(119 days)
The ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The ACP 1™ system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Trauma (including fractures)
Tumors
Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
Pseudarthrosis
Failed previous fusion
Decompression of the spinal cord following total or partial cervical vertebrectomy
Spondylolisthesis
Spinal stenosis
The ACP 1TM Anterior Cervical Plating System are one-, two-, three- and four-level plate configurations ranging in lengths 10mm to 22mm for the one-level plates, 24mm to 46mm for the two-level plates, 39mm to 69mm for the three-level plates and 56mm to 96mm for the four-level plates. A locking screw is utilized as an anti-backout mechanism to lock the bone screws in place. The bone screws are provided with either fixed or variable angles available in self-tapping or self-drilling designs. The variable angle bone screws allow the screw to be placed into bone at various degrees of angulation, while the fixed bone screws are inserted at a defined angle. Any combination of bone screws can be used to secure the cervical plate. The bone screws are offered in 4.0mm and 4.5mm diameters in lengths 10mm - 20mm. The implants (bone screws and cervical plates) are provided as single-use, sterile devices manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.
This document is a 510(k) summary for the Stryker Corporation's ACP 1™ Anterior Cervical Plating System. The information provided heavily emphasizes the substantial equivalence of the new device to previously cleared predicate devices, rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.
Therefore, the response below is structured to reflect the information available in the provided text, primarily focusing on the comparison to predicate devices and the mechanical testing performed, as a direct AI-style acceptance criteria and study section isn't explicitly present.
Acceptance Criteria and Study for the ACP 1™ Anterior Cervical Plating System
The ACP 1™ Anterior Cervical Plating System's acceptance criteria and the study proving it meets these criteria are primarily based on demonstrating substantial equivalence to existing predicate devices through risk analysis and mechanical testing, rather than a clinical performance study with specific diagnostic accuracy metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance | |
| Static Compression Strength (per ASTM F1717-14) | Met predefined acceptance criteria. |
| Dynamic Compression Endurance (per ASTM F1717-14) | Met predefined acceptance criteria. |
| Static Torsion Strength (per ASTM F1717-14) | Met predefined acceptance criteria. |
| Substantial Equivalence to Predicates | |
| Identical Indications for Use | Confirmed due to no alteration of fundamental scientific technology or change/introduction of an energy source; modified devices retained previously FDA cleared indications/intended use and mode of operation. |
| Similar Technological Characteristics | The primary modification is a new locking screw mechanism; implants remain manufactured from surgical grade implantable titanium alloy. |
| Similar Principles of Operation | No change in the fundamental scientific technology or mode of operation. |
| Safety & Efficacy | Risk analysis performed to demonstrate substantial equivalence; modifications did not raise new questions of safety or efficacy. |
Study Description:
The provided document describes a "510(k) Summary" process which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "study" in this context refers to the assessment performed to support this claim.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Mechanical Testing: The document does not specify the exact number of test samples (e.g., number of plates or constructs) used for the static and dynamic mechanical tests per ASTM F1717-14.
- Data Provenance: The data provenance for the mechanical testing is not explicitly stated (e.g., country of origin, specific lab). It is implicitly prospective testing conducted by the manufacturer to support the 510(k) submission. There is no patient data involved in this assessment as it's a mechanical device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This type of information is not applicable for the ACP 1™ Anterior Cervical Plating System as described in this document. The assessment is for a physical implantable medical device and relies on engineering principles and mechanical testing standards (ASTM F1717-14), not on expert clinical interpretation of data or diagnostic accuracy.
4. Adjudication Method for the Test Set:
This is not applicable. There is no "test set" in the sense of a dataset requiring expert adjudication, as the study involves mechanical performance testing of a physical device against predefined engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is not applicable here. This study type is typically used for diagnostic devices (e.g., AI in radiology) to evaluate the performance of human readers with and without AI assistance. The ACP 1™ System is an implantable surgical device, not a diagnostic tool.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
This concept is not applicable to the ACP 1™ Anterior Cervical Plating System. The device is a physical implant, not an algorithm. Its performance is evaluated through mechanical testing and comparison to predicate devices, not as a standalone AI system.
7. Type of Ground Truth Used:
The "ground truth" for the performance evaluation of the ACP 1™ System is based on established engineering standards and requirements for spinal intervertebral body fixation orthoses, specifically the ASTM F1717-14 standard for static and dynamic compression and torsion testing. The ultimate "ground truth" for regulatory clearance is substantial equivalence to legally marketed predicate devices, meaning the new device performs as safely and effectively as the existing ones.
8. Sample Size for the Training Set:
This is not applicable. The ACP 1™ System is a physical medical device. It does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no "training set."
