(60 days)
The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Asfora Anterior Cervical Plate System is composed of plates of varying lengths to accommodate surgical procedures from one to four levels. The plates are designed for application to the anterior aspect of the cervical spine and have manual locking mechanisms to reduce the potential for screws to back out of the vertebral body. The screws are provided in diameters from 4.0mm to 5.0mm (rescue) and lengths from 14mm to 16mm.
The provided document is a 510(k) summary for the Asfora Anterior Cervical Plate System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria in the manner of AI/software devices. Therefore, much of the requested information regarding AI device evaluation is not explicitly available in this document.
Here's an attempt to extract and interpret the information based on the context of a medical device submission for a spinal implant:
1. Table of Acceptance Criteria and Reported Device Performance
For mechanical implants like the Asfora Anterior Cervical Plate System, "acceptance criteria" and "reported device performance" are typically defined by compliance with recognized ASTM standards for spinal implants. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs according to specification. | Demonstrated by mechanical testing. |
| Device is able to withstand clinical loading. | Demonstrated by mechanical testing. |
| Device maintains mechanical integrity. | Demonstrated by mechanical testing. |
| Device is suited for its intended purpose. | Demonstrated by mechanical testing. |
| Compliance with ASTM F 1717 (Static/Dynamic Compression Bending, Static Torsion). | Mechanical testing was conducted in accordance with ASTM F 1717. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this type of mechanical device evaluation. The "test set" would refer to the physical samples of the device and its components used for mechanical testing. The document does not specify the number of individual plates, screws, or constructs tested.
- Data Provenance: The mechanical testing data would be generated from laboratory tests conducted on the physical device prototypes. The country of origin for the testing itself is not specified but would typically occur at the manufacturer's facility or a contract testing lab. This is a prospective evaluation in the sense that the device prototypes were specifically manufactured and tested for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts & Qualifications: Not applicable. For mechanical testing of an orthopedic implant, "ground truth" is not established by human experts in the same way as, for example, image interpretation for an AI algorithm. The "ground truth" would be the engineering specifications and performance standards defined by the ASTM F 1717 standard itself. The engineers and technicians conducting the tests are qualified in mechanical testing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Mechanical test results are typically objective measurements (e.g., load at failure, displacement). There is no "adjudication" in the sense of reconciling differing expert opinions. The test results are compared directly against the performance requirements of the relevant ASTM standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- MRMC Study: No. This is a mechanical orthopedic implant, not an AI-powered diagnostic or assistive tool. MRMC studies are specific to evaluating AI algorithms that assist human readers (e.g., radiologists, pathologists).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: No. This is not an AI algorithm.
7. The Type of Ground Truth Used
- Ground Truth: For the mechanical testing, the "ground truth" is the performance specifications and requirements defined by the ASTM F 1717 standard for spinal intervertebral body fixation orthoses. The device is expected to meet or exceed these established engineering benchmarks.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device. The design and manufacturing processes are based on established engineering principles and materials science, not machine learning.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there's no training set, there's no ground truth needing to be established for it. The design of such a device relies on accepted biomechanical principles, material properties, and clinical experience, rather than data-driven "ground truth" in the AI sense.
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K122497
510(k) Summary
OCT 15 2012
| Submitter: | Medical Designs, LLC6709 S. Minnesota Ave, Suite 204Sioux Falls, South Dakota 57108-2593 |
|---|---|
| Contact Person: | Kristi Vondra, Vice President of OperationsTel: (605) 275-1032FAX: (605) 335-3734 |
| Date Prepared: | August 15, 2012 |
| Trade Name: | Asfora Anterior Cervical Plate System |
| Classification: | Class IISpinal intervertebral body fixation orthosis21 CFR §888.3060 |
| Product Code: | KWQ |
| PredicateDevice(s): | The subject device is substantially equivalent to the following devices:• Synthes Anterior CSLP System (Synthes, K030866)• Trinica Select™ Anterior Cervical Plate System (CenterpulseSpine-Tech, K022344), currently marketed by Zimmer Spine |
| DeviceDescription: | The Asfora Anterior Cervical Plate System is composed of plates ofvarying lengths to accommodate surgical procedures from one to fourlevels. The plates are designed for application to the anterior aspect ofthe cervical spine and have manual locking mechanisms to reduce thepotential for screws to back out of the vertebral body. The screws areprovided in diameters from 4.0mm to 5.0mm (rescue) and lengths from14mm to 16mm |
