MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.

Device Description

MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium phosphate bone graft substitute consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (β-TCP). MBCP™ is available in granules or blocks. MBCP™ is provided sterile for single patient use. MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human cancellous bone. MBCP™ implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced by bone. The progressive resorption of the filler is intended to prevent premature resorption.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called MBCP™, a resorbable calcium salt bone void filler. This document describes the device, its intended use, safety information, and a summary of its safety and effectiveness.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with target values. Instead, it focuses on demonstrating safety and effectiveness through conformance to standards, biocompatibility, and evidence of osseous rehabilitation.

Acceptance Criteria (Implied)	Reported Device Performance
P-1: Chemical SafetyConformance to recognized consensus standard for ceramic hydroxylapatite.	MBCP™ conforms to ASTM F1185, meeting required specifications for heavy metals and trace elements.
P-2: BiocompatibilityNon-toxic, non-allergenic, biocompatible, no inflammation, no adverse effects/foreign body reactions.	Biocompatibility of HA, β-TCP, and the mixture (MBCP™) is well-documented. Proven to be non-toxic, non-allergenic, biocompatible, and elicits no inflammation. No adverse effect or foreign body reactions reported.
P-3: Osseous Rehabilitation (Bone Ingrowth)Evidence of bone ingrowth and eventual transformation/remodeling into new bone.	After 6 weeks, bone ingrowth appeared essentially in the cortical part of the implant, invading all macropores. After 12 weeks, the implant was transformed into new cortical bone, and bone remodeling was observed (in dogs).
P-4: Substantial EquivalenceSimilar material characteristics and same intended use as predicate devices.	The device is substantially equivalent based on similar material characteristics and the same intended use. Animal studies and clinical data support its safety and effectiveness.

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

Sample Size for Test Set: The document mentions a study on "canines of dogs [1]" (likely a typo and meant “canines” or “dogs”) for osseous rehabilitation. However, a specific numerical sample size for this study is not provided.
Data Provenance: The osseous rehabilitation study was conducted on "dogs," indicating an animal study. The country of origin for the data is not specified. The study type is prospective in nature, as it tracks bone ingrowth and remodeling over a set period (6 and 12 weeks).

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the osseous rehabilitation study. It only states that "Radiological, histological and analytical techniques were used to evaluate the bone ingrowth."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for evaluating the results of the osseous rehabilitation study. Results appear to be based on direct observation and analysis using the stated techniques.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported in this 510(k) summary. The document does not mention any studies involving human readers, AI assistance, or effect sizes related to human performance improvement.

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

No standalone (algorithm-only) performance was done. This device is a bone graft substitute, not an AI or software algorithm. Therefore, "algorithm only" performance is not applicable.

7. The Type of Ground Truth Used

For the osseous rehabilitation study, the ground truth was established through direct scientific observation and analysis using:
- Radiological techniques
- Histological techniques (examining tissue microstructures)
- Analytical techniques (likely biochemical or biomechanical assessments)
- This is a form of experimental evidence and pathological assessment (histology).

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm; thus, the concept of a "training set" in the context of an algorithm does not apply. The document does not mention any training sets for either human readers or algorithms.

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

As the concept of a "training set" for an algorithm is not applicable, the method of establishing ground truth for a training set is also not relevant to this document.

Summary

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Image /page/0/Picture/0 description: The image shows the date December 11, 2003. The month is represented by the abbreviation DEC. The day is 11 and the year is 2003. The text is in a bold, sans-serif font.

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K032268'. The characters are handwritten in a bold, somewhat rough style, giving them a distinct and informal appearance. The contrast between the characters and the background is high, making them easily readable.

Image /page/0/Picture/2 description: The image shows a logo with the word "BIOMATLANTE" in a stylized font. The text is positioned to the right of a curved graphic element that resembles a stylized letter or symbol. The overall design is simple and clean, with a focus on the text and the accompanying graphic.

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МВСР pending тм

510(k) Summary of Safety and Effectiveness

This 510(k) Summary for MBCP™ is provided as required per Section 513(1)(3) of the Food, Drug and Cosmetic Act.

1. GENERAL INFORMATION

Submitter's name and address :	BIOMATLANTEZA DES IV NATIONS5, rue Edouard Belin-F- 44360 VIGNEUX DE BRETAGNEFrance
Contact :	Myriam VINCENT, Chemical EngineerTel : +33 228 02 00 09myriamvincent@biomatlante.com
FDA Establishment Number :	not known
Trade Name:	MBCP™
Common Name:	Resorbable Calcium Salt Bone Void Filler
Classification Name :	Resorbable Calcium Salt Bone Void Filler
Product Code :	MQV
CFR Section :	888.3045
Device Panel :	Orthopedic

Summary preparation date :

Revised December 9, 2003

2. PREDICATE DEVICES

Product Code	Manufacturer	510(k) #	Product
MQV	Orthovita	K994337	Vitoss
MQV	Sofamor Danek	K020986	Mastergraft
MQV	Interpore International	K990131	ProOsteon 500R

3. DEVICE DESCRIPTION

MBCP™ is a bone graft substitute. MBCP™ is a microporous and macroporous biphasic calcium MDOT - 10 a Bono gran consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (β-TCP). MBCP™ is available in granules or blocks. MBCP™ is provided sterile for single patient use.

