(40 days)
Spineology Pedicular Fixation Systems are intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients 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, kyphosis and/or lordosis); turnor; pseudoarthrosis; and/ or failed previous fusion.
Spineology Fortress™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems consist of screws (titanium alloy), curved and straight rods (see table below for diameters and material), and ConneX™ Connector (see table below for configurations and materials) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating. These systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
Spineology Connex Cross Connector devices are transversely-placed titanium alloy implants that are intended to connect the rod on one side of a spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connextor devices are intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Spineology ConneX Rod Connector devices are titanium alloy implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Connex Rod Connector devices are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Spineology Power Adapter is an instrument accessory intended to facilitate the preparation and placement of pedicle screws using powered instrumentation as an optional alternative to the existing manual technique. The Power Adapter is intended for exclusive use with Spineology Fortress, Threshold, Threshold V2, and Palisade System surgical instruments. The Power Adapter serves as a mechanical interface between the power driver and surgical instruments. When the Power Adapter is attached, the power driver provides appropriate power to rotate the surgical instrument for preparation and placement of pedicle screws.
The provided text describes modifications to existing pedicular fixation systems and a new power adapter for surgical instrumentation, rather than a standalone AI device with specific acceptance criteria and a study to prove its performance in the typical sense of AI/ML evaluation (e.g., sensitivity, specificity, AUC, etc.).
Therefore, the requested information elements related to AI/ML device evaluation metrics, expert ground truth development, MRMC studies, or training sets are not applicable or derivable from this submission, as the submission pertains to a conventional medical device and not an AI/ML-driven diagnostic or prognostic tool.
However, I can extract the non-clinical testing performed to establish substantial equivalence for the modifications and the new Power Adapter, which functionally serve as "acceptance criteria" and the "study" demonstrating they meet those criteria within the context of a 510(k) submission for a non-AI device.
1. Table of Acceptance Criteria and Reported Device Performance
| Component/Modification | Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|---|
| 4.75mm and 5.5mm Rods | Confirmatory ASTM F1798 Grip Testing | Deemed acceptable (implied as no issues reported) |
| Drawing verification | Deemed acceptable (implied as no issues reported) | |
| Sterilization adoption | Deemed acceptable (implied as no issues reported) | |
| Risk Assessment | Deemed acceptable (implied as no issues reported) | |
| Confirmatory ASTM F1717 (dynamic compression bending) | Deemed acceptable (implied as no issues reported) | |
| Packaging adoption | Deemed acceptable (implied as no issues reported) | |
| Shelf Life adoption | Deemed acceptable (implied as no issues reported) | |
| 4.5mm Pedicle and Reduction Screws | Review, risk assessment, and comparison to cleared equivalent devices (primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, product experience) | Substantially equivalent to predicate devices, no new risks identified |
| 7.5mm Pedicle and Reduction Screws (Additional Lengths) | Review, risk assessment, and comparison to cleared equivalent devices (primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, product experience) | Substantially equivalent to predicate devices, no new risks identified |
| Power Adapter | Strength assessment testing of instrumentation and implantable devices under simulated clinical use conditions | Deemed acceptable (implied as no issues reported) |
| Screw loading and screw insertion during normal use without loss of function | Deemed acceptable (implied as no issues reported) | |
| Compatibility with existing surgical instruments | Deemed acceptable (implied as no issues reported) | |
| Evaluation of quality and accuracy of screw placement in simulated use environment | Deemed acceptable (implied as no issues reported) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in terms of number of devices tested for each test. The tests are described by type (e.g., ASTM F1798, ASTM F1717, simulated clinical use for the Power Adapter). For screw modifications, "a thorough review, risk assessment, and comparison" was performed.
- Data Provenance: Not specified. Standard mechanical and performance tests (e.g., ASTM standards) are typically conducted in a laboratory setting. The "simulated use environment" for the Power Adapter implies lab-based testing rather than clinical data. No country of origin for data is mentioned. The studies appear to be laboratory-based and prospective in the sense that they were conducted for this specific submission, but not prospective clinical trials.
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 is a conventional medical device submission, not an AI/ML device relying on expert-annotated "ground truth" for performance evaluation. The "ground truth" is typically defined by engineering specifications, material properties, and adherence to performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device requiring human adjudication of results from a diagnostic or prognostic algorithm.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device and an instrument accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the rods: Engineering specifications, material properties, and established mechanical testing standards (ASTM F1798, ASTM F1717).
- For the pedicle screws: Comparison to the primary design characteristics, materials, manufacturing processes, existing mechanical performance testing, and product experience of already cleared equivalent devices.
- For the Power Adapter: Functional performance in simulated use conditions, adherence to mechanical and functional specifications (e.g., screw loading, screw insertion, compatibility).
8. The sample size for the training set
- Not applicable. There is no AI/ML component, and therefore no "training set."
9. How the ground truth for the training set was established
- Not applicable. Since there is no training set, there is no ground truth established for it.
§ 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.