(113 days)
The Laguna Spinal System is intended for 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 Laguna TM 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 Laguna Spinal 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 for the individual case. Multi axial implant screws are supplied in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The Laguna Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
The provided text is a 510(k) summary for the Allez Spine Laguna™ Pedicle Screw System and a determination letter from the FDA. This document is for a medical device and therefore, the acceptance criteria and study information typically associated with AI/ML-based software (like those related to diagnostic performance or multi-reader studies) are not applicable.
Instead, the "performance data" section in this submission refers to biomechanical tests for the pedicle screw system, comparing its physical properties and mechanical strength to similar, already-approved implants. This is a common practice for hardware-based medical devices seeking 510(k) clearance via substantial equivalence.
Here's how to interpret the provided information in the context of a medical device submission, focusing on the available "performance data" section:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to predicate device in biomechanical properties | "The test results were equivalent to other similar implants" |
