Accell TBM-R is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders, bone void fillers or bone graft substitutes in the extremities, pelvis and spine (i.e. posterolateral spine fusion). The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Device Description

The Accell TBM-R is an extension to the Accell Family of Products 510(K) K061880. The Accell Family of Products, including Accell TBM-R, contain human demineralized bone matrix (ground, demineralized cortical bone). The Accell TBM-R is an addition to the Accell product family which has improved ease of use in handling characteristics and manual manipulation of the device.

AI/ML Overview

The provided document describes a Bone Void Filler device called Accell TBM-R, which is an extension of the existing Accell Family of Products. This is a 510(k) submission, indicating a focus on demonstrating substantial equivalence to a predicate device rather than a comprehensive study to establish novel performance criteria. Therefore, the information typically found in a study demonstrating how a device meets specific acceptance criteria for a novel AI/medical imaging device is largely absent.

Below is an analysis based on the provided text, highlighting what is available and what is not in the context of your request:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or a quantitative measure of bone healing). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing legally marketed predicate devices.

Acceptance Criterion (Implied)	Reported Device Performance
Substantial Equivalence	Accell TBM-R is determined to be substantially equivalent in intended use, principal of operation, and technological characteristics to the predicate Accell Family of Products (K061880).
Osteoinductive Potential	Each lot of DBM (demineralized bone matrix) in Accell TBM-R is tested in vitro for osteoinductive potential. This in vitro assay is validated to correlate with an athymic mouse osteoinductive potential assay.
Viral Inactivation	The processing methods for DBM in Accell TBM-R were evaluated for viral inactivation potential using a panel of viruses, demonstrating suitable inactivation.
Safety and Efficacy (General)	"All necessary verification testing has been performed for the Accell TBM-R product to assure substantial equivalence to the predicate device as well as safety and efficacy." (This is a general statement, not specific performance data.)
Intended Use	Accell TBM-R shares the same intended uses as the predicate devices: filling voids/gaps in the skeletal system, bone graft extenders, bone void fillers, or bone graft substitutes in extremities, pelvis, and spine (e.g., posterolateral spine fusion) for surgically created defects or traumatic injuries.
Technical Characteristics	Accell TBM-R utilizes ground and demineralized human cortical bone (DBM), similar to the predicate, with improved ease of use and handling characteristics. The DBM exhibits osteoinductive potential in validated animal and/or in vitro models.

Study Information (as requested for an AI/Medical Imaging Device)

Based on the provided text, the following aspects related to a "study proving the device meets acceptance criteria" for an AI/Medical Imaging device are not applicable or not present:

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 document describes a medical device (bone void filler), not an AI/medical imaging device that would typically have a test set of data. The "test set" here refers to the verification tests for the material properties and biological aspects of the DBM and the product itself.
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" in the context of an AI/medical imaging device usually refers to expert interpretation of medical images or pathology results. For this bone void filler, the "ground truth" for certain characteristics would be established by scientific testing and biological assays.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of medical images, which is not the subject of this submission.
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 is not an AI-assisted diagnostic or imaging device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone void filler material, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the osteoinductive potential, the "ground truth" is a correlation to an athymic mouse osteoinductive potential assay which is considered a validated model. For viral inactivation, the "ground truth" is the effective reduction of a selected panel of viruses. For ease of use/handling, the implied "ground truth" is user feedback or internal assessment comparing it to the predicate.
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
How the ground truth for the training set was established: Not applicable.

Summary of Relevance

This 510(k) submission for Accell TBM-R focuses on demonstrating substantial equivalence to existing predicate devices based on:

Similar intended use.
Similar technological characteristics (composition, principle of operation).
Laboratory testing for biological activity (osteoinductive potential correlating to an animal model) and safety (viral inactivation).
Improved handling characteristics, which generally means improved ergonomics and ease of application for the user.

The document does not contain the type of clinical study data with detailed acceptance criteria, sample sizes, and ground truth establishment that would be typically found for a novel AI/medical imaging device. The "proof" of meeting "acceptance criteria" is primarily the demonstration of equivalence through bench testing and comparison to predicates, which is standard for 510(k) submissions of this type of medical device. The "acceptance criteria" are broad and relate to safety, efficacy (as demonstrated by biological function and equivalence), and intended use.

Summary

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SECTION 5

5.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SFP 2 4 2000

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	IsoTis OrthoBiologics, Inc.
TRADE NAME:	ACCELL TBM-R
COMMON NAME:	Bone Void Filler
CLASSIFICATIONNAME:	Resorbable calcium salt bone void filler
DEVICECLASSIFICATION:	Class II
PRODUCT CODE	MQV, MBP
PREDICATE DEVICES:	Accell Family of Products K061880 (Accell DBM100, AccellTBM, Accell A2i and Accell Connexus), and Grafton DBM-Flex K051195

5.1 Substantially Equivalence:

The Accell TBM-R is substantially equivalent in intended use, principal of operation and technological characteristics to the current Accell Family of Products (Accell DBM100, Accell TBM, Accell A2i and Accell Connexus); 510(K) - K061880.

Description of the Device Subject to Premarket Notification: 5.2

5.3 Indication for Use:

The Accell TBM-R is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders, bone void fillers or bone graft substitutes in the extremities, pelvis and spine (i.e. posterolateral spine fusion). The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

Technical Characteristics: 5.4

The Accell TBM-R and Accell Family of Products (K061880) utilize ground and demineralized,

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human cortical bone (DBM) in the formulation of the product. The DBM component exhibits osteoinductive potential in validated animal and/or in vitro models. It is unknown how the osteoinductive potential, measured in these validated models, will correlate with clinical performance in human subjects.

ર્સ્ડ Performance Data:

All necessary verification testing has been performed for the Accell TBM-R product to assure substantial equivalence to the predicate device as well as safety and efficacy.

5.6 Osteoinductive Potential

Each lot of DBM used to manufacture the Accell TBM-R and the Accell Family of Products is tested for osteoinductive potential using an in vitro test. The in vitro assay has been validated to correlate to an athymic mouse osteoinductive potential assay. It is unknown how osteoinductive potential measured via the in viro or athymic mouse assays will correlate with human clinical performance.

5.7 Viral Inactivation Validation

The methods for processing of the DBM contained in Accell TBM-R and the Accell Family of Products were evaluated for their viral inactivation potential. A selected panel of viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable inactivation potential of the processing methods for a wide range of potential viruses.

Basis for Determination of Substantial Equivalence: 5.8

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Accell TBM-R, has been determined by IsoTis OrthoBiologics to be substantially equivalent to an existing legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

SEP 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Iso Tis Orthobiologics, Inc. % Integra Lifesciences Corporation Ms. Judith E. O'Grady Senior VP, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

Rc: K081817

Trade/Device Name: Accell TBM-Regulation Number: 21 CFR 888.3045 Regulation Names: Resorbable calcium salt bonc void filler device. Regulatory Class: II Product Code: MBP, MOV Dated: June 25, 2008 Received: June 26, 2008

Dear Ms. O'Grady:

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.

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

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Page 2 - Ms. Judith E. O'Grady

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K081817

Device Name: Accell TBM-R

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.D.
(Division Sign Off)

(Division ign-Off) Division of General, Restorative, and Neurological Devices

510(k) Numbe

Page 1 of 1

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.