AIDI Dental Implant Systems® (AIDI Fixtures and AIDI Abutments with AIDT Dental implant Systembents intended to be surgically placed in the Sorews) are enabose lower jaw arches to provide support for prosthetic bone of the upper of artificial tooth, in order to restore patient esthetics deviocs, suon ao an arming abutments indicated for both screw and chewing function. Straigrations are included. The implants are indicated for single or multiple unit restorations and can be used in indicator for oingle applications. The device is intended for Splinted and non opinious appress and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Device Description

AID! Dental Implant System (AIDI) is a threaded root-form dental implant intended for use (function) in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments which provide cemented and screw retained restorative options.

AIDI is an improved version of the predicated IDI Implant System (IDI). AIDI has the same scientific concepts as predicated IDI which include same internal connection design, same internal thread at apical end, same thread design at external surfaces and same surface treatment which is Soluable Blast Media (SBM).

The physical and performance characteristic of AIDI, predicated IDI and predicated NobelActive Dental Implant (NA) includes gradually expanding tapered implant body allowing for alveolar bone expanding and condensing capabilities. The material composition of AIDI and predicated IDI are Titanium ASTM F67 Grade 4 or ASTM F-136 6AL4V ELI. AIDI is also similar to predicated NA Implants in tapered coronal design and hex-cavity internal connection design.

AI/ML Overview

The provided document is a 510(k) summary for the AIDI Dental Implant System (K101755). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical studies for novel technologies.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy, etc.) you would expect for a diagnostic AI device. Instead, the "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness.

The key performance attribute evaluated and reported is torque strength.

Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance (AIDI Dental Implant System)
High torque strength, comparable to predicate devices.	"high torque strength for AIDI Dental Implants." "resembled the same torque strength" as predicate devices.

Study Information:

Given this is a 510(k) for a dental implant, the type of "studies" and "ground truth" are very different from what you would typically find for an AI medical device.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size. The "test set" in this context refers to the AIDI Dental Implant System components used in the nonclinical torque strength tests.
- Data Provenance: The study was a "nonclinical test data... Torque Test Report." No country of origin is specified, and it's inherently a prospective lab test, not retrospective patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for torque strength testing in medical devices like implants is established through standardized engineering tests, not expert consensus.
- Qualifications of Experts: N/A for this type of test.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. This is a physical, mechanical test, not a subjective interpretation requiring adjudication.
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:
- MRMC Study: No, this type of study was not done. This is a physical dental implant, not a diagnostic AI device that assists human readers.
- Effect Size: N/A.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This is a physical dental implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth for the "torque strength" was established by mechanical testing (Torque Test Report) following presumably an established standard for dental implants.
The sample size for the training set:
- Training Set Sample Size: Not applicable. There is no "training set" in the context of this 510(k) submission, as it describes a physical device, not a machine learning model.
How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set mentioned or implied for this device.

Overall Conclusion from the Provided Text:

The K101755 submission for the AIDI Dental Implant System is a predicate-based 510(k). The primary "study" supporting its safety and effectiveness is a nonclinical torque strength test. The "acceptance criteria" are met by demonstrating that the AIDI system exhibits a "high torque strength" that "resembles the same torque strength" as its legally marketed predicate devices (IDI™ Implant System (K081860) and NobelActive™ Internal Connection Implant (K071370)). No clinical studies or AI/software performance studies were submitted or required for this type of device. The ground truth for the single reported performance metric (torque strength) was established through objective mechanical testing.

Summary

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K101755

510 (K) Summary of Safety and Effectiveness (Revised on 10/7/2010)

NOV 2 2 2 2010

Submitted by:	William Yuen-Siang hung, D.D.S., J.D.
Address:	AIDI Biomedical, LLC
	34859 Frederick St #105
	Wildomar CA 92595
Telephone:	(951)678-9626
Direct:	(951)288-8819
Fax:	(951)678-6786
Date of Submission:	May 18th, 2010
Classification Name	Endosseous dental implant 21 CFR 872.3640 and endosseous dentalimplant abutment 21 CFR 872.3630
Trade Name:	AIDI Dental Implant System
Legally Marketed Device	NobelActive™ Internal Connection Implant (K071370)IDI™ Implant System (K081860)

1. Device Description:

ﺔ ﻧﻴﻮﻳﺎ ﺑ

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4. Nonclinical Test Summary

The nonclinical test data of AIDI Dental Implant System Torque Test Report revealed a high torque strength for AIDI Dental Implants. The predicated IDI™ implant and predicated NobelActive™ dental implant resembled the same torque strength.

5. Clinical Test Summary

No clinical studies are submitted.

6. Conclusion

In Sum, we can conclude that AIDI Dental Implant System (K101755) is safe and effective for its intended use and performs as well as predicated IDI Implant System (K081806) and predicated NobelActive Internal Connection Implant System (K071370) for the following reasons:

A. The torque strength test data revealed a high torque strength for AIDI Dental Implants. The corque strong IN toolant system and predicated NobelActive™ Internal Connection Implant System resembled the same torque strength.
B. IDI Implant System (K081806) and NobelActive Internal Connection Implant System (K071370) are substantially equivalent to AIDI dental implant system (K101755) regarding materials, design and technological characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Dr. William Y.S. Hung Chief Executive Office AIDI BioMedical, LLC 34859 Frederick Street, #105 Wildomar, California 92595

NOV 2 2 2010

Re: K101755

Trade/Device Name: AIDI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 7, 2010 Received: October 14, 2010

Dear Dr. Hung:

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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Page 2- Dr. Hung

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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Runer

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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Klo1755

-Indications-for-Use :-

Over-The-Counter Use Prescription Use x (21 CFR 801 Subpart (Part 21 CFR801 Subpart AND/OR C) D)

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

Susan Rixner

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

510(k) Number: K101753

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K101755

NOV 2 2 2010

2. Indication for Use

AIDI Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The device is intended for immediate placement and immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Predicate Devices Devices 3 3 3 30 30 30 30 30 30 30 30 30 30 30 30 3 LL & Subject Device Subject Device Subject Device Subject De IDI Implant Systems (IDI NobelActive Internal Connection AIDI Dental Implant System Name Internal Fitures and Implant System and Abutments (AIDI Internal Fixture and Abutments) (K081806) (K071370) Abutments) (K101755) Titanium ASTM F67 Titanium ASTM F67 Grade 4 or Titanium ASTM F67 Grade 4 Material Grade 4 or ASTM F-136 ASTM F-136 6AL4V ELI or ASTM F-136 6AL4V ELI 6AL4V ELI Back-Tapered Coronal Design No Tapered Coronal Design Coronal Design Yes Yes Internal Screw Yes Thread Tapered Tapered Tapered Implant Body Design 3.7, 4.7, 5.4, 6.4 3.5, 4.3, 5.0 Implant Body 3.2, 3.7, 4.7, 5.4 Diameter (mm) 8.816.0 8.518.0 8.8~16.0 Length (mm) No Yes One-Stage Surgical Yes Procedures Yes Yes Two-Stages Yes Surgical Procedures Hex-Lobe Interlocking Hexagonal Interlocking Implant/ Abutment Hexagonal Interlocking Interface Resorbable media TiUnite Soluable Blast Media Surface Treatment Blasting (Tricalcium (Tricalcium Phosphate/ Phosphate/ Hydroxyapatite, conform to Hydroxyapatite, conform ASTM F1185-03) to ASTM F1185-03) Yes Yes Gamma Sterilized Yes Screw-retained restoration Screw-retained Screw-retained restoration Attachments restoration system system system

3. Technological Characteristics

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.