· pressure ulcers
venous ulcers
· diabetic ulcers
· chronic vascular ulcers
· surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence)
· trauma skin wounds (abrasions, laceration, second degree burns, skin tears)

Device Description

The device is an animal-sourced, acellular wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. The Geistlich Wound Matrix is terminally sterilized in its packaging.

The device has a thickness of 2.5-5mm and is offered in 3 sizes: 15 mm x 20 mm; 20 mm x 30 mm; and 30 mm x 40 mm. The device can be trimmed as needed.

The device is intended to be used by licensed surgeons and will be supplied sterile for single one time use.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Geistlich Wound Matrix. It primarily establishes substantial equivalence to a predicate device and does not involve AI/ML performance data or a detailed clinical study with ground truth establishment in the way your request implies.

Therefore, many of the requested criteria cannot be directly extracted from this document, as they are not relevant to a 510(k) submission for a non-AI/ML device like a wound matrix. The document focuses on material composition, indications for use, and comparison to legally marketed predicate devices to assure safety and effectiveness.

Here's an attempt to address your points based on the provided document, noting where information is not applicable (N/A) or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or performance metrics for a device in the way an AI/ML product would. The "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparison of:

Indications for Use: The subject device's indications must be the same as or a subset of the predicate device.
Technological Characteristics: Key characteristics (material, design, sterilization, etc.) must be similar, and any differences must not raise new questions of safety or effectiveness.
Performance Data (implicit): For this type of device, performance data (e.g., biocompatibility) is often derived from the established safety profile of the material or similar devices, rather than a clinical trial with specific performance endpoints.

Acceptance Criteria Category	Reported Device Performance (from document)
Indications for Use	Geistlich Wound Matrix is intended for management of partial/full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds, and trauma skin wounds. (Deemed substantially equivalent to predicate, with the predicate having two additional indications which were excluded by the subject device, not raising new questions of safety/effectiveness).
Technological Similarity	Derived from porcine connective tissue, acellular, non-crosslinked, mostly collagen Type 1, bilayer (2.5-5mm thickness), terminally sterilized. (Found similar to Miromatrix Wound Matrix (porcine liver, acellular, non-crosslinked, collagen Type 1, sterile) despite differences in tissue source, single vs. bilayer, and thickness, with these differences not raising new safety/effectiveness questions. Identical to MUCOGRAFT reference device).
Biocompatibility	"Because the material of the subject device is identical to the reference device (K102531), the existing biocompatibility, sterilization, and shelf life information fully applies." (Implies the device meets biocompatibility standards established for the reference device, which is considered sufficient for equivalence).
Sterilization	Terminally sterilized in its packaging. (Existing sterilization information from the reference device (K102531) fully applies, implying it meets standards).
Shelf Life	N/A - Not explicitly stated, but "existing...shelf life information fully applies" from the reference device (K102531).

2. Sample Size for the Test Set and Data Provenance

This document states: "Bench, animal, and clinical data are not necessary to support the substantial equivalence of a wound dressing."
Therefore, there is no "test set" in the context of an algorithmic performance evaluation.
The data provenance, in this case, would refer to the existing safety and effectiveness profile of the predicate device and the "reference device" (Geistlich MUCOGRAFT® Collagen Matrix, K102531), which the subject device is stated to be identical to in material and design. No new clinical or animal studies were conducted for this 510(k) submission.

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

N/A. No ground truth establishment by experts for a test set was performed as part of this 510(k) submission. The FDA's review process involves their own experts, but not in the context of creating a dataset for device evaluation in the way you describe.

4. Adjudication Method for the Test Set

N/A. No test set was used in this manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

N/A. This is a non-AI medical device (wound matrix). MRMC studies are not relevant to its evaluation for substantial equivalence.

