(30 days)
The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
The Spineology Fortress™ Pedicular Fixation System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Fortress System screws are available with or without hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile. The associated instruments are provided non-sterile.
The provided text describes a 510(k) premarket notification for a medical device called the "Fortress™ Pedicular Fixation System." This document is a regulatory approval, and as such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria in the manner one might expect for a new AI/software device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device is not directly applicable or available in the provided text.
Here's why and what information is available:
- Type of Device: The Fortress™ Pedicular Fixation System is a physical medical implant (pedicle screws and rods) used in spinal fusion surgery. It's not an AI or software device that processes data or makes diagnostic/predictive outputs.
- Regulatory Pathway: The 510(k) pathway is for devices that are "substantially equivalent" to legally marketed predicate devices. This means the primary goal is to show that the new device has the same intended use, technological characteristics, and safety and effectiveness as a previously cleared device. It does not typically involve the kind of performance studies with acceptance criteria, test sets, ground truth, and expert adjudication that would be performed for AI/software.
- "Study" in this Context: The "study" mentioned for this device is the "Coating characterization/analyses" and a "risk analysis." These are focused on the physical properties and safety of the hydroxyapatite coating, not on algorithmic performance.
However, I can extract information relevant to the comparison made in the 510(k) process, which functions as the nearest equivalent to "acceptance criteria" and "proof" in this regulatory context:
1. Table of Acceptance Criteria and Reported Device Performance (as interpreted for a 510(k) submission):
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Demonstrated Equivalence) |
|---|---|
| Intended Use: Same as predicate device(s). | The Fortress™ Pedicular Fixation System is for posterior, non-cervical fixation as an adjunct to fusion for indications like degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and/or failed previous fusion. This matches the intended use of the primary predicate device, Spineology Fortress Pedicle Screw System [K140010]. |
| Technological Characteristics: Same or similar to predicate device(s), with any differences not raising new questions of safety or effectiveness. | The subject screws have a hydroxyapatite coating on the screw threads. The base material, thread form, and screw sizes are the same as the predicate devices. The technological characteristics are stated to remain the same as the predicate devices with respect to intended use, indications for use, design, fundamental technology, and operational principles, except for the addition of the HA coating. (The coating characterization/analyses were provided to support the safety and effectiveness of this specific technological difference). |
| Performance (Safety & Effectiveness): Demonstrated through physical/material testing and risk analysis, showing equivalence to predicate(s). | "Coating characterization/analyses were provided." "The results of a risk analysis support a determination that the device is substantially equivalent to the identified predicate devices." This implies that the testing performed demonstrated that the HA coating did not compromise the safety or effectiveness, and likely met relevant mechanical or biocompatibility standards comparable to the predicate. |
Regarding the specific questions about an AI/software device:
- Sample size for the test set and data provenance: Not applicable. This is not an AI/software device. The "test set" would be the samples of the physical device or its components used for mechanical, material, or biocompatibility testing. The document does not specify sample sizes for these tests. Data provenance would refer to the materials/components themselves.
- Number of experts used to establish ground truth & qualifications: Not applicable. No "ground truth" (in the AI/clinical data sense) was established by experts for this device. The evaluation is based on engineering specifications, material science, and regulatory comparison.
- Adjudication method: Not applicable. There is no clinical data or expert interpretation requiring adjudication mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic or imaging device.
- Standalone (algorithm-only) performance: Not applicable. This is a physical implant, not an algorithm.
- Type of ground truth used: Not applicable in the AI sense. Ground truth in this context would implicitly be established engineering standards, material properties, and biocompatibility requirements for spinal implants.
- Sample size for the training set: Not applicable. This is not a machine learning model.
- How ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device (spinal implant) via the 510(k) pathway, which focuses on demonstrating substantial equivalence to predicate devices, not on the performance criteria and studies typical for AI/software devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2015
Spineology, Incorporated Ms. Karen Roche Vice President, Operations & Technology 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K152148
Trade/Device Name: Fortress™ Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: July 31, 2015 Received: August 3, 2015
Dear Ms. Roche:
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. Karen Roche
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" (21 CFR 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 vours.
Lori A. Wiggins -S
for 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) K152148
Device Name Fortress™ Pedicular Fixation System
Indications for Use (Describe)
The Spineology Fortress™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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2. 510(k) Summary
| Applicant: | Spineology Inc.7800 3rd Street N., Suite 600Saint Paul, MN 55128Phone: 651-256-8500Fax: 651-256-8505 |
|---|---|
| Contact Person: | Karen Roche |
| Date Prepared: | July 31, 2015 |
| Trade Name: | Fortress™ Pedicular Fixation System |
| ProductClassificationand Code: | Pedicle Screw Spinal SystemClass III per 21 CFR 888.3070, Product Codes NKB, MNI, MNH |
| PredicateDevice(s): | Primary: Spineology Fortress Pedicle Screw System [K140010]Additional: Globus Beacon® Stabilization System [K121922] |
| DeviceDescription: | The Spineology Fortress™ Pedicular Fixation System consists of screws(titanium) and rods (cobalt chrome) to allow the surgeon to build an implantsystem to fit the patient's anatomical and physiological requirements. TheFortress System screws are available with or without hydroxyapatitecoating. The system is intended to provide immobilization and stabilizationof spinal segments in skeletally mature patients as an adjunct to fusion inthe treatment of acute and chronic instabilities or deformities of the thoracic,lumbar, and sacral spine. The devices are provided sterile. The associatedinstruments are provided non-sterile. |
| Intended Use: | The Spineology Fortress™ Pedicular Fixation System is intended forposterior, non-cervical fixation as an adjunct to fusion for the followingindications: degenerative disc disease (defined as back pain of discogenicorigin with degeneration of the disc confirmed by history and radiographicstudies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinalstenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor;pseudoarthrosis; and/or failed previous fusion. |
| Purpose of this510(k): | The purpose of this submission is to request clearance for addinghydroxyapatite (HA)-coated screws to the Fortress™ System. |
| Summary ofTechnologicalCharacteristics: | The subject screws have a hydroxyapatite coating on the screw threads.The base material, thread form, and screw sizes are the same as thepredicate devices. The technological characteristics remain the same as thepredicate devices with respect to intended use, indications for use, design,fundamental technology, and operational principles. |
| Testing | Coating characterization/analyses were provided. The results of a riskanalysis support a determination that the device is substantially equivalent tothe identified predicate devices. |
| Conclusion: | The information submitted in this premarket notification supports adetermination that the Fortress™ Pedicular Fixation System is substantiallyequivalent in technological characteristics and intended use to the predicatedevices. |
§ 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.