(148 days)
The Inertia® Pedicle Screw and Deformity Correxxion™ System is intended for 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 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, cyphosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pediatic patients, the Inertia® Pedicle Screw and Deformity Correxxion™ System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Inettia® Pedicle Screw and Deformity Correxxion™ System is to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Inertia® Pedicle Screw and Deformity Correxxion™ System consists of longitudinal members (rods), anchors (screws and hooks), interconnections (offset, rod-rod and crosslink) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Inertia® Pedicle Screw and Deformity Correxxion™ System implants are sold sterile and non-sterile.
The provided text describes a 510(k) premarket notification for the "Inertia® Pedicle Screw and Deformity Correxxion™ System," a medical device for spinal stabilization and immobilization. However, the document does not contain information regarding an AI/Machine Learning-enabled device or a study proving its performance against specific acceptance criteria for such a device.
The acceptance criteria described in the document, and the study conducted, pertain to the mechanical performance of the pedicle screw system itself, not to the performance of an AI algorithm.
Therefore, I cannot provide the details requested in your prompt regarding AI/ML device performance, such as:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size for the test set and data provenance for an AI/ML device.
- Number of experts and their qualifications for establishing ground truth for an AI/ML device.
- Adjudication method for an AI/ML device.
- MRMC comparative effectiveness study results or effect size for AI assistance.
- Standalone performance for an AI/ML device.
- Type of ground truth used for an AI/ML device.
- Sample size for the training set for an AI/ML device.
- How ground truth for the training set was established for an AI/ML device.
What the document does describe (related to mechanical device performance):
The document implicitly defines acceptance criteria by stating that the device's performance needs to be "substantially equivalent" to predicate devices.
1. A table of acceptance criteria and the reported device performance (for the mechanical device):
| Acceptance Criteria (Implicit) | Reported Device Performance (Mechanical Testing) |
|---|---|
| Substantial equivalence to predicate devices in mechanical performance | Mechanical test results demonstrate that the Inertia® Pedicle Screw and Deformity Correxxion™ System performance is substantially equivalent to the predicate devices for static and dynamic compression bending and static torsion according to ASTM F1717. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of devices, but refers to "worst case Inertia® Pedicle Screw and Deformity Correxxion™ System constructs."
- Data Provenance: The tests are described as mechanical testing, implying in-vitro lab testing rather than human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" here refers to established engineering standards (ASTM F1717) for mechanical performance, not expert clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable, as it refers to a clinical or AI-based assessment, not 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:
- No, this type of study was not done, as the document concerns a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the mechanical device's performance is established by ASTM F1717 standards for static and dynamic compression bending and static torsion.
8. The sample size for the training set:
- Not applicable; mechanical testing doesn't involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.