Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.

The Simpact implant is a threaded/tapered internal connection implant. The Simpact implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into the extraction socket.

The Simpact implant is intended for immediate provisional loading when primary stability and proper occlusion are present. Immediate Provisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for the placement of an interim prosthesis with occlusal contact with the opposing dentition, at the same clinical visit of implant placement. The Simpact implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications.

Device Description

The SIMPACT Endosseous Dental Implant System.

The Simpact implant is a threaded/tapered internal connection implant.

AI/ML Overview

The medical device in question, the SIMPACT Endosseous Dental Implant System, is a dental implant. The provided text from the 510(k) summary (K081226) does not contain a detailed study report with specific acceptance criteria and performance data for the device in the way one would expect for an AI/ML medical device or a device requiring extensive clinical trials for efficacy.

Instead, this 510(k) submission primarily focuses on establishing substantial equivalence to predicate devices. This means that formal acceptance criteria and a study demonstrating the device meets those criteria in terms of numerical performance metrics (like sensitivity, specificity, accuracy, or effect size) are not present in the provided document, because the regulatory pathway for this type of device at the time did not typically require such studies for substantial equivalence.

The document states: "The SIMPACT implant system and its predicate devices have the same indications for use have a similar design and are made of the similar materials." and "The SIMPACT implant system is substantially equivalent to its predicate devices. This conclusion is based upon the fact that this device is substantially equivalent in terms of indications for use, materials, design and principles of operation." This indicates that the "performance" of the SIMPACT implant is deemed acceptable because it is similar to already legally marketed devices.

Therefore, for the specific questions related to acceptance criteria and study details, the answer will reflect the nature of a 510(k) submission for a non-software device establishing substantial equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Strictly speaking, the document does not define specific acceptance criteria (e.g., numerical thresholds for success) or report quantitative performance data for the SIMPACT Endosseous Dental Implant System in the way one would for a clinical trial or performance study of an AI/ML device. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices in terms of materials, design, indications for use, and principles of operation.

Acceptance Criteria (Implicit)	Reported Device Performance
Material Equivalence: Materials are similar to predicates.	Made of "similar materials" to predicate devices.
Design Equivalence: Design is similar to predicates.	Has a "similar design" to predicate devices.
Indications for Use Equivalence: Same as predicates.	Has the "same indications for use" as predicate devices.
Principle of Operation Equivalence: Same as predicates.	Has the "same principles of operation" as predicate devices.
Overall Safety & Effectiveness: Substantially Equivalent.	Determined to be "substantially equivalent" to predicate devices K051614, K041509, K012681, K00099.

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

Not Applicable (N/A). The provided 510(k) summary does not describe a "test set" of data or a clinical study in the typical sense (e.g., for performance metrics) for the SIMPACT device itself. Substantial equivalence was primarily established through comparison of specifications, materials, design, and indications for use against predicate devices.

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

Not Applicable (N/A). As no test set from a clinical study is described, no experts were used to establish ground truth for such a set based on this document.

4. Adjudication Method for the Test Set

Not Applicable (N/A). No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done for the SIMPACT Endosseous Dental Implant System, as it's a physical medical device (implant) and not a diagnostic imaging system or AI software that would typically utilize such a study design.

6. If a Standalone Performance Study Was Done

No, a standalone performance study (algorithm only performance without human-in-the-loop) was not primarily relied upon or described. The regulatory strategy was substantial equivalence to predicate devices, focusing on materials, design, and intended use as the basis for performance assumptions. The performance is assumed to be similar to legally marketed predicate devices, not demonstrated through an independent, standalone study with specific performance metrics in this document.

7. The Type of Ground Truth Used

Not Applicable (N/A) in the software/AI sense. For a physical device like an implant, "ground truth" concerning its direct "performance" (e.g., osseointegration, stability, longevity) would typically come from long-term clinical outcomes, histological analysis, or mechanical testing. However, the provided document only focuses on demonstrating substantial equivalence based on design, materials, and intended use compared to existing devices rather than new clinical ground truth establishment for this specific device.

8. The Sample Size for the Training Set

Not Applicable (N/A). This device is a physical dental implant, not an AI/ML algorithm requiring a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable (N/A). This device is a physical dental implant, not an AI/ML algorithm with a training set and corresponding ground truth.

Summary

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K081226

SEP 1 2 2008

510(k) Summary of Safety and Effectiveness:

SIMPACT Implant System

Submitter:	SIMPACT LLC300 Interpace ParkwaySuite 410Parsippany, NJ 07054
Contact Person	Alan LombardoPresidentPhone: 973-698-1128Email: aappolloria@hotmail.com
Date Prepared	September 2, 2008
Trade Name	SIMPACT Endosseous Dental Implant
Classification Nameand Number	Endosseous dental implant and abutment21 CFR 872.363021 CFR 872.3640
Product Code	DZE, NHA
Predicate Devices	Lifecore Biomedical K051614Friadent K041509Ankylos K012681CAMLOG K00099
Device Description	The SIMPACT Endosseous Dental Implant System.
Intended Use	Simpact Dental Implant System is intended for use in partiallyor fully edentulous mandibles and maxillae, in support of singleor multiple-unit restorations including; cement retained terminalor intermediate abutment support for fixed bridgework.
	The Simpact implant is a threaded/tapered internal connection
	implant. The Simpact implant is intended for immediate
	placement, where immediate implant placement is defined by
	the International Congress of Oral Implantologists (ICOI) as the
	placement of an implant at the time of tooth extraction, into the
	extraction socket.

	The Simpact implant is intended for immediate
	provisional loading when primary stability and proper occlusion
	are present. Immediate Provisionalization is defined by the
	International Congress of Oral Implantologists (ICOI) as a
	clinical protocol for the placement of an interim prosthesis
	with occlusal contact with the opposing dentition, at the same
	clinical visit of implant placement. The Simpact implant can be
	restored with a temporary prosthesis in single tooth and multiple
	tooth applications.

Statement of	The SIMPACT implant system and its predicate devices have
Technological	the same indications for use have a similar design and are made
Comparison	of the similar materials.
Conclusion	The SIMPACT implant system is substantially equivalent to its
	predicate devices. This conclusion is based upon the fact that
	this device is substantially equivalent in terms of indications for
	use, materials, design and principles of operation.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized depiction of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2008

Mr. Alan Lombardo Simpact, LLC 300 Interpace Parkway Building C 3rd Floor Parsippany, New Jerscy 07054

Rc: K081226

Trade/Device Name: SIMPACT Endosseous Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: September 2, 2008 Received: September 3, 2008

Dear Mr. Lombardo:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Lombardo

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Khamails Ludi-r for u

Chiu S. Lin, Ph. D Division 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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Indications for Use

510(k) Number K081226

SIMPACT Endosseous Dental Implant

Indications for Use:

Device Name:

Simpact Dental Implant System is intended for use in partially or fully edentulous mandibles and maxillae; in support of single or multiple-unit restorations including; cement retained terminal or intermediate abutment support for fixed bridgework.

Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runpe

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

510(k) Number: LCDS12076

Revised September 2, 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.