Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

Device Description

Actifuse is a phase-pure calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold, either granules or granules delivered in a matrix of resorbable polymer. 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse™ is similar to human cancellous bone.

AI/ML Overview

The provided text is for a 510(k) Premarket Notification for a bone graft substitute called Actifuse. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a de novo study to establish performance against acceptance criteria in the same way one would for a novel diagnostic AI device. Therefore, much of the requested information (like sample sizes for test sets, expert-established ground truth, MRMC studies, or training set details) is not present because it is not typically part of a 510(k) for a bone void filler based on material composition.

Here's an analysis of the available information in the context of the provided document, addressing what can be inferred or explicitly stated:

Acceptance Criteria and Device Performance

The document doesn't define explicit numerical acceptance criteria for device performance as you would expect for an AI diagnostic device (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device and adherence to relevant standards for Calcium Salt Bone Void Fillers.

Acceptance Criteria (Inferred from 510(k) Context)	Reported Device Performance
Substantial Equivalence to Predicate Device:- Same indications for use- Same technological characteristics- Same contraindications, risks, and potential adverse events	Actifuse™ is composed of a porous calcium salt equivalent to that contained in the predicate device and to that in routine clinical use.Actifuse™ has the same indications, contraindications, risks and potential adverse events as the predicate device.
Safety and Effectiveness:- Meeting requirements of all relevant standards for Calcium Salt Bone Void Fillers- Providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold	Testing has shown Actifuse™ to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers.Testing has confirmed Actifuse™ to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold.
Material Composition:- Phase-pure calcium phosphate- 0.8wt% silicon (Si) incorporated into crystalline structure- Interconnected and open porous structure similar to human cancellous bone	Actifuse is a phase-pure calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold... 0.8wt% silicon (Si) is incorporated into the crystalline structure. The interconnected and open porous structure of Actifuse™ is similar to human cancellous bone.

Study Information (Based on Available Document)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document states "Testing has shown Actifuse™ to meet the requirements of all relevant standards" and "Testing has confirmed Actifuse™ to be safe and effective." However, it does not provide details about the specific studies, sample sizes, or data provenance. For a bone graft substitute, this "testing" would typically refer to biocompatibility, mechanical properties, and possibly animal studies, not human clinical test sets in the context of AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not specified. This pertains to establishing ground truth for diagnostic devices, particularly AI. For a bone graft substitute, "ground truth" would be established through laboratory analyses, histological examination (in animal studies), and potentially clinical follow-up for bone formation, but not typically through an expert panel reviewing diagnostic images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This is relevant for diagnostic image review.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This type of study is specific to evaluating AI-assisted diagnostic tools.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical bone graft substitute, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in detail, but inferred "ground truth" for a bone graft substitute's performance would typically involve:
  - Biocompatibility testing (e.g., cell culture, implantation models).
  - Histological analysis (in animal studies) to confirm bone ingrowth and resorption.
  - Mechanical testing of the material.
  - Chemical analysis to confirm composition.
- The document states "the product provides a bone void filler that resorbs and is replaced by bone during the healing process," implying that evidence of resorption and bone replacement would be the ultimate "outcome data" or "pathology" in relevant studies.
The sample size for the training set:
- Not applicable/Not specified. This product is not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable/Not specified. This product is not an AI algorithm that requires a training set.

Summary

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K082575

Premarket Notification [510(K)] Summary (per 21 CFR 807 92)

Submitter:	ApaTech Limited370 Centennial AvenueElstree, Hertfordshire WD6 3TJUnited Kingdom	NOV 25 2008
Contact Person:	James J. Cassidy, Ph.D.(320) 355-2679 (phone)(320) 355-3206 (fax)
Date Prepared:	3 September 2008
Classification:	Resorbable calcium salt bone void filler devices havebeen classified by the Orthopedics Device Panel asClass II Special Controls per 21 CFR 888.3045,Product Code MQV.
Trade Name:	Actifuse™ Bone Graft SubstituteActifuse™ Microgranules Bone Graft SubstituteActifuse™ E-Z PrepActifuse™ ABX E-Z-fil Bone Graft SubstituteActifuse™ MISActifuse™ Shape Bone Graft Substitute
Common Name:	Bone Void Filler

Intended use:

Device Description

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Technological Characteristics and Substantial Equivalence

Actifuse™ is composed of a porous calcium salt equivalent to that contained in the predicate device and to that in routine clinical use. The technologies employed in Actifuse™ and its predicate device are therefore substantially equivalent. Actifuse™ has the same indications, contraindications, risks and potential adverse events as the predicate device and thus substantial equivalence is claimed for the device.

Testing

Testing has shown Actifuse™ to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Testing has confirmed Actifuse™ to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold.

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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 and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white and appears to be a simple, vectorized design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 5 2008

ApaTech, Ltd. % Ms. Candace F. Cederman 15058 Armel Drive Oregon City, Oregon 97045

Re: K082575

Trade/Device Name: Actifuse™ Bone Graft Substitute, Actifuse™ Microgranules Bone Graft Substitute, Actifuse "E-Z Prep. Actifuse" ABX E-Z fil Bone Graft Substitute, Actifuse™ MIS, Actifuse™ Shape Bone Graft Substitute

Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Codc: MQV Dated: September 3, 2008 Received: September 5, 2008

Dear Ms. Cederman:

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 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. Candace F. Cederman

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prestmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the from the Division of Small Manufacturers, International and Consumer Assistance at toll fire not more (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

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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Statement of Indications for Use

510(k) Number (if known):

Device Name:

Actifuse™ Bone Graft Substitute Actifuse™ Microgranules Bone Graft Substitute Actifuse™ E-Z Prep Actifuse™ ABX E-Z-fil Bone Graft Substitute Actifuse™ MIS Actifuse™ Shape Bone Graft Substitute

Indications for Use:

Actifuse™ is a bone void filler intended only for orthopaedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e., extremities, pelvis, and spine, including use in posterolateral fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process

Prescription Use × (Part 21 CFR 801 Subpart D) 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)

AND/OR

Mark A. Millerson

Division Sign-Off) Division of General, Restorative,

510(k) Number

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.