The Spectrum Designs Concave Back 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 six sizes.

AI/ML Overview

The provided document focuses on the 510(k) summary for the "Spectrum Designs Concave Back Chin Implant" and the FDA's clearance letter. This type of submission, particularly for a Class II device like a chin implant in 1998, typically relies on substantial equivalence to a predicate device rather than extensive new clinical trials with detailed performance acceptance criteria and study designs in the way that, for example, a novel AI diagnostic device would.

Therefore, the information requested in your prompt (especially regarding AI-specific questions like MRMC studies, standalone performance, training sets, and ground truth establishment for AI models) is not applicable to this document. This document describes a physical medical implant device, not an AI or software-as-a-medical-device (SaMD).

Here's an analysis based on the information provided, recognizing the nature of the device:

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

The document does not explicitly present a table of quantitative acceptance criteria or detailed performance results in the way one would for a diagnostic or AI device. For a physical implant like this, "acceptance criteria" are generally met by demonstrating:

Substantial Equivalence: The primary "acceptance criterion" for 510(k) clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Biocompatibility: Implied by the use of medical-grade silicone and historical use of similar predicate devices.
Manufacturing Quality: Assumed by compliance with GMP regulations (Quality System Regulation - 21 CFR Part 820).
Intended Use: The indications for use match or are comparable to the predicate.

Reported Device Performance (based on substantial equivalence):

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness comparable to predicate device	Substantially equivalent to McGhan Medical Corp. Concave Back Chin Implant
Material Biocompatibility	Manufactured from medical-grade solid silicone elastomer
Functional Augmentation/Reconstruction of Chin Deficiencies	Designed to augment or reconstruct congenital or traumatic chin deficiencies
Manufacturing Quality Standards	Assumed to comply with Quality System Regulation (21 CFR Part 820)
Presence of Contraindications	Same contraindications as routine aesthetic surgery (infection)
Potential Complications	Same potential complications as similar implants (displacement, tissue necrosis, bone resorption, encapsulation, infection, etc.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as there is no "test set" in the context of clinical trial data or performance evaluation for a software/AI device. The clearance is based on substantial equivalence to a predicate device, material properties, and intended use, not on a specific clinical study with a detailed test set described in this summary.

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)

This is not applicable as there was no test set requiring expert ground truth for this type of device and submission.

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

This is not applicable as there was no test set requiring adjudication.

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

This is not applicable. This is a physical implant, not an AI or diagnostic device.

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

This is not applicable. This is a physical implant, not an AI or diagnostic device.

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

For this type of device, the "ground truth" for safety and effectiveness is primarily based on:

Historical performance of predicate devices: The FDA's assessment relies on the established safety and efficacy profile of the "McGhan Medical Corp. Concave Back Chin Implant."
Material properties: The use of "medical-grade solid silicone elastomer" with a known history of safe implantation.
General clinical understanding of chin augmentation: The medical community's knowledge of the indications, contraindications, and potential complications of such procedures.

8. The sample size for the training set

This is not applicable as there is no training set for an AI model.

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

This is not applicable as there is no training set for an AI model.

Summary

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6 1998 MAY

SUMMARY OF SAFETY AND EFFECTIVENESS

SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT 510K SUMMARY

K980445

1. Submitter's Data

Spectrum Designs Inc. 5921 C. Matthews Street Goleta, CA 93117

Contact Person: Jim Dishman (805) 681-4899 Telephone: December 30, 1997 Date Prepared:

2. Device Name, Classification

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

3. Identification of Substantially Equivalent Devices

McGhan Medical Corp. Concave Back Chin Implant

4. Device Description

5. Indications for Use

The Spectrum Designs Concave Back 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design, with three wavy lines representing the department's mission of promoting health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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C 1698 MAY

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

Re : K980444 Bilateral Groove Chin Implant Trade Name: K980445 Concave Back Chin Implant Trade Name: K980446 Anterior Chin Implant Trade Name: Regulatory Class: II Product Code: FWP Dated: January 17, 1998 Received: February 5, 1998

Dear Mr. Dishman:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, subject to the qeneral 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory

144 - 122

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Page 2 - Mr. Dishman

In addition, FDA may publish further announcements action. concerning your devices 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 requlations.

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

If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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,

Aristotle

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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INDICATIONS FOR USE

Applicant: Spectrum Designs Inc.

x980445 510(k) Number ( if known):

Device Name: Spectrum Designs Concave Back Chin Implant

Indications for Use:

The Spectrum Designs Concave Back 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 usePer 21 CFR 801.109	X
or	Over-the counter __________

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K980445
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P. 6

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.