(58 days)
The TiTLE 2 Polyaxial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The TiTLE 2 Polyaxial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, TiTLE 2 Polyaxial System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illium sacrum. The non-pedicle screw indications are spondylolisthesis, degeneralive disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.
The TiTLE 2 Polyaxial System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.
The TiTLE® 2 Polyaxial Spinal System Implants are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of screws joined with spinal rods and should be removed after fusion.
The TiTLE® 2 Polyaxial Spinal System is designed to aid in the surgical correction of several types of spinal conditions, as stated in the section below. The TiTLE® 2 Polyaxial Spinal System consists of screws, rods, connection components that are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of screws joined with spinal rods and should be removed after fusion. The polyaxial spinal system is a rod and top-loading screw fixation system. This system can be placed surgically using either open or endoscopic surgical techniques. The system is provided non-sterile, for single use only.
The TiTLE® 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.
The Zimmer Spine TiTLE® 2 Polyaxial Spinal System is a medical device and its "acceptance criteria" and "study" refer to the performance testing and resulting substantial equivalence determination by the FDA, rather than clinical efficacy studies often associated with AI/software devices. Therefore, the information provided corresponds to the regulatory requirements for medical devices.
Acceptance Criteria and Device Performance
The acceptance criteria for the TiTLE® 2 Polyaxial Spinal System are based on establishing substantial equivalence to its predicate devices concerning design, materials, function, and intended use. The device's performance was evaluated through various types of testing, the results of which confirmed its suitability for its intended use and its substantial equivalence to the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance (Bench Testing) | Confirmed product performance is suitable for intended use based on: |
- Static Axial Compression (Bending) per ASTM F1717-12
- Static Torsion per ASTM F1717-12
- Axial Compression (Bending) Fatigue per ASTM F1717-12
- Static Axial Gripping Capacity per ASTM F1798-97 (Reapproved 2008)
- Static Torsion Gripping Capacity per ASTM F1798-97 (Reapproved 2008)
- Static Flexion-Extension Moment per ASTM F1798-97 (Reapproved 2008)
- Dynamic Flexion-Extension Moment per ASTM F1798-97 (Reapproved 2008) |
| Human Factors (Cadaver Lab Testing) | Confirmed substantial equivalence of design changes (instrument and labeling) and interaction with implants compared to predicate devices. |
| Biocompatibility | Ensured materials are biocompatible after manufacturing, based on minor design changes compared to predicate devices. |
| Sterilization & Dry Time | Ensured steam sterilization and dry time requirements and instructions are substantially equivalent to the predicate devices. |
| Overall Substantial Equivalence | Considered substantially equivalent to predicate devices due to no changes in product performance specifications or device functional scientific technology. This determination was reviewed and accepted by the FDA (K133086). |
Study Information (Applicable to medical device regulatory context)
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of AI or software performance evaluation. Instead, testing was conducted on manufactured components of the TiTLE® 2 Polyaxial Spinal System.
- Bench Testing: The sample size for mechanical testing (implants, screws, rods, and connection components) is not explicitly stated in terms of number of units tested, but it refers to "components of the subject TiTLE® 2 Polyaxial Spinal System" being reviewed and tested.
- Cadaver Lab Testing: The sample size (number of cadavers or tests) for evaluating human factors is not specified.
- Data Provenance: The studies were conducted by Zimmer Spine, Inc. for regulatory submission to the FDA. This indicates the testing was performed internally or by contracted labs for the manufacturer, in the context of a prospective submission for marketing authorization.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device's regulatory review. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717-12, ASTM F1798-97) and internal design specifications, not by expert consensus on clinical data. For human factors, the evaluation likely involved surgical or relevant medical professionals, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This concept is not directly applicable to the type of performance testing described for this medical device. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/software evaluations, particularly when human expert disagreement needs to be resolved. The performance testing here follows established engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of AI on human reader performance for diagnostic or screening tasks. The TiTLE® 2 Polyaxial Spinal System is a physical implantable medical device, not an AI or diagnostic software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This concept is relevant for AI/software devices. The performance testing for the TiTLE® 2 Polyaxial Spinal System focused on the physical and mechanical properties of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this medical device generally refers to:
- Engineering Standards: Compliance with established ASTM standards (F1717-12, F1798-97) for mechanical properties.
- Biocompatibility Standards: Compliance with standards for material safety.
- Design Specifications: Meeting internal design requirements for function and form.
- Predicate Device Performance: The predicate device itself served as a benchmark for "substantially equivalent" performance.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the way it would be defined for AI/software or diagnostic devices.
8. The Sample Size for the Training Set
This question is not applicable. The TiTLE® 2 Polyaxial Spinal System is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of medical device.
§ 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.