(27 days)
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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: desc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ Minimally Invasive System is intended for non-cervical pedicle fixation 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 failed previous fusion in skeletally mature patients.
When used for hook fixation. The Lancer™ Open Pedicle Screw System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems include implant components made of implant grade titanium alloy (Ti-6AI-4V ELI; ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems also include instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), stainless steel (ASTM F899/A564) and aluminum (ASTM B221). These components are available in various designs and sizes that allow the surgeon to build an implant construct suited to a patient's anatomical and physiological requirements. The components include: polyaxial pedicle screws, set screws, rods, instruments and sterilizer trays. The Lancer™ Open Pedicle Screw System also includes cross connector and hook components.
The provided FDA 510(k) clearance letter does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the manner you've outlined for diagnostic AI/CADe systems. This document is for a physical medical device (pedicle screw systems) and focuses on substantial equivalence to predicate devices, primarily through engineering analysis rather than clinical performance metrics typically associated with AI/CADe.
Therefore, many of the requested fields cannot be filled from the provided text. I will indicate where information is not available.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable (for AI/CADe style clinical performance) | Not Applicable (for AI/CADe style clinical performance) |
| The submission indicates that the "subject implants were demonstrated to not represent a new worst case through engineering analysis." This implies an engineering-based acceptance criterion related to mechanical strength and safety, which was met. The specific engineering acceptance criteria (e.g., specific load thresholds, fatigue limits) are not detailed in this summary. | The engineering analysis concluded that the new sizes of screws do not represent a 'new worst case' compared to the predicate devices. This suggests they met the same structural and safety characteristics as the already cleared devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not Applicable. The evaluation was based on engineering analysis, not a clinical test set with patient data for diagnostic performance.
- Data Provenance: Not Applicable (no patient data used for this type of evaluation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No diagnostic ground truth was established as this was an engineering evaluation of a physical implant.
4. Adjudication method for the test set
- Not Applicable. No test set requiring adjudication 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
- Not Applicable. This is a physical implant device, not an AI/CADe system, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant device, not an algorithm.
7. The type of ground truth used
- For this device, the "ground truth" or basis for evaluation would be established engineering principles, material science specifications (e.g., ASTM standards for implant-grade titanium and cobalt chrome), and potentially a biomechanical comparison to the predicate devices, rather than clinical outcomes or expert consensus on diagnosis.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI/CADe system for this physical implant.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth in the context of an AI/CADe system for this physical implant.
Summary of the document's relevance to your request:
The provided document is an FDA 510(k) clearance letter for a physical medical device (pedicle screw systems) which involves expanding the available sizes of existing cleared devices. The "study" mentioned is an engineering analysis to demonstrate that the new sizes do not represent a "new worst case" compared to the predicate devices and maintain substantial equivalence. This is fundamentally different from the performance evaluation of AI/CADe devices, which involve clinical accuracy metrics, ground truth establishment, and often multi-reader studies.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
Choice Spine, LP Ms. Kim Finch Manager of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K170942
Trade/Device Name: The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: March 24, 2017 Received: March 30, 2017
Dear Ms. Finch:
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
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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 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/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) K170942
Device Name
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
Indications for Use (Describe)
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems are 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: desc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used in a posterior percutaneous approach with MIS instrumentation, the Thunderbolt™ Minimally Invasive System is intended for non-cervical pedicle fixation 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 failed previous fusion in skeletally mature patients.
When used for hook fixation. The Lancer™ Open Pedicle Screw System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and 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 Prepared: | April 19, 2017 |
|---|---|
| Sponsor: | Choice Spine, LP400 Erin DriveKnoxville, TN 37919 |
| Phone: | 865-243-3969 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Manager of Regulatory Affairs |
| Proposed ProprietaryTrade Name: | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems |
| Product Class: | Class II |
| Classification Name: | 888.3070 – Thoracolumbosacral Pedicle Screw System |
| Device Product Code: | NKB, KWP |
| Purpose ofSubmission: | The purpose of this submission is to gain clearance for additional size screws tothe already cleared Thunderbolt™ Minimally Invasive and Lancer™ Open Pediclescrew Systems. |
| Device Description: | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systemsinclude implant components made of implant grade titanium alloy (Ti-6AI-4V ELI;ASTM F136) and cobalt chrome alloy (Co-28Cr-6Mo; ASTM F1537). The systems alsoinclude instruments made of PEEK (ASTM F2826), Tantalum (ASTM F560), stainlesssteel (ASTM F899/A564) and aluminum (ASTM B221). These components areavailable in various designs and sizes that allow the surgeon to build an implantconstruct suited to a patient's anatomical and physiological requirements.The components include: polyaxial pedicle screws, set screws, rods, instrumentsand sterilizer trays. The Lancer™ Open Pedicle Screw System also includes crossconnector and hook components. |
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| Indications: | The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systemsare intended to provide immobilization and stabilization of spinal segments inskeletally mature patients as an adjunct to fusion in the treatment of thefollowing acute and chronic instabilities or deformities of the thoracic, lumbar,and sacral spine: degenerative disc disease (DDD; defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation);spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis, and/orlordosis); tumor; pseudoarthrosis; and failed previous fusion. |
|---|---|
| When used in a posterior percutaneous approach with MIS instrumentation, theThunderbolt™ Minimally Invasive System is intended for non-cervical pediclefixation for the following indications: degenerative disc disease (defined as backpain of discogenic origin with degeneration of the disc confirmed by history andradiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation);spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor,pseudoarthrosis; and failed previous fusion in skeletally mature patients. | |
| When used for hook fixation, The Lancer™ Open Pedicle Screw System isintended for posterior, non-cervical pedicle and non-pedicle fixation for thefollowing indications: degenerative disc disease(DDD) (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed by history andradiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation);spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor;pseudoarthrosis; and failed previous fusion. | |
| Predicate Devices: | Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw SystemsK132049 and K160775 (Primary Predicate). |
| Non-Clinical Evaluations: | The subject implants were demonstrated to not represent a new worst casethrough engineering analysis. |
| Conclusion: | Choice Spine concludes that the Thunderbolt™ Minimally Invasive andLancer™ Pedicle Screw System is equivalent to Thunderbolt™ MinimallyInvasive and Lancer™ Open Pedicle Screw System K132049 and K160775.Equivalence is based on the similarities in the indications for/intended use,design, product offering, materials used and levels of attachment whencompared to the predicates. |
§ 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.