The OsteoCentric Dental Implants are indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The OstecCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.

Device Description

The OsteoCentric Dental Implants consist of self-tapping and threaded endosseous implants with root-form or wide thread forms, and cover screws. The root-form implant diameters range from 3.5 mm to 5.5 mm (8 mm to 14 mm lengths) and the wide thread implant diameters are available in 4.1 mm and 4.5 mm (8 mm lengths), 5.5 mm (8 mm to 12 mm lengths), and 6.5 mm (8 mm to 10 mm lengths). The specific diameters and length combinations are specified below:

Root Form Implants:
- Ø 3.5/ 8, 10, 12, and 14 mm
- Ø 4.0/ 8, 10, 12, and 14 mm
- Ø 4.5/ 8, 10, 12, and 14 mm
- Ø 5.0/ 8, 10, 12, and 14 mm
- Ø 5.5/ 8, 10, 12, and 14 mm
Wide Form Implants:
- Ø 4.1/ 8, 10, 12, and 14 mm
- Ø 4.5/ 8, 10, 12, and 14 mm
- Ø 5.5/ 8, 10, and 12 mm
- Ø 6.5/ 8 and 10 mm

Cover screws provide protection to the threads of the connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. The OsteoCentric dental implants and cover screws are provided sterile. The implants, and cover screws are manufactured from titanium alloy (Ti-6A1-4V ELI; ASTM F136) or wrought titanium alloy (Ti-6Al-4V; ASTM F1472).

The OsteoCentric Dental Implants are intended for use with compatible abutments and healing caps manufactured by Implant Logistics.

AI/ML Overview

This document is a 510(k) summary for OsteoCentric Dental Implants, a Class II medical device. The primary purpose of this type of submission is to demonstrate substantial equivalence to an already legally marketed predicate device, not necessarily to prove specific performance metrics against pre-defined acceptance criteria in the same way one might for a novel device or a software-as-a-medical-device (SaMD).

Therefore, the information typically requested regarding acceptance criteria, specific study designs (like MRMC), expert ground truthing, and training/test set details for AI/ML-based devices is not present in this document. This submission focuses on comparing the new device's design, materials, and mechanical performance (fatigue testing) to a predicate device, along with leveraging existing data for biocompatibility, sterility, shelf-life, etc.

Here's an attempt to answer your questions based on what is available in the document, and where applicable, explaining why the information is not present:

Analysis of the Provided Document for Acceptance Criteria and Device Performance Study Information:

The provided document is a 510(k) summary for OsteoCentric Dental Implants. This is a traditional medical device (dental implants), not a software or AI/ML-based device that would typically involve a test set, expert ground truth, multi-reader studies, or large training sets. The "acceptance criteria" here refer to demonstrating substantial equivalence to a predicate device, focusing on material, design, and mechanical performance, rather than clinical performance metrics in the way your questions are framed for AI/ML.

Here's a breakdown based on your questions:

