Meticuly patient-specific tianium mesh implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.

Device Description

Meticuly's Patient-specific Titanium Mesh Implant is a device designed individually to replace each patient's bony voids in the cranial and/or craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The subject device has been validated and tested with titanium screws with the diameter of 1.4 mm - 1.8 mm (K141452 : Jeil Medical's LeForte Neuro system screws). The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.

AI/ML Overview

The provided text describes the Meticuly Patient-Specific Titanium Mesh Implant and its substantial equivalence determination by the FDA. However, it does not contain the specific information requested regarding an AI/ML powered device, specifically:

It does not describe acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or F1-score, which are typical for AI/ML devices.
It does not specify sample sizes for test or training sets in terms of patient numbers or image counts, nor data provenance (country of origin, retrospective/prospective).
It does not mention the number or qualifications of experts used for ground truth, any adjudication methods, or MRMC comparative effectiveness studies.
It does not refer to standalone performance for an algorithm or the type of ground truth (e.g., pathology, outcomes data).

Instead, the document details the performance testing for a physical medical device (a patient-specific titanium mesh implant). The performance tests focus on material properties, manufacturing quality, biocompatibility, sterilization, packaging, and mechanical properties. The "comparative device modeling with Finite Element Analysis (FEA)", "comparative mechanical testing with modified compression test", and "comparative roughness testing" are all hardware-related validation activities, not AI/ML algorithm validation.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details for an AI-powered device based on the provided text, as the text describes a physical implant and its regulatory submission, not an AI/ML device.

Summary

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December 21, 2021

Meticuly Co., Ltd. Peeranoot Lohwongwatana Managing Director 32/77, Soi Samakkee 58/20, Samakkee rd., Tasai Muang Nonthaburi, Nonthaburi 11000, Thailand

Re: K210099

Trade/Device Name: Meticuly Patient-Specific Titanium Mesh Implant Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: November 17, 2021 Received: November 22, 2021

Dear Peeranoot Lohwongwatana:

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) K210099

Device Name

Meticuly Patient-specific Titanium Mesh Implant

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K210099

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary of the K210099 Meticuly Patient-Specific Titanium Mesh Implant:

1. Submitter Information

Company/Applicant:	Mrs. Peeranoot Lohwongwatana
	Managing Director
	Meticuly Co., Ltd.
	924 B bldg., Rm. B116-118, B210-212
	Soi Chula 7, Wang Mai, Pathum Wan
	Bangkok, Thailand 10330
	Telephone: +6688-834-7777
	Email: peeranoot@meticuly.com
Contact:	Paweena U-Thainual, PhD
	MDR Solutions Co., Ltd.
	1435, Kanjanapisek Rd., Bang Khae Nuea
	Bang Khae, Bangkok 10160 Thailand
	Telephone: +662-804-2101
	Email: paweena@mdrsolutions.co.th
Date Summary Prepared:	December 13, 2021
2. Device Name
Trade Name:	Meticuly Patient-Specific Titanium Mesh
Common Name:	Implant Preformed Nonalterable Cranioplasty
Classification Name:	Plate Neurology
Review Panel:	Neurology (NE)
Regulation:	882.5330
Class:	Class II
Product Code:	GXN

3. Predicate Device

Meticuly Patient-specific Titanium Mesh Implant is substantially equivalent to the following legally marketed predicate device:

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Applicant	Device Name	510(k) Number
Jeil MedicalCorporation	LaForte Neuro System Bone Plate and Screw	K141452

Table 1.1 Primary Predicate device

Table 1.2 Reference device*

Applicant	Device Name	510(k) Number
BioArchitects USA, LLC.	BioArchitects Patient SpecificCranial/Craniofacial Plate	K151692

*This device is referred to support the use of a similar material and manufacturing for the subject device

4. Description

5. Indications for Use

Meticuly Patient-specific Titanium Mesh Implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.

