(156 days)
The True™ Spinal Fixation System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for 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, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
The True™ Spinal Fixation System consists of pairs of longitudinal members (rods), anchors (polyaxial pedicle screws) and interconnections (rod-rod connectors). The changes include a rod to rod connector for ease of delivery, thermoformed instruments to replace the stainless steel instruments, a lower final torque value of 7.5Nm previously 8.5 Nm
The provided document describes a 510(k) submission for the True™ Spinal Fixation System, which is a medical device, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study details relevant to AI/ML performance (like sample size for test sets, expert consensus for ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable here.
However, I can extract the relevant "acceptance criteria" and "study" details for this medical device as presented in the document, which primarily revolve around mechanical performance and substantial equivalence to predicate devices.
Here's the information based on the provided text, structured to best fit your request:
Acceptance Criteria and Device Performance for True™ Spinal Fixation System
Given that this is a 510(k) submission for a traditional medical device (spinal fixation system) and not an AI/ML algorithm, the "acceptance criteria" relate to mechanical performance and "substantial equivalence" to legally marketed predicate devices. The "study" refers to mechanical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Benchtop Mechanical Tests) | Reported Device Performance (Worst Case Construct) |
|---|---|
| Static Compression Bending (per ASTM F1717) | Demonstrates performance substantially equivalent to predicate devices. |
| Static Torsion (per ASTM F1717) | Demonstrates performance substantially equivalent to predicate devices. |
| Dynamic Compression Bending (per ASTM F1717) | Demonstrates performance substantially equivalent to predicate devices. |
| Torque Value (Final) | Lower final torque value of 7.5Nm (previously 8.5 Nm) - This is a design change, not explicitly an acceptance criterion for performance itself, but part of the changed characteristics being evaluated. |
| Material | Titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 - Matches predicate device material. |
| Basic Design | Rod-based pedicle screw fixation system - Matches predicate device design. |
| Anatomic Location | Posterior, noncervical (T1-S1) pedicle fixation - Matches predicate device's use. |
| Intended Use | Adjunct to fusion for various spinal instabilities/deformities (e.g., severe spondylolisthesis, fracture, dislocation, scoliosis, etc.) - Matches predicate device's intended use. |
Note: The primary "acceptance criterion" for 510(k) submissions is demonstrating "substantial equivalence" to one or more legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The performance tests are conducted to support this claim, especially for any technological differences.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the document. Mechanical tests typically involve multiple samples to ensure statistical validity, but the exact number for "worst case construct" is not provided.
- Data Provenance: The tests were "performed according to ASTM F1717 and ASTM 1798." This implies the tests were conducted in a controlled environment, likely a lab, following standardized testing protocols. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms typically apply to clinical data, not benchtop mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. For mechanical testing of a spinal fixation system, ground truth is established by objective physical measurements using calibrated equipment according to design specifications and industry standards (ASTM), not by expert human graders or medical professionals.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like "2+1" typically apply to human expert review of clinical cases. For mechanical testing, quantitative measurements are taken, and compliance is determined against predefined physical specifications and standards.
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 a medical device for spinal fixation, not an AI/ML algorithm requiring human reader performance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- Benchtop Mechanical Measurement against ASTM Standards and Predicate Device Performance. The "ground truth" for the device's performance is established by its ability to meet the defined mechanical properties and safety profiles as set by FDA guidelines, industry standards (ASTM F1717, ASTM 1798), and by demonstrating "substantial equivalence" to the mechanical performance of legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. There is no "training set" or corresponding ground truth for this type of 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.