The ScrewVent and Tapered ScrewVent implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete In countilious of partially or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.

In patients with an edentulous mandible, ScrewVent and Tapered ScrewVent implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

Device Description

ScrewVent and Tapered ScrewVent implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the new device. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of algorithmic performance metrics (like sensitivity, specificity, etc.) is not applicable or available in this submission.

Here's a breakdown based on the provided text, addressing what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not outline specific performance acceptance criteria for the ScrewVent® and Tapered ScrewVent® implants in the way one would for an AI/ML device (e.g., sensitivity, specificity, F1-score). Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating substantial equivalence to predicate devices.

The "performance" is implicitly demonstrated through the comparison of technological characteristics and intended use, asserting that the new device performs similarly to or no worse than the predicate devices for their stated intended uses.

Characteristic	Acceptance Criteria (Implicit for Substantial Equivalence to Predicate)	Reported Device Performance (ScrewVent® & Tapered ScrewVent®)
Intended Use	Must be the same as or very similar to predicate devices: "Intended for surgical implantation in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement."	"Intended for surgical implantation in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement." (Matches predicate)
Technological Characteristics	Must be similar to predicate devices (design, material, diameter, length, surface, packaging, sterilization). Any differences must not raise new questions of safety or effectiveness.	Similar overall design to predicate implants. No modifications to ScrewVent and Tapered ScrewVent implants. No change to implant materials or implant/abutment interface. (See Table 1 for detailed comparisons).
Material	Commercially Pure Titanium (Branemark), Commercially Pure Titanium (ITI)	Titanium alloy
Sterilization	Dry heat (Branemark), Gamma irradiation (ITI)	Gamma irradiation

Note: The "acceptance criteria" here are not numerical thresholds for performance metrics but rather a demonstration of similarity in design and function to legally marketed devices, ensuring safety and effectiveness are maintained.

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

This document does not describe a clinical "test set" in the context of an AI/ML device. It is a 510(k) submission for a physical medical device (dental implants). Therefore, concepts like "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable.

The "comparison" is based on the technical specifications and intended uses of previously cleared predicate devices.

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

This information is not applicable to a 510(k) submission for a dental implant. There is no "ground truth" establishment by experts in the context of a dataset for algorithmic evaluation. The safety and effectiveness are established through material compatibility, mechanical testing (which is not detailed here but implied by substantial equivalence), and historical clinical use of similar devices.

4. Adjudication Method for the Test Set

Not applicable. There is no test set adjudication for a physical dental implant in this type of submission.

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

No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance. This document concerns a physical dental implant and therefore an MRMC study was not conducted or is not relevant to this submission.

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

No. This is not an AI/ML device.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI performance evaluation (e.g., pathology, outcomes data for diagnostic accuracy) is not directly applicable here.

For a physical device like a dental implant, the "ground truth" for its safety and effectiveness is established through:

Established clinical practice and long-term outcomes of very similar predicate devices.
Material properties and biocompatibility testing (implied, not detailed).
Mechanical performance such as strength, fatigue, and interface stability (implied, not detailed).
Adherence to recognized standards (implied).

The document states, "There have been no modifications to the ScrewVent and Tapered ScrewVent implants. There has been no change to the implant materials or to the implant/abutment interface." This statement and the comparison table are the primary "evidence" presented for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device and therefore does not have a "training set."

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

Not applicable.

Summary

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Attachment 16

NOV 1 9 2001

510(K) SUMMARY

K013227

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.

Company Name:	Sulzer Dental Inc.
Address:	1900 Aston Avenue, Carlsbad, CA 92008-7308
Telephone Number:	760-929-4104
Registration Number:	2023141
Contact Person:	Foster Boop
Date Summary Prepared:	September 26, 2001
Classification Name:	Implant, Endosseous (76DZE)
Common/Usual Name:	Dental Implant
Device Trade Name:	ScrewVent® and Tapered ScrewVent®

The primary devices used for comparison in this summary are the dental implants and indications for use clear under the Branemark System (K992937 and K993595) and the ITI implants (K984104 and K002374).

1. Intended Use:

Sulzer Dental's implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.

ScrewVent and Tapered ScrewVent implants have the same intended use as the predicate implants.

2. Description:

3. Technological Characteristics:

There have been no modifications to the ScrewVent and Tapered ScrewVent implants. There has been no change to the implant materials or to the implant/abutment interface.

Page 1 of 2

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4. Comparison Analysis:

The overall design of the ScrewVent and Tapered ScrewVent implants are similar to the predicate implants. See Table 1 below for a comparison of the Advent and Swiss Plus implants and the predicate devices.

Characteristic	Branemark System	ITI Implants	ScrewVent & Tapered ScrewVent
Intended Use	Intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patients chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.	Intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.	Intended for surgical implantation in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.
Indication	Immediate Load	Immediate Load	Immediate Load
Design	Threaded, root form implant	Threaded, root form implant	Threaded, root form implant
Placement Method	Two or Single Stage Surgery	Single Stage Surgery	Two or Single Stage Surgery
Material	Commercially Pure Titanium	Commercially Pure Titanium	Titanium alloy
Diameter (mm)	3.75mm and 4.0mm	3.3mm, 4.1mm and 4.8mm	ScrewVent: 3.7mm & 4.7mmTapered ScrewVent: 3.7mm, 4.7mm & 6.0mm
Lengths	10mm – 18mm	8mm – 16mm	8mm – 16mm
Implant Surface	MachinedRoughened - TiUnite	TPS coatedRoughened - SandblastedLargegrit Acid washed (SLA)	HA coated/RoughenedorRoughened - HA blasted
Packaging	Glass ampoule in peel-open blister pack	Ampoule	Double vial system
Sterilization	Dry heat	Gamma irradiation	Gamma irradiation

Table 1: Summary of Comparison

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2001

Mr. Foster Boop Manager, Submissions & Complaints Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

Re: K013227

Trade/Device Name: Screw Vent Implant; Tapered Screw Vent Implant Regulation Number:872.3640 Regulation Name: Dental Implant or Endosseous Implant Regulatory Class: III Product Code: DZE Dated: September26, 2001 Received: September 27, 2001

Dear Mr. Boop:

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.

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 9 2001

KOi3227

10(K) Number (if known): K013227د

Device Name: ScrewVent Dental Implant

Indications for Use:

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Suan Runner
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ Prescription Use

(Per 21 CFR 801.109)

Over-The-Counter-Use_

(Optional Format 1-2-96)

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.