OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with Osteo Tape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue regeneration (GTR). Titanium tack-screws may be used to immobilize OsteoTape®

Device Description

OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape) in various preformed shapes, is a resorbable bone grafting substitute comprised of highly purified Type I bovine collagen, used as a carrier derived from bovine Achilles tendon, combined with crystals of the product OsteoGen®, a synthetic bioactive resorbable graft of the non-ceramic hydroxylapatite category. The product is supplied in cubes and strip forms, sterile, and for single use only.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific pass/fail acceptance criteria in terms of numerical performance metrics for the OsteoTape® device (e.g., a certain percentage of bone growth, or a specific strength of bone regeneration). Instead, the acceptance criteria are framed in terms of conformance to established standards and demonstrated safety/effectiveness through testing and literature review.

Acceptance Criteria (General)	Reported Device Performance/Evidence
Substantial Equivalence to Predicate Devices	The submission's purpose is to "establish substantial equivalence for the product OsteoTape® to devices marketed in interstate commerce prior to May 28, 1976, and to legally marketed predicate devices cleared via the 510(k) process." The FDA's letter confirms: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Conformance with Performance Standards (Voluntary Standards)	OsteoTape® complies with: - ASTM F2212-08e1 (Characterization of Type I Collagen) - ASTM F1185-03 (Composition of Hydroxylapatite) - ANSI/AAMI/ISO 11137 (Radiation Sterilization) - AAMI TIR 27 (Substantiation of 25kGy as a sterilization dose - Method VDmax) (Sterilization and Biocompatibility standards are also referenced in Sections 14 and 15, not provided here).
Compliance with Special Controls Guidance	The device adheres to "Guidance for Industry and FDA Staff: Class II Special Control Guidance Document: Dental Bone Grafting Materials, issued on April 28, 2005."
Safety and Effectiveness	"OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, has been evaluated as to its safety and effectiveness by a number of standardized tests to assess its safety, viral inactivation, and biocompatibility in vivo and in vitro, and is confirmed in the medical literature as being safe and effective for a variety of dental applications." (Specific results of these tests are not detailed in the provided text, but their successful completion is asserted).
Similarity of Technical Characteristics to Predicate Devices	"OsteoTape®... and its predicate devices have the same technology characteristics according to specified standards. In particular, OsteoTape® and its predicate devices are similar with respect to intended use, material application, structure, material composition, characterization and similar sizes."

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

The provided 510(k) summary does not detail a specific "test set" in the context of an AI-driven device or a clinical trial with a defined sample size for performance evaluation. The "study" proving the device meets acceptance criteria is primarily an assertion of compliance with existing standards and a review of safety and effectiveness data (including "standardized tests" and "medical literature").

There is no indication of a specific sample size for a clinical or in-vitro test set.
The data provenance is broadly described as "standardized tests" and "medical literature," which could encompass both retrospective and prospective data, and potentially international data, but no specifics are given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable or provided in the context of this 510(k) summary. The device clearance is based on material characteristics, biocompatibility, sterilization, and substantial equivalence to existing devices, not on expert-adjudicated ground truth for an AI algorithm's performance on a specific dataset.

4. Adjudication Method for the Test Set

This information is not applicable or provided. As there's no mention of a "test set" requiring human adjudication for performance evaluation (like in medical imaging AI), no 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

There is no indication of an MRMC comparative effectiveness study being done. This document describes a traditional medical device (bone graft material), not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.

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

There is no indication of a standalone algorithm performance study. This is a material device, not an algorithm.

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

The concept of "ground truth" as typically applied to AI performance evaluation is not directly mentioned or applicable in the provided document. The "truth" for this device revolves around:

Conformity to material composition standards (e.g., ASTM F1185-03 for hydroxylapatite).
Demonstrated biocompatibility and viral inactivation (likely through laboratory tests and animal studies, not detailed here).
Clinical safety and effectiveness as supported by "medical literature" and "standardized tests" (which would include various forms of outcomes data, pathology in animal models, etc., but specific methods are not provided).
Comparison to predicate devices.

8. The sample size for the training set

This information is not applicable or provided. As this is not an AI/ML device, there is no "training set."

