(126 days)
The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain 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.
The Stainless Steel Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, and cross-connectors. The Stainless Steel Spinal System components can be rigidly locked together creating a rigid construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F-138 and ISO 5832-1.
Here's a summary of the acceptance criteria and study information for the Stainless Steel Spinal System (K100970) based on the provided text, formatted to address your specific points:
Since the provided text describes a spinal implant system and its mechanical testing, not a diagnostic AI device, many of the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable. I will specify "N/A" for these fields.
Acceptance Criteria and Device Performance for Stainless Steel Spinal System (K100970)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Axial Compression Test (in accordance with ASTM F-1717) | Performed as designed and met or exceeded all product specifications. |
| Static Torsion Test (in accordance with ASTM F-1717) | Performed as designed and met or exceeded all product specifications. |
| Dynamic Axial Compression Test (in accordance with ASTM F-1717) | Performed as designed and met or exceeded all product specifications. |
Note: The document explicitly states "The construct performed as designed and met or exceeded all product specifications." This implies that the specific numerical criteria were met, but the exact numerical thresholds for "product specifications" and the measured performance values are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. (The study involves mechanical testing of device constructs, not data from human subjects or images.)
- Data Provenance: N/A (Mechanical tests are conducted on manufactured devices, not patient data.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A (Ground truth for mechanical performance is established by engineering standards and test results, not expert consensus.)
- Qualifications of Experts: N/A
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: N/A (Not relevant for 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
- MRMC Study: No, this is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No, this is not an AI/diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Engineering standards and design specifications as defined by ASTM F-1717.
8. The sample size for the training set
- Sample Size for Training Set: N/A (This is not an AI/machine learning device that requires a training set.)
9. How the ground truth for the training set was established
- Ground Truth for Training Set: N/A
Study Summary:
The study conducted for the Stainless Steel Spinal System involved mechanical testing to demonstrate its performance and substantial equivalence to predicate devices. The tests performed were:
- Static axial compression
- Static torsion
- Dynamic axial compression
These tests were performed in accordance with ASTM F-1717. The results indicated that the device performed as designed and met or exceeded all specified product requirements, supporting its substantial equivalence to the predicate devices.
§ 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.