(108 days)
The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion (C2-C7). The GSO ACP1 Anterior Cervical Plate System is intended for single use only.
The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthroses, and/or failed previous fusions.
The ACPI Anterior Cervical Plate System consists of a variety of anterior cervical spinal bone plates and self-drilling / self-tapping bone screws for fixation of the vertebral body(s) of the cervical spine, using an anterior approach for the development of a cervical spinal fusion (C2-C7), and associated instruments. The bone screws form an interlocked construct on the vertebral bodies. The spinal bone plates include an integrated bone screw locking mechanism consisting of an integrated tab retained by a captive locking screw, covering a portion of the underlying bone screw head to prevent bone screw back-out. The bone screws are self-drilling / self-tapping, in various diameters and lengths, and are available in variable angle and fixed angle configurations. All implant components are ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI). The ACP1 system was designed to be compatible with common surgical instruments available in operating rooms equipped for spine surgery. The device specific instruments are considered to be Class II. The instruments are medical grade stainless steel, some have silicone rubber handles, and they are provided non-sterile. Stainless steel and titanium implant components must not be used together in a construct.
The provided text describes a medical device, the GSO ACP1 Anterior Cervical Plate System, and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, the questions related to AI/ML specific acceptance criteria, study details, and performance metrics—such as sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies—are not applicable to this document.
The "acceptance criteria" for this device are demonstrated through non-clinical testing against established ASTM standards and a comparison to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Method) | Performance Goal (Basis) | Reported Device Performance |
|---|---|---|
| Static Compressive Bending | Equivalent to predicate devices (ASTM F1717) | Mechanical testing conducted according to ASTM F1717. (Results implied to meet equivalence) |
| Static Torsional Stiffness | Equivalent to predicate devices (ASTM F1717) | Mechanical testing conducted according to ASTM F1717. (Results implied to meet equivalence) |
| Dynamic Axial Compression Bending | Equivalent to predicate devices (ASTM F1717) | Mechanical testing conducted according to ASTM F1717. (Results implied to meet equivalence) |
| Material Safety | Use of ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI) | All implant components are ASTM standard, medical implant grade titanium alloy (Ti 6Al-4V ELI). |
| Design and Functionality | Substantially equivalent in indications for use, design, and materials to predicate devices (Multiple 510(k) cleared devices) | Demonstrated substantial equivalence to multiple predicate devices (listed in section 8). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This device's acceptance was based on non-clinical mechanical testing and comparison to predicate devices, not on a clinical test set with data provenance.
3. 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. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and direct measurement, not by expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not used for mechanical testing.
5. 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 not an AI-powered device, so MRMC studies involving human readers and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's acceptance is based on:
- Adherence to ASTM F1717 standard for mechanical testing.
- Conformity to material specifications (ASTM standard, medical implant grade titanium alloy).
- Demonstrated substantial equivalence in indications for use, design, mechanical testing, and materials to previously cleared predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI-powered device, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI-powered device, there is no training set or ground truth associated with it in that context.
{0}------------------------------------------------
JUL 25 2011
| 1. 510(k) Owner | Gold Standard Orthopaedics, LLC1226 Rowan StreetLouisville, KY 40203Contact Information:Phone: 502-581-8770Fax: 502-581-1704Establishment Registration Number: 3006215390Owner/Operator Number: 10023859 |
|---|---|
| 2. Applicant / Sponsor | Gold Standard Orthopaedics, LLC1226 Rowan StreetLouisville, KY 40203Contact Information:Phone: 502-581-8770Fax: 502-581-1704Establishment Registration Number: 3006215390Owner/Operator Number: 10023859 |
| 3. Contact Person | James RitterAquila Consultants, LLC3415 N. Old Farm Rd. E.Warsaw, IN 46582Phone: (574) 527-3256Fax: (574) 267-7516 |
| 4. Device Proprietary Name | GSO ACP1 Anterior Cervical Plate System |
| 5. Device Common Name | Anterior cervical plate system |
| 6. Date Summary Prepared | March 29, 2011 |
| 7. Classification Name | Spinal intervertebral body fixation orthosis, 21 CFR 888.3060 |
| 8. LegallyMarketedPredicate Device | The GSO ACP1 Anterior Cervical Plate System was shown to besubstantially equivalent in indications for use, design, mechanicaltesting, and materials to other commercially available anterior cervicalplate systems cleared for distribution through the 510(k) processincluding:• Medtronic Sofamor Danek Atlantis Vision Anterior Cervical Plate,510(k) Number K021461, cleared July 22, 2002• Synthes Cervical Spine Locking Plate (CSLP), 510(k) NumberK030866 cleared for distribution on April 18, 2003• Blackstone Medical Anterior Cervical Plate, 510(k)NumberK974885 cleared for distribution on June 17, 1998• Life Spine, LLC, NEOTM Cervical Plating System, 510(k) NumberK040844, cleared for distribution on July 23, 2004• Spinal USA, Slimplicity Anterior Cervical Plate System, 510(k)Number K060025, cleared for distribution on April 18, 2006• EBI, L.P., VueLock Anterior Cervical Plate System, 510(k) NumberK023133, cleared for distribution on October 18, 2002 |
