The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

AI/ML Overview

The provided text is a 510(k) summary for the Longeviti ClearFit OTS Cranial Implants. It focuses on demonstrating substantial equivalence to a predicate device, not on proving that a specific new device (such as an AI/ML powered device) meets acceptance criteria for classification tasks (e.g., detecting disease, segmenting organs).

Therefore, the document does not contain the information needed to answer questions 1-9 in the requested format, as those questions typically apply to studies evaluating the performance of AI/ML algorithms, especially in diagnostic or clinical decision support contexts.

The document discusses:

Device Description: Off-the-shelf polymethyl methacrylate (PMMA) cranial implants.
Intended Use: Correct and/or restore bony voids and/or defects of the cranium.
Comparison to Predicate: The key difference highlighted is that the subject device is a fixed-size implant, while the predicate is a patient-specific implant. However, the document emphasizes that they use the same materials and manufacturing processes.
Performance Testing: References several ASTM standards for tensile, flexural, and impact properties of plastics, stating that these tests were "passed" and are applicable due to similar materials and manufacturing.

It does not describe:

Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC).
A "study" in the sense of a clinical trial or algorithm performance evaluation using a test set of data with ground truth.
Sample sizes for AI training or test sets.
Expert involvement for ground truth establishment or MRMC studies.
Any AI/ML components.

Therefore, it is impossible to populate the requested table and answer the study-related questions based on the provided text, as this document pertains to a physical medical device (cranial implant) and not an AI/ML powered device.

Summary

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September 8, 2021

Longeviti Neuro Solutions, LLC Heather Hourihan, RAC Director of Regulatory Affairs 303 International Circle Suite 190 Hunt Valley, Maryland 21030

Re: K212058

Trade/Device Name: Longeviti ClearFit OTS Cranial Implants Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN, PJN Dated: July 21, 2021 Received: August 5, 2021

Dear Heather Hourihan:

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

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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 (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 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

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Indications for Use

510(k) Number (if known) K212058

Device Name

Longeviti ClearFit OTS Cranial Implants

Indications for Use (Describe)

The Longeviti ClearFit OTS Cranial Implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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LONGEVITI NEURO SOLUTIONS
510(k) Summary
Date Prepared:	September 8, 2021
Applicant:	Longeviti Neuro Solutions303 International Circle Suite 190Cockeysville, Maryland 21030(410) 527-1803
Contact Person:	Heather Hourihanhhourihan@longeviti.comDirector of Regulatory Affairs, RACLongeviti Neuro Solutions
SUBJECT DEVICE
Trade Name:	Longeviti ClearFit™ OTS Cranial Implants
Common Name:	PMMA cranial implant
Class:	2
Classification:	882.5330
Procode:	GXN, PJN
Predicate Device:	Longeviti ClearFit™ Cranial Implant K202901
Device Description:	The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are fixed sizeprosthetic cranioplasty plates intended to correct and/or restore bonyvoids and/or defects of the cranium. The implants are manufactured frompolymethyl methacrylate materials. The devices are provided sterile andcan be fixated to cranial bone using commercially available fasteners.
Indication for Use:	The Longeviti ClearFit™ OTS Cranial Implants are manufactured tocorrect and/or restore bony voids and/or defects of the cranium.
Comparison ofTechnologicalCharacteristics:	There are no significant technological differences between the LongevitiClearFit™ Cranial Implant (K202901) and the Longeviti ClearFit™ OTSCranial Implant. Longeviti manufactures ClearFit™ OTS Cranial Implantsusing the same raw materials and applying the same manufacturingprocesses used for their ClearFit™ Cranial Implant.

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Tabular Comparison of Technological Characteristics:
Characteristics	K212058Longevity ClearFit TMOTS Cranial Implant(Subject Device)	K202901Longevity ClearFit TMCranial Implant(Predicate Device)	Comments
Device Classification	Class II	Class II	Same
Product Code	GXN, PJN	GXN, PJN	Same
Indications for Use	The Longeviti ClearFit TMOTS Cranial Implantsare manufactured tocorrect and/or restorebony voids and/ordefects of the cranium.	The Longeviti ClearFit TMCranial Implant isdesigned andmanufacturedindividually for eachpatient to correct bonyvoids and/or defects ofthe cranium.	Similar
Material	Polymethylmethacrylate(PMMA)	Polymethylmethacrylate(PMMA)	Same
Design	Fixed Size Implant	Patient Specific Implant	Different
Dimensions (cm²)	9cm² - 37 cm²	25cm² - 411cm²	Similar
Maximum thickness	5mm	5mm	Same
Radiopacity	Radiolucent	Radiolucent	Same
Sterilization	Ethylene Oxide	Ethylene Oxide (EO) orVaporized HydrogenPeroxide (VHP)	Similar
Biocompatibility	Implant device withpermanent (>30 d)contact withtissue/bone	Implant device withpermanent (>30 d)contact withtissue/bone	Same

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Evaluations andResults to SupportSubstantialEquivalence:	Performance testing completed for the ClearFit™ (K202901) is applicable to theClearFit™ OTS as Longeviti uses the manufacturing processes and materialsvalidated for the ClearFit™ Cranial Implant to produce the ClearFit™ OTS CranialImplant. Performance testing completed includes:
	Method	Standard	Results
	Tensile	ASTM D638-19: Standard Test Method for TensileProperties of Plastics	Pass
	Flexural	ASTM D790-15:Standard Test Methods for Flexural Properties ofUnreinforced and Reinforced Plastics and ElectricalInsulating Materials	Pass
	Impact	ASTM D4812-10:Standard Test Method for Unnotched Cantilever BeamImpact Resistance of Plastics	Pass
Conclusion:	Based on the similarities of the intended use/indications for use, technologicaland functional characteristics, and the results of the non-clinical performancetesting, the ClearFit OTS cranial implant is substantially equivalent to the legallymarked 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).