Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Quantum Dental Implant System abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants, or when using any 5 mm or 6 mm length implant.

Device Description

The Quantum Dental Implant System includes root form, endosseous dental implants with internal Morse taper and external hex abutment interfaces. The implants are made of titanium alloy with three surface options (RBM, acid etch, HA coated), and are provided in both threaded and a grooved (fin-type) designs. There are four sizes of the internal Morse taper (implant well), designated as the 2.0, 2.5, 2.75, and 3.0 Series. For all series, the threaded and fin-type implant designs are each provided in the following sizes: diameters of 4.5, 5.0, 5.5, and 6.0 mm, with each diameter in lengths of 5, 6, 9, 11, and 14 mm. The 2.0 Series of the threaded and fin-tvpe implant designs also include: 4.0 mm diameter in 5 and 6 mm lengths, 8.0 mm diameter implants in 5 and 14 mm lengths, and 5.0 mm diameter available only in lengths of 5 and 6 mm. The 2.5 Series of the threaded and fin-type implant designs also include 4.0 mm diameter in lengths of 5, 6, 9, 11, and 14 mm.

Abutments for cement-retained prostheses are provided for each diameter implant. All abutments are made of titanium alloy. Abutments with a Morse taper interface are provided for all implant series in straight, 15° and 25° angled designs. The 2.0 Series Morse taper abutments are provided in 5 mm and 7 mm platforms; all other Series are provided in 3.5, 4, and 5 mm platforms. External hex interface abutments are provided for the 2.5. 2.75. and 3.0 Series implants in straight, 15° and 25° angled designs. The 2.5 Series hex abutments are 4 mm platform; the 2.75 and 3.0 Series hex abutments are 4.5 mm platform. Healing plugs are provided for each implant series in titanium alloy and polyethylene.

AI/ML Overview

The Quantum™ Dental Implant System is a medical device and its 510(k) summary does not contain information typically found in a study for AI/Software as a Medical Device (SaMD) products. Therefore, the questions related to AI/SaMD specific criteria, such as acceptance criteria based on performance metrics, ground truth establishment for algorithms, and human-in-the-loop studies, cannot be fully answered from the provided document.

This submission is for a traditional dental implant system, and its "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical testing, rather than performance metrics of an AI algorithm.

However, I can extract information regarding the non-clinical testing performed to establish substantial equivalence.

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

Since this is a dental implant system (a hardware device), the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices. The performance criteria are therefore related to mechanical and physical properties rather than diagnostic accuracy.

Acceptance Criteria (based on predicate device equivalence)	Reported Device Performance (as demonstrated by non-clinical testing)
Same intended use	The device has the same intended use as the predicate devices: immediate or delayed placement in the bone of the maxillary or mandibular arch, and abutments for support of crowns, bridges, or overdentures.
Same technological characteristics	The device has the same technological characteristics (design principles, implant and abutment dimensions, materials (titanium alloy), and surface options (RBM, acid etch, HA coated)) as the predicate devices.
Same range of physical dimensions	The device encompasses the same range of physical dimensions for implants (diameter and length) and abutments (diameter, height, and angulation) as the predicate devices. Specifically, the subject device implant largest diameter and shortest lengths are the same as predicates K092035, K050712, K010185 and K101732.
Same materials and surface options	The subject device implant and abutment designs, materials, and surfaces are the same as predicates K011223, K002241 and K991250. This includes titanium alloy for implants and abutments, and RBM, acid etch, and HA coated surface options.
Similar packaging and sterilization methods	The subject device and predicate devices are packaged in similar materials and sterilized using similar methods, or provided nonsterile to be sterilized using similar methods.
Mechanical strength and durability	Detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801 were conducted and provided or referenced to demonstrate substantial equivalence. These tests would demonstrate that the Quantum™ Dental Implant System meets the mechanical requirements for dental implants, similar to the predicate devices. [Specific numerical performance values from these tests are not provided in the summary.]

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

This document describes a premarket notification (510(k)) for a medical device (dental implant system), not an AI/SaMD product. Therefore, the concept of "test set" in the context of an algorithm's performance data does not apply here. The "testing" refers to non-clinical laboratory tests.

