Spectrum Designs Projection Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Spectrum Designs Projection Malar Implant." This type of document is a pre-market notification submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not a detailed study report proving the device meets specific acceptance criteria through clinical trials or performance studies as one might expect for a new, higher-risk device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, study design, sample sizes, expert involvement, and ground truth derivation is not present in this type of regulatory submission. The 510(k) process primarily relies on demonstrating equivalence to an existing device rather than presenting novel performance data.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)

The provided document is a 510(k) summary for a malar implant. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against explicitly defined acceptance criteria. Therefore, the document does not contain the level of detail regarding acceptance criteria and performance study results typically associated with a clinical trial or a novel device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not specify quantitative acceptance criteria or clinical performance metrics. The "performance" described relates to the intended function and substantial equivalence, not detailed clinical outcomes or efficacy rates from a study.

Acceptance Criterion (Type)	Reported Device Performance (as implied by 510(k))
Material Composition	Manufactured from solid silicone elastomer (same as predicate).
Intended Use	To augment or reconstruct the malar region of the face (same as predicate).
Surgical Implantation Method	Implanted in a pocket created by the surgeon in the malar-zygomatic region (implied same as predicate).
Identified Risks/Complications	Potential for displacement, positioning errors, tissue necrosis, bone resorption, fibrous encapsulation, infection, neural damage, hematoma, poor wound healing, patient intolerance to foreign body (same as or similar to predicate).
Substantial Equivalence	Deemed substantially equivalent to legally marketed predicate devices (Spectrum Designs Silhouette Malar Implant).

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

The document does not describe a "test set" or a formal clinical study with a determined sample size. The 510(k) process is typically based on a comparison to a predicate device and may involve bench testing, but not clinical trials with human subjects for performance evaluation unless specifically required for novel aspects. Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective nature) is not available in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since a formal clinical "test set" and corresponding ground truth establishment for performance evaluation are not described in this 510(k) summary, there is no information on the number or qualifications of experts used for this purpose.

4. Adjudication Method for the Test Set

As there is no described "test set" or clinical study for performance evaluation, an adjudication method is not applicable or mentioned in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study is typically relevant for interpretative devices (e.g., imaging AI). This device is a physical implant. The document does not mention or imply any MRMC study, nor does it refer to human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

This device is a physical implant, not an algorithm or software. Therefore, a "standalone (algorithm only)" performance study is not applicable and not mentioned.

7. Type of Ground Truth Used

Given the nature of a 510(k) submission for a physical implant, and the absence of a detailed clinical study for performance evaluation, the concept of "ground truth" as typically used for diagnostic or AI-driven devices is not directly applicable or described. The "ground truth" for substantial equivalence often relates to material properties, intended use, and known safety/performance characteristics of the predicate device.

8. Sample Size for the Training Set

The document does not describe a "training set" as this is not an AI/ML device. The 510(k) process relies on demonstrating equivalence to an existing device, not training a novel algorithm.

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

As there is no training set described for this physical implant, the method for establishing "ground truth" for a training set is not applicable or mentioned.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

SPECTRUM DESIGNS INC. PROJECTION MALAR IMPLANT 510k SUMMARY

MAR - 3 1998

498014

1. Submitter's Data

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

Contact Person: Telephone: Date Prepared:

Jim Dishman 805 681 4899 December 30, 1997

2. Device Name, Classification

Name: Spectrum Designs Projection Malar Implant FDA Classification: Class II, Implant, Malar, Classification 79LZK

3. Identification of Substantially Equivalent Devices

Spectrum Designs Silhouette Malar Implant

4. Device Description

5. Indications for Use

The Spectrum Designs Projection Malar Implant is a silicone facial implant, designed to augment or reconstruct the malar region of the face.

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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAR - 3 1998

K980139, K980140 & K980141 Re: Trade Name: Spectrum Designs Profile Malar Implant Spectrum Designs Medial Malar Implant and Spectrum Designs Projection Malar Implant Regulatory Class: II Product Code: LZK Dated: December 30, 1997 Received: January 15, 1998

Dear Mr. Dishman:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the 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 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification

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Page 2 - Mr. Dishman

submissions 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.

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 a legally marketed predicate device 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,

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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Include the following "Indications For Use" page that contains the applicant's name, name of the device and the intended use of the device. The information, data and labeling claims in the entire 510(k) submission must support and agree with the "indications for use" statement.

*For a new submission, do NOT fill in the 510(k) number blank.

INDICATIONS FOR USE

Applicant: Spectrum Designs, Inc.

K98014 * 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Spectrum Designs Projection Malar Implant

Indications For Use

The Spectrum Designs Projection Malar Implant is intended to augment or reconstruct the malar region of the face.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of General Restorative Devices
510(k) Number	K980014

Prescription Use		or	Over-the counter
Per 21 CFR 801.109

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.