Intended for use in filling bone voids or defects of the skeletal system (such as the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Device Description

CaP Plus is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, an inert carrier, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within the CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of CaP Plus osteoinductivity in humans.

AI/ML Overview

The provided text is a 510(k) summary for the CaP Plus bone void filler and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria, performance metrics, and ground truth information as typically found in studies for diagnostic devices or AI algorithms.

Therefore, many of the requested fields cannot be directly extracted from the provided document. The device is a "bone void filler," which is a material implanted to aid bone healing, not a diagnostic or imaging device that would typically have acceptance criteria based on sensitivity, specificity, or AUC, nor "test sets" or "training sets" as these terms are used in the context of AI/ML performance evaluation.

Here's an attempt to answer the questions based solely on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as would be expected for a diagnostic or AI-powered device. The basis of acceptance is "substantial equivalence" to predicate devices, meaning it shares the same function and intended use, and its safety and effectiveness are "adequately supported by the substantial equivalence data and testing results provided within this premarket submission." These "testing results" are not detailed in the provided summary.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative metrics for device performance. The primary acceptance criterion for 510(k) devices is the demonstration of substantial equivalence to a legally marketed predicate device. This implies that the new device is as safe and effective as the predicate.	CaP Plus was found to be substantially equivalent to the predicate devices (CaP3 Bone Substitute Material, Optium DBM™ Gel & Putty, ALLOMATRIX® Putty, InterGro® DBM). It shares the same function and intended use.
(Implicit) Biocompatibility	CaP Plus is described as a biocompatible bone graft substitute material.
(Implicit) Resorption and Remodeling	CaP Plus resorbs and remodels during the healing process, consistent with its function as a bone graft substitute.
(Implicit) Osteoinductive potential (for DBM component)	Each lot of DBM within CaP Plus is assayed for osteoinductive potential in an athymic nude mouse model. (Note: The document states this "may or may not be predictive of CaP Plus osteoinductivity in humans").

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

Not applicable. The document describes a medical device (bone void filler) submission for regulatory clearance based on substantial equivalence, not a study evaluating an AI algorithm or diagnostic test on a "test set." The term "test set" is not used in the document. The document refers to "testing results" in the broader context of premarket submission data, but no specifics are provided regarding sample sizes for human or animal studies that might have been conducted to support biocompatibility or performance.

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

Not applicable. There is no mention of a "test set" and thus no "ground truth" established by experts in the context of an AI or diagnostic study.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" or adjudication process described.

5. 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

Not applicable. This device is a bone void filler, not an AI or diagnostic tool. The document does not describe any MRMC studies or human reader performance with/without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For a bone void filler, the "ground truth" for performance would generally refer to histological evidence of bone ingrowth, successful fusion (if applicable), and resorption of the material, typically demonstrated in animal models or clinical studies. However, the document does not detail the specific studies or their "ground truth" outcomes. It only states that the safety and effectiveness are supported by "testing results." For the DBM component, "osteoinductive potential" as assayed in an athymic nude mouse model can be considered a form of "ground truth" for that specific characteristic.

8. The Sample Size for the Training Set

Not applicable. This document is not about an AI device or a "training set."

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

Not applicable. There is no "training set."

Summary

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ETEX Corporation Medical Device 510(k) Submission CaP Plus CONFIDENTIAL

510(k) SUMMARY AS REQUIRED UNDER 21 CFR 807.87(H) 8.

SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR:	ETEX CorporationUniversity Park at MIT38 Sidney Street, 3rd FloorCambridge, MA 02139Phone: (617) 577-7270Fax: (617) 577-7170		NOV 1 9 2007
510(k) CONTACT:	Pamela W. Adams, RACSenior Vice President and Chief Operating Officer
TRADE NAME:	CaP Plus
COMMON NAME:	Bone Void FillerBone Graft MaterialBone Substitute Material
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	21 CFR 888.3045Resorbable Calcium Salt Bone Void Filler Device
PRODUCT CODE:	MQV
PREDICATE DEVICE(S):	CaP3 Bone Substitute Material (K033138)Optium DBM™ Gel & Putty (K053098)ALLOMATRIX® Putty (K020895)InterGro® DBM (K031399)

ETEX Corporation 510(k) CaP Plus Submission K063050

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ETEX Corporation Medical Device 510(k) Submission CaP Plus CONFIDENTIAL

Device Description:

Indications for Use:

Basis of Substantial Equivalence:

CaP Plus shares the same function and intended use as the predicate devices. CaP Plus was found to be substantially equivalent to the predicate devices. The safety and effectiveness of CaP Plus is adequately supported by the substantial equivalence data and testing results provided within this premarket submission.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem, indicating the department's name and national affiliation. The logo is simple and recognizable, often used in official documents and communications related to health and human services in the United States.

NOV 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ETEX Corp % Ms. Pamala W. Adams Senior Vice President & Chief Operating Officer The Clark Bldg 38 Sidney Street, 3rd Floor Cambridge, MA 02139

Re: K063050

Trade/Device Name: CaP Plus Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: September 17, 2007 Received: September 24, 2007

Dear Ms Adams:

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 mav 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 -

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organization of substantial equivalence of your device to a legally prematics notineation. The Presults 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 If you desire specific and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (240) 210 0120. This, process 100 and 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 Durveillance at (110) 270g (MDR)), please contact the Division of Surveillance Systems (Wedical Do Hopening (112 - 17)) For general information on your responsibilities under the at (210) 210 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 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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510(k) Number (if known) K063050

Device Name: CaP Plus

Indications for Use:

CaP Plus is intended for use in filling bone voids or defects of the skeletal system (such as the extremities and the pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use

Over-The Counter Use

(Per 21 CFR 801.109)

Barbara Breen for may

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

510(k) Number K063050

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.