| Intended Use: | The Asfora Anterior Cervical Plate System is intended to providetemporary stabilization to the anterior spine during the development ofcervical spine fusions (C2-T1) for the following indications:degenerative disc disease (DDD) (defined as neck pain of discogenicorigin with degeneration of the disc confirmed by history andradiographic studies), spondylolisthesis, trauma (i.e., fracture ordislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previousfusion |
page 1 of 4
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Substantial Equivalence:
| Similarities to Predicate Devices | |||
|---|---|---|---|
| Parameter | Medical DesignsCervical PlateSystem(Subject Device) | Synthes AnteriorCSLP System(K030866) | CenterpulseSpine-TechTrinica Select™Anterior CervicalPlate System(K022344) |
| Intended Use | The cervical platesystem is intendedfor use in anteriorinterbody screwfixation of thecervical spine. | same | same |
| Principle ofOperation | Fixation isachieved byinserting bonescrews throughopenings in theplate into thevertebral bodies ofthe cervical spine. | same | same |
| SystemComponents | Plates (1-4levels)LockingScrewsScrew lockingmechanisms | same | same |
| Material | Titanium(Ti-6Al-4V alloyper ASTM F136) | same(Implant gradecommercially puretitanium) | same(Ti-6Al-4V alloyper ASTM F136) |
| Sterility | Non-Sterile.Hospital steamsterilizationrecommended | same | same |
| Differences from Predicate Devices | |||
| Parameter | Medical DesignsCervical PlateSystem(Subject Device) | Synthes AnteriorCSLP System(K030866) | CenterpulseSpine-TechTrinica SelectTMAnterior CervicalPlate System(K022344) |
| Indications forUse Statement | The Asfora TheAsfora AnteriorCervical PlateSystem is intendedto providetemporarystabilization to theanterior spineduring thedevelopment ofcervical spinefusions (C2-T1)for the followingindications:degenerative discdisease (DDD)(defined as neckpain of discogenicorigin withdegeneration ofthe disc confirmedby history andradiographicstudies),spondylolisthesis,trauma (i.e.,fracture ordislocation),spinal stenosis,deformities orcurvatures (i.e.,scoliosis,kyphosis, and/orlordosis), tumor,pseudoarthrosis,and failedprevious fusion | The Synthes AnteriorCSLP System isintended for anteriorscrew fixation to thecervical spine (C2-C7) for the followingindications:1. Spondylolisthesis2. Fracture3. Spinal stenosis4. TumorDegenerative discdisease (as defined byneck pain ofdiscogenic originwith degeneration ofthe disc confirmed bypatient history andradiographic studies). | TheTrinica/TrinicaSelect AnteriorCervical PlateSystem is intendedfor anteriorinterbody screwfixation of thesurgical spine atlevels C2-T1. Thesystem isindicated for usein the temporarystabilization of theanterior spineduring thedevelopment ofcervical spinefusions in patientswith degenerativedisc disease (asdefined by neckpain of discogenicorigin of the discconfirmed bypatient history andradiographicstudies), trauma(includingfractures), tumors,deformity (definesas kyphosis,lordosis, orscoliosis),pseudoarthrosis,and/or failedprevious fusions. |
| Plate Lengths | 23-93 mm | 23-109 mm | 22-92mm |
| Locking ScrewSize | • Ø 4.0 mm14-16 mm | • Ø 4.0-4.5mm12-20 mm length | • Ø 4.2-4.6 mm12-20 mm length |
| Screw LockingMechanisms | Locking rings arepreassembled ontothe plate andinclude anti-rotational lockingfeatures and safetylocking tabs thatengage to preventthe screws frombacking out. | The system includesexpansionheadscrews and lockingscrews which lock tothe plate. | Locking caps arepreassembled ontothe plate and aredesigned with tabsthat prevent bonescrews frombacking out. |
| Additional ScrewTypes | TemporaryFixation : Ø 3.5mm, 14 mmRescue: Ø 5.0mm, 14 mm andØ 5.0 mm, 16 mm | none | Threadedtemporary fixationpins, sizes notavailable |
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K122417
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Mechanical testing was conducted, in accordance with Guidance for Industry and FDA Staff Spinal System 510(k)s and safety testing using ASTM F 1717 to ensure the device performs according to specification, to verify that the device is able to withstand clinical loading and maintain mechanical integrity, and is suited for its intended purpose. Testing included static and dynamic compression bending, and static torsion.
Medical Designs, LLC considers the Asfora Anterior Cervical Plate System to be equivalent to the predicate devices listed above. This Conclusion: conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.
Functional and
Safety Testing:
K 122497 4 of 1
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
15
2012
Medical Designs, LLC % Ms. Kristi Vondra Vice President of Operations . 6709 South Minnesota Avenue, Suite 204 Sioux Falls, South Dakota 57108-2593
Re: K122497
Trade/Device Name: Asfora Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 15, 2012 Received: August 16, 2012
Dear Ms. Vondra:
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
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Page 2 - Ms. Kristi Vondra
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/CDRH/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 Biometrics/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.0 Indications for Use Statement
Device Name: Asfora Anterior Cervical Plate System
The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
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)
Cal-R
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122497
page 1 of 1
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.