(17 days)
The Spineology Palisade™ Pedicular Fixation System is intended for posterical fixation as an adjunct to fusion in skeletally mature patients for the following indications: 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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
The Spineology Palisade Pedicular Fixation System consists of screws (titanium alloy), curved and straight rods (cobalt chrome), adjustable Connex Cross Connector (titanium alloy), and fixed ConneX Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Palisade screws are available with or without a hydroxyapatite coating. The system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
This document is a 510(k) premarket notification decision letter from the FDA for the Spineology Palisade™ Pedicular Fixation System. It grants clearance for the device based on its substantial equivalence to a legally marketed predicate device.
The document does not contain any information about a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantifiable performance measure that would be typically established for an AI-powered device or for clinical outcome studies.
The "acceptance criteria" and "device performance" discussed in this document relate to the substantial equivalence of a modified medical device to a previously cleared predicate device. This is a regulatory pathway, not a clinical performance study against specific, pre-defined outcome metrics.
Here's why the requested information cannot be fully provided based on the given text:
- No acceptance criteria for performance: The document confirms the device meets regulatory requirements for substantial equivalence, but it doesn't define specific performance criteria (e.g., "sensitivity > 90%") or report quantitative performance results from a study designed to measure clinical effectiveness or diagnostic accuracy.
- No study to prove device performance in a clinical context: The "Non-Clinical Testing" section describes verifications and adoptions for new instruments and rods (e.g., Sawbones Verification Lab, Drawing Verification, Sterilization Adoption). These are engineering and material compatibility tests, not studies assessing clinical outcomes or diagnostic performance.
- No AI component: The device described is a pedicular fixation system, which is a physical implant, not an AI-powered diagnostic or therapeutic device. Therefore, questions related to AI performance, ground truth, expert consensus, and MRMC studies are not applicable.
Therefore, many parts of your request are not applicable or cannot be answered from the provided text.
However, I can extract the relevant information regarding the basis for its regulatory clearance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for Regulatory Clearance via Substantial Equivalence) | Reported Device Performance / Justification |
|---|---|
| Intended Use: Same as predicate | Met: "the modified Palisade System has the same: Intended Use" |
| Indications for Use: Same as predicate | Met: "the modified Palisade System has the same: Indications for Use" (Specifically mentioned in A. Purpose of Submission and D. Comparison to Predicate - "posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for... degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and/or failed previous fusion.") |
| Fundamental Scientific Technology: Same as predicate | Met: "the modified Palisade System has the same: Fundamental Scientific Technology" |
| Principle of Operation: Same as predicate | Met: "the modified Palisade System has the same: Principle of Operation" |
| Device Design: Similar to predicate (for added components) | Met: Non-clinical verifications and product adoptions performed for additional surgical instruments and 4.75mm Straight Rods (e.g., Sawbones Verification Lab, Drawing Verification, Implant/Inserter Interface Verification). |
| Materials of Construction: Similar/Same as predicate | Met: System consists of screws (titanium alloy), curved and straight rods (cobalt chrome), adjustable Connex Cross Connector (titanium alloy), and fixed ConneX Rod Connector (titanium alloy). Materials are consistent with those typically used in predicate devices. |
| Primary Method of Access: Similar to predicate | Met: "Primary Method of Access (Percutaneous)" is the same. The submission adds an optional alternative percutaneous method. |
| Safety and Effectiveness: Demonstrated through non-clinical testing | Met: "Spineology conducted a risk assessment for the additional surgical instruments and 4.75mm Straight Rod devices. Based on the risk assessment, the following non-clinical verifications and product adoptions were performed: Modified Surgical Technique (Instruments) - Sawbones Verification Lab, Drawing Verification, Sterilization Adoption, Surgical Technique Guide Update; Straight Rods (Implants) - Implant/Inserter Interface Verification, Drawing Verification, Sterilization Adoption, Packaging and Shelf Life Adoption." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This device is a physical pedicular fixation system. The "testing" involved non-clinical engineering verifications (e.g., Sawbones lab, drawing verification) and regulatory adoptions (sterilization, packaging). There was no "test set" in the context of clinical data or AI performance evaluation.
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)
- Not applicable. No clinical ground truth was established from expert review for this type of device and submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. As a physical implant, the "ground truth" for regulatory clearance is based on engineering specifications, material properties, and comparison to the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not applicable. No training set was used as this is not an AI device.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth in this context.
§ 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.