The OsteoSync™ Ti Dental Mesh is a system of dental membranes intended for permanent fixation in adults and designed to aid in the reconstruction and augmentation of the alveolar ridges of the maxilla and mandible. They are available in a variety of sizes and shapes and can be contoured to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold sterile.

AI/ML Overview

The provided document is a 510(k) Summary for the OsteoSync™ Ti Dental Mesh, which is a medical device. This type of document is concerned with demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study in the way one might for a novel diagnostic AI algorithm.

Therefore, many of the specific questions about acceptance criteria, study types, sample sizes, and expert adjudication as they pertain to algorithm performance are not directly applicable to this device submission. The device is a physical dental mesh, and its evaluation focuses on material properties, mechanical performance, biocompatibility, sterilization, and shelf-life, typically compared against standards and known predicate devices.

However, I can extract information related to the device's "acceptance criteria" in the context of its non-clinical testing and the "studies" that support its substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of acceptance criteria and device performance in the format typically used for AI algorithm evaluation (e.g., sensitivity, specificity). Instead, it lists non-clinical tests and their outcomes, indicating that the device "met the predetermined acceptance criteria."

Test Category	Acceptance Criteria (Implied / Stated)	Reported Device Performance
Mechanical Testing	N/A (Worst-case devices evaluated per ASTM F564)	N/A (Implied to be acceptable for substantial equivalence)
Biocompatibility	Mitigation of risks with respect to biocompatibility.	Supported by a biological risk assessment and preclinical animal studies leveraged from an FDA authorized master file.
Sterilization	Sterility Assurance Level (S.A.L.) of 10⁻⁶.	Achieved the predetermined acceptance criteria for S.A.L. of 10⁻⁶.
Shelf-Life	Five-year shelf-life.	Met the predetermined acceptance criteria for a five-year shelf-life.
Pyrogenicity	Bacterial endotoxin limit of 20 EU/device.	Bacterial endotoxin testing results met the predetermined pyrogen limit of 20 EU/device.
Dimensional	Dimensional differences from predicates do not raise new questions of substantial equivalence.	Overall dimensions (thickness, pore diameter, insert diameter, widths, lengths) were found to be within or to extend the range of predicate devices without raising new questions of substantial equivalence.
Surface Texture	Surface texture of the subject device (smooth/smooth or smooth/rough) supported by preclinical animal studies.	The roughened side is intended to assist in securing the mesh to bone; preclinical animal studies in a canine model provided support for this design.

2. Sample Size Used for the Test Set and Data Provenance

Mechanical Testing: "worst-case devices were evaluated." (Specific sample size not provided, but implies a selection of device configurations).
Biocompatibility/Preclinical Animal Studies: Not specified, but animal studies (in a canine model) were leveraged from an FDA-authorized master file. Data provenance is implied to be from these leveraged studies.
Sterilization Validation: Not specified.
Shelf-Life Validation: Not specified, but "sterile integrity was verified by visual, seal strength and seal integrity evaluations."
Pyrogenicity (Bacterial Endotoxin Testing): Not specified.

It is important to note that these are not "test sets" in the context of validating an AI algorithm, but rather samples used for physical and biological testing of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as there is no "ground truth" to be established by experts in the context of an AI algorithm's diagnostic performance for this physical medical device submission. The "ground truth" for the non-clinical tests is determined by standardized test methods and criteria (e.g., ASTM standards for mechanical testing, ISO standards for sterilization).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. There are no "test sets" in the AI sense, and thus no adjudication of expert opinions.

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 question is not applicable. The device is a physical dental mesh, not an AI-powered diagnostic tool used with human readers.

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

This question is not applicable. The device is a physical dental mesh, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

Mechanical Testing: Ground truth is defined by performance against industry standards (e.g., ASTM F564).
Biocompatibility: Ground truth is established through biological risk assessment and preclinical animal studies.
Sterilization: Ground truth is a measured sterility assurance level (S.A.L.) meeting ISO 11137-1 and ISO 11137-2 standards.
Shelf-Life: Ground truth is the maintenance of sterile integrity and functional properties over time, evaluated against ASTM F1886, ASTM F88, ASTM F1929 and ASTM F2096.
Pyrogenicity: Ground truth is the measured bacterial endotoxin level against ANSI/AAMI ST72 standards.
Dimensional/Technological Characteristics: Ground truth is the physical measurements and properties of the device compared to predicate devices, and the established safety and effectiveness of those predicates.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical dental mesh, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as #8.

Summary

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Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

Sites Medical, LLC % Karen Warden President BackRoads Consulting Po Box 566 Chesterland, Ohio 44026

July 14, 2021

Re: K202918

Trade/Device Name: OsteoSync™ Ti Dental Mesh Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: June 15, 2021 Received: June 16, 2021

Dear Karen Warden:

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.

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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 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.

for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name OsteoSync™ Ti Dental Mesh

Indications for Use (Describe)

The OsteoSync™ Ti Dental Mesh is intended for stabilization and support of bone grafts in dento-alveolar bony defect sites.

