(30 days)
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.
Actifuse™ ABX E-Z-fil Putty is phase-pure silicon-substituted hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the hydroxylapatite phase of Actifuse ABX E-Z-fil Putty is similar to human cancellous bone. Actifuse™ ABX E-Z-fill Putty is available as a hydrated putty.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Actifuse™ ABX E-Z-fil Putty Bone Graft Substitute:
Based on the provided document (K071206), the review process for Actifuse™ ABX E-Z-fil Putty was a 510(k) Premarket Notification. This regulatory pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove newfound safety and effectiveness.
Therefore, the document does not contain the typical "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that would be seen in a study evaluating a diagnostic or AI-driven device. Instead, the "acceptance criteria" are related to demonstrating that the new device is as safe and effective as its predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstrated Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Technological Characteristics: The device is composed of materials and has a structure equivalent to predicate devices and in routine clinical use. | Actifuse™ ABX E-Z-fil Putty is composed of a porous calcium salt, hydroxylapatite, equivalent to that contained in both predicate devices (Actifuse™ Bone Graft Substitute, K040082) and to that in routine clinical use. It is a phase-pure silicon-substituted hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold delivered in a matrix of resorbable polymer. Its interconnected and open porous structure is similar to human cancellous bone. |
| Intended Use: The device shares the same intended use as predicate devices. | Actifuse™ ABX E-Z-fil Putty has the same indications, contraindications, risks, and potential adverse events as the predicate devices. Its intended use is as a bone void filler for orthopaedic applications as a filler for gaps and voids not intrinsic to bony structure stability, including extremities, pelvis, and spine (posterolateral fusion with hardware). |
| Safety and Effectiveness: The device is safe and effective in providing a scaffold for rapid bone repair and meets relevant standards for Calcium Salt Bone Void Fillers. | "Bench testing has shown Actifuse™ ABX E-Z-fil Putty to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Testing has confirmed Actifuse™ ABX E-Z-fil Putty to be safe and effective in providing a scaffold for rapid bone repair via bony infiltration of the porous scaffold." |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. As a 510(k) submission primarily relies on demonstrating substantial equivalence through existing data on predicate devices and bench testing, detailed clinical "test sets" with patient data (e.g., country of origin, retrospective/prospective) are typically not included in this summary unless new clinical data was specifically required, which is not indicated here. The document mentions "bench testing," implying laboratory-based studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable/provided. Since the evaluation was based on demonstrating substantial equivalence primarily through technical characteristics and bench testing against standards, there's no mention of experts establishing a "ground truth" for a clinical test set in the context of diagnostic device validation.
4. Adjudication Method for the Test Set:
This information is not applicable/provided. No clinical test set requiring adjudication in the context of expert consensus (like for imaging studies) is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improve with AI vs without AI Assistance:
This information is not applicable. The device is a bone void filler, a physical medical device, not an AI-driven image analysis or diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This information is not applicable. As stated above, this is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
For the "safety and effectiveness" claim, the ground truth was based on:
- "Relevant standards for Calcium Salt Bone Void Fillers": This implies adherence to established industry or regulatory standards for material properties, biocompatibility, mechanical performance, etc.
- "Bony infiltration of the porous scaffold": This likely refers to in vitro or in vivo (animal) studies demonstrating the biological activity of the material in promoting bone ingrowth, assessed perhaps through histological analysis or imaging.
8. The Sample Size for the Training Set:
This information is not applicable/provided. The concept of a "training set" is typically associated with machine learning or AI algorithms. For a physical medical device like a bone void filler, product development involves material science, engineering, and biological testing, rather than an AI training/testing paradigm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided for the reasons stated in point 8.
In summary, the provided document for K071206 describes a 510(k) premarket notification for a physical medical device. The "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a predicate device through shared technological characteristics, intended use, and bench testing against established standards, rather than clinical trial results with specific performance metrics (like sensitivity, specificity) for a diagnostic tool or AI algorithm.
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Premarket Notification [510(K)] Summary (per 21 CFR 807.92)
MAY 3 1 2007
| Submitter: | ApaTech Limited370 Centennial AvenueCentennial ParkElstree, Hertfordshire WD6 3TJUnited Kingdom |
|---|---|
| Contact Person: | Thomas Buckland PhD+44 (0) 20 8731 4649 (phone)+44 (0) 20 8731 4669 (fax) |
| Date Prepared: | 27 April 2007 |
| Classification: | Resorbable calcium salt bone void filler deviceshave been classified by the Orthopedics DevicePanel as Class II Special Controls per 21 CFR888.3045 |
| Trade Name: | Actifuse™ ABX E-Z-fil Putty Bone GraftSubstitute |
| Common Name: | Bone Void Filler |
| Predicate Devices: | Actifuse™ Bone Graft Substitute, K040082 |
Intended 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.
Device Description
Actifuse™ ABX E-Z-fil Putty is phase-pure silicon-substituted hydroxylapatite osteoconductive bone void filler, comprising a single-phase calcium hydroxylapatite scaffold delivered in a matrix of resorbable polymer. The interconnected and open porous structure of the hydroxylapatite phase of Actifuse ABX E-Z-fil Putty is similar to human cancellous bone. Actifuse™ ABX E-Z-fill Putty is available as a hydrated putty.
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Technological Characteristics and Substantial Equivalence
Actifuse™ ABX E-Z-fil Putty is composed of a porous calcium salt, hydroxylapatite, equivalent to that contained in both predicate devices and to that in routine clinical use. The technologies employed in Actifuse™ ABX E-Z-fil Putty and its predicate devices are therefore substantially equivalent. Actifuse™ ABX E-Z-fil Putty has the same indications, contraindications, risks and potential adverse events as the predicate devices, and thus substantial equivalence is claimed for the device.
Testing
Bench testing has shown Actifuse™ ABX E-Z-fil Putty to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Testing has confirmed Actifuse™ ABX E-Z-fil Putty 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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a simple, sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2007
Apa Tech Limited % Ms. Candace Cederman Consultant 15058 Armel Drive Oregon City, Oregon 97045
Re: K071206
Trade/Device Name: Actifuse™ ABX E-Z-fil Putty Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: April 30, 2007 Received: May 1, 2007
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. Iisting 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. Candacc 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 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 and 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 yo
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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510(k) Number (if known):
Device Name: Actifuse™ ABX E-Z-fil Putty
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 × AND/OR (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)
(Division Sign-Off Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number
63
§ 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.