(47 days)
The Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The Intuitive Anterior Cervical System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.
The provided text describes a medical device, the "Intuitive Anterior Cervical System," and its clearance process, which relies on demonstrating substantial equivalence to a predicate device. This is not the type of study typically associated with AI/ML devices where specific acceptance criteria are defined for algorithmic performance. Instead, it focuses on physical and mechanical performance.
Therefore, many of the requested categories related to AI/ML studies are not applicable to this document. I will fill in the relevant information and indicate when information is "Not Applicable" or "Not Provided" in the context of this device's regulatory submission.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Mechanical Performance: - Static compression bending - Static torsion - Dynamic compression bending | "The mechanical test results demonstrated that Intuitive performs as well as the predicate device." (Implies meeting or exceeding predicate's performance in these tests, which serves as the de facto acceptance criteria.) |
| Technological Characteristics: - Intended Use - Design (plate-based fixation system having self-tapping screws in various sizes) - Material (titanium alloy) - Sizes (plate and screw sizes) | "The Intuitive Anterior Cervical System is identical to the predicate Fixed, Variable & Corpectomy Cervical Plate System [...] Therefore, the system possesses the same technological characteristics as the predicate." |
| Material Composition: - Plates and screws: titanium alloy (Ti-6Al-4V per ASTM F136) - Screw-retaining central rail: nickel titanium alloy (NiTi per ASTM F2063) | The device is manufactured from these specified materials. Implicitly, meeting these material specifications is an acceptance criterion. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the context of data for an AI/ML system. Instead, the testing refers to "a worst-case, cervical plate construct" for mechanical tests. The "sample" likely refers to the physical constructs tested according to ASTM F1717.
- Data Provenance: Not applicable in the context of patient data. The mechanical testing is laboratory-based.
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 in the sense of expert annotation for AI/ML performance is not relevant here. The "ground truth" for the mechanical tests would be the established scientific principles of material strength and durability, and the ASTM F1717 standard itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are for conflicting expert opinions in data labeling, which is not part of this type of device evaluation.
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 a physical implant device, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" used for this device's acceptance is based on mechanical testing standards (ASTM F1717) and the established performance of a legally marketed predicate device. The fundamental scientific principles governing material strength and biomechanics, as codified in the ASTM standard, serve as the basis for evaluating device performance.
8. The sample size for the training set
- Not Applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As this is not an AI/ML device, there is no "training set" and thus no ground truth established for it.
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8. 510(k) Summary
| FEB 15 2011 | |
|---|---|
| Date: | 29 December 2010 |
| Sponsor: | Precision Surgery Limited2700 W. 9th Ave, Suite 120Oshkosh, WI 54904Phone 920-223-0547Fax 920-223-0551 |
| Contact Person: | Kamaljit S. Paul, MD |
| Proposed TradeName: | Intuitive Anterior Cervical System |
| Device Classification | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation: | 888.3060 |
| Device ProductCode: | KWQ |
| Device Description: | The Intuitive Anterior Cervical System comprises plate and screwcomponents in a variety of sizes and lengths. Three styles of plate,including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered. |
| Intended Use: | The Intuitive Anterior Cervical System is intended for anterior screwfixation of the cervical spine (C2-C7). These implants have beendesigned to provide stabilization as an adjunct to cervical fusion.Indications for the use of this implant system are: degenerative discdisease defined as neck pain of discogenic origin with thedegeneration of the disc confirmed by history and radiographicstudies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor,pseudarthrosis or failed previous fusion.WARNING: The Intuitive Anterior Cervical System is not intended forscrew attachment or fixation to the posterior elements (pedicles) ofthe cervical, thoracic or lumbar spine. |
| Materials: | The Intuitive Anterior Cervical System components are manufacturedfrom titanium alloy (Ti-6Al-4V per ASTM F136). The screw-retainingcentral rail is manufactured from nickel titanium alloy (NiTi per ASTMF2063). |
| Predicate Device: | Fixed, Variable & Corpectomy Cervical Plate System(K032815/K073708) |
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| TechnologicalCharacteristics: | The Intuitive Anterior Cervical System identical to the predicateFixed, Variable & Corpectomy Cervical Plate System, only thesystem name has changed. Therefore, the system possesses thesame technological characteristics as the predicate. These include:• intended use (as described above),• design (plate-based fixation system having self-tapping screws invarious sizes),• material (titanium alloy) and• sizes (plate and screw sizes are the same as those offered bythe predicate system).The fundamental scientific technology of Intuitive is the same as thepreviously cleared device. |
|---|---|
| Performance Data: | Static compression bending and torsion, and dynamic compressionbending were performed according to ASTM F1717 on a worst-case,cervical plate construct. The mechanical test results demonstratedthat Intuitive performs as well as the predicate device. |
| Conclusion: | The Intuitive Anterior Cervical System is substantially equivalent tothe devices referenced above and is therefore safe and effective forits intended use. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, depicted in a minimalist, flowing style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Precision Surgery, Ltd. % BackRoads Consulting, Inc. Karen E. Warden. Ph.D. 8202 Sherman Road Chesterland, Ohio 44026
FEB 1 5 201
Re: K103838
Trade/Device Name: Intuitive 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: December 29, 2010 Received: December 30, 2010
Dear Dr. Warden:
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
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Page 2 - Karen E. Warden, Ph.D.
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/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/ReportalProblem/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.
A.J. B. n. Ata
per
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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7. Indications for Use Statement
510(k) Number: K103838
Device Name: Intuitive Anterior Cervical System
Indications for Use:
The Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 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 Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K103838 510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.