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2015
Stryker Corporation Ms. Tina Mornak Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K150700
Trade/Device Name: ACP 1™ Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 18, 2015 Received: June 19, 2015
Dear Ms. Mornak:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Tina Mornak
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
ACP 1TM Anterior Cervical Plating System
Indications for Use (Describe)
The ACP 1™ Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
The ACP 1™ system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
· Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Trauma (including fractures)
- Tumors
- · Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- Pseudarthrosis
- · Failed previous fusion
- · Decompression of the spinal cord following total or partial cervical vertebrectomy
- · Spondylolisthesis
- · Spinal stenosis
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | |
|---|---|
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 |
| Contact Person | Tina MornakRegulatory Affairs SpecialistPhone: 201-760-8193Fax: 201-962-4193E-mail: tina.mornak@stryker.com |
| Date Prepared | June 30, 2015 |
| Trade Name | ACP 1TM Anterior Cervical Plating System |
| Common Name | Appliance, fixation, spinal intervertebral body |
| Proposed Class | Class II |
| Classification Name andNumber | Spinal intervertebral body fixation orthosis21 CFR §888.3060 |
| Product Code | KWQ |
| Predicate Devices | Primary Predicate:Stryker Spine, Aviator® Anterior Cervical Plating (ACP) System, K142237Additional Predicates:Synthes Anterior CSLP System, K000742BioMet MaxAn® Anterior Cervical Plate System, K133518 |
| Device Description | The ACP 1TM Anterior Cervical Plating System are one-, two-, three- and four-levelplate configurations ranging in lengths 10mm to 22mm for the one-level plates, 24mmto 46mm for the two-level plates, 39mm to 69mm for the three-level plates and 56mmto 96mm for the four-level plates. A locking screw is utilized as an anti-backoutmechanism to lock the bone screws in place. The bone screws are provided with eitherfixed or variable angles available in self-tapping or self-drilling designs. The variableangle bone screws allow the screw to be placed into bone at various degrees ofangulation, while the fixed bone screws are inserted at a defined angle. Anycombination of bone screws can be used to secure the cervical plate. The bone screwsare offered in 4.0mm and 4.5mm diameters in lengths 10mm - 20mm. The implants(bone screws and cervical plates) are provided as single-use, sterile devicesmanufactured from titanium alloy (Ti6Al4V) per ASTM F136 and ISO 5832-3, as wellas associated manual general surgical instrumentation. The implants are available in avariety of sizes to accommodate various patient anatomies. |
| Indications for Use | The ACP 1TM Anterior Cervical Plating System is intended for use as an aid in cervicalspinal fusion and is intended for unilateral fixation.The ACP 1TM system is intended for anterior intervertebral screw fixation of thecervical spine at levels C2-T1. The system is indicated for temporary stabilization ofthe anterior spine during the development of cervical spine fusions in patients with thefollowing indications:Degenerative Disc Disease (as defined by neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographic studies)Trauma (including fractures)TumorsDeformities or curvatures (including kyphosis, lordosis, or scoliosis)PseudarthrosisThe associated instrumentation are Class I / 510(k) exempt devices under 21 CFR§888.4540. |
| 510(k) Summary | |
| Failed previous fusion Decompression of the spinal cord following total or partial cervical vertebrectomy Spondylolisthesis Spinal stenosis | |
| Summary of theTechnologicalCharacteristics | The purpose of this Traditional 510(k) is to summarize the design changes and sterilelabeling that have been implemented to the Aviator® Anterior Cervical Plating (ACP)System. These modifications did not alter the fundamental scientific technology orchange/introduce an energy source. The modified devices retained by previouslyFDA cleared indications/intended use and mode of operation as presented in 510(k)#K142237.The ACP 1TM System introduces a locking screw as an anti-backout mechanism. Theprimary screw locking mechanism is a locking screw, which is designed to lock overthe bone screw heads. Insertion of the locking screw locks the bone screws in placeand allows for additional visual and tactile feedback that the bone screws are locked.The ACP 1TM System will be provided sterile to the end-user. The implants continueto be manufactured from surgical grade implantable titanium alloy.The implemented modifications did not raise new questions of safety or efficacy. |
| Summary of thePerformance Data | Risk analysis was performed to demonstrate that the ACP 1TM System is substantiallyequivalent to its predicate devices. The risk analysis determined that the predefinedacceptance criteria associated with the following mechanical testing was met: Static and dynamic compression testing per ASTM F1717-14 Static torsion testing per ASTM F1717-14 |
| Conclusions | The ACP 1TM System has identical indications, technological characteristics, andprinciples of operation as its predicates. The risk analysis performed demonstratesthat any minor differences do not impact device performance as compared to thepredicates. The ACP 1TM System was shown to be substantially equivalent to itspredicate devices. |
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