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

Acceptance Criteria: For this type of device, the acceptance criteria are not clinical performance metrics in the sense of sensitivity/specificity, but rather engineering and safety benchmarks to demonstrate substantial equivalence to the predicate. The key "acceptance criterion" mentioned is fatigue testing per ISO 14801.
Reported Device Performance: The document states: "As noted in the table above, the subject and predicate devices are identical with respect to design, materials of construction, method of stabilization, implant size offerings, surface treatment, and sterility status. A gripping feature was introduced to the implant to eliminate the need for a carrier; however, as demonstrated by fatigue testing, the introduction of this feature does not impact substantial equivalence."
- This implies that the device met the fatigue testing requirements of ISO 14801, demonstrating that the design change (the gripping feature) did not negatively impact its mechanical performance compared to the predicate. Specific numerical results of the fatigue testing are not provided in this summary document, only the statement that it was performed and met the criteria for substantial equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical integrity and durability (via ISO 14801 fatigue testing)	"As demonstrated by fatigue testing, the introduction of this [gripping] feature does not impact substantial equivalence." (Implies successful completion and meeting of applicable ISO 14801 standards for dental implants, relative to the predicate.)
Biocompatibility	Leveraged data from predicate device K173701 (contractual license agreement with Implant Logistics Inc.) – Implies it meets biocompatibility standards.
Sterilization	Leveraged data from predicate device K173701 – Implies it meets sterilization standards.
Shelf-life	Leveraged data from predicate device K173701 – Implies it meets shelf-life standards.
Packaging Validation	Leveraged data from predicate device K173701 – Implies it meets packaging validation standards.
Modified Surface Testing	Leveraged data from predicate device K173701 – Implies it meets modified surface testing standards.
Endotoxin Testing	Leveraged data from predicate device K173701 – Implies it meets endotoxin testing standards.
MRI Compatibility (Non-clinical worst-case review)	Performed using scientific rationale and published literature, addressing magnetically induced displacement force and torque. (Implies it meets MRI compatibility criteria based on this review and established guidance).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable in the context of this 510(k) summary. This is a mechanical device, not an AI/ML system. The "test set" would refer to the mechanical samples used for fatigue testing. The document does not specify the number of samples tested for fatigue, only that "Fatigue testing per ISO 14801" was performed.
Data provenance for mechanical testing is typically in-house or third-party lab testing, not patient data in the sense of retrospective/prospective clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. This relates to AI/ML ground truthing, which is not part of this device's submission. Ground truth for mechanical testing is established by engineering standards (e.g., ISO 14801 thresholds for failure) and laboratory measurements.

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

Not applicable. This relates to human expert review for AI/ML validation.

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 is a hardware device, not an AI assistance tool.

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

Not applicable. There is no algorithm.

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

For the mechanical aspects, the "ground truth" implicitly refers to the failure criteria defined by ISO 14801 and the material properties and design specifications. For biocompatibility, sterilization, etc., the "ground truth" is adherence to relevant ISO standards and regulatory guidelines, which was demonstrated by leveraging data from the predicate device.

8. The sample size for the training set

Not applicable. This is a hardware dental implant, not an AI/ML system that requires a "training set."

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

Not applicable. As above, no training set for this type of device.

In summary, the provided document is a 510(k) submission for a non-AI/ML dental implant. The "acceptance criteria" and "study" are primarily focused on demonstrating engineering and safety equivalence to a predicate device via standardized mechanical testing (like fatigue) and compliance with general device regulations (biocompatibility, sterilization, etc.), often by leveraging existing data from the predicate. The detailed breakdown of AI/ML validation (test sets, ground truth experts, MRMC studies) is not relevant to this type of traditional medical device submission.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

OsteoCentric Technologies Todd Evans Senior Director Quality and Regulatory Affairs 75 W 300 N Suite 150 Logan, Utah 84321

Re: K230242

Trade/Device Name: OsteoCentric Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 5, 2023 Received: September 6, 2023

Dear Todd Evans:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K230242

Device Name

OsteoCentric Dental Implants

Indications for Use (Describe)

The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.

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

I. Submitter

OsteoCentric Technologies 75 West 300 N, Suite 150 Logan, UT 84321 Phone: 1-800-969-0639

Contact Person: Todd Evans, Senior Director of Quality and Regulatory Affairs Date Prepared: October 5th, 2023

II. Device

Device Proprietary Name:	OsteoCentric Dental Implants
Common or Usual Name:	Dental Implants
Classification Name:	Endosseous dental implant
Regulation Number:	21 CFR 872.3640
Product Code:	DZE
Device Classification	Class II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Implant Logistics Implant-One™ System, K173701, Implant Logistics, Inc. ●

