A Temporary Abutment is indicated for use for a maximum of six weeks as an abutment for cemented provisional prostheses. This abutment can be used for single tooth provisional restorations or splinted to other abutments for multi-unit provisional restorations. Single use.

Device Description

The Spline Dental Implant System - Temporary Abutment will consist of a titanium alloy abutment cylinder with a separate titanium alloy retaining screw. A Temporary Abutment will attach.directly to the Spline implant with the retaining screw but does not engage the tines. It will be available in three different cuff diameters at the abutment/implant interface: 3.25mm, 4.0mm and 5.0mm. Abutments will also be available with straight wall or stepped cuffs with either a straight or a tapered retentive wall.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the "Spline Dental Implant System - Temporary Abutment." This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device. Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study designs for AI/software-based devices is not present in this document.

However, I can extract the relevant information that is available about the "performance data" and comparison to a predicate device, interpreting the request in the context of this specific regulatory submission.

Explanation of Device and Regulatory Context:

The device is a "Temporary Prosthetic Component" for dental implants. It's designed to be used for a limited duration (maximum of six weeks) to support temporary restorations. The submission focuses on demonstrating that this "Temporary Abutment" is substantially equivalent to an already legally marketed "Spline Dental Implant System - Fixed Abutment" (the predicate device).

Substantial equivalence is demonstrated by showing that the new device has the same intended use and technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

Here's how I can address your prompt based on the provided text:

Acceptance Criteria and Device Performance for Spline Dental Implant System - Temporary Abutment (K982305)

Regulatory Context: This submission is a 510(k) premarket notification, which establishes "substantial equivalence" to a predicate device, not necessarily standalone safety and efficacy through clinical outcomes. Acceptance criteria here refer to the demonstration of identical or highly similar technological characteristics and equivalent performance in bench testing to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Characteristic	Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance (Temporary Abutment)
Intended Use	Same as predicate, with specific duration limitation.	"To be used for a maximum of six weeks as an abutment for cemented provisional prostheses." (Identical to predicate's use for permanent abutments, but with time limit)
Available Diameters	Identical to predicate device.	3.25mm, 4.0mm & 5.0mm
Material	Identical to predicate device.	Titanium alloy
Manufacturing Site	Identical to predicate device.	Sulzer Calcitek, Carlsbad, CA.
Packaging	Identical to predicate device.	tray with tyvek lid
Sterility	Identical to predicate device.	Non-sterile
Overall Design	Identical to predicate device.	"identical" to predicate device
Technological Characteristics	Same as predicate device.	"The Temporary Abutments have the same technological characteristics as the predicate device."
Bench Top Testing	Demonstrated substantial equivalence to predicate device.	"Bench top testing demonstrate the substantial equivalence of the Temporary Abutment to the predicate device."

2. Sample Size for the Test Set and Data Provenance

Sample Size: Not specified. The submission mentions "bench top testing," which refers to laboratory-based mechanical or physical tests, not human subject data. The number of units tested is not provided.
Data Provenance: Not specified, but generally, bench testing data for such submissions would be generated by the manufacturer (Sulzer Calcitek Inc.) in a controlled laboratory environment. It is not retrospective or prospective clinical data from patients.

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

This concept is not applicable here. "Ground truth" from experts is relevant for diagnostic devices (e.g., radiologists interpreting images). For a mechanical device like a dental abutment, "ground truth" is established through engineering specifications, material properties, and mechanical performance standards via bench testing, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations (e.g., imaging studies). For bench testing, results are typically objective measurements against predefined engineering standards.

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 not an AI/software device, and no MRMC study or human reader performance assessment was conducted or required for this type of medical device.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for this device would be the engineering specifications, material properties, and established mechanical performance characteristics of the predicate device. The Temporary Abutment's performance in bench testing was compared against these established characteristics to show it performs equivalently.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning/AI device, so there is no training set in the conventional sense.

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

Not applicable. There is no training set.

Summary

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K982305

510(K) SUMMARY

Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended,

Company Name:	Sulzer Calcitek Inc.
Address:	2320 Faraday Avenue, Carlsbad, CA 92008
Telephone Number:	(760) 431-9515
Registration Number:	2023141
Contact Person:	Foster Boop
Date Summary Prepared:	June 30, 1998
Classification Name:	Implant, Endosseous (76DZE)
Common/Usual Name:	Temporary Prosthetic Component
Device Trade Name:	Spline Dental Implant System - Temporary Abutment

The primary device used for comparison purposes in this summary is the Spline Dental Implant System - Fixed Abutment

1. Intended Use:

The statements of intended use are identical with the exception that the duration of Temporary Abutment use is limited. Temporary Abutments are intended to be used in the same manner as their permanent counterpart except that the former are used to support temporary (provisional) restorations.

. 2. Description:

3. Technological Characteristics:

The Temporary Abutments have the same technological characteristics as the predicate device.

4. Performance Data:

Bench top testing demonstrate the substantial equivalence of the Temporary Abutment to the predicate device.

Page 1 of 2

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5. Comparison Analysis :

The overall design of the Temporary Abutment is identical to the predicate device. :

SUMMARY OF COMPARISON
Feature	Temporary Abutment	Predicate Device
Available Diameters	3.25mm, 4.0mm & 5.0mm	3.25mm, 4.0mm & 5.0mm
Material	Titanium alloy	Titanium alloy
Manufacturing site	Sulzer Calcitek, Carlsbad, CA.	Sulzer Calcitek, Carlsbad, CA.
Packaging	tray with tyvek lid	tray with tyvek lid
Sterility	Non-sterile	Non-sterile

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized image of an eagle with three human profiles embedded within its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1998

Mr. Foster Boop Regulatory Affairs Associate Sulzer Calcitek, Incorporated 2320 Faraday Avenue Carlsbad, California 92008

Re : K982305 Spline™ Dental Implant System - Temporary Trade Name: Abutments Regulatory Class: III Product Code: DZE Dated: June 30, 1998 Received: July 1, 1998

Dear Mr. Boop:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Boop

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours, 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

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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510 (K) Number (if known) :

Temporary Abutment Device Name:

Indications For Use:

. a

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

Concurrence of CDRH, Office of Device Evaluation (ODE) sover Wago (Division Sign-Off) Division of Dental. Infection Control, and General Hospital, Devices 510(k) Number OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109)

(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.