Allogran-N™ is intended for use as a bone void filler or bone void substitute that are not intrinsic to the stability of the bony for bony voids or gaps structure.

Allogran-N™ is to be packed into bony voids or gaps in the skeletal system (e.g., the spine, pelvis and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. Allogran-N™ is completely incorporated with new bone during the healing process.

Device Description

Allogran-N™ Bone Void Filler is a hydroxyapatite bone graft substitute for the repair of bony defects. The granules are provided sterile for single patient use. When the Allogran-N™ granules are placed in direct contact with viable host bone, new bone grows in apposition to the surface of the implant, filling the pores with new bone during the healing process. The product is completely incorporated into the newly formed bone.

AI/ML Overview

The provided document is a 510(k) summary for the device Allogran-N™ Bone Void Filler and the FDA's clearance letter. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical studies with predefined acceptance criteria and performance data in the same way a PMA (Premarket Approval) submission would.

Therefore, the requested information regarding detailed acceptance criteria, specific device performance against those criteria, sample sizes for test sets, data provenance, expert panels, and various types of clinical studies (MRMC, standalone) in the typical sense of a clinical trial will not be available in this document.

However, based on the provided text, I can infer and summarize what is stated about its "acceptance" and "proof."

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

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, formal "acceptance criteria" in the sense of predefined statistical targets for a specific clinical outcome study are not presented. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The "performance" is qualitative, asserting the device performs similarly to its predicates.

Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Qualitative)
Material Composition	Meets standard for implantable hydroxyapatite. Equivalent to predicate devices. (Non Clinical Testing)
Functional Mechanism	New bone grows in apposition to the implant, filling pores, completely incorporated into new bone during healing. Equivalent to predicate devices.
Safety	"Well tolerated" and "no adverse events have been reported" over 6 years of clinical use. Implied to be equivalent to predicate devices.
Effectiveness	"Completely incorporated into the defect site into which it is implanted" and "safe and effective when used as indicated." Implied to be equivalent to predicate devices.
Indications for Use	Same as predicate devices.
Risks/Adverse Events	Same as predicate devices.

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

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. No specific "test set" of patients was used in a controlled clinical trial for proving performance against a statistical endpoint. The "test set" is essentially the real-world usage over 6 years.
Data Provenance: Clinical use for the past 6 years (retrospective observation). Country of origin is not explicitly stated for this clinical use, but the applicant is based in the UK.

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

Not applicable. This was not a study that involved establishing ground truth by experts in the typical sense (e.g., adjudicating images). The "ground truth" for the aggregated clinical experience is derived from lack of reported adverse events over 6 years in general clinical practice.

4. Adjudication Method for the Test Set

Not applicable. There was no formal adjudication process described for the 6 years of clinical use in the context of a clinical study. Adverse events are typically reported through established post-market surveillance mechanisms.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

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

Not applicable. This is a medical device (bone void filler), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating safety and effectiveness relied on:

Chemical composition standards: Meeting established standards for implantable hydroxyapatite (non-clinical testing).
Historical clinical use/Outcomes data: Six years of previous clinical use without reported adverse events. This functions as a form of real-world "outcomes data" to support safety and acceptable performance.
Substantial equivalence: The primary ground for clearance is equivalence to existing, legally marketed predicate devices, implying their established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable as this is not a machine learning model. If interpreted as the "training" for the substantial equivalence claim, it would refer to the existing preclinical and clinical evidence on the predicate devices, for which no sample size is provided here.

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

Not applicable. There is no "training set" ground truth in the context of this 510(k) submission. The "ground truth" for the predicate devices is implied by their FDA clearance based on their own safety and effectiveness data (which may or may not have been presented in similar 510(k)s or PMAs).

Summary

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JAN 2 1 7005

K0435/V

EXHIBIT VII

510(k) SUMMARY

Allogran-N™

Applicant Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 SNL

Contact Person	J Stephen Bratt LL.B
	Tel: +44 1782 338580
	Fax +44 1782 338599
	Email: info@biocomposites.com

1.	Classification Name:	Resorbable Calcium Salt Bone Void Filler Device
	Common/Usual Name:	Bone Void Filler
	Trade/Proprietary Name	Allogran-N TM - Bone Void Filler
	Product Code	MQV

Legally Marketed Predicate Devices

	Common/Usual Name	Manufacturer
1	ApatightTM-HA Bone Graft Substitute	CERAbio LLC
2	ApaPore® Bone Graft Substitute	ApaTech Ltd

Device Description

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Intended Use / Indications

Allogran-N™ is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Allogran-N™ is packed into bony voids of the skeletal system (e.g., the spine, pelvis and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product is completely incorporated during the healing process. The Indications For Use statement is shown in Exhibit I.

Summary of Technology

Allogran-N™ is composed of a porous calcium salt, hydroxyapatite, equivalent to that contained in the predicate devices and to that in routine clinical use. The technologies employed in Allogran-N™ and the predicate devices are therefore substantially equivalent. Allogran-N™ is presented in granules in the same manner as the predicate devices. The indications, contraindications, risks and potential adverse events are the same and thus substantially equivalent.

Non Clinical Testing

Non clinical testing has been used to examine the chemical composition of Allogran-N™ which satisfies the standard for implantable hydroxyapatite.

Clinical Testing

Allogran-N™ has been regularly used clinically for the past 6 years and no adverse events have been reported in that time concerning the quality, safety or effectiveness of Allogran-N™.

Substantial Equivalence

Documentation provided demonstrates that Allogran-N™ is substantially equivalent to the legally marketed predicate devices in design, materials and indications. Allogran-N™ is well tolerated and completely incorporated into the defect site into which it is implanted and is safe and effective when used as indicated.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 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 extending from its head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JAN 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Bratt Managing Director Keele Science Park, Keele, Staffordshire, England ST5 5NL

Re: K043514 Trade/Device Name: Allogran-N™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Bone Void Filler Regulatory Class: II Product Code: MQV Dated: December 14, 2004 Received: December 20, 2004

Dear Mr. Bratt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars) to regars and the Medical Device Amendments, or to conimeres prior to may 20, 2017 11:31 in accordance with the provisions of the Federal Food, Drug, de vices mat nave been receasined in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, merelove, mains of the Act include requirements for annual registration, listing of general controls provision 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 if your de rice to such additional controls. Existing major regulations affecting your device can may or sate to are to deem 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 r reaso be aar nove 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 or any I vith 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. Kacy Arnold, RN, MBA

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you to ogen manieting your antial equivalence of your device to a legally prematicated 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 If you ucsife specific at 100 for Jour acchieves at (240) 276-0120. Also, please note the regulation entitled, Comation of Compulation in the market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

O Mark A. Melhusen

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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EXHIBIT I

INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Allogran-N™

Indications For Use:

Allogran-N™ is intended for use as a bone void filler or bone void substitute that are not intrinsic to the stability of the bony for bony voids or gaps structure.

Prescription Use メ (Part 21 CFR 801 Subpart D) Over-The-Counter use (Part 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)

Mark A. Millerson

(Division Sign-Off)
Division of General, Restorative,

110 1820

510(k) Number K043574

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.