Accell Connexus™ DBM Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a paste or putty-like consistency.

Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device, Accell Connexus DBM Putty. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a diagnostic AI/ML device would.

This document describes a medical device (bone graft material) and seeks clearance based on "substantial equivalence" to a predicate device. For such devices, performance is typically demonstrated through material data, animal studies, and comparison to existing products, rather than the kind of AI/ML performance metrics (like sensitivity, specificity, F1-score, or ROC AUC) that would have acceptance criteria and be proven through a clinical study with detailed ground truth, expert adjudication, and statistical analysis as implied by your questions.

Therefore, I cannot provide the requested information in the format of your questions, as the input document does not contain it.

Here's a breakdown of why each of your requested points cannot be answered from the provided text:

A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (like sensitivity, specificity, accuracy) are mentioned. The document relies on substantial equivalence.
Sample size used for the test set and the data provenance: No test set in the diagnostic sense is mentioned. Clinical studies with sample sizes are not discussed for performance evaluation in this context.
Number of experts used to establish the ground truth... and their qualifications: Ground truth in the context of diagnostic performance (e.g., image interpretation) is not applicable here.
Adjudication method... for the test set: Not applicable as there is no test set for diagnostic performance evaluation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: No MRMC study or comparison of human readers with/without AI assistance is mentioned. The device is a bone putty, not an AI or diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; the device is a physical bone graft material, not an algorithm.
The type of ground truth used: For a device based on substantial equivalence, the "ground truth" revolves around its material properties, biocompatibility, and intended use matching those of the predicate device, often supported by animal studies for osteoinductivity. The text states "The osteoinductive potential is demonstrated in athymic mouse model," which is a form of pre-clinical "ground truth" for one property.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
How the ground truth for the training set was established: Not applicable.

What the document does state about performance:

"Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material."
"The osteoinductive potential is demonstrated in athymic mouse model." (This is the closest to a performance study mentioned).
"Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification."

In summary, this document is for a traditional medical device submitting a 510(k) for substantial equivalence, not for an AI/ML diagnostic device with performance characterized by detailed statistical metrics against a ground truth established by experts.

Summary

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IsoTis OrthoBiologics, Inc. Accell Connexus " DBM Putty 510(k) Premarket Notification

KOBO306

February 2006

MAR 2 7 2006

510(k) Summary for IsoTis OrthoBiologics, Inc. Accell Connexus DBM Putty

1. SPONSOR
  IsoTis OrthoBiologics, Inc. 2 Goodyear, Suite B Irvine, CA 92618 U.S.A

Contact Person:	Eliane Schutte
Telephone:	+31-(0) 30-2295253
Facsimile:	+31-(0) 30-2280255
Date Prepared:	February 03, 2006

2. DEVICE NAME

Proprietary Name: Accell Connexus Demineralized Bone Matrix Puttv Requlation Name: Human Bone Graft Material Regulatory Class: 11 NUN Product Code:

3. PREDICATE DEVICE

DynaGraft II Dental (Demineralized Bone Matrix) [K043573]

4. DEVICE DESCRIPTION

Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

ട. Intended Use

Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

Filling of defects after root resection, apicoectomy and cystectomy -
Filling of extraction sockets to enhance preservation of the alveolar ridge -
Elevation of maxillary sinus floor -
Treatment of periodontal defects -

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Accell Connexus DBM Putty is substantially equivalent to DynaGraft II Dental Putty previously cleared by FDA under 510(k) K043573. Both products utilize

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K060306

IsoTis OrthoBiologics, Inc.
Accell Connexus " DBM Putty 510(k) Premarket Notification

February 2006

ground, human donor cortical demineralized bone for the product. Both products utilize an inactive poloxamer reverse phase carrier (RPM) as a containing agent to provide the product's putty-like consistency and handling characteristics. The proposed device and predicate device have the same indications for use, provided sterile and for single patient. The main difference between the two products is that Accell Connexus DBM Putty contains more demineralized bone by weight and volume and less synthetic carrier.

7. Performance data

Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification.

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Image /page/2/Picture/1 description: The image is a logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circle.

MAR 2 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Isotis NV Ms. Elaine Schutte Director of Regulatory Affairs Isotis Orthobiologics, Incorporated 2 Goodyear, Suite B Irvine, California 92618

Re: K060306

Trade/Device Name: Accell Connexus Demineralized Bone Matrix Putty Regulation Number: 872.3930 Regulation Name: Bone Graft Material Regulatory Class: II Product Code: NUN Dated: February 6, 2006 Received: February 7, 2006

Dear Ms. Schutte:

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 (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 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 Ms. Elaine Schutte

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.

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Clues

Chiu Lin, Ph.D 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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February 2006

IsoTis OrthoBiologics, Inc. Accell Connexus™ DBM Putty 510(k) Premarket Notifica

4 INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if Known):

Device Name: Accell Connexus Demineralized Bone Matrix Putty

Indications for Use:

Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

Filling of defects after root resection, apicoectorny and cystectomy -
Filling of extraction sockets to enhance preservation of the alveolar ridge -
Elevation of maxillary sinus floor
Treatment of periodontal defects

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

'Susan Rumps

logy General Hosp
ntal Devices

060306

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.