Augmentation around implants placed in immediate extraction sockets;
Augmentation around implants placed in delayed extraction sockets;
Localized ridge augmentation for later implantation;
Alveolar ridge reconstruction for prosthetic treatment;
Filling of bone defects after root resection, cystectomy, removal of retained teeth;
Guided bone regeneration in dehiscence defects;
Guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

Augmentation or reconstructive treatment of the alveolar ridge;
Filling of periodontal defects;
Filling of defects after root resection, apicoectomy, and cystectomy;
Filling of extraction sockets to enhance preservation of the alveolar ridge;
Elevation of the maxillary sinus floor;
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

The two products are being packaged together as a convenience kit for the ease of clinician use in periodontal regenerative procedures. In addition, Geistlich Bio-Gide® Perio will be packaged and sold as individual units.

Device Description

Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio.

Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by gamma irradiation.

Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications.

The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm.

Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

AI/ML Overview

The provided text describes the Geistlich Perio-System Combi-Pack, a medical device for bone and tissue regeneration, and refers to performance data from published studies to demonstrate its substantial equivalence to predicate devices. However, the document does not contain the level of detail requested for acceptance criteria, specific device performance metrics, or study design parameters (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information).

The document states:

"Performance Data: A published nonclinical animal study provides histological evidence that Geistlich Bio-Gide® Perio, in combination with Geistlich Bio-Oss Collagen®, regenerates bone in 5 mm diameter rabbit femoral defects (1). Several published clinical studies demonstrate improvements in clinical attachment levels and probing pocket depths through 5-year follow-up versus the control (access flap surgery) (2,3,4). Histological evaluation of teeth in a case series demonstrated periodontal regeneration (5)."
"The results of these published studies demonstrate the substantial equivalence of Geistlich Bio-Gide® Perio and Geistlich Bio-Oss Collagen® to their respective predicate devices."

Based on this, here's what can be extracted and what is missing:

Acceptance Criteria and Study Details for Geistlich Perio-System Combi-Pack

The provided K112575 submission indicates that the device's performance was evaluated through a review of published nonclinical and clinical studies demonstrating substantial equivalence to predicate devices. However, the specific, quantitative "acceptance criteria" for the device's performance as a whole, typical of what one might find for a diagnostic or AI-based device, are not explicitly stated in this document. Instead, the performance claims refer to evidence of bone regeneration and improvements in clinical metrics from prior studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds typically found in AI/ML device submissions. Instead, "performance criteria" are inferred from the outcomes described in the referenced studies, which relate to the intended use and demonstrate effectiveness comparable to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (from referenced studies)
Nonclinical: Evidence of bone regeneration	Histological evidence of bone regeneration in 5 mm diameter rabbit femoral defects (when Geistlich Bio-Gide® Perio and Bio-Oss Collagen® are used in combination) (1)
Clinical: Improvement in clinical attachment levels	Demonstrated improvements in clinical attachment levels through 5-year follow-up vs. control (access flap surgery) (2,3,4)
Clinical: Improvement in probing pocket depths	Demonstrated improvements in probing pocket depths through 5-year follow-up vs. control (access flap surgery) (2,3,4)
Clinical: Evidence of periodontal regeneration (histological)	Histological evaluation of teeth in a case series demonstrated periodontal regeneration (5)
Overall: Substantial Equivalence to predicate devices	Results of published studies demonstrate substantial equivalence to Bio-Oss Collagen® and Bio-Gide®

Missing Information Analysis:

The provided text does not contain the following information:

Sample size used for the test set and the data provenance: The document references external published studies. The sample sizes for these studies are not provided in this 510(k) summary. Data provenance (e.g., country of origin, retrospective/prospective) is also not detailed here, as these are summaries of individual publications.
Number of experts used to establish the ground truth for the test set and their qualifications: This information would be found within the methodologies of the referenced studies, but it is not included in the 510(k) summary. For histological evaluations, experts (e.g., pathologists, histologists) would have established ground truth, but their number and qualifications are not specified here.
Adjudication method for the test set: Not specified in this 510(k) summary.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a bone and tissue regeneration material, not an AI/ML-based diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device (bone/tissue graft material), not an algorithm or AI.
The type of ground truth used:
- Histology: For bone regeneration and periodontal regeneration, histology was used.
- Clinical measurements: For clinical attachment levels and probing pocket depths, direct clinical measurements were used.
- Outcomes: The ultimate "ground truth" related to the success of treatment in the clinical studies involves patient outcomes (e.g., sustained improvements over 5 years).
The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K112575

DEC 2 7 2011

510(k) Summary

GEISTLICH PERIO-SYSTEM COMBI-PACK

SPONSOR

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

Contact Person:	Daniel Kracov, Arnold & Porter, LLP
e-mail:	Daniel.Kracov@aporter.com
Phone:	(202)942-5120
Date Prepared:	December 13, 2011

DEVICE NAME

Proprietary Name:	Geistlich Perio-System Combi-Pack (containing oneunit of Geistlich Bio-Oss Collagen® and oneunit of Geistlich Bio-Gide® Perio)
Common/Usual Names:	Natural Bone Grafting Material Plus CollagenResorbable Bilayer Membrane for GTR/GBR
Classification Name:	Bone grafting material, animal source (NPM)Barrier animal source intraoral (NPL)

PREDICATE DEVICES

Bio-Oss Collagen® (K092428, K033815, K974399) Bio-Gide® (K050446, K042197, K960724)

DEVICE DESCRIPTION

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Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio.