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

This information is not applicable or provided. There is no "training set" or ground truth in the AI sense for this device.

Summary

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www.impladentitd.com

Image /page/0/Picture/1 description: The image shows the logo for IMPLADENT LTD. The logo consists of a symbol on the left and the company name on the right. The symbol is a geometric shape with a square in the center and lines extending from each side. The text is in a bold, sans-serif font.

Advancing the Science of Implantology

Avenue, Holliswood NY 11423

K0910794

510(K) SUMMARY

Type of Submission:

Traditional Premarket Notification 510(k) 21 CFR 807.92 March 19, 2009

Submitted by:

ﭘﺮ

くな

DEC 1 0 2009

Impladent Ltd. 198-45 Foothill Avenue Holliswood NY 11423-1611

Contact Person:

Maurice Valen President; Director of R&D Phone: 718 465-1810 Fax: 718 464-9620 Email: maurice(@impladentItd.com or ginnyv@earthlink.net

Under section 21 CFR 807.95, selected pages and/or sections have been marked as "CONFIDENTIAL"; any request for same under

Establishment Registration: 2431866

Common Name:
Proprietary Name:
Classification:
Classification Regulation:
Product Code:
Review Panel:

Bone Graft Material OsteoTape® Class II 21 CFR 872.3930 LYC - Bone Grafting Material, Synthetic Dental

Confidentiality:

Freedom of Information Act should be purged.

Purpose of Submission: Evidence herein is submitted to establish substantial equivalence for the product OsteoTape® to devices marketed in interstate commerce prior to May 28, 1976, and to legally marketed predicate devices cleared via the 510(k) process.

Performance Standards: No performance standards have been established under Section 514

Special Controls: Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices

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Impladent Ltd. OsteoTape® 510(k) Summary

K090794

March 19, 2009 SECTION 5

DEVICE DESCRIPTION

INDICATIONS FOR USE

OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with OsteoTape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue regeneration (GTR). Titanium tack-screws may be used to immobilize OsteoTape®

CONFORMANCE WITH PERFORMANCE STANDARDS

Voluntary standards to which OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, complies include:

ASTM F2212-08e1	Standard Guide for Characterization of Type I Collagen as StartingMaterial for Surgical Implants and Substrates for Tissue EngineeredMedical Products (TEMPs)
ASTM F1185-03	Standard Specification for Composition of Hydroxylapatite forSurgical Implants ·
ANSI/AAMI/ISO 11137	Sterilization of Health Care Products- Radiation Sterilization
AAMI TIR 27	Sterilization of Health Care Products - Radiation Sterilization-Substantiation of 25kGy as a sterilization dose - Method VDmax

For Sterilization and Biocompatibility standards used, please refer to Sections 14 and 15.

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Impladent Ltd. OsteoTape® 510(k) Summary

K090794

March 19, 2009 SECTION 5

SPECIAL CONTROLS

A Special Control that applies to OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, is the Guidance for Industry and FDA Staff: Class II Special Control Guidance Document: Dental Bone Grafting Materials, issued on April 28, 2005.

SUMMARY/COMPARISON OF TECHNICAL CHARACTERISTICS

OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, and its predicate devices have the same technology characteristics according to specified standards. In particular, OsteoTape® and its predicate devices are similar with respect to intended use, material application, structure, material composition, characterization and similar sizes.

SAFETY

OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, has been evaluated as to its safety and effectiveness by a number of standardized tests to assess its safety, viral inactivation, and biocompatibility in vivo and in vitro, and is confirmed in the medical literature as being safe and effective for a variety of dental applications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head turned to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Maurice Valen President Director of R&D Impladent, Limited 198-45 Foothill Avenue Holliswood, New York 11423-1611

Re: K090794

Trade/Device Name: OsteoTapeTM Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: NPM Dated: December 2, 2009 Received: December 3, 2009

Dear Mr. Valen:

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.

DEC 1 0 2009

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. Valen

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

for
Sue- Renner, D.D.S.

Susan Runner, D.D.S Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K090794

Device Name: OsteoTape®

Indications for Use:

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter NO (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ke. Muly for MSR

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

510(k) Number: K090794

Page 1 of 1

ﻤ

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.