fixation, comparison to "axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model" serves as the reference.
- 3D Digital Models/Physical Prototypes: For "Evaluation of Fit," the 3D digital model of the implant and representative anatomical models served as the reference for fit.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a "training set" of data in the machine learning sense. The manufacturing process uses patient-specific CT scan data as input for design, but this is not a training set for an AI model.

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

Not applicable, as there is no AI/ML training set in this context.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

August 26, 2022

MedCAD % Linda Braddon, Ph.D. CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188

Re: K220357

Trade/Device Name: MedCAD AccuShape Titanium Patient-Specific Cranial Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: July 20, 2022 Received: July 20, 2022

Dear Dr. Linda Braddon:

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

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220357

Device Name

MedCAD AccuShape Titanium Patient-Specific Cranial Implant

Indications for Use (Describe)

The MedCAD AccuShape Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY: MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant

Date Prepared	August 26, 2022
Sponsor Contact	MedCADBrian Buss501 S 2nd Ave, Suite A-1000Dallas, TX 75226(214) 453-8864brian@medcad.com
	510(k) Contact	Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com
		Trade Name	MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant
		Common Name	Cranial Implant
		Code –Classification	Classification Name: Preformed nonalterable cranioplasty plate (21 CFR 882.5330)Regulatory Class: IIProduct Code: GXN
Predicate Device			K110684 MedCAD® AccuShape® PEEK Patient Specific Cranial Implant
Reference Device	K053199 Synthes Patient Specific Cranial ImplantK193280 MedCAD® AccuPlate® Patient-Specific PlateK192282 MedCAD® AccuPlan® System

{4}------------------------------------------------

Device Description	The MedCAD® AccuShape® Titanium Patient-Specific CranialImplant is a preformed non-alterable cranioplasty plate that cannot bealtered or reshaped at the time of surgery and is designed to beimplanted in a patient to repair a skull defect.The subject device is composed of commercially pure (CP) Grade2 titanium per ASTM F67. The manufacturing process issubtractive manufacturing (CNC milled) from models created anddeveloped from patient specific CT Scan Data. The software usedin this process is identical to the software used in the predicatedevice (K110684). The device is designed to have, as requested by thephysician, drainage holes over the defect void area, fixation holesover an onlay area, and retractions and other features that fallwithin the approved design envelope. All designs must beapproved by the physician prior to manufacture.
Indications for UseStatement	The MedCAD® AccuShape® Titanium Patient-Specific CranialImplant is designed individually for each patient and intended to correctdefects / replace bony voids in the cranial skeleton.

Device Description

The MedCAD® AccuShape® Titanium Patient-Specific CranialImplant is a preformed non-alterable cranioplasty plate that cannot bealtered or reshaped at the time of surgery and is designed to beimplanted in a patient to repair a skull defect.The subject device is composed of commercially pure (CP) Grade2 titanium per ASTM F67. The manufacturing process issubtractive manufacturing (CNC milled) from models created anddeveloped from patient specific CT Scan Data. The software usedin this process is identical to the software used in the predicatedevice (K110684). The device is designed to have, as requested by thephysician, drainage holes over the defect void area, fixation holesover an onlay area, and retractions and other features that fallwithin the approved design envelope. All designs must beapproved by the physician prior to manufacture.

Indications for UseStatement

The MedCAD® AccuShape® Titanium Patient-Specific CranialImplant is designed individually for each patient and intended to correctdefects / replace bony voids in the cranial skeleton.

Comparison of Technological Characteristics

Characteristic	Subject DeviceMedCAD® AccuShape®Titanium Patient-SpecificCranial Implant	Predicate DeviceMedCAD® AccuShape®PEEK Patient SpecificCranial ImplantK110684
Device Classification	Class II	Class II
Product Code	GXN	GXN
Indications for Use	The MedCAD®AccuShape® TitaniumPatient-Specific CranialImplant is designedindividually for each patientand intended to correctdefects / replace bony voidsin the cranial skeleton.	The MedCAD®AccuShape® PEEK PatientSpecific Cranial Implant isdesigned individually foreach patient and intended tocorrect defects / replace bonyvoids in the cranial skeleton.
Material	Commercially pure (CP)titanium	PEEK
Design	Patient Specific Implant	Patient Specific Implant
Dimensions	Min: 10mm x 10mmMax: 200mm x 200mm	Min: 10mm x 10 mmMax: 200mm x 200mm

{5}------------------------------------------------

Characteristic	Subject DeviceMedCAD® AccuShape®Titanium Patient-SpecificCranial Implant	Predicate DeviceMedCAD® AccuShape®PEEK Patient SpecificCranial ImplantK110684
Maximum Thickness	5mm	5mm
Attachment Method	Commercially availablefixation systems	Commercially availablefixation systems
Modifications	No Modifications allowed	No Modifications allowed
Non-Pyrogenic	Yes	Yes
Sterility	Provided non-sterile, to besteam sterilized	Provided non-sterile, to besteam sterilized
Biocompatibility	Implant device withpermanent (>30 days)contact with tissue and bone	Implant device withpermanent (>30 days) contactwith tissue and bone

Technological Characteristics

There are no significant technological differences between the subject and predicate device. The subject device uses the same material as the reference device (K053199) and all devices are manufactured using subtractive techniques.

Non-Clinical Performance Testing Summary

Performance testing for the MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is summarized in the table below:

Test	Test Method Summary	Results
MRCompatibilityTesting	Per ASTM F2503-20: Standard Practice ForMarking Medical Devices And Other Items ForSafety In The Magnetic ResonanceEnvironment	The subject device wascharacterized to be MRUnsafe . Thisdesignation is noted inthe labeling.
Screw FixationTesting	Verification that fixation retention of theimplant at the point of fixation of the screw is atleast as strong as the axial pullout forcesmeasured in prior testing of FDA-cleared neuroscrews in an established cortical bone model.	PASSThe fixation retention ofthe implant at the pointof fixation of the screwis at least as strong asthe axial pullout forcesmeasured in priortesting of FDA-clearedneuro screws in anestablished cortical bonemodel.

{6}------------------------------------------------

Test	Test Method Summary	Results
Evaluation of FitTesting	Subject devices using worst case CT data(1.25mm scan thickness) from 3 large defectpredicate historical cases (K110684) withknown CT scanners and configurations wereused. The manufactured implant was opticallyscanned to verify alignment with the 3D model.Evaluation of fit was also validated by qualifiedinspectors by fitting the implant over thecorresponding defect in a representativeanatomical model.	PASSAll samples met thepredeterminedacceptance criteria.
ComparativeStrength	Identical subject and predicate devices(K110684 AccuShape PEEK) were used fortesting. Pre-drilled fixation holes were placed atidentical locations on all fixtures to ensure thatall test samples were fixated at the samelocations. All devices were applied to the samedefect (same fit and fixation). A plunger wasused to displace the center of each implant untilfailure. Load / displacement curves werecollected.	PASSThe subject device wassubstantially equivalentto the predicate device.

Conclusions

Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the 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).