Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure (e.g., the extremities, spine or pelvis) and may be combined with saline or blood. Defects may be due to trauma or surgery.

Device Description

Allogran-R® is a bioabsorbable device manufactured from calcium salts and may be supplied in the form of granules or other preformed shapes.

AI/ML Overview

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for Allogran-R® does not explicitly state specific quantitative acceptance criteria or performance metrics that the device was designed to meet. Instead, the basis for clearance is substantial equivalence to predicate devices. This means that the device's performance is deemed acceptable because it is similar enough to devices already legally marketed, which are themselves considered safe and effective.

Therefore, the table below reflects this approach:

Acceptance Criteria (Implicit)	Reported Device Performance
Substantially equivalent in safety and effectiveness to predicate devices	"Test data supplied demonstrates that the Allogran-R® is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness."
No new concerns regarding safety and effectiveness	"No new concerns have been identified regarding safety and effectiveness of Allogran-R®"
Meeting intended use for filling bony voids/gaps	"Allogran-R® is a resorbable implant intended to fill bony voids or gaps that are not intrinsic to the stability of the bony structure..." (Matches predicate intent)
Technological characteristics similar to predicates	"Allogran-R® has the same technological characteristics as the predicate devices and any differences do not raise concerns concerning safety and effectiveness."

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

The document does not provide information on a specific "test set" in the context of a clinical study with human subjects. The 510(k) relies on "Non Clinical Testing" and comparison to predicate devices. Therefore, details like sample size, country of origin, or retrospective/prospective nature for a clinical test set are not available in this filing.

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

Since there is no mention of a human-subject clinical "test set" requiring ground truth establishment by experts, this information is not provided in the document.

4. Adjudication Method for the Test Set

As there is no mention of a human-subject clinical "test set" and expert ground truth, an adjudication method is not applicable or mentioned.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study is not mentioned or indicated in the provided 510(k) summary. This type of study is more common for diagnostic imaging devices where human interpretation is a critical component.

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

This device (Allogran-R®) is a medical implant, not an algorithm or software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" for demonstrating substantial equivalence primarily relies on:

Established safety and effectiveness of the predicate devices: The predicate devices (Vitoss Scaffold and βGran) were already cleared, implying their safety and efficacy were accepted.
Non-clinical testing: The document mentions "Test data supplied," which typically refers to in-vitro studies, material characterization, biocompatibility testing, mechanical testing, and potentially animal studies, demonstrating the device's properties are acceptable and comparable to predicates.

8. The Sample Size for the Training Set

The concept of a "training set" is usually associated with machine learning algorithms. Since Allogran-R® is a medical implant and not an AI/ML device, a training set in that context is not applicable and therefore not provided.

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

As explained in point 8, the concept of a training set is not applicable to this type of device.

Summary

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K061311

SEP 2 2 2006

510(k) SUMMARY

Allogran-R®

Applicant Biocomposites Ltd Keele Science Park Keele Staffordshire England ST5 SNL
Mr Simon Fitzer Contact Person +44 (0) 1782 338580 Tel: Fax +44 (0) 1782 338599 Email: sf@biocomposites.com

Classification Name:	Filler, bone void, calcium compound
Common/Usual Name:	Filler, bone void, calcium compound
Trade/Proprietary Name	Allogran-R®
Product Code	MVQ

Legally Marketed Predicate Devices

	Trade Name	Manufacturer	510(k) No
1	Vitoss Scaffold	Orthovita	K032409
2	βGran	Orthos (UK) Ltd	K041616

Device Description

Allogran-R® is a bioabsorbable device manufactured from calcium salts and may be supplied in the form of granules or other preformed shapes.

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Intended Use / Indications

Summary of Technology

Allogran-R® has the same technological characteristics as the predicate devices and any differences do not raise concerns concerning safety and effectiveness.

Non Clinical Testing

Test data supplied demonstrates that the Allogran-R® is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness.

Substantial Equivalence

Documentation provided demonstrates that Allogran-R® is substantially equivalent to the legally marketed predicate devices in basic features and intended uses. No new concerns have been identified regarding safety and effectiveness of Allogran-R®

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2006

Biocomposites Ltd. % Mr. Simon Fitzer Quality and Regulatory Affairs Manager Keele Science Park Keele Staffordshire United Kingdom ST5 5NL

· Re:-K061311

Trade Name: Allogran-R® Regulation Number: 21 CFR 888.3045 Regulation Name: Filler, Bone Void, Calcium Compound Regulatory Class: Class II Product Code: MQV Dated: September 6, 2006 Received: September 8, 2006

Dear Mr. Fitzer:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a showe 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 for use stated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner of pror to ria) 2011-07-11 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). and Ocometier fore, market the device, subject to the general controls provisions of the Act. The r ou may, dierelere, mains 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 If your device 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 r trate be actived a determination that your device complies with other requirements of the Act that I Dr Has Intactions and regulations administered by other Federal agencies. You must or mr) 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 Cr re rate 077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorni in the quisions of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Simon Fitzer

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 Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Malkerson

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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APPENDIX I

INDICATIONS FOR USE

510(k) Number (if known): K061311

Allogran-R® Device Name:

Indications For Use:

Prescription Use (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)

barbare Brielud formin

(Division Sega-Off) (Division of Ceneral Secsiorative, and Neurolagical I

Page 1 of 1

510(k) Num -------------------------------------------------------------------------------------------------------------------------------------------------------------------

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.