(129 days)
The SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
The SpineFrontier® PedFuse® Pedicle Screw System consists of longitudinal rods, polyaxial screws, tulips, transverse connectors, and instrumentation to facilitate installation of this system.
The PedFuse® Pedicle Screw is offered in multiple screw types, with multiple diameters and lengths to accommodate individual patient needs. PedFuse® Pedicle Screw assemblies consist of the screw, a tulip, and a washer that secures the tulip to the screw and also serves as the saddle for the longitudinal rod. The tulip and screw designs allow the screw to have a polyaxial rotation relative to the tulip. A locking cap is placed on top of the pedicle screw assembly to secure the position of the implant and to retain the longitudinal rod.
The PedFuse® Pedicle Screw assembly serves as the central fixation device to which various rods and cross connectors are secured to provide desired fixation.
Longitudinal rods are provided in two configurations, straight and lordotic, have a fixed diameter (5.5mm), and vary by length.
Cross connector assemblies are provided in multiple configurations, varying by length. Cross connectors are used to provide additional fixation support.
For percutaneous, minimally invasive surgical (MIS) procedure, extended Respond tulips and bulleted rods are introduced. Instruments for the MIS technique are also used.
The SpineFrontier® PedFuse® Pedicle Screw System components are fabricated from medical grade titanium conforming to ASTM F-136 specifications.
The provided text describes the SpineFrontier® PedFuse® Pedicle Screw System, a medical device for spinal fixation. It details the device's technical characteristics, intended use, and substantial equivalence to predicate devices, but it does NOT include information typically associated with acceptance criteria or studies proving performance for an AI/software device. This document is a 510(k) summary for a physical medical implant (pedicle screw system), not an AI algorithm.
Therefore, many of the requested categories for information (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance) are not applicable or cannot be extracted from this document, as they relate to the validation of AI/software rather than a mechanical implant.
However, I can extract the relevant information from the provided text for a physical medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from FDA Guidance and Recognized Test Methods) | Reported Device Performance |
|---|---|
| Mechanical Performance: Adherence to established standards for spinal implant constructs in a vertebrectomy model. | The SpineFrontier® PedFuse® Pedicle Screw System was evaluated in accordance with FDA Document, Guidance for Industry and FDA Staff – Spinal System 510(k)s, May 3, 2004, and has been found to meet criteria defined in the guidance document. Mechanical testing includes performance assessments per ASTM Standard F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". |
| Material Compatibility: Use of medical-grade materials. | Components are fabricated from medical grade titanium conforming to ASTM F-136 specifications. |
| Substantial Equivalence: Comparison of indications for use, function, operating principles, and materials to predicate devices. | The device was shown to be substantially equivalent to predicate devices (K092420, K950099, K992739, K100605, K061591) in terms of indications for use, function, materials, and performance (mechanical testing). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the device is a physical implant and its performance was evaluated through mechanical testing, not a clinical study involving a "test set" of patient data in the context of an AI/software device. The document states "Clinical data was not required for this device."
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)
This information is not applicable. Ground truth establishment by experts is relevant for clinical data interpretation or labeling in AI/software validation, not for the mechanical testing of a physical medical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical "test set" requiring adjudication methods was used.
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
This information is not applicable as the device is a physical implant, not an AI-assisted diagnostic or interpretive tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" for performance is defined by the established mechanical testing standards (ASTM F1717) and the material specifications (ASTM F-136). The device's substantial equivalence was also based on its alignment with the characteristics of legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable as the device is a physical implant and does not involve AI/machine learning requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical implant and does not involve AI/machine learning requiring a training set or its associated ground truth.
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5.0 510(k) Summary
1. Sponsor
FEB 1 5 2013
SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915
Fredy H. Varela, MSRA, RAC Primary Contact: 1- 978-232-3990 Telephone:
Date Prepared:
December 14, 2012
2. Device Name and Classification:
SpineFrontier® PedFuse® Pedicle Screw Proprietary Names: System
Common/Usual Name: Pedicle Screw Spinal System
Classification Name:
Orthosis, Spondylolisthesis Spinal Fixation Orthosis, Spinal Pedicle Fixation (21 CFR 888.3070(b)(1)), Class II
Product Code:
MNH, MNI
3. Predicate Devices
K092420 - SpineFrontier® KRD1™ Pedicle Screw System K950099 - Synergy Posterior Spinal System K992739 - Synthes USS Click-X Variable Axis System K100605 – Spine Wave MIS Pedicle Screw System
K061591 – Medtronic CD Horizon Spinal System
4. Device Description
The SpineFrontier® PedFuse® Pedicle Screw System consists of longitudinal rods, polyaxial screws, tulips, transverse connectors, and instrumentation to facilitate installation of this system.
The PedFuse® Pedicle Screw is offered in multiple screw types, with multiple diameters and lengths to accommodate individual patient needs. PedFuse® Pedicle Screw assemblies consist of the screw, a
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tulip, and a washer that secures the tulip to the screw and also serves as the saddle for the longitudinal rod. The tulip and screw designs allow the screw to have a polyaxial rotation relative to the tulip. A locking cap is placed on top of the pedicle screw assembly to secure the position of the implant and to retain the longitudinal rod.
The PedFuse® Pedicle Screw assembly serves as the central fixation device to which various rods and cross connectors are secured to provide desired fixation.
Longitudinal rods are provided in two configurations, straight and lordotic, have a fixed diameter (5.5mm), and vary by length.
Cross connector assemblies are provided in multiple configurations, varying by length. Cross connectors are used to provide additional fixation support.
For percutaneous, minimally invasive surgical (MIS) procedure, extended Respond tulips and bulleted rods are introduced. Instruments for the MIS technique are also used.
The SpineFrontier® PedFuse® Pedicle Screw System components are fabricated from medical grade titanium conforming to ASTM F-136 specifications.
5. Intended Use
The SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral
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spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondviolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
6. Technological Characteristics and Substantial Equivalence Determination
The SpineFrontier® PedFuse® Pedicle Screw System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles and materials.
The SpineFrontier® PedFuse® Pedicle Screw System was evaluated in accordance with FDA Document, Guidance for Industry and FDA Staff – Spinal System 510(k)s, May 3, 2004, and has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials and performance (mechanical testing). Clinical data was not required for this device.
Mechanical testing includes performance assessments per the following recognized test methods:
- ASTM Standard F1717, "Standard Test Methods for Spinal Implant -Constructs in a Vertebrectomy Model".
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 15, 2013
SpineFrontier, Incorporated % Fredy H. Varela, MSRA, RAC Regulatory Affairs Specialist 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915
Re: K123164
Trade/Device Name: SpineFrontier® PedFuse® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: December14, 2012 Received: December 18, 2012
Dear Mr. Varela:
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 -Fredy H. Varela, MSRA, RAC
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin - Meith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K123164 Page 1 of 1
4.0 Indications for Use Statement
510(k) Number (if Known): __ K123164
Device Name: SpineFrontier® PedFuse® Pedicle Screw System
Indications For Use:
The SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).
In addition, the SpineFrontier® PedFuse® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
When used in a percutaneous approach with MIS instrumentation, the SpineFrontier® PedFuse® Pedicle Screw System is 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 instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (Pseudarthrosis) and severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine.
Prescription Use: X (Part 21 CFR 801.109) Over-The-Counter Use:
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Colin O'Neill
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123164
§ 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.