(126 days)
The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 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, kyphosis and/or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System consists of longitudinal members (rods), anchors (hooks and screws), interconnections (cross connector) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
This document describes a 510(k) premarket notification for the "SurgTech Thoracolumbosacral (TLS) Posterior Fixation System," a spinal implant, not an AI/ML powered device.
Therefore, the requested information about acceptance criteria and study design relevant to AI/ML device performance (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) is not applicable and cannot be found within the provided text.
The document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of technological characteristics.
Here’s the information that is present regarding the device's performance and testing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (What was tested) | Reported Device Performance (Results) |
|---|---|
| Mechanical testing of worst-case SurgTech TLS System constructs: | Demonstrated performance substantially equivalent to the predicate devices. |
| - Static compression bending | Comparable to predicate devices. |
| - Dynamic compression bending | Comparable to predicate devices. |
| - Static torsion | Comparable to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The testing performed was mechanical testing of the device itself, not a clinical study on human subjects in the context of an AI/ML model's performance. The "test set" here refers to the device constructs subjected to mechanical stress. The number of constructs tested is not specified, but it's stated they were "worst-case" constructs.
- Provenance: Not specified beyond the tests being conducted on physical device constructs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not an AI/ML diagnostic or predictive device requiring expert ground truth for its performance evaluation in that context. The "ground truth" for mechanical testing is based on established engineering standards (ASTM F1717) and the ability to withstand specified loads without failure, usually validated by engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for clinical assessments, particularly in AI studies where expert consensus on image interpretation or diagnoses is needed. This was mechanical testing.
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 device is a spine implant, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical testing, the "ground truth" is defined by the acceptance criteria specified in the ASTM F1717 standard (mechanical performance thresholds and failure modes). The device's performance was compared to that of legally marketed predicate devices, implying that their performance under the same standard serves as a comparative benchmark.
8. The sample size for the training set:
- Not Applicable. There is no AI/ML model, hence no training set.
9. How the ground truth for the training set was established:
- Not Applicable. There is no AI/ML model, hence no training set ground truth.
In summary, the provided document describes a medical device (spinal fixation system) that received 510(k) clearance based on substantial equivalence demonstrated through mechanical testing against established standards and comparison to predicate devices, not through performance evaluation of an AI-powered diagnostic or therapeutic algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
SurgTech Inc. % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland. Ohio 44026
Re: K163363
Trade/Device Name: SurgTech Thoracolumbosacral (TLS) Posterior Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: March 27, 2017 Received: March 29, 2017
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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/ResourcesforYou/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,
Mark N. Melkerson -S
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) K163363
Device Name
SurgTech Thoracolumbosacral (TLS) Posterior Fixation System
Indications for Use (Describe)
The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, 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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510(k) Summary
| Date: | 23 March 2017 |
|---|---|
| Sponsor: | SurgTech Inc.24600 Center Ridge Road, Suite 195Westlake, OH 44145Phone (216) 421-2613 |
| Sponsor Contact: | Xuegong Yu, General Manager |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Proposed Trade Name: | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System |
| Common Name: | Posterior pedicle screw and hook system |
| Regulatory Class: | Class II |
| Regulation Name,Regulation Number,Product Code(s): | Thoracolumbosacral pedicle screw system, 21 CFR 888.3070, NKBSpinal interlaminal fixation orthosis, 21 CFR 888.3050, KWP |
| Device Description: | The SurgTech Thoracolumbosacral (TLS) Posterior Fixation Systemconsists of longitudinal members (rods), anchors (hooks and screws),interconnections (cross connector) and fasteners in a variety of sizes toaccommodate differing anatomic requirements. |
| Indications for Use: | The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System isintended to provide pedicle and non-pedicle immobilization and stabilizationof the posterior non-cervical spine (T1-S2/Illium) in skeletally mature patientsas an adjunct to fusion in the treatment of the following acute and chronicinstabilities or deformities: degenerative disc disease (defined as back painof discogenic origin with degeneration of the disc confirmed by history andradiographic studies), spondylolisthesis, trauma (i.e., fracture ordislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis and/orlordosis), tumor, pseudarthrosis, and/or failed previous fusion. |
| Materials: | SurgTech TLS System is manufactured from titanium alloys (Ti-6Al-4V ELIper ASTM F136 and Ti-6Al-7Nb per ASTM F1295). |
| Primary Predicate: | CD Horizon® Spinal System (Medtronic Sofamor Danek - K152457) |
| Additional Predicates: | Matrix Spine System (Synthes Spine - K092929), Moss Miami™ SpinalSystem (DePuy AcroMed, Inc. - K022623) and Optima™ Spinal System(U&I Corporation - K051971) |
| Performance Data: | Mechanical testing of worst case SurgTech TLS System constructs includedstatic and dynamic compression bending and static torsion according toASTM F1717.The mechanical test results demonstrate that SurgTech TLS Systemperformance is substantially equivalent to the predicate devices. |
| TechnologicalCharacteristics: | The SurgTech TLS System possesses the same technologicalcharacteristics as one or more of the predicate devices. These include:intended use (as described above) basic design (rod and screw/hook configuration), material (titanium alloy) and sizes (dimensions are comparable to those offered by the predicate systems) The fundamental scientific technology of the SurgTech TLS System is thesame as previously cleared devices. |
| Conclusion: | The SurgTech TLS System possesses the same intended use andtechnological characteristics as the predicate devices. Therefore SurgTechTLS System is substantially equivalent for its intended use. |
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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.