IV. Device Description

Root Form Implants: ●
- Ø 3.5/ 8, 10, 12, and 14 mm o
- Ø 4.0/ 8, 10, 12, and 14 mm O
- Ø 4.5/ 8, 10, 12, and 14 mm O
- Ø 5.0/ 8, 10, 12, and 14 mm O
- Ø 5.5/ 8, 10, 12, and 14 mm O
Wide Form Implants:
- Ø 4.1/ 8, 10, 12, and 14 mm o
- Ø 4.5/ 8, 10, 12, and 14 mm o
- Ø 5.5/ 8, 10, and 12 mm O

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0 0 6.5/ 8 and 10 mm

The OsteoCentric Dental Implants are intended for use with compatible abutments and healing caps manufactured by Implant Logistics. Information was shared by Implant Logistics based on a contractual license agreement which was leveraged to demonstrate implant abutment compatibility.

V. Indications for Use

The OsteoCentric Dental Implants are indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The OsteoCentric Implants are indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

The OsteoCentric Dental Implants are intended to be used with the Implant Logistics 300, 400, and 500 Series abutments and healing caps.

VI. Comparison of Technological Characteristics

	OsteoCentric Dental ImplantSystem	Implant Logistics Implant-One™System(K173701)	Analysis
Endosseous Implants
Design	Root-formWide form	Root-formWide-form	Identical
Material	Titanium and/or titanium alloy	Titanium and/or titanium alloy	Identical
Method ofStabilization	Threaded fixation	Threaded fixation	Identical
ImplantOfferings	Root Form Implants:Ø 3.5/ 8, 10, 12, and 14 mmØ 4.0/ 8, 10, 12, and 14 mmØ 4.5/ 8, 10, 12, and 14 mmØ 5.0/ 8, 10, 12, and 14 mmØ 5.5/ 8, 10, 12, and 14 mmWide Form Implants:Ø 4.1/ 8, 10, 12, and 14 mmØ 4.5/ 8, 10, 12, and 14 mmØ 5.5/ 8, 10, and 12 mmØ 6.5/ 8 and 10 mm	Root Form Implants:Ø 3.5/ 8, 10, 12, and 14 mmØ 4.0/ 8, 10, 12, and 14 mmØ 4.5/ 8, 10, 12, and 14 mmØ 5.0/ 8, 10, 12, and 14 mmØ 5.5/ 8, 10, 12, and 14 mmWide Form Implants:Ø 4.1/ 8, 10, 12, and 14 mmØ 4.5/ 8, 10, 12, and 14 mmØ 5.5/ 8, 10, and 12 mmØ 6.5/ 8 and 10 mm	Identical

The table below provides a comparison between the subject and predicate devices.

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	OsteoCentric Dental ImplantSystem	Implant Logistics Implant-One™System(K173701)	Analysis
ImplantCarrier	NoSmall gripping feature added	Yes	Different
SurfaceTreatment	Resorbable media blasted	Resorbable media blasted	Identical
Sterile	Yes	Yes	Identical
Cover Screws
Material	Titanium and/or titanium alloy	Titanium and/or titanium alloy	Identical
Sterile	Yes	Yes	Identical

As noted in the table above, the subject and predicate devices are identical with respect to design, materials of construction, method of stabilization, implant size offerings, surface treatment, and sterility status. A gripping feature was introduced to the implant to eliminate the need for a carrier; however, as demonstrated by fatigue testing, the introduction of this feature does not impact substantial equivalence.

VII. Performance Data

The following performance data was submitted to demonstrate substantial equivalence:

Fatigue testing per ISO 14801 ●
Non-clinical worst-case MRI review was performed to evaluate the devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque. "

The following data was leveraged from the predicate device K173701, this information was shared based on a contractual license agreement with Implant Logistics Inc:

Biocompatibility ●
Sterilization ●
Shelf-life
Packaging Validation ●
Modified Surface Testing ●
Endotoxin Testing ●

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VIII. Conclusion

The information provided above supports that the OsteoCentric Dental Implants are substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.