(145 days)
The DEL MAR® Monoaxial Pedicle Screw System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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); tumor; pseudarthrosis; and/or failed previous fusion.
The Del Mar® Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Del Mar® Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor-made to fit the patient's individual anatomy. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of length, ranging from 30 mm to 100 mm and in 5 mm, 6 mm, 7 mm, 8mm and 9 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. Pre-bent rods are available in 10 mm increments from 30 to 120 mm in length. Additional components, such as a Single Piece Set Screw, Cobalt Chrome Rods ranging from 400 mm to 600 mm and several types of Deformity Connectors have been added. The Del Mar® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136 and Cobalt Chrome alloy per ASTM F1058.
The provided 510(k) summary (K110679) describes a spinal fixation system, not a device that generates performance metrics like sensitivity, specificity, or AUC, which are typically associated with AI/ML-based diagnostic or prognostic devices. Therefore, a direct application of the requested structured response for AI/ML device studies is not fully appropriate.
However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them, focusing on the mechanical and substantial equivalence aspects as presented in the document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance | ASTM F1717-10: | Test results were equivalent to the predicate device and/or other similar implants and are sufficient for in vivo loading. |
| a. Static Compression Bending Tests | ||
| b. Static Torsion Test | ||
| c. Dynamic Compression Bending Tests | ||
ASTM F1798-97 (2008): | ||
| d. Static Axial Gripping Capacity | ||
| e. Axial Torque Gripping Capacity | ||
| Substantial Equivalence | Equivalence to legally marketed predicate device (K091219 S/E 7/9/2009 and K051275 S/E 12/9/2005) for the stated indications for use. | The modified Del Mar® Pedicle Screw System is substantially equivalent to the Del Mar® Pedicle Screw System (K091219 and K051275). |
Study Details (based on what's available for a non-AI/ML mechanical device):
The device is a mechanical spinal fixation system, and the "study" referred to in the document is a series of mechanical bench tests rather than a clinical study with human subjects, diagnostic accuracy endpoints, or AI/ML algorithm performance.
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Sample size used for the test set and the data provenance: Not applicable in the context of human subjects or clinical data for this type of device. The "test set" would refer to the physical device samples subjected to mechanical testing. The provenance is the manufacturer (Phygen, LLC).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by adherence to ASTM standards and engineering principles, not expert medical consensus on human data.
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Adjudication method for the test set: Not applicable. Mechanical tests have pass/fail criteria based on measured physical properties against established standards.
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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 mechanical device, not an AI/ML diagnostic tool requiring human reader studies.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
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The type of ground truth used:
- For mechanical performance: Adherence to ASTM F1717-10 and ASTM F1798-97 (2008) standards for spinal implant mechanical testing. The "ground truth" is the established performance requirements within these standards.
- For substantial equivalence: Comparison against the predicate device's previously cleared design, materials, and indications for use, as evaluated by the FDA.
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The sample size for the training set: Not applicable. This is a manufactured medical device, not an AI/ML model that undergoes a "training set" process.
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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.