Sample size for testing: Not specified in terms of number of devices tested, but the non-clinical tests mentioned are: "detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801." These are laboratory-based tests typically conducted on a representative sample of finalized devices.
Data provenance: Not applicable in the context of clinical data for AI/SaMD. The non-clinical testing would have been conducted by the manufacturer or a contracted testing facility.

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)

This is not applicable to this 510(k) submission. "Ground truth" in this context would refer to objective measurements and standard test methods (e.g., ISO 14801) for evaluating the physical and mechanical properties of the dental implants, rather than expert consensus on diagnostic images.

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

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/SaMD datasets where expert disagreement needs to be resolved. This document focuses on non-clinical engineering and material equivalence.

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 conventional medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and the concept of "human readers" and "AI assistance" do not apply.

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

Not applicable. This is a physical medical device, not an algorithm or software.

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

For the non-clinical testing, the "ground truth" or reference for evaluating performance would be recognized ASTM or ISO standards (specifically ISO 14801 for static and dynamic compression-bending testing), engineering specifications, and established material properties for titanium alloys. These are objective, scientifically defined standards, not subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

Not applicable. There is no software algorithm or AI model being trained for this device.

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

Not applicable. There is no software algorithm or AI model being trained for this device.

Summary

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Quantum™ Dental Implant System

510(k) Summary K112279

MAY - 4 2012

510(k) Summary Quantum BioEngineering, Ltd. Quantum™ Dental Implant System K112279

· May 1, 2012

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Quantum BioEngineering, Ltd. 201 N. University Drive, Suite 101 Plantation, FL 33324 Telephone: +1 (954) 474-2556 +1 (954) 474-2533 Fax:

Official Contact:

Representative/Consultant:

Raul R. Mena, D.M.D., President

Linda K. Schulz Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: Email: lschulz@paxmed.com flarson@paxmed.com .

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Quantum™ Dental Implant System
Common Name:	Dental Implant and abutment
Classification Name:	Implant, endosseous, root form
	Endosseous dental implant abutment
Classification Regulations:	Class II, 21 CFR 872.3640
Product Code:	DZE, NHA
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

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510(k) Summary K112279

INTENDED USE

Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Quantum Dental Implant System abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. When using the push-in technique for fin-type or threaded implants, delayed loading is required.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

The Quantum Dental Implant System is substantially equivalent in indications and design principles to the following predicate devices:

Quantum BioEngineering, Ltd., Components of the Quantum™ Versatility Dental Implant System, cleared under K011223.

Quantum BioEngineering, Ltd., Quantum™ Versatility Dental Implant System, cleared under K002241.

Quantum BioEngineering, Ltd., Quantum Versatility™ Implant System, cleared under K991250,

Bicon. LLC., Bicon Implants with a 2.5mm Internal Connection, cleared under K092035,

Bicon, Inc., 4.5 x 6.0mm and 6.0 x 6.0mm Dental Implant, cleared under K050712,

Bicon. Inc., 6.0 x 5.7mm Dental Implant, cleared under K010185, and

Astra Tech AB. Astra Tech Implant System, cleared under K101732.

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510(k) Summary K112279

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject device and the predicate devices also encompass the same range of physical dimensions for both the implants (diameter and length) and abutments (diameter, height, and angulation). The subject device implant and abutment designs, materials, and surfaces are the same as the predicates K011223, K002241 and K991250. The subject device implant largest diameter and shortest lengths are the same as the predicates K092035, K050712, K010185 and K101732.

The subject and predicate devices are packaged in similar materials and sterilized using similar methods, or provided nonsterile to be sterilized using similar methods.

Non-clinical testing data that was provided or referenced to demonstrate substantial equivalence included detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801.

Anv differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy.

Overall, the Quantum Dental Implant System has the following similarities to the predicate devices:

. has the same intended use,
uses the same operating principle, .
incorporates the same basic design, .
incorporates the same or very similar materials, and .
has similar packaging and is sterilized using the same materials and processes .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Quantum BioEngineering, Ltd. C/O Ms. Linda K. Schulz Consultant PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

Re: K112279

Trade/Device Name: Quantum™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 1, 2012 Received: May 2, 2012

Dear Ms. Schulz:

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. 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.

MAY - 4 2012

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Page 2 - Ms. Schulz

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Wh foc

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Summary K112279

Indications for Use

K112279 510(k) Number:

Quantum™ Dental Implant System Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Siva Ramne

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

510(k) Number: K112279

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.