The newly improved AIDI Dental Implant System (AIDI Fixtures and AIDI Abutments with Screws) is made up of endosseous implants intended to be surgically placed in the bone of the upper or lower jaws to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved with the appropriate occlusal loading.

Device Description

The improved AIDI Dental Implant System is a threaded root-form dental implant intended for use 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), cover screws, abutment screws, and healing abutments.

AI/ML Overview

The provided text is a 510(k) summary for the AIDI Dental Implant System. It describes the device, its indications for use, technical characteristics, and a nonclinical test summary, concluding with a statement of substantial equivalence. However, it does not contain information about acceptance criteria, specific device performance metrics (beyond generalized statements of "high torque strength"), or detailed study methodologies that would allow for a comprehensive answer to the requested questions.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

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

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly stated as acceptance criteria. The submission relies on establishing substantial equivalence to predicates.	"high torque strength for AIDI Dental Implants" (current submission). "The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength."

Missing Information: The document does not explicitly define acceptance criteria in terms of quantitative thresholds or specific metrics. It focuses on demonstrating equivalence to predicate devices, particularly regarding "torque strength." The exact measurement or quantitative comparison of "high torque strength" is not provided.

2. Sample sized used for the test set and the data provenance

Missing Information: The document states, "The nonclinical test data of the currently submitted AIDI Dental Implant System Torque Test Report revealed high torque strength for AIDI Dental Implants." However, it does not specify:

The sample size used for the torque test set.
The data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Missing Information: This section is not applicable to the provided document. The submission pertains to a medical device (dental implant system) for which performance is assessed through nonclinical engineering tests (like torque strength), not by expert interpretation of images or other data that would require "ground truth" established by experts in a clinical context.

4. Adjudication method for the test set

Missing Information: Not applicable. As mentioned above, this is an engineering performance test, not a clinical study involving human interpretation with adjudication.

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

Missing Information: Not applicable. This document describes a dental implant system, not an AI-powered diagnostic or assistive tool that would necessitate an MRMC study or assessment of human reader improvement with AI. No clinical studies were submitted.

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

Missing Information: Not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used

Missing Information: For the "Torque Test," the "ground truth" would be the measured torque strength itself, comparing the subject device to predicate devices. However, the exact methodology and quantitative results are not detailed in this summary.

8. The sample size for the training set

Missing Information: Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Missing Information: Not applicable.

Study Summary (Based on Section 4 & 6):

The device's performance was evaluated through a nonclinical Torque Test.

Objective: To demonstrate that the AIDI Dental Implant System (current submission) possesses comparable or superior torque strength to its predicate devices.
Methodology (limited detail): The "Torque Test Report" was submitted, which presumably details the experimental setup and measurements.
Findings: The test "revealed high torque strength for AIDI Dental Implants (current submission)." Furthermore, the study concluded that "The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength."
Conclusion: Based on this nonclinical testing, among other comparisons of materials, design, and technical characteristics, the manufacturer concluded that the "AIDI Dental Implant System (current submission) is substantially equivalent for its intended use and performs as well as the predicates."

In essence, the entire submission hinges on demonstrating "substantial equivalence" through nonclinical testing (specifically, a torque test) and comparison of technical characteristics, rather than establishing performance against defined acceptance criteria via comprehensive clinical studies or expert-driven evaluations.

Summary

{0}------------------------------------------------

K123861 DEC 1 2 2013

Image /page/0/Picture/1 description: The image shows the logo for AIDI Biomedical, LLC. The logo features a stylized figure with outstretched arms above the letters "AIDI" in bold, sans-serif font. Below "AIDI" is the text "BIOMEDICAL, LLC" in a smaller, sans-serif font.

AIDI Biomedical, LLC 34859 Frederick St. #105 Wildomar, CA 92595 Tel: (951) 678-9626 Fax: (951) 471-6147

8. 510(k) Summary (21 CFR 807.92)

510(k) Owner: Dr. William Y.S. Hung Chief Executive Officer

Address: AIDI Biomedical, LLC 34859 Frederick St. #105 . Wildomar. CA 92595
Telephone: Fax:
Contact person: Chen Tian QA Manager
Date of Summary Preparation:

November 29, 2012

(213) 595-9134

(951) 678-9626 (951) 471-6147

Name of device: Dental Implant System

Classification Name: Endosseous dental implant (21 CFR 872.3640, product code DZE) and Endosseous dental implant abutment (21 CFR 872.3630, product code NHA)

Trade Name: AIDI Dental Implant System
Classification: II under 872.3640

Predicate devices(2): AIDI Dental Implant System (K101755) IDI Implant System (K081806)

Materials: Implants are made from ASTM F-67 CO Ti Grade 4. Abutments, healing abutments, cover screws, and abutment screws are made from ASTM F-136 Ti6AI4V.

