Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implants 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. The Ø3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.

Device Description

The Quantum Dental Implant System implants included in this submission are root form, endosseous dental implants with a Morse taper and external hex abutment interface. They are made of titanisous alloy, with three surface options. Implants are provided in both a threaded and a grooved (fin-ype) design. The implants are 3.0 mm in diameter and are available in four lengths (8, 9, 11, & 14 m(1)

AI/ML Overview

Here's an analysis of the provided text regarding the Quantum™ Dental Implant System, focusing on acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for Quantum™ Dental Implant System (K130787)

This 510(k) summary for the Quantum™ Dental Implant System (K130787) focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel safety and effectiveness criteria through
a de novo clinical study with specific acceptance thresholds. As such, the "acceptance criteria" are primarily defined by the performance of the predicate devices and the relevant ISO standard for dental implants.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Quantum™ Dental Implant System)
Functional Equivalence	Same intended use as predicate devices.	"has the same intended use." This is explicitly stated and supported by the "Indications for Use" which mirrors that of predicate devices.
Technological Equivalence	Same operating principles, basic design, and materials as predicate devices. Similar packaging and sterilization processes.	"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."
Physical Dimensions & Characteristics	Encompasses same range of physical dimensions and characteristics as predicate devices.	"The subject device and the predicate devices encompass the same range of physial dimensions and characteristics, including implant diameter, length, and surface traatment."
Mechanical Performance (Static and Dynamic)	Meets or exceeds the static and dynamic compression-bending requirements of ISO 14801, demonstrating equivalence to predicate devices.	"Performance testing is provided to demonstrate substantial equivalence and includes static and dynamic compression-bending testing according to ISO 14801. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above."
Safety and Efficacy Equivalence	Differences in technological characteristics do not raise new issues of safety or efficacy.	"Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy."

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

Test Set Sample Size: The document does not specify a sample size for a clinical "test set" or human subjects. The performance testing referenced is bench testing for mechanical properties.
Data Provenance: The data provenance for the performance testing is in vitro (bench test), conducted according to ISO 14801. There is no information regarding country of origin for any human data, as none was used directly for this submission to demonstrate substantial equivalence. The study is not a retrospective or prospective human study.

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

This question is not applicable to this 510(k) summary. The "ground truth" for the mechanical performance testing (static and dynamic compression-bending) is established by the ISO 14801 standard itself and the measured physical properties of the device and predicate devices, not by expert consensus on clinical outcomes or diagnoses.

4. Adjudication Method for the Test Set

This question is not applicable for the reasons stated above. There was no "test set" involving human data or expert review requiring an adjudication method.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a dental implant, a physical medical device, not an AI-powered diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not relevant here.

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

No, a standalone (algorithm-only) performance study was not done. This is a physical dental implant, not a software algorithm.

7. The type of ground truth used

The primary "ground truth" used for demonstrating equivalence in this 510(k) submission is:
- Mechanical properties benchmarks defined by the ISO 14801 standard for dental implants (static and dynamic compression-bending).
- Design specifications and materials that are comparable to legally marketed predicate devices.
- Intended Use comparison to predicate devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device. The device's design, manufacturing, and testing inform its performance, not a training set of data.

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

This question is not applicable as there was no training set for an algorithm. The "ground truth" for the device's development was based on established engineering principles, biocompatibility requirements for titanium alloys, and the design parameters of existing, legally marketed dental implants.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a bench test (in vitro) performance study conducted according to ISO 14801. This study assessed the static and dynamic compression-bending strength of the Quantum™ Dental Implant System. The results from this testing demonstrated that the device's mechanical properties were substantially equivalent to those of the identified predicate devices, which themselves meet the safety and effectiveness standards for dental implants. The 510(k) did not rely on clinical trials or human data, but rather on direct comparison of technological characteristics and recognized performance standards for physical properties.

Summary

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JUN 1 3 2013

510(k) Summary Quantum BioEngineering, Ltd. Quantum™ Dental Implant System K130787

May 20, 2013

ADMINISTRATIVE INFORMATION

Manufacturer Name

Quantum BioEngineering, Ltd. 201 N. University Drive, Suite 101 Plantation, FL 33324 Telephone: +1 (954) 474-4707 Fax: +1 (954) 474-2533

Official Contact

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

Representative/Consultant

Linda K. Schulz Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: lschulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Quantum™ Dental Implant System
Common Name	Dental Implant
Classification Name	Implant, endosseous, root form
Classification Regulations	Class II, 21 CFR 872.3640
Product Code	DZE
Classification PanelReviewing Branch	Dental Products PanelDental Devices Branch

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INTENDED USE

Quantum™ Dental Implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. Wenn onestage surgical approach is applied, threaded implants 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. The Ø3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

The Quantum Dental Implant System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially quivalent to pre-amendment devices:

K I 12279 - Quantum BioEngineering, Ltd., Quantum™ Dental Implant System K002241 - Quantum BioEngineering, Ltd., Quantum™ Versatility Dental Implant System K991250 - Quantum BioEngineering, Ltd., Quantum Versatility™ Implant System K101849 - Bicon, LLC, Bicon Dental Implant System 3.0mm K101732 - Astra Tech AB, Astra Tech Implant System

The subject device and the predicate devices have intended use and have the same technological characteristics. The subject device and the predicate devices encompass the same range of physial dimensions and characteristics, including implant diameter, length, and surface traatment. Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy.

Performance testing is provided to demonstrate substantial equivalence and includes static and dynamic compression-bending testing according to ISO 14801. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

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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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the caduceus. The seal is presented in black and white.

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

June 13, 2013

Quantum BioEngineering, Limited C/O Ms. Linda Schulz PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130

Re: K130787

Trade/Device Name: Quantum™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 20, 2013 Received: May 21, 2013

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.

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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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Mary-S.
Susan Runner -S

Kwame Ulmer. M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K130787 510(k) Number:

Quantum™ Dental Implant System Device Name:

X Prescription Use (Part 21_CFR 801_Subpart D)

Over-The-Counter Use AND/OR (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 _

Andrew I. Steen
2013.06.07 14:45:16-04'00'

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

510(k) Number: K130787

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.