(86 days)
The Aladyn Rigid Spine Plate is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system Aladyn Rigid Spine Plate is indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spinc (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Aladyn Rigid Spine Plates, pedicle screws and a polyaxial nut. It is a modification to the plates and nuts of the ISOLOCK Pedicle Screw System (K990721) and uses the same hemispherical screws of the ISOBAR system (K990118). Pedicle screws are inserted into the vertebrae. An Aladyn plate is placed over the screws. The rigid plates are available in six multi-hole lengths. The construct is then scurely fixed with nuts. The implantation steps of the Aladyn are the SOLOCK Plate system. The only difference is that there are no washers used with the Aladyn plate.
The hemispherical screws come in two diameters (6.2mm and in lengths ranging from 38mm to 50mm. There is also a polyaxial nut available.
The provided text describes the "Aladyn Rigid Spine Plate," a pedicle screw system. However, it does not contain information about acceptance criteria, the specific study design to prove device performance against those criteria, or details regarding sample sizes, expert ground truth establishment, or clinical effectiveness studies.
The document primarily focuses on:
- Device Description: What the device is, its components, and modifications from previous devices.
- Intended Use/Indications for Use: The medical conditions and patient populations for which the device is intended.
- Nonclinical Tests: A very brief statement that "Testing was performed per ASTM F1717. Results were comparable with other devices on the ISOLOCK and ISOBAR Pedicle Screw Systems."
Therefore, I cannot populate the requested table or provide detailed answers to most of the study-related questions based on the input text.
Here's a breakdown of what can be inferred from the text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from ASTM F1717) | Reported Device Performance (from text) |
|---|---|
| Mechanical performance, fatigue, static testing (Standard for spinal implant constructs) | "Results were comparable with other devices on the ISOLOCK and ISOBAR Pedicle Screw Systems." (This implies it met the expectations for these types of tests.) |
| Biocompatibility (implied for medical devices) | Not explicitly stated, though a K-number approval usually implies this was addressed. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not mentioned. ASTM F1717 specifies testing procedures for specific numbers of constructs.
- Data Provenance: Not mentioned (implied to be laboratory testing of the device itself, not human data).
- Retrospective or Prospective: Not applicable, as this refers to mechanical device testing, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. Ground truth in this context would be derived from engineering specifications and standardized test methods (like ASTM F1717), not expert interpretation of clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to consensus-building amongst experts for clinical ground truth, 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
- MRMC Study: No. This device is a mechanical implant; it does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This relates to AI algorithms, not a mechanical spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering specifications and standardized material/mechanical testing protocols (specifically ASTM F1717).
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This device is not an AI algorithm that requires a training set. The "training" for a mechanical device comes from design, material selection, and manufacturing processes, guided by engineering principles.
9. How the ground truth for the training set was established
- Not applicable. Again, this concept pertains to AI algorithms. For a mechanical device, performance is established through adherence to design specifications and subsequent validation via testing.
§ 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.