Rev. 12/08/2003

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-Confidential-

Image /page/1/Picture/1 description: The image shows the word "BIOMATLANTE" in bold, italicized font. Above the word is a black hexagon shape. To the left of the hexagon is a curved shape that resembles a crescent moon.

MBCP pending тм

510(k) Summary of Safety and Effectiveness

MBCP™ presents a multidirectional interconnected porosity structure, similar to that of human MBCP™ presents a multuriectional intervennoted ing the remodeling and bone defect repair cancellous bone. MBCP "" implant slowly teserbe dailing the vol. The progressive resorption of process and 15 progress.very of tiller is intended to prevent premature resorption.

4. INTENDED USE

tradinatic injury to the bone. may often be recommended.

may often be recommention.
When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.

5. CONTRAINDICATIONS

MBCP™ has limited initial mechanical properties. Therefore, this product is contraindicated where the device is intended as structural support in the skeletal system.

Conditions representing contraindications include also :

. osteomyelitis
implantation in necrotic surgical sites .
degenerative bone disease .
intra-articular implantations .

6. ADVERSE EFFECTS

Possible adverse effects include but are not limited to :

Wound complications including hematoma, infection, and other complications that are . possible with any surgery
possible with any ourgery . filler

7. WARNINGS AND PRECAUTIONS

Rigid fixation techniques may be required to assure rigid stabilization of the defect in all planes. Maximum contact between the product and the recipient bone must be established. The implantation in a revision surgical site containing non-resorbable fragments of material (e g. polyethylene ligament waste, carbon fibers) are not recommended.

polyethylene igament waste, care should be exercised in treating individuals with preexisting As with any surgical procedure, care one of the surgical procedure. This includes (but is not limited

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-Confidential-

Image /page/2/Picture/1 description: The image shows a logo with a stylized graphic element on the left, resembling a curved shape with a textured or grainy fill. Above the text, there is a solid black hexagon. To the right of the graphic is the word "BIOMATLANTE" in a bold, sans-serif font. The overall design appears to be a company logo or brand mark.

MBCP pending тм

510(k) Summary of Safety and Effectiveness

to) individuals with long-term steroidal therapy or treatment acting on the calcium or phosphorus metabolism.

MBCP™ is radiopaque until resorbed. Radiopacity may mask underlying pathological conditions. MDGT - Is fadiopaque until rootibelly assess the ingrowth of new bone.

MBCP™ is intended for use by surgeons familiar with bone grafting and rigid fixation techniques.

8. SAFETY AND EFFECTIVENESS SUMMARY

8.1. Chemical safety

Chemical safety of MBCP™ is based on the recognized consensus standard specification, ASTM Chemical Salety of MDOT - 13 baced on the Feesghized of Ceramic Hydroxylapatite for Surgical Implants. MBCP™ conforms to the required specifications for heavy metals trace elements level.

8.2. Biocompatibility

The biocompatibility of HA, B-TCP, mixture of both and MBCP™ is well documented. All these The blocompanibility of The preven to be non toxic, non allergenic, biocompatible and elicits no inflammation. No adverse effect or foreign body reaction have been reported.

8.3. Osseous rehabilitation

Radiological, histological and analytical techniques were used to evaluate the bone ingrowth in Nadiological, filstologiour and andryted. contines of dogs [1]. After 6 weeks, the bone ingrowth appeared essentially in the cortical part of the implant, invading all implant macropores. ingrowth appeared oboomially in the implant was transformed into new cortical bone and bone remodelling was observed.

9. SUBSTANTIAL EQUIVALENCE

The device is substantially equivalent based on similar material characteristics and the same intended use. In addition, animal studies and clinical data with the device support its safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 2003

Ms. Myriam VINCENT Regulatory Affairs Manager BIOMATLANTE ZA DES IV NATIONS 5. rue Edouard Belin -F-44360 VIGNEUX DE BRETAGNE France

Re: K032268

Trade Name: MBCP Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 31, 2003 Received: November 5, 2003

Dear Ms. VINCENT:

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

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Page 2 - Ms. Myriam VINCENT

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 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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely vours.

Mark A Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MBCP pending TM

Indications for Use

510(k) Number: K032268

Device Name: MBCP pending TM

Indications for Use:

MBCP™ is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

MBCP™ is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended.

When packed into a bony site, MBCP™ gradually resorbs and is replaced with bone during the healing process.

Contraindications:

MBCP™ has limited initial mechanical properties. Therefore, this product is contraindicated where the device is intended as structural support in the skeletal system. Conditions representing contraindications include also :

. osteomyelitis
implantation in necrotic surgical sites .
degenerative bone disease .
intra-articular implantations .

Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	or	Over the Counter Use
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Rev. 12/08/2003	Section 03Page 1 of 1
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for Mark N Millikin
of Cranial, Restorative
Neurological Devices

K Number:	K032268
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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.