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

N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

N/A. For this particular 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established performance and safety profiles of the legally marketed predicate device (Miromatrix Wound Matrix, K140510) and the reference device (Geistlich MUCOGRAFT® Collagen Matrix, K102531), to which the subject device is claimed to be substantially equivalent or identical. The basis for approval is that the new device is as safe and effective as a device already on the market, rather than meeting absolute performance criteria against an independent "ground truth" dataset.

8. The Sample Size for the Training Set

N/A. No training set was used, as this is not an AI/ML device.

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

N/A. No training set was used.

Summary

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November 3, 2017

Geistlich Pharma AG % Stephen Rhodes Senior Consultant, Devices Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, Virginia 22314

Re: K171842

Trade/Device Name: Geistlich Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 9, 2017 Received: June 20, 2017

Dear Stephen Rhodes:

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. 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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171842

Device Name Geistlich Wound Matrix

Indications for Use (Describe)

The Geistlich Wound Matrix is intended for the management of wounds including:

· partial and full thickness wounds

· pressure ulcers
venous ulcers
· diabetic ulcers
· chronic vascular ulcers
· surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence)
· trauma skin wounds (abrasions, laceration, second degree burns, skin tears)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below.

SUBMITTER 1.

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

Contact Person: Jan van der Ploeg Phone: +41 41 492 69 28 Email: jan.vanderploeg@geistlich.ch

Prepared By: Stephen P. Rhodes, Biologics Consulting Group, rhodes@biologicsconsulting.com Date Prepared: November 1, 2017

2. DEVICE

Name of Device: Geistlich Wound Matrix Common Name: Collagen Wound Dressing Classification Regulation/Class: unclassified Product Code: KGN Panel: General and Plastic Surgery

PREDICATE DEVICE 3.

Predicate Device: Miromatrix Wound Matrix (K140510)

Reference Device: Geistlich MUCOGRAFT® Collagen Matrix (K102531)

DEVICE DESCRIPTION 4.

The device has a thickness of 2.5-5mm and is offered in 3 sizes: 15 mm x 20 mm; 20 mm x 30 mm; and 30 mm x 40 mm. The device can be trimmed as needed.

The device is intended to be used by licensed surgeons and will be supplied sterile for single one time use.

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ട. INDICATION FOR USE

The Geistlich Wound Matrix is intended for the management of wounds including:

partial and full thickness wounds
pressure ulcers
venous ulcers ●
diabetic ulcers ●
chronic vascular ulcers
surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, ● wound dehiscence)
trauma skin wounds (abrasions, laceration, second degree burns, skin tears)

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

The Geistlich Wound Matrix is an acellular wound dressing derived from non-crosslinked porcine (skin and connective) tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is mostly collagen Type 1, and is intended for use in the management of wounds. The Geistlich Wound Matrix is terminally sterilized in its packaging. The device is offered in sizes ranging from 15 mm x 20 mm x 40 mm and can be trimmed as needed.

The predicate Miromatrix Wound Matrix is also a non-crosslinked porcine-derived wound dressing that undergoes processing and sterilization to produce an acellular, virally-inactivated dressing that is mostly collagen Type 1 and that covers and protects the wound. Like the Geistlich Wound Matrix, the Miromatrix Wound Matrix is available in a range of sizes and may be cut to shape during surgery.

As is the case with collagen wound dressings on the market, there are differences in the design of the Geistlich Wound Matrix and the predicate dressing. For example, the subject device is derived from porcine connective tissue, whereas the predicate is derived from porcine liver tissue. The subject dressing is a bilayer with a thickness ranging from 2.5 - 5 mm. The predicate is provided in a single layer with a thickness of 0.3 - 1.5 mm. The predicate device is available in a wider range of sizes than the subject device. The difference between the single layer and bilayer design, sizes and thickness of the Geistlich Wound Matrix does not impact the safety and effectiveness of the dressing when compared to the Miromatrix Wound Matrix.

Overall, the technological characteristics of the Geistlich Wound Matrix and the Miromatrix Wound Matrix are similar. Both matrices are porcine-derived and are intended for wound management. While the intended uses of the subject and predicate dressing are the same, the technologies, are not the same.