| 9. DeviceDescription | The ACPI Anterior Cervical Plate System consists of a variety ofanterior cervical spinal bone plates and self-drilling / self-tapping bonescrews for fixation of the vertebral body(s) of the cervical spine, usingan anterior approach for the development of a cervical spinal fusion(C2-C7), and associated instruments. The bone screws form aninterlocked construct on the vertebral bodies. The spinal bone platesinclude an integrated bone screw locking mechanism consisting of anintegrated tab retained by a captive locking screw, covering a portionof the underlying bone screw head to prevent bone screw back-out.The bone screws are self-drilling / self-tapping, in various diametersand lengths, and are available in variable angle and fixed angleconfigurations. All implant components are ASTM standard, medicalimplant grade titanium alloy (Ti 6Al-4V ELI). The ACP1 system wasdesigned to be compatible with common surgical instruments availablein operating rooms equipped for spine surgery. The device specificinstruments are considered to be Class II. The instruments are medicalgrade stainless steel, some have silicone rubber handles, and they areprovided non-sterile.Stainless steel and titanium implant components must not be usedtogether in a construct. |
| 10. Intended Use | The GSO ACP1 Anterior Cervical Plate System is intended for anteriorinterbody screw fixation of the cervical spine during the developmentof a cervical spinal fusion (C2-C7). The GSO ACP1 Anterior CervicalPlate System is intended for single use only. |
| 11. Indications | The GSO ACP1 Anterior Cervical Plate System is intended for anteriorinterbody screw fixation of the cervical spine (C2-C7). The system isindicated for use in the temporary stabilization of the anterior spineduring the development of cervical spinal fusions in patients withdegenerative disc disease (as defined by neck pain of discogenic originwith degeneration of the disc confirmed by patient history andradiographic studies), spondylolisthesis, trauma (including fractures),spinal stenosis, tumors, deformity (defined as kyphosis, lordosis, orscoliosis), pseudarthroses, and/or failed previous fusions.WARNING: This device system is intended for anterior cervicalinterbody fusions only. This device is not approved for screwattachment to the posterior elements (pedicles) of the cervical, thoracic,or lumbar spine. |
| 12. Summary ofTechnologies andSubstantialEquivalence | The GSO ACP1 Anterior Cervical Plate System is substantiallyequivalent in indications for use, design, and materials to othercommercially available anterior cervical plate systems cleared fordistribution through the 510(k) process including: the MedtronicSofamor Danek Atlantis Vision Anterior Cervical Plate, 510(k)Number K021461, cleared July 22, 2002, the Synthes Cervical SpineLocking Plate (CSLP), 510(k) Number K030866 cleared fordistribution on April 18, 2003, and the Blackstone Medical AnteriorCervical Plate, 510(k) Number K974885 cleared for distribution onJune 17, 1998, the Life Spine, LLC NEO™ Cervical Plating System,510(k) Number K040844, cleared for distribution on July 23, 2004, theSpinal USA Simplicity Anterior Cervical Plate System, 510(k) NumberK060025, cleared for distribution on April 18, 2006, and the EBIVueLock™ Anterior Cervical Plate System, 510(k) Number K02313,cleared for distribution on October 18, 2002. |
| 13. Non-ClinicalTesting | Mechanical testing to determine substantial equivalence to predicatedevices was conducted according to ASTM F1717 including staticcompressive bending, static torsional stiffness, and dynamic axialcompression bending. |
| 14. ClinicalTesting | Clinical testing was not necessary to demonstrate the substantialequivalence of the GSO ACP1 Anterior Cervical Plate System to theMedtronic Sofamor Danek Atlantis Anterior Cervical Plate, theSynthes Cervical Spine Locking Plate (CSLP), the Blackstone MedicalAnterior Cervical Plate, the Life Spine, LLC NEO™ Cervical PlatingSystem, the Spinal USA Simplicity Anterior Cervical Plate System,and the EBI VueLock™ Anterior Cervical Plate System. |
3. 510(k) Summary
{1}------------------------------------------------
{2}------------------------------------------------
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an eagle-like symbol with three stylized lines representing the wings and body. The symbol is black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Gold Standard Orthopaedics, LLC % Aquila Consultants, LLC Mr. James Ritter 3415 North Old Farm Road East Warsaw, Indiana 46582
JUL 25 2011
Re: K110990
Trade/Device Name: GSO ACP1 Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis . Regulatory Class: Class II Product Code: K.WQ Dated: June 08, 2011 Received: June 13, 2011
Dear Mr. Ritter:
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 deternination that your device complies with other requirements of the Act
{4}------------------------------------------------
Page 2 - Mr. James Ritter
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Biornetrics/Division of Postmarket Surveillance,
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
2. Indications for Use Statement
Device Name: GSO ACP1 Anterior Cervical Plate System
Indications For Use:
The GSO ACP1 Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with
- · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · spondylolisthesis
- · trauma (including fractures)
- · spinal stenosis
- · tumors, deformity (defined as kyphosis, lordosis, or scoliosis)
- · pseudarthroses, and/or failed previous fusions
WARNING: This device system is intended for anterior cervical interbody fusions only. This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
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)
Page 1 of 1
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KII0990 510(k) Number_
N/A