Type of Use (Select one or both, as applicable)
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

Date:	14 July 2021
Sponsor:	Sites Medical, LLC5865 E State Road 14Columbia City, IN 46725Office: 260.625.3347
Sponsor Contact:	Greg Stalcup, President/CEO
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457
Trade Name:	OsteoSync™ Ti Dental Mesh
Common Name:	Bone plate
Regulatory Class:	Class II
Regulation Name,Regulation, ProductCode:	Bone plate, 872.4760, JEY
Device Description:	The OsteoSync™ Ti Dental Mesh is a system of dental membranes intendedfor permanent fixation in adults and designed to aid in the reconstruction andaugmentation of the alveolar ridges of the maxilla and mandible. They areavailable in a variety of sizes and shapes and can be contoured toaccommodate the individual anatomic and clinical circumstances of eachpatient. The implants are sold sterile.
Indications for Use:	The OsteoSync™ Ti Dental Mesh is intended for stabilization and support ofbone grafts in dento-alveolar bony defect sites.
Materials:	The OsteoSync™ Ti Dental Mesh implants are manufactured from Grade 2titanium as described by ASTM F67.
Primary Predicate:	Neo Titanium mesh and CTi-mem (neobiotech Co., Ltd – K111761)
Reference Devices:	SMARTbuilder System (OSSTEM Implant Co., Ltd – K130840), TraumaOne(Biomet Microfixation - the K081067), BoniPlus Dental G-Mesh System(MontJade Engineering Co., Ltd – K182759)
Non-clinical Testing:	Mechanical testing - worst case devices were evaluated per ASTM F564.Biocompatibility evaluation was leveraged from an FDA authorized master file.Sterilization validation was performed using gamma radiation and MethodVDmax, in accordance with ISO 11137-1 and ISO 11137-2.Shelf life validation - sterile integrity was verified by visual, seal strength andseal integrity evaluations in accordance with ASTM F1886, ASTM F88, ASTMF1929 and ASTM F2096.Pyrogenicity - Bacterial endotoxin testing (specifically Limulus amebocytelysate, LAL) was performed per ANSI/AAMI ST72.Preclinical animal studies in a canine model were relied upon to establishsubstantial equivalence.
TechnologicalCharacteristics:	The OsteoSync™ Ti Dental Mesh has many of the same technologicalcharacteristics as the predicate devices. These include anatomic location,material of manufacture, basic design, method of stabilization, sterilecondition, variety of components offered and their general dimensionalcharacteristics. The similarities and differences are provided in the followingtables.

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Overall system	Subject Device	PrimaryPredicate	Reference Devices
FeaturesSystem →	OsteoSync™ TiDental Mesh	Neo Titaniummesh & CTI-mem	SMARTbuilderSystem	BoniPlus DentalG-Mesh System	TraumaOne
510(k)	K202918	K111761	K130840	K182759	K081067
Manufacturer:	Sites MedicalLLC	neobiotech Co.,Ltd.	OSSTEMImplant Co.,Ltd.	MontJadeEngineeringCo., Ltd.	BiometMicrofixation,Inc.
Technologicalcharacteristics
Basic design:	Dental mesh,various shapes	Dental mesh,various shapes	Dental mesh,various shapes	Dental mesh,various shapes	Dental meshand plates,various shapes
Material ofmanufacture:	ASTM F67, Gr2	ASTM F67, Gr2	ASTM F67, Gr2	ASTM F67, Gr2	ASTM F67, Gr2& Gr4
Method ofstabilization:	Envelopment ofbone graft withoptionalfastenerattachment	Envelopment ofbone graft withoptionalfastenerattachment	Envelopment ofbone graft withoptionalfastenerattachment	Envelopment ofbone graft withoptionalfastenerattachment	Envelopment ofbone graft withoptionalfastenerattachment
Condition whenused:	Sterile	Sterile	Sterile	Sterile	Sterile
Systemcharacteristics:
Thickness:	0.41 to 0.52mm	0.07 &0.085mm	0.1mm	0.1 to 0.3mm	0.2 to 0.6mm
Surface:	Smooth/smoothorsmooth/roughsides	Smooth on bothsides	Smooth on bothsides	Smooth on bothsides	Smooth on bothsides
Pore Diameter:	0.43 to 0.66mm	0.4 to 0.8mm	0.6 to 1.0mm	Unknown	Unknown

Comments:

The thickness of the subject device is greater than that of the Neo Titanium & CT-mem and the . SMARTbuilder systems but only fractionally larger than the largest BoniPlus implants. The thickness of the subject device is within the range offered by TraumaOne.

The pore diameter size of the subject devices lies within those specified by the predicates. .

The surface texture of the subject device and cited predicates is smooth on both sides. However the . subject device additionally offers a smooth gingival side / rough bone side option. The roughened side is intended to assist in securing the mesh to bone. Preclinical animal studies in a canine model provided support for this design. The preclinical animal studies were leveraged from an FDA-authorized master file.

