(72 days)
The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain 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 purpose of this submission is the addition of alternative varieties of pedicle screws and surgical instruments to provide surgeons with further options for implant placement and deformity correction. The Stainless Steel Spinal System components can be rigidly locked together creating a construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F 138 and ISO 5832-1.
The provided text describes a medical device, the Stainless Steel Spinal System, and its substantial equivalence to a predicate device based on performance tests. However, it does not include information about AI or machine learning. Therefore, I cannot answer most of your detailed questions regarding acceptance criteria, study design, expert involvement, or ground truth establishment in the context of an AI device.
Here's what I can extract from the provided text regarding the device's performance based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Static compression bending per ASTM F-1717 | Met or exceeded all product specifications |
| Static torsion per ASTM F-1717 | Met or exceeded all product specifications |
| Dynamic compression bending with run out per ASTM F-1717 | Met or exceeded all product specifications |
| Static cantilever bending per ASTM F-1798 | Met or exceeded all product specifications |
| Static tensile pull test | Met or exceeded all product specifications |
Missing Information (Not Available in the Provided Text for AI-related questions):
- Sample size used for the test set and the data provenance: Not applicable as this is a mechanical device, not an AI system using a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Explanation of the Provided Information:
The Stainless Steel Spinal System is a physical medical device. The "acceptance criteria" for this device are based on mechanical performance standards (ASTM F-1717 and ASTM F-1798) for spinal implant constructs. The study performed involved conducting these mechanical tests on the device. The reported performance is that the "construct performed as designed and met or exceeded all product specifications," which indicates successful fulfillment of the acceptance criteria based on these mechanical standards.
The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device, primarily through material composition, design concept, indications for use, manufacturing, and performance testing for physical, non-AI devices. There is no mention of AI, machine learning, or software components that would require the kind of data-driven performance analysis you've asked about (e.g., test sets, ground truth, expert review).
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Ki20829
510(k) Summary (21 CFR Part 807.92)
A. Submitter Information
Submitter's Name: Establishment Registration # Address:
Telephone Number: Fax Number: Contact Person: Email: Date Prepared:
Device Information B. Trade Name:
Common Name:
Classification:
Predicate Device:
Device Description:
Intended Use:
Material Composition:
Theken Spine, LLC 3008657535 1153 Medina Rd Medina, Ohio 44256 330-239-7709 330-239-4216 Dale Davison dale.davison@integralife.com 2/29/2012
Stainless Steel Spinal System
Pedicle Screw Spinal Instrumentation System
MNI - Class II per 888.3070(b)(1) - Pedicle Screw Spinal System MNH - Class II per 888.3070(b)(1) - Pedicle Screw Spinal System KWQ - Class II per 888.3060 -- Spinal Intervertebral Body Fixation Orthosis KWP - Class II per 888.3050 - Spinal Interlaminal Fixation Orthosis
NKB - Class III per 888.3070(b)(2) - Spondylolisthesis Spinal Fixation System
Stainless Steel Spinal System, Theken Spine, K100970
The purpose of this submission is the addition of alternative varieties of pedicle screws and surgical instruments to provide surgeons with further options for implant placement and deformity correction. The Stainless Steel Spinal System components can be rigidly locked together creating a construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F 138 and ISO 5832-1.
The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain 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.
Implant grade stainless steel per ASTM F-138.
MAY 3 0 2012
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K120829
C. Substantial Equivalence
Integra Spine believes sufficient evidence exists to reasonably conclude that the additional components are substantially equivalent to the predicate device Stainless Steel Spinal System (K1000970 SE), manufactured by Theken Spine, LL.C. Substantial Equivalency is based on the design concept; the use of established, known materials; feature comparisons; mechanical testing; indications for use; pre-production quality assurance planning and engineering analysis,
The subject device similarities include:
- . The same indications for use
- . The same operating principle
- The same biocompatible materials t
- . Implanted using the same surgical techniques and equipment type
- . The same manufacturing environment
- . The same sterilization process
- The same packaging configurations .
Performance Tests:
Static compression bending per ASTM F-1717 Static torsion per ASTM F-1717 Dynamic compression bending with run out per ASTM F-1717 Static cantilever bending per ASTM F-1798 Static tensile pull test
Summary of Test Data:
Mechanical testing of the subject device consisted of static axial compression, static torsion, and dynamic axial compression in accordance with ASTM F-1717. Static cantilever bend tests were performed in accordance with ASTM F-1798 and static tensile pull tests were performed. The construct performed as designed and met or exceeded all product specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
· Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Theken Spine, LLC % Mr. Dale Davison Vice President-Engineering 1153 Medina Road Medina Ohio 44256
MAY 3 0 2012
Re: K120829
Trade/Device Name: Stainless Steel Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWQ, KWP Dated: May 03, 2012 Received: May 04, 2012
Dear Mr. Davison:
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 – Mr. Dale Davison
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.
for
N. Malkerson
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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K120829
Indications for Use
510(k) Number: K120829
Device Name: Stainless Steel Spinal System
Indications for Use:
The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain 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, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
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)
signature
(Division Sign-Off) Dision of Surgical, Orthopedic, and Restorative Devices
510(k) Number_ KI20829
Pgl of
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§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.