· covering of implants placed in immediate or delayed extraction sockets;
· localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
· alveolar ridge reconstruction for prosthetic treatment; and
· recession defects for root coverage.

Device Description

Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.

The products are provided as follows:

Geistlich Mucograft®: 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm ●
. Geistlich Mucograft® Seal: 8 mm and 12 mm diameter

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding Geistlich Mucograft® and Geistlich Mucograft® Seal. It concludes that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically expected for medical device performance evaluation (e.g., accuracy, sensitivity, specificity, or clinical outcomes with defined thresholds).

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

Identical Indications for Use.
Similar technological characteristics (material, shape, single-use, sterilization method).
Leveraging performance data from the applicant's own predicate device (mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance testing).
Risk assessment to demonstrate that minor changes (new size configuration and slight manufacturing changes) do not raise new questions of safety or effectiveness.

Therefore, many of your requested details, such as a table of acceptance criteria, device performance, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of FDA submission for substantial equivalence.

Here's an analysis based on the information available in the provided text:

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

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical metrics (e.g., success rates, healing times) for the subject device. The primary "performance" reported is its substantial equivalence to predicate devices, which implies that it performs similarly to devices already on the market.

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

Not applicable. This submission relies on "performance data... from the applicant's own predicate device" and a "risk assessment" rather than specific new clinical or performance test sets for the current iteration of the device. Therefore, details about test set sample size or data provenance for a new study are not provided.

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)

Not applicable. Ground truth establishment by experts for a specific test set is not described, as the submission focuses on substantial equivalence to predicate devices based on a comparison of characteristics and leveraging existing predicate data.

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

Not applicable. No new test set or adjudication method is described.

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 device is a collagen matrix (bone grafting material), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

Not applicable. This is not an algorithmic or AI-based device.

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

The document states "clinical performance testing from the applicant's own predicate device was leveraged." This implies that outcomes data from previous clinical studies on the predicate device were considered, rather than a new "ground truth" being established for the current submission.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. This device does not involve a "training set" or establishing ground truth for machine learning.

Summary regarding acceptance criteria and study data:

The provided text for K210280 (Geistlich Mucograft® and Geistlich Mucograft® Seal) is an FDA 510(k) summary for a "substantial equivalence" determination. It does not describe a new clinical study with specific acceptance criteria and performance metrics for the subject device. Instead, it demonstrates substantial equivalence by:

Highlighting identical Indications for Use with predicate devices.
Confirming identical materials, manufacturing, sterilization methods, and packaging to predicate devices (with minor exceptions for size and slight manufacturing process changes).
Leveraging performance data (mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance) from the applicant's own predicate device.
Performing a risk assessment to conclude that minor changes do not raise new questions of safety or effectiveness.

Therefore, the "proof" that the device meets "acceptance criteria" here is the FDA's determination of substantial equivalence, based on the documented comparison to predicate devices and the existing performance data of those predicates. There are no new, specific quantitative acceptance criteria or a dedicated study described for this submission in the way you might find for novel device performance claims.

Summary

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March 03, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Geistlich Pharma AG % Roshana Ahmed Sr Regulatory Specialist TELOS Partners LLC 571 Christina Lake Drive Lakeland. Florida 33813

Re: K210280

Trade/Device Name: Geistlich Mucograft®, Geistlich Mucograft® Seal Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: January 30, 2021 Received: February 1, 2021

Dear Roshana Ahmed:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210280

Device Name

Geistlich Mucograft® and Geistlich Mucograft® Seal

Indications for Use (Describe) Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:

· covering of implants placed in immediate or delayed extraction sockets;
· localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
· alveolar ridge reconstruction for prosthetic treatment; and
· recession defects for root coverage.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55

Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: March 3, 2021

II. Device

Device Proprietary Names:	Geistlich Mucograft®Geistlich Mucograft® Seal
Common or Usual Name:	Collagen Matrix
Classification Name:	Bone Grafting Material
Regulation Number:	872.3930
Product Code:	NPL
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Product Name	510(k)	Applicant
Geistlich Mucograft® and Mucograft® Seal	K192042	Geistlich Pharma AG
	K140518	Geistlich Pharma AG
	K102531	Geistlich Pharma AG
	K073711	Geistlich Pharma AG

IV. Device Description

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collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.

The products are provided as follows:

Geistlich Mucograft®: 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm ●
. Geistlich Mucograft® Seal: 8 mm and 12 mm diameter

V. Indications for Use

Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:

covering of implants placed in immediate or delayed extraction sockets;
localized gingival augmentation to increase keratinized tissue (KT) around teeth and ● implants;
alveolar ridge reconstruction for prosthetic treatment; and ●
recession defects for root coverage. ●

VI. Comparison of Technological Characteristics

The Indications for Use Statement is identical to the predicate device.

The subject devices are equivalent to the predicate devices with respect to materials characteristics, manufacturing and sterilization methods, and packaging. Both the subject and predicate devices have identical final product specifications. A comparison of the subject and predicate device is provided in the table below.

	Subject Devices	Predicate Devices(K192042, K140518,K102531, K073711)	Analysis
Material	Porcine collagen	Same	Equivalent
Shape	Geistlich Mucograft®:RectangleGeistlich Mucograft® Seal:Circle	Same	Equivalent
Sizes	Geistlich Mucograft®:15 x 20 mm20 x 30 mm30 x 40 mmGeistlich Mucograft® Seal:8 mm diameter12 mm diameter	Geistlich Mucograft®:15 x 20 mm20 x 30 mm30 x 40 mmGeistlich Mucograft® Seal:8 mm diameter	Different. The subjectdevices include a largersize of GeistlichMucograft® Seal. Thedifference in size doesnot raise different

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	Subject Devices	Predicate Devices(K192042, K140518,K102531, K073711)	Analysis
			questions of safety oreffectiveness.
Single-Use	Yes	Same	Equivalent
Sterilization	Gamma	Same	Equivalent

Since prior clearance, the following minor changes were made:

. addition of a new 12 mm diameter Geistlich Mucograft® Seal configuration, and
slight changes in the manufacturing processes for intermediate and final products.

These changes do not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.

Performance Data VII.

Mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate device was leveraged in support of substantial equivalence.

Based on the results of risk assessment, no additional testing was required to support the new size configurations.

VIII. Conclusion

The subject devices are identical to the predicate device. The addition of a new 12 mm diameter for Geistlich Mucograft® Seal and slight changes in the manufacturing processes for the final product does not raise different questions of safety and effectiveness as demonstrated by risk assessment and verification and validation testing. Therefore, it is concluded that Geistlich Mucograft® and Geistlich Mucograft® Seal are substantially equivalent to the identified predicate devices.

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Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.