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Oval/roundFeatures↓System →	Subject Device	Primary Predicate	Reference Device
510(k)	K202918	K111761	K130840
Manufacturer:	Sites Medical LLC	neobiotech Co., Ltd.	OSSTEM Implant Co., Ltd.
Overall dimensions	Image: OsteoSync™ Ti Dental Mesh	Image: Neo Titanium mesh & CTi-mem	Image: SMARTbuilder System
Insert diameter	2 to 6mm	2.5mm	~3mm (approximated)
Proximal width	5 to 12mm	4 to 15mm	4 to 12mm
Buccal width	4 to 8mm	8 to 15mm	7 to 12mm
Buccal length	5 to 8mm	6 to 20mm	3 to 9mm

Comments:

. The insert diameter of the subject device encompasses the ranqe offered by the Neo Titanium & CTi-mem and the SMARTbuilder systems but extends to a larger range to broaden the system functionality for the end user by minimizing the need for manipulation of generic mesh.
The buccal width of the subject device overlaps those provided in the Neo Titanium & CTi-. mem and the SMARTbuilder systems but extends narrower to accommodate smaller defects such that the end user does not have to trim a generic mesh to obtain the implant form.

Posterior Graft	Subject Device	PrimaryPredicate	Reference Devices
FeaturesSystem →	OsteoSync™ TiDental Mesh	Neo Titaniummesh & CTi-mem	BoniPlus DentalG-Mesh System	TraumaOne
510(k)	K202918	K111761	K182759	K081067
Manufacturer:	Sites MedicalLLC	neobiotech Co.,Ltd.	MontJadeEngineering Co.,Ltd.	BiometMicrofixation, Inc.
Overalldimensions	Image: OsteoSync™ Ti Dental Mesh	Image: Neo Titanium mesh & CTi-mem	Image: BoniPlus Dental G-Mesh System	Image: TraumaOne
Insert diameter	2 to 6mm	NA	NA	NA
Proximal width	15 to 34mm	12 to 35mm	25 to 60mm	80 to 85mm
Buccal width	10 to 20mm	12 to 35mm	17 to 60mm	80 to 85mm

None of the dimensional differences in the individual mesh shapes raise new questions of substantial equivalence.

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Posterior Graft	Subject Device	PrimaryPredicate	Reference Devices
FeaturesSystem →	OsteoSync™ TiDental Mesh	Neo Titaniummesh & CTi-mem	BoniPlus DentalG-Mesh System TraumaOne
Buccal length(total)	15 to 24mm	15 to 30mm	NA 50 to 53mm

Comments:

None of the predicate devices have a preformed insert diameter slot to accommodate a . dental implant. However, all of the mesh shapes can be trimmed to form and perforated to accommodate a screw. The option broadens the functionality for the end user by minimizing the need for manipulation of generic mesh.
. The proximal width, buccal width and buccal length dimensions of the subject device lie within the range offered by the Neo Titanium & CTi-mem, BoniPlus G-mesh and the TraumaOne mesh systems.

None of the dimensional differences in the individual mesh shapes raise new questions of substantial equivalence.

Socket Graft	Subject Device	PrimaryPredicate	Reference Devices
FeaturesSystem →	OsteoSync™ TiDental Mesh	Neo Titaniummesh & CTi-mem	SMARTbuilderSystem	BoniPlus DentalG-Mesh System
510(k)	K202918	K111761	K130840	K182759
Manufacturer:	Sites MedicalLLC	neobiotech Co.,Ltd.	OSSTEM ImplantCo., Ltd.	MontJadeEngineering Co.,Ltd.
Overalldimensions	Image: OsteoSync Ti Dental Mesh	Image: Neo Titanium mesh & CTi-mem	Image: SMARTbuilder System	Image: BoniPlus Dental G-Mesh System
Insert diameter	2 to 6mm	2.5mm	3.5-4mm	~3mm(approximated)
Proximal width	5 to 9.3mm	4 to 12mm	4 to 12mm	~5mm(approximated)
Buccal Length	10 to 13.5mm	6 to 10mm	7 & 9mm	9.5mm
Buccal Width	7 to 29mm	8 to 12mm	8 to 12mm	9mm

Comments:

The insert diameter of the subject device encompasses the range offered by the Neo . Titanium & CTi-mem and the SMARTbuilder systems but extends to a larger range to broaden the system functionality for the end user by minimizing the need for manipulation of generic mesh.
. The buccal width and length of the subject device overlap but extend longer than the range offered by the cited predicates to accommodate larger defects as necessary.
. The proximal width of the subject device lies within the range offered by the Neo Titanium & CTi-mem system.
. None of the dimensional differences in the individual mesh shapes raise new questions of substantial equivalence.

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Conclusion:	The OsteoSync™ Ti Dental Mesh possesses the same intended use andtechnological characteristics as the predicate devices.Nonclinical performance testing demonstrated substantial equivalence.Specifically,
•	A biological risk assessment showed the submitted information and thepreclinical animal studies provided in an FDA authorized master filemitigated risks with respect to biocompatibility.

The sterilization validation achieved the predetermined acceptance . criteria for a sterility assurance level (SAL) of 10-6.
The shelf-life validation met the predetermined acceptance criteria for a . five year shelf-life.
The bacterial endotoxin testing results met the predetermined pyrogen ● limit of 20EU/device.

Therefore the OsteoSync™ Ti Dental Mesh is substantially equivalent for its intended use.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.