Actifuse ™ Shape 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 Shape 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™ Shape is phase-pure silicon-substituted calcium phosphate osteoconductive bone void filler, comprising a single-phase calcium phosphate scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the calcium phosphate phase of Actifuse Shape is similar to human cancellous bone.

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for Actifuse™ Shape, a bone void filler. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) application would.

Therefore, the document does not contain information on many of the requested items, particularly those related to human-in-the-loop studies, ground truth establishment with experts, or detailed statistical performance metrics of the device as if it were an AI diagnostic tool.

However, I can extract the information that is present and indicate where the requested information is not available:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Meet requirements of relevant standards for Calcium Salt Bone Void Fillers.	"Testing has shown Actifuse™ Shape to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers." (Specific standards are not enumerated in this summary.)
Safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold.	"Testing has confirmed Actifuse™ Shape to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold." (No specific quantitative metrics for "rapid bone repair" or "bony infiltration" are provided in this summary. The safety and effectiveness are primarily supported by substantial equivalence to the predicate device, Actifuse™ ABX E-Z-fil Putty, K071206, which also implies similar indications, contraindications, risks, and potential adverse events.)
Substantial Equivalence to Predicate Device (Actifuse™ ABX E-Z-fil Putty, K071206).	"Actifuse™ Shape is composed of a porous calcium salt equivalent to that contained in the predicate device... The technologies employed in Actifuse™ Shape and its predicate device are therefore substantially equivalent. Actifuse™ Shape has the same indications, contraindications, risks and potential adverse events as the predicate device and thus substantial equivalence is claimed for the device." (The FDA's decision to clear the device confirms this claim of substantial equivalence, allowing it to be marketed.)

Additional Information Not Present in the Provided Document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The "testing" mentioned is likely bench testing or pre-clinical animal studies to confirm material properties and biocompatibility, rather than human clinical trials with defined test sets for performance metrics in a diagnostic or AI context.
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 in this context. The evaluation is not based on expert-adjudicated diagnostic performance of an AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a bone void filler, not an AI diagnostic tool for image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for a bone void filler involves demonstrating its material properties, biocompatibility, and ability to be resorbed and replaced by bone, likely through in vitro and in vivo (animal) studies mimicking the human healing process. No specific "ground truth" establishment with human experts for diagnostic purposes is described.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of what the document implies for this specific device:

The Actifuse™ Shape is a Class II medical device, cleared through the 510(k) pathway, meaning it demonstrates "substantial equivalence" to a legally marketed predicate device. The "testing" referred to is primarily to confirm its material characteristics, biocompatibility, and functionality (resorption and scaffolding for bone repair) meets relevant standards and is comparable to the predicate. This is a very different type of submission and testing methodology compared to what would be expected for an AI-powered diagnostic tool, which typically involves extensive clinical data, human reader input, and statistical performance metrics against a defined ground truth.

Summary

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K080736

APR 1 6 2008

Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

Submitter:

ApaTech Limited 370 Centennial Avenue Centennial Park Elstree, Hertfordshire WD6 3TJ United Kinadom

Contact Person:

Thomas Buckland PhD +44 (0) 20 8731 4649 (phone) +44 (0) 20 8731 4669 (fax)

Actifuse™ Shape Substitute

Date Prepared:

Classification:

14 March 2008

Resorbable calcium salt bone void filler devices have been classified by the Orthopedics Device Panel as Class II Special Controls per 21 CFR 888.3045, Product Code MQV.

Trade Name:

Common Name:

Bone Void Filler

Predicate Device:

Actifuse™ ABX E-Z-fil Putty, K071206

Intended use:

Device Description

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Technological Characteristics and Substantial Equivalence

Actifuse™ Shape 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™ Shape and its predicate device are therefore substantially equivalent. Actifuse™ Shape 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™ Shape to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Testing has confirmed Actifuse™ Shape to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold.

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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 stripes forming its body and wings. The eagle faces left and has a curved beak. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 1 6 2008

Re: K080736 Trade/Device Name: Actifuse™ Shape Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 14, 2008 Received: March 17, 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 Postmarket 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 Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark H. 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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510(k) Number (if known):

Device Name: Actifuse™ Shape

Indications for Use:

Actifuse Shape 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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil RP Ogha formxm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K080736

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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.