The Geistlich Wound Matrix is the same product as the MUCOGRAFT reference device. The biocompatibility testing and product characterization studies performed on the MUCOGRAFT reference device apply to the Geistlich Wound Dressing.

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The table provides a summary comparison between the subject device, the proposed predicate, and the reference device.

	Subject Device	Predicate Device	Reference Device
510(k) Number	TBD	K140510	K102531
Applicant	Geistlich Pharma AG	Miromatrix Medical, Inc.	Geistlich Pharma AG
Device Name	Geistlich Wound Matrix	Miromatrix Wound Matrix	MUCOGRAFT® Collagen Matrix
ClassificationRegulation,Class	Unclassified	Unclassified	21 CFR 872.3930, class II
Product Code	KGN	KGN	NPL
Indications forUse	Geistlich Wound Matrix is intendedfor the management of woundsincluding:• partial and full thickness wounds• pressure ulcers• venous ulcers• diabetic ulcers• chronic vascular ulcers• surgical wounds (donor sites/grafts,post Moh's surgery, post lasersurgery, podiatric, wounddehiscence)• trauma skin wounds (abrasions,laceration, second degree burns,skin tears)	Same as subject device, exceptthat indications also includetunnel/undermined wounds anddraining wounds.	MUCOGRAFT® Collagen Matrixis indicated for:• Covering of implants placed inimmediate or delayed extractionsockets• Localized gingivalaugmentation to increasekeratinized tissue (KT) aroundteeth and implants• Alveolar ridge reconstructionfor prosthetic treatment• guided tissue regenerationprocedures in recession defectsfor root coverage
DeviceDescription	Geistlich Wound Matrix is a collagenmatrix obtained by a standardizedcontrolled manufacturing process. Thematrix is made of collagen withoutfurther crosslinking. The collagen isextracted from veterinary certified pigsand is carefully purified to avoidantigenic reactions.The device is composed of twostructures: one smooth structure andone porous structure. The 'outer" sidewith a smooth surface consists ofcompact collagen and has a smoothtexture. The "inner" porous structureconsists of collagen fibers in a loose,porous arrangement.	The Miromatrix Wound Matrix isan animal-sourced, acellularwound dressing that is derivedfrom porcine liver tissue. Theliver tissue undergoes perfusiondecellularization and the resultingwound dressing is comprisedprimarily of collagen type 1. TheMiromatrix Wound Matrix isterminally sterilized in itspackaging and is hydrated, moistand flexible when its packaging isopened.	Same as subject device.
Material	Porcine	Porcine	Porcine
Thickness, mm	2.5 - 5 mm	0.3 - 1.5 mm	2.5 - 5 mm
Range of sizes	15 mm x 20 mm20 mm x 30 mm30 mm x 40 mm	1 cm x 2 cm to 10 cm x 25 cm,and may be trimmed or cut asrequired	15 mm x 20 mm20 mm x 30 mm30 mm x 40 mm
Single Use	Yes	Yes	Yes

Device Comparison Table Table 1:

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7. PERFORMANCE DATA

Because the material of the subject device is identical to the reference device (K102531), the existing biocompatibility, sterilization, and shelf life information fully applies.

Bench, animal, and clinical data are not necessary to support the substantial equivalence of a wound dressing.

CONCLUSIONS 8.

The subject Geistlich Wound Matrix is nearly identical in indications to the predicate Miromatrix Wound Matrix. The exclusion of two predicate indications does not constitute a new intended use. There are similar technological characteristics between the subject Geistlich Wound Matrix and the predicate. The differences in technological characteristics do not raise any new questions of safety or effectiveness. The Geistlich Wound Matrix is identical in design and material to the reference device, the Geistlich MUCOGRAFT Collage Matrix (K102531). Accordingly, the Geistlich Wound Matrix is substantially equivalent to the predicate device.

Regulation Number and Section

N/A