(180 days)
The Pallas M Spinal system is intended for posterior, noncervical pedicle and non-pedicle fixation 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The Pallas M Spinal System consists of rods, screws, revision rod system, Miss pedicle screw system and associated instruments. The Pallas M Spinal System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Pallas M Spinal System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Various sizes of these implants and specialized instruments are available for the application and removal of the Pallas M Spinal System. The products are supplied clean and "NON STERILE".
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pallas M Spinal System:
Based on the provided 510(k) summary, the device is a spinal fixation system, and its performance is evaluated through bench testing, rather than clinical studies involving human or AI performance. Therefore, many of the requested categories (like sample size of a test set, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this type of submission.
The acceptance criteria are based on established standards for spinal implants.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM F1717-04 Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model (Characterization of components and system) | Bench testing performed, including: |
- Static axial compression bending test
- Dynamic axial compression bending test
- Static torsion test (of worst-case Pallas M Spinal System structure) |
| Conformity to ASTM F136 (Material specification for Ti-6Al-4V ELI) | Fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. |
| Conformity to relevant ISO Standards (for materials) | Devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO Standards. |
Explanation: The device aims to meet the mechanical performance and material specifications defined by these ASTM and ISO standards for spinal implant systems. The reported performance indicates that the required bench tests were conducted and the materials conform to the specified standards, implying the device met the criteria outlined in those standards.
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "samples" in a clinical sense. For bench testing, "worst-case" configurations of the spinal system were tested. The mechanical testing report (Appendix 1) would typically contain detailed specimen numbers, but this is not included in the summary.
- Data Provenance: Bench testing, performed by the manufacturer, Korea Bone Bank Co., Ltd. (South Korea).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device underwent bench testing against engineering standards, not clinical ground truth established by medical experts for diagnostic or clinical performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for human interpretation or clinical outcomes, not for mechanical bench testing. The results are typically interpreted against the pass/fail criteria defined in the ASTM standard.
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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:
- N/A. This is a hardware spinal implant, not an AI or imaging device that would involve human readers or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware spinal implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards: The ground truth for performance is compliance with established engineering and biocompatibility standards (e.g., ASTM F1717-04 for mechanical performance, ASTM F136 for material composition and biocompatibility).
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The sample size for the training set:
- N/A. There isn't a "training set" in the context of mechanical bench testing for a physical implant. The design process and selection of materials are based on general engineering principles and material science.
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How the ground truth for the training set was established:
- N/A. See point 7.
§ 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.