(98 days)
The TiLock2 Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc 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; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Genesys Spine TiLock- Spinal System will be offered in polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths and materials.
The provided text is a 510(k) summary for the Genesys Spine TiLock2 Spinal System. It does not contain information about acceptance criteria for device performance, nor does it describe studies that prove the device meets specific performance acceptance criteria in the context of an AI/ML device.
Instead, this document focuses on the mechanical performance testing of a spinal fixation system, comparing it to predicate devices to establish substantial equivalence for FDA clearance. The summary states:
"The predetermined pass/fail criterion was that the mechanical tests for the Genesys Spine TiLock Spinal System be equivalent to (or greater than) previously cleared spinal systems."
This indicates the acceptance criterion for the mechanical tests was that the TiLock2 system performed no worse than the predicate devices. The study involved analyzing the construct in accordance with ASTM F1717-04 and F1798.
Therefore, I cannot fulfill the request as it pertains to AI/ML device performance acceptance criteria and studies within the provided text. The document describes a mechanical performance study comparing the new device to existing predicate devices.
However, I can extract the information that is present about the mechanical performance study:
1. A table of acceptance criteria and the reported device performance
No specific numerical acceptance criteria or reported performance values are provided for the TiLock2 Spinal System. The criterion is qualitative: "equivalent to (or greater than) previously cleared spinal systems."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document states constructs were "analyzed," and mechanical tests were "performed on the worst case TiLock Spinal System constructs." However, it does not specify the sample size (number of constructs tested) or the data provenance (country of origin, retrospective/prospective). This is typical for mechanical testing documentation, which often focuses on test methods and results rather than data provenance in the same way clinical studies do.
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)
Not applicable. This was a mechanical performance study, not a study involving human interpretation or ground truth establishment by experts in the context of an AI/ML device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical testing would be the measured physical properties and performance characteristics as defined by the ASTM standards.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device study.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized image of a human face in profile, with three overlapping faces creating a sense of depth and continuity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2015
Genesys Spine Mr. William W. Sowers Vice President, Quality & Regulatory 1250 Capital of Texas Highway South Building Three, Suite 600 Austin, Texas 78746
Re: K152039
Trade/Device Name: Genesys Spine TiLock2 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: September 30, 2015 Received: October 1, 2015
Dear Mr. Sowers:
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 Parts 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 - Mr. William Sowers
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 yours.
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) K152039
Device Name Genesys Spine TiLock2 Spinal System
Indications for Use (Describe)
The TiLock2 Spinal System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine: degenerative disc 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; 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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Image /page/3/Picture/1 description: The image shows the logo for Genesys Spine. The word "Genesys" is in gray, with the "Ge" portion of the word in orange. To the left of the word "Genesys" is an orange graphic that resembles a sun. The word "spine" is in orange and is located below and to the right of the word "Genesys."
510(K) SUMMARY
| Submitter's Name: | Genesys Spine |
|---|---|
| Submitter's Address: | 1250 Capital of Texas Highway SouthBuilding Three, Suite 600Austin, Texas 78746 |
| Submitter's Telephone: | 512-381-7080 |
| Submitter's Fax: | 512-381-7076 |
| Contact Name: | William W. Sowers |
| Date Summary wasPrepared: | July 20, 2015 |
| Trade or Proprietary Name: | Genesys Spine TiLock2 Spinal System |
| Common or Usual Name: | Spinal Fixation System |
| Classification Name: | Spinal Pedicle Screw System, Spinal InterlaminalFixation Orthosis, Spinal Intervertebral BodyFixation orthosis. |
| Classification: | Class III |
| Regulation Number: | 21 CFR 888.3070 – Pedicle screw spinal system |
| Product Codes: | NKB, MNH, MNI |
| Classification Panel: | Orthopedic Devices Panel |
| Legally Marketed(unmodified) devices toWhich SubstantialEquivalence is Claimed: | Primary Predicate: TiLock Pedicle Screw System(Genesys Spine - K100757 / K103671)Additional Predicates: Interpore Cross Synergy PolyaxialSystem (K984578), and DePuy Spine Moss MiamiSystem (K955348) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Genesys Spine TiLock- Spinal System will be offered in polyaxial screws (solid and cannulated) and monoaxial screws in various lengths and diameters, offset connectors, washers, hooks, rod-to-rod connectors, lock screws, crosslinks, and rods in various lengths and materials.
INDICATIONS FOR USE
The TiLock- Spinal 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
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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.