The Spectrum Designs Anatomical Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in two sizes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Spectrum Designs Anatomical Chin Implant, based on the provided text.

Based on the provided document, the "study" that proves the device meets acceptance criteria is implied through the 510(k) submission process, which relies on demonstrating substantial equivalence to a previously legally marketed predicate device. This is not a traditional clinical study with defined performance metrics, but rather a regulatory pathway demonstrating that the new device is as safe and effective as existing ones.

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a Class II device relying on substantial equivalence, there isn't a table of discrete acceptance criteria with numerical performance targets in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" are met by demonstrating the device is:

As safe and effective as legally marketed predicate devices.
Has the same intended use as legally marketed predicate devices.
Has the same technological characteristics as legally marketed predicate devices, or if there are differences, those differences do not raise different questions of safety and effectiveness.

The "reported device performance" is implicitly that the device performs equivalently to its predicates for the stated indications.

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance (Implied by 510(k) Clearance)
Safety: Device is as safe as predicates.	Device is considered safe for its intended use.
Effectiveness: Device is as effective as predicates.	Device is considered effective for its intended use.
Intended Use: Same as predicates.	Augment or reconstruct congenital or traumatic chin deficiencies.
Technological Characteristics: Same or comparable to predicates without raising new safety/effectiveness questions.	Manufactured from medical-grade solid silicone elastomer, implanted in the mandibular region.

Study Information (Based on 510(k) Substantial Equivalence Determination)

Given the nature of the 510(k) summary provided, the following points address the questions in the context of a substantial equivalence determination rather than a specific clinical trial.

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of this 510(k) summary. There is no mention of a traditional "test set" from a clinical study. The determination is based on a comparison to predicate devices already on the market.
- Data Provenance: Not applicable. The submission relies on information about the predicate devices and the physical characteristics/materials of the new device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined in the context of performance studies (e.g., for AI) is not established here. The FDA reviews the submitted documentation and makes a regulatory decision.
Adjudication method for the test set:
- Not applicable. No "test set" and no expert adjudication process described for performance evaluation.
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 device is a physical chin implant, not a diagnostic AI system or a system requiring human interpretation of output.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the typical sense. The "ground truth" for a 510(k) determination is the established safety and effectiveness of the predicate devices that already have a market history, coupled with the review of the new device's engineering characteristics, materials, and intended use.
The sample size for the training set:
- Not applicable. There is no AI model or "training set" for this device.
How the ground truth for the training set was established:
- Not applicable. No AI model or "training set" for this device.

Summary

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

SUMMARY OF SAFETY AND EFFECTIVENESS

6 1998 MAY

SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT Y 98 Off 2 510K SUMMARY

1. Submitter's Data

Spectrum Designs Inc.5921 C. Matthews StreetGoleta, CA 93117	Contact Person: Jim DishmanTelephone: (805) 681-4899Date Prepared: December 30, 1997
----------------------------------------------------------------------	----------------------------------------------------------------------------------------------

2. Device Name, Classification

Name: Spectrum Designs Anatomical Chin Implant FDA Classification: Class II, Prosthesis, Chin, Internal, Classification Number 79FWP, 21 CFR 878.3550

3. Identification of Substantially Equivalent Devices

Spectrum Designs Meniscus Chin Implant McGhan Medical Corp. Curvilinear Chin Implant Implantech Associates Anatomical Chin Implant

4. Device Description

5. Indications for Use

The Spectrum Designs Anatomical Chin Implant is a silicone facial implant, designed to augment or reconstruct congenital or traumatic chin deficiencies.

6. Contraindications for Use

Contraindications for routine aesthetic surgery include the presence of infection anywhere in the body and in particular, in the region in which the device will be implanted.

7. Warnings, Precautions

Possible complications include:

Displacement of the implant may occur, especially from dissection of too large a . pocket.
Errors in positioning the implant may result in patient dissatisfaction ●
Tissue necrosis may result in extrusion of the implant. This can occur as a result ● of such factors as the pocket created being too small, use of too large an implant, or when soft tissues are inadequate to maintain coverage over the prosthesis
Resorption of the underlying bone may occur with use of the implant. ●
Fibrous tissue encapsulation can occur around any implant, with subsequent ◆ increased firmness, possible displacement, and/or pains.
Complications from this or any similar surgery may include infection, neural ● damage, hematoma, poor would healing, patient intolerance to foreign body implantation, and other similar complications.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1898 MAY

Mr. Jim Dishman ·Spectrum Designs, Incorporated 5921-C Matthews Street 93117 Goleta, California

Re: K980462 Spectrum Designs Anatomical Chin Implant Trade Name: Requlatory Class: ı İ Product Code: FWP Dated: December 30, 1997 Received: February 5, 1998

Dear Mr. Dishman:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 obliqation 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.

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

Page 2 - Mr. Dishman

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 victo diagnobere actions), productionally, 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,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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

INDICATIONS FOR USE

Applicant: Spectrum Designs Inc.

980462 510(k) Number ( if known):

Device Name: Spectrum Designs Anatomical Chin Implant

Indications for Use:

The Spectrum Designs Anatomical Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

× Prescription use Per 21 CFR 801.109

Over-the counter


Station of client

(Division Sign-Off)
Division of General Restorative Devices,
510(k) Number K980462

Regulation Number and Section

§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.