CAMCERAM TCP is a bone void filler is a resorbable implant intended to fill bony void 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.

Device Description

CAMCERAM TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product comprises of a beta-Tricalcium Phosphate and is 90% porous. The product is provided sterile available in granules 1-4 mm and a block form.

AI/ML Overview

The provided text is a 510(k) summary for CAMCERAM TCP, a bone void filler. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets specific acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence through:

Physico-chemical testing: Confirmed composition and resorption profile.
Safety and biocompatibility testing: As per general calcium phosphate products.
Compliance with recognized standards: ASTM F1088.
Long history of safe clinical use: For the predicate devices.

Therefore, I cannot fulfill all parts of your request as the information about acceptance criteria and a study proving device performance is not present in the provided text.

Here's a breakdown of what can be extracted based on your request, with "N/A" for information not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Composition: Conformance to Beta-Tricalcium Phosphate composition	CAMCERAM TCP comprised of beta-Tricalcium Phosphate (90% porous) and confirmed by physico-chemical testing to meet composition.
Resorption Profile: Similar to predicate devices	Confirmed by physico-chemical testing to have a similar resorption profile to predicate devices.
Safety & Biocompatibility: Meets standards for calcium phosphates	Safety and biocompatibility testing performed for calcium phosphates.
Standard Compliance: Conforms to ASTM F1088	Tested to conform to ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for surgical Implantation."
Clinical Equivalence: Safe use	Predicate devices (Vitoss scaffold, Conduit TCP) have been used safely for many years in the clinical environment, supporting the safe use of CAMCERAM TCP due to substantial equivalence.
Intended Use Equivalence:	Intended use matches predicate devices (filling bony voids in extremities, spine, and pelvis not intrinsic to stability).

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: N/A (No specific "test set" in the context of clinical performance data is mentioned. The testing mentioned refers to physico-chemical and standard compliance.)
Data Provenance: N/A (The document refers to physico-chemical tests and standard compliance, not specific clinical data with provenance.)

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

N/A (No ground truth established by experts for a test set is mentioned in the context of clinical performance.)

4. Adjudication Method for the Test Set

N/A (No adjudication method is mentioned.)

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A (No MRMC study is mentioned. This device is a material, not an AI-assisted diagnostic tool for human readers.)

6. If a Standalone (algorithm only without human-in-the loop performance) Study was done

N/A (This device is a material, not an algorithm.)

7. The Type of Ground Truth Used

Ground Truth for device characteristics: Based on recognized standards (ASTM F1088) and physico-chemical laboratory testing to confirm composition and resorption profile.
Ground Truth for safety: Long history of safe clinical use of predicate devices and general knowledge/testing for calcium phosphates.

8. The Sample Size for the Training Set

N/A (This device is a material, not an AI model, so there is no training set in the typical AI sense.)

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

N/A (No training set for an AI model is mentioned.)

Summary

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510(k) Summary for CAMCERAM TCP

SPONSOR 1.

Name : CAM implants BV Address: Zernikedreef 6, Leiden, The Netherlands Contact Person: Kim Groenewegen van der Weijden Telephone: +31 (0)71 5240624 Facsimile: +31 (0)71 5240690

Date Prepared: February 2005

2. DEVICE NAME

Proprietary Name:	CAMCERAM TCP
Common/Usual Name:	Bone void filler
Classification Name:	Bone void filler

3. PREDICATE DEVICES

Proprietary Name:	Vitoss scaffold (OrthoVita), K994337
Proprietary Name:	Conduit TCPgranules (Depuy Acromed), K01405

DEVICE DESCRIPTION 4.

INTENDED USE ਨੰ

CAMCERAM TCP is a resorbable bone void filler intended to fill bony void 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.

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KOS0357

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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The CAMCERAM TCP and the predicate devices are all similar in design, materials of construction and function. CAMCERAM TCP has been compared in physico-chemical testing with the predicate devices which confirmed the composition and resorption profile. The safety and biocompatibility testing performed for calcium phosphates and the long history of safe clinical use for tricalcium phosphate products support the safe use of CAMCERAM TCP. CAMCERAM TCP meets the applicable requirements of the FDA guidance documents on bone void fillers.

7. TESTING

The CAMCERAM TCP is tested to conform to the recognized standard, ASTM F1088 "Standard Specification for Composition of Beta-Tricalcium Phosphate for suregical Implantation". The devices to which the CAMCERAM TCP claims substantial equivalence are the Vitoss scaffold (Orthovita) and Conduit TCP (Depuy Acromed) have been used safely for many years in the clinical environment.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and people. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Public Health Service

APR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Rutger Kuipers Manager QA/RA CAM Implants BV Zernikedreef 6 2333 CL Leiden The Netherlands

Re: K050357

R050337
Trade/Device Name: CAMCERAM TCP Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 14, 2005 Received: February 14, 2005

Dear Mr. Kuipers:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) prematice is substantially equivalent (for the indications referenced above and nave uctchimical the devices marketed predicate devices marketed in interstate for use stated in the enclosure, to regally manced prouther and the Federal Food. Food Drug commerce prior to May 28, 1970, the enaement auto of the Federal Food. Drug, devices that have been reclassified in accerative what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket of the Act, and Cosment Act (Act) that to not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of You may, therefore, market the devreet, belyer to the go
general controls provisions of the Act include requirements for annual registration, and general controls provisions of the rectments of the received in the branding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) inlove in the existing your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such additional controls. Existing major of 998. hr addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Feach. Feegaring your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualitat equires with other requirements of the Act
that FDA has made a determination that your device and concension - You must that FDA has made a decemination that your administered by other Federal agencies. You must or any Federal statutes and regulations daminders on registration and listing (21
comply with all the Act's requirements, including, but not limited to: returnments as set comply with an the Act s requirements, mercements are many of course requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing and if continently, the CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Party 21 CFR 1000 (1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Rutger Kuipers

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stipt Rurdy

Miriam Provost, Ph.D. Acting 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):

Device Name: CAMCERAM TCP Bone Void Filler

Indications for Use:

Prescription Use _ X__________________________________________________________________________________________________________________________________________________________ (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)

Stupt Rlurlu

(Divisio Division of General, Restorative. and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.