6. Comparison of Technological Characteristics with the Predicate Device

The subject device is substantially equivalent to the following legally marketed predicate devices. Meticuly Patient-specific Titanium Mesh Implant and the predicate devices have the similar characteristics, for example, indication for use, intended use, sterilization method, manufacturing method, device design, and device performance. The differences of these characteristics have been addressed with the provided performance test data in this submission and do not raised different questions of safety and effectiveness.

Table 2: Technical Characteristics in Comparison to the Predicate and Reference Devices
Devicecomparison	Subject Device:Meticuly Patient-specificTitanium Mesh Implant	Predicate Device: LeForteNeuro SystemBone Plate and Screw	Reference Device:BioArchitects PatientSpecific Cranial/CraniofacialPlate
510(K) number	K210099	K141452	K151692
Product Code(s)	GXN	GWO, GXR, HBW	GXN

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510(k) Summary

Table 2: Technical Characteristics in Comparison to the Predicate and Reference Devices
Devicecomparison	Subject Device:Meticuly Patient-specificTitanium Mesh Implant	Predicate Device: LeForteNeuro SystemBone Plate and Screw	Reference Device:BioArchitects PatientSpecific Cranial/CraniofacialPlate
Classification	Class II	Class II	Class II
Indications forUse	Meticuly Patient-specificTitanium Mesh Implant is adevice that is designedindividually for each patient.This device is intended foruse in selective trauma of thecranial and craniofacialskeleton (e.g., frontal bone,temporal bone, occipitalbone, parietal bone, sphenoidbone, supraorbital process,vomer), cranial andcraniofacial surgery, andreconstructive procedures.	This device is intended foruse in selective trauma of thecranial skeleton, cranialsurgery and reconstructiveprocedures.	The BioArchitects PatientSpecific Cranial/CraniofacialPlate implant device isintended to replace bonyvoids in the cranial and/orcraniofacial skeleton (e.g.,frontal bone, temporal bone,occipital bone, nasal bone,parietal bone, supraorbitalprocess, lacrimal bone,zygomatic bone, sphenoidbone, ethmoid process,vomer). It is a patientspecific device.
Material(s)	Titanium Ti-6Al-4V ELI(Grade23)	Commercially pure Titanium	Titanium alloy (Ti-6Al-4VELI)
TechnicalSpecifications	Custom-made to each patientusing CT data	Custom sized to each patient	Custom-made to each patientusing CT or MRI data
ManufacturingMethod	3D printed using laserpowder bed fusion additivemanufacturing	Machined and surface treatedby anodization	3D printed using electronbeam melting additivemanufacturing
FixationMethod	Commercially availabletitanium screws systems	Own plate and screw system	Commercially availabletitanium screws systems
Sterilization	Non-sterile	Non-sterile	Non-sterile

7. Performance Tests

Materials and manufacturing method quality of Meticuly Patient-specific Titanium Mesh Implant were assessed through physical properties and mechanical properties. The device testing was designed to validate the manufacturing process and to ensure that the subject device complicable voluntary consensus standards for biocompatibility, packaging, transportation, and sterilization and validation testing confirms that the product specifications have been met, demonstrating that the device will perform as intended. There were no unexpected results which indicate the suitable material used and manufacturing process compared to the standards for medical devices.

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Table 3: Testing and compliance standards summary table
Test	Standard (FDA recognition number)
Materials and manufacturing method	ASTM F3001-14 (8-439)Standard Specification for Additive ManufacturingTitanium-6 Aluminum-4 Vanadium ELI (Extra LowInterstitial) with Powder Bed Fusion
Biological evaluation and Biocompatibility	ASTM F756-17 Standard Practice for Assessment ofHemolytic Properties of MaterialsISO 10993-1 Fourth edition 2009-10-15 (2-220)Biological evaluation of medical devices - Part 1:Evaluation and testing within a risk management process[Including: Technical Corrigendum 1 (2010)]ISO 10993-3 Third edition 2014-10-1 (2-228)Biological evaluation of medical devices - Part 3:Testsfor genotoxicity carcinogenicity and reproductivetoxicityISO 10993-4:2017 Biological evaluation of medicaldevices - Part 4: Selection of tests for interactions withbloodISO 10993-5 Third edition 2009-06-01 (2-245)Biological evaluation of medical devices - Part 5:Testsfor in vitro cytotoxicityISO 10993-6 Third edition 2016-12-01 (20247)Biological evaluation of medical devices -- Part 6:Tests for local effects after implantationISO 10993-10 Third Edition 2010-08-01 (2-174)Biological evaluation of medical devices - Part 10:Testsfor irritation and skin sensitizationISO 10993-11 Third edition 2017-09 (2-255)Biological evaluation of medical devices - Part 11:Tests for systemic toxicity
Table 3: Testing and compliance standards summary table
Test	Standard (FDA recognition number)
Sterilization process control and validation	ANSI AAMI ST72:2011/(R)2016 (14-360)Bacterial endotoxins - Test methods routinemonitoring and alternatives to batch testing
	USP 42-NF37:2019 <85> Bacterial Endotoxins Test(14-533)
	USP 42-NF37:2019 <161> Medical Devices-BacterialEndotoxin and Pyrogen Tests (14-534)
	ISO 17665-1 First edition 2006-08-15 (14-333)Sterilization of health care products - Moist heat - Part1:Requirements for the development validation and routinecontrol of a sterilization process for medical devices
	ISO 11737-1 Third edition 2018-01 (14-514)Sterilization of health care products - Microbiologicalmethods - Part 1: Determination of a population ofmicroorganisms on product
	ISO 11737-2 Third edition 2019-12 (14-540)Sterilization of medical devices - Microbiologicalmethods - Part 2: Tests of sterility performed in thedefinition validation and maintenance of a sterilizationprocess
Packaging and transportation control andvalidation	ASTM F88/F88M-15 (14-482)Standard Test Method for Seal Strength of FlexibleBarrier Materials
	ASTM D7386-16 (5-113)Standard Practice for Performance Testing of Packagesfor Single Delivery Systems

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8. Pre-clinical performance test

The Meticuly Patient-specific Titanium Mesh Implant was mechanically tested for tensile and elastic strength, with test results similar to those of predicates. The performance of the subject device was assessed through three comparative tests. According to the Meticuly Patient-specific Titanium Mesh Implant is considered substantially equivalent to the predicate device.

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Table 4: Performance testing summary table
Test	Test method summary	Results
Comparative device modelingwith Finite Element Analysis(FEA)	Computational simulation wasperformed with a compression loadin the normal direction on thecenter of the mesh implant. Theload was applied on the surface ofthe implant. This static loadingrepresents a simulation of a relaxedperson resting on a pillow.	The FEA consideration is based onmaximum equivalent stress, safetyfactor and maximum deformation.The result of the comparative testshows that the subject device issubstantially equivalent to thepredicate device.
Comparative mechanicaltesting with modifiedcompression test	- The subject device and thepredicate device were designed orshaped into a similar design. Bothsubject device and predicatedevice were fixated onto theplastic anatomic model thatrepresented the skull with screws.- Compression test was performedunder the displacement control tomaximum displacement in thenormal direction on the center ofthe mesh implant.	The mechanical consideration isbased on the stiffness and energyabsorption. The result of thecomparative test shows that thesubject device is substantiallyequivalent to the predicate device.
Comparative roughness testingvia non-contact method	The surface roughness evaluationwas performed following the ISO4288 and ISO 25178.	The result of the comparative testshows that the subject device issubstantially equivalent to thepredicate device.
Device fidelity and validationof device dimensional fit	Confirm the design qualificationand fidelity of the device with thequality instruments.	The results show the fidelity of thedevice and the traceability betweenthe CT scan data and the finalproduct.

9. Conclusion

Based upon testing and comparison to the predicate device, the Meticuly Patient-specific Titanium Mesh Implant has the same intended use and similar technological characteristics. The device performs as intended and does not raise new questions of safety or effectiveness; Thus, the subject device is concluded to be substantially equivalent to the legally commercialized predicate devices for the purposes of this 510(k) submission.

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).