INTENDED USE

Geistlich Bio-Gide® Perio is intended for the following uses:

Augmentation around implants placed in immediate extraction sockets;
Augmentation around implants placed in delayed extraction sockets;
Localized ridge augmentation for later implantation;
Alveolar ridge reconstruction for prosthetic treatment;
Filling of bone defects after root resection, cystectomy, removal of retained teeth;
Guided bone regeneration in dehiscence defects;
Guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

Augmentation or reconstructive treatment of the alveolar ridge;

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

Filling of periodontal defects;
Filling of defects after root resection, apicoectomy, and cystectomy;
Filling of extraction sockets to enhance preservation of the alveolar ridge;
Elevation of the maxillary sinus floor;
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);
Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

TECHNOLOGICAL CHARACTERISTICS

Geistlich Bio-Oss Collagen® and Geistlich Bio-Gide® Perio, the two component devices of Geistlich Perio-System Combi-Pack, have the same technological characteristics (e.g., design, material) and intended use of their respective predicate devices, Bio-Oss Collagen® and Bio-Gide®.

PERFORMANCE DATA

A published nonclinical animal study provides histological evidence that Geistlich Bio-Gide® Perio, in combination with Geistlich Bio-Oss Collagen®, regenerates bone in 5 mm diameter rabbit femoral defects (1). Several published clinical studies demonstrate improvements in clinical attachment levels and probing pocket depths through 5-year follow-up versus the control (access flap surgery) (2,3,4). Histological evaluation of teeth in a case series demonstrated periodontal regeneration (5).

The results of these published studies demonstrate the substantial equivalence of Geistlich Bio-Gide® Perio and Geistlich Bio-Oss Collagen® to their respective predicate devices.

Lysiak-Drwal K, Dominiak M, Solski L, Zywicka B, Pielka S, Konopka T, Gerber 1. H. Early histological evaluation of bone defect healing with and without guided

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

bone regeneration techniques: Experimental animal studies. Postepy Hig Med Dosw (online) 2008;62:282-288.

Sculean A, Berakdar M, Chiantella GC, Donos N, Arweiler NB, Brecx M. Healing 2. of intrabony defects following treatment with a bovine-derived xenograft and collagen membrane. A controlled study. J Clin Periodontol. 2003;30:73-80, 2003.
Sculean A, Chiantella GC, Windisch P, Arweiler NB, Brecx M, Gera I. Healing of 3. intra-bony defects following treatment with a composite bovine-derived xenograft (Bio-Oss Collagen) in combination with a collagen membrane (Bio-Gide Perio). J Clin Periodontol. 2005;32:720-724.
Sculean A, Schwarz F, Chiantella GC, Donos N, Arweiler NB, Brecx M, Becker J. 4. Five-year results of a prospective, randomized, controlled study evaluating treatment of intra-bony defects with a natural bone mineral and GTR. J Clin Periodontol. 2007;34:72-77.
Sculean A, Stavropoulos A, Windisch P, Keglevich T, Karring T, Gera I. Healing ഗ് of human intrabony defects following regenerative periodontal therapy with a bovine-derived xenograft and guided tissue regeneration. Clin Oral Invest. 2004;8:70-74.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with flowing lines, representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 7 2011

Geistlich Pharma AG C/O Mr. Daniel A. Kracov Arnold & Porter LLP 555 Twelfth Street, NW Washington, D.C. 20004

Re: K112575

Trade/Device Name: Geistlich Perio-System Combi-Pack Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM, NPL Dated: December 20, 2011 Received: December 21, 2011

Dear Mr. Kracov:

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 approvisions 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.

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Page 2 - Mr. Kracov

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 modi matt 1 Dr. mas made a statutes and regulations administered by other Federal agencies. of the Act of any I vact's requirements, including, but not limited to: registration r ou must compty with and 07); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of incurents as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance: "Theo, prease not 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 r ou into of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): Kl l2 5 7 5

Device Name: Geistlich Perio-System Combi-Pack

Indications For Use:

Geistlich Bio-Gide® Perio is intended for the following uses:

Geistlich Dio-Olde - Peno is ants placed in immediate extraction sockets;

Augmentation around implants placed in delayed extraction sockets;
Localized ridge augmentation for later implantation;
Alveolar ridge reconstruction for prosthetic treatment;
Filling of bone defects after for presction, cystectorny, removal of retained teeth;
Guided bone regeneration in dehiscence defects;
Guided bone regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

Augmentation or reconstructive treatment of the alveolar ridge;
Filling of periodontal defects;
Filling of perfodoman dolotter
Filling of defects after root resection, apicoectorny, and cystectorny,
Filling of defootballs ansockets to enhance preservation of the alveolar ridge;
Elevation of the maxillary sinus floor;
Elevation of the maxillary sinus noor,
Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);

Guided Bone Regeneration (GBR),

Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR),

Prescription Use	X
(21 CFR 801 Subpart C)

AND/OR

Over-The-Counter Use	______
(Part 21 CFR 801 Subpart D)

(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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.