{1}------------------------------------------------

1. Device Description:

The AIDI Dental Implant System (current submission) is an improved version of the previously approved AIDI Dental Implant System (K101755). However, the improved AIDI has the same scientific concepts as the predicates IDI Implant System (K081806) and the previous AIDI Dental Implant System (K101755). For instance, they all have the same internal thread in the apical end, the same thread design on external surfaces, and the same surface treatment - Soluble Blast Media (SBM). The subject device and the predicates are all machined from ASTM F-136 Titanium Ti6AL4V ELI. The abutment screws, cover screws, straight abutments, and healing abutments are also machined from the same alloy.

The physical and performance characteristics of the subject device and the predicate devices include a tapered implant body. AIDI dental implants (current submission) have an octagonal interlocking implant/abutment interface. The improved AIDI also has a similar tapered coronal design as the previous AIDI Dental Implant System (K101755).

2. Indication for Use

	Subject Device	Predicate Devices
Name	AIDI Dental ImplantSystem (CurrentSubmission) (AIDIInternal Fixture andAbutments)	AIDI Dental ImplantSystem (Previous)(AIDI Internal Fixture andAbutments) K101755	IDI Implant Systems(IDI Internal Fixturesand Abutments)K081806
Material	Titanium ASTM F67Grade 4 or ASTM F-1366AL4V ELI	Titanium ASTM F67Grade 4 or ASTM F-1366AL4V ELI	Titanium ASTM F67Grade 4 or ASTM F-136 6AL4V ELI
Coronal Design	Tapered Coronal Design	Tapered Coronal Design	No

3. Technical Characteristics

{2}------------------------------------------------

Internal ScrewThread	Yes	Yes	Yes
Implant BodyDesign	Tapered	Tapered	Tapered
Implant BodyDiameter (mm)	3.3, 3.7	3.2, 3.7, 4.7, 5.4	3.7, 4.7, 5.4, 6.4
Length (mm)	8.8~16.0	8.8~16.0	8.8~16.0
One-StageSurgicalProcedures	Yes	Yes	No
Two-StagesSurgicalProcedures	Yes	Yes	Yes
Implant/AbutmentInterface	Octagonal Interlocking	Hexagonal Interlocking	Hex-LobeInterlocking
SurfaceTreatment	Soluble Blast Media(Tricalcium Phosphate/Hydroxyapatite,conform to ASTMF1185-03)	Soluble Blast Media(Tricalcium Phosphate/Hydroxyapatite, conformto ASTM F1185-03)	Resorbable mediaBlasting (TricalciumPhosphate/Hydroxyapatite,conform to ASTMF1185-03)
GammaSterilized	Yes	Yes	Yes
Attachments	Screw-retainedrestoration system	Screw-retained restorationsystem	Screw-retainedrestoration system

4. Nonclinical Test Summary

The nonclinical test data of the currently submitted AIDI Dental Implant System Torque Test Report revealed high torque strength for AIDI Dental Implants. The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength.

5. Clinical Test Summary

No clinical studies were submitted.

6. Conclusion

We conclude that our AIDI Dental Implant System (current submission) is substantially equivalent for its intended use and performs as well as the predicates IDI Implant System (K081806) and AIDI Dental Implant System (K101755):

{3}------------------------------------------------

A. The torque strength test data revealed high torque strength for AIDI Dental Implants (current submission). The predicate IDI implant system (K081806) and predicate AIDI Dental Implant System (K101755) resembled the same torque strength.
B. The newly improved AIDI dental implant system is substantially equivalent in terms of materials, design, and technical characteristics to the IDI Implant System (K081806) and AIDI Dental Implant System (previous) (K101755)

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo of the Department of Health & Human Services - USA. The logo features a stylized human figure with outstretched arms, representing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is printed to the right of the logo.

Public Health Service

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

December 12, 2013

AIDI Biomedical, LLC Chen Tian Quality Assurance Manager 34859 Frederick Street, #105 Wildomar, CA 92595

Re: K123861

Trade/Device Name: AIDI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 15, 2013 Received: December 2, 2013

Dear Mr. Tian:

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.

{5}------------------------------------------------

Page 2 - Mr. Tian

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/Resourcesfor You/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/McdicalDevices/Safety/ReportaProblem/dcfault.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/Industrv/default.htm.

Sincerely vours.

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

FOR

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

Enclosure

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows a logo for AIDI Biomedical, LLC. The logo features a stylized emblem above the text "AIDI" in large, bold letters. Below "AIDI" is the text "BIOMEDICAL, LLC" in a smaller font. The emblem appears to be a shield with wings and a flame-like object on top.

AIDI Biomedical. L.C. 34859 Frederick St. #105 Wildomar. CA 92595 Tel: (951) 678-9626 Fax: (951) 471-6147

K123861

7. Indications for Use

Device Name: AIDI Dental Implant System

Indications for Use:

The newly improved AIDI Dental Implant System (AID) Fixtures and AIDI Abutments with Screws) is made up of endosseous implants imended to be surgically placed in the bone of the upper or lower jaws to provide support for prositietic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved with the appropriate occlusal loading.

Prescription use: _ > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (2) CFR 801 Subpart C)

PLEASE DO NOT WRITE BEEOW THIS LINE: CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH. Office of Device Evaluation (ODE)

Mary S. Runner -S
Susan Runner DDS, MA 2013.12.12
08:58:39-05'00'

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.