ARDS DENTAL IMPLANTS by ARDS, LTD

ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery.

Device Description

ARDS implants are made from Titanium alloy. The ARDS implants geometrical shape is characterized by altering drilling profile, with double thread at the upper part that change to one thread at the lower part, which increases its surface, and as a result, increases in the preliminary contact surface with the bone. The ARDS dental implants are : S type: Internal hex implants, length 10/13 mm, diameter 3.75/4.5 mm, with double thread at the upper part that goes over in a single thread at the lower part. S implant types are supplied sterile in a double vial system, inside a plastic box which includes the covering screw and the Instructions For Use. The abutments are for single use only and supplied non-sterile. The tools are reusable and supplied non-sterile, they must be sterilized by autoclave before use.

AI/ML Overview

The documents provided are FDA 510(k) clearance letters and related summaries for "ARDS Dental Implants." These documents establish that the device is "substantially equivalent" to a legally marketed predicate device.

It is important to note that 510(k) clearance usually signifies a device is as safe and effective as a predicate device, but it does not typically involve specific acceptance criteria, comprehensive clinical studies, or performance metrics in the same way a PMA (Pre-Market Approval) or a more rigorous clinical trial for a novel device would. The focus of a 510(k) is on substantial equivalence.

Therefore, based solely on the provided text, a detailed table of acceptance criteria and reported device performance, information on sample sizes for test sets, expert adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment methods as you've requested cannot be fully provided in the manner normally associated with studies proving discrete performance metrics for AI/ML devices.

The information available primarily discusses the device's classification, intended use, and comparison to a predicate device.

However, I can extract and infer some points based on the provided text:

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

The documents do not provide a table of quantitative acceptance criteria or specific device performance metrics in terms of accuracy, sensitivity, specificity, etc., because this is a 510(k) summary for a dental implant, not an AI/ML device. The "performance" being assessed here is the substantial equivalence to a predicate device in terms of design, materials, and intended use.

Acceptance Criterion (Implied by 510(k))	Reported Device Performance (Implied by 510(k) Clearance)
Substantial Equivalence to Predicate Device (Alpha Bio Dental Implant System K063364)	ARDS Dental Implants are "substantially equivalent" in technology and intended use. Differences (proprietary in nature) do not raise additional safety or efficacy concerns.
Intended Use	Indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function and indicated for two-stage surgery.
Materials	Made from Titanium alloy.
Sterility & Reusability of Components	S implant types are supplied sterile. Abutments are for single use only and supplied non-sterile. Tools are reusable and supplied non-sterile, requiring sterilization by autoclave before use.

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. The clearance is based on comparison to a predicate device, not on a clinical test set in the traditional sense for evaluating an AI/ML diagnostic or prognostic device's performance metrics. The "testing results" mentioned in point 6 of K071803 refer to tests related to the proprietary differences and ensuring they don't impact safety/efficacy relative to the predicate, likely involving bench testing, material properties, and possibly limited in vitro or in vivo studies, but not a large-scale clinical test set for performance metrics.

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 is not a diagnostic device where expert ground truth is established for a test set.

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

Not applicable.

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 physical dental implant, not an AI/ML diagnostic or assistive device for human readers.

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

Not applicable.

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

The "ground truth" for this 510(k) clearance is primarily the established safety and effectiveness of the predicate device (Alpha Bio Dental Implant System, K063364) and the demonstration that the ARDS Dental Implants are substantially equivalent to it. This involves:

Physical and mechanical characteristic comparison (materials, geometry, dimensions).
Intended use comparison.
"Testing results" (mentioned in section 6 of K071803 summary) which likely refer to engineering, biocompatibility, and perhaps mechanical fatigue tests to support that the "proprietary" differences do not raise new safety or effectiveness concerns compared to the predicate.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a training set.

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

Not applicable.

Summary

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June 10, 2019

Ards, Limited, RAC & CQE George Hattub Senior Staff Consultant Medicsense, USA 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K071803

Trade/Device Name: ARDS Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 12, 2008 Received: August 14, 2008

Dear George Hattub:

This letter corrects our substantially equivalent letter of September 05, 2008.

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

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

For comprehensive regulatory information about mediation-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

for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: ARDS Dental Implants

Indications For Use: ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suan Suape

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

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510(k) Number: K071833

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510(k) Summary of Safety & Effectiveness

Ko71803

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. (a) Submitter George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com SEP - 5 2008 1. (b) ARDS, Ltd. Manufacturer 4 Hasikma St. Address: Rishon Lezion, Israel 75201 Mfa. Phone: 972-3-969-0954 Contact Person: Dr. Uri Arny, CEO Date: March 7, 2008 2. Device & Endosseous Dental Implant, Class 2, Product Code DZE, 21 CFR 872.3640 Classification Name: ARDS Dental Implants 3. Predicate Device: Alpha Bio Dental Implant System (K063364) 4. Description: ARDS implants are made from Titanium allov. The ARDS implants geometrical shape is characterized by altering drilling profile, with double thread at the upper part that change to one thread at the lower part, which increases its surface, and as a result, increases in the preliminary contact surface with the bone. The ARDS dental implants are : S type: Internal hex implants, length 10/13 mm, diameter 3.75/4.5 mm, with double thread at the upper part that goes over in a single thread at the lower part. S implant types are supplied sterile in a double vial system, inside a plastic box which includes the covering screw and the Instructions For Use. The abutments are for single use only and supplied non-sterile. The tools are reusable and supplied non-sterile, they must be sterilized by autoclave before use. 5. Intended Use: ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery. 6. Comparison of With respect to technology and intended use, the ARDS dental implants are Technological substantially equivalent to its predicate device which is the Alpha Bio Dental Characteristics: Implant System. The primary differences are propriety in nature. Based upon its testing results, ARDS believes these differences do not raise additional safety of efficacy concerns.
  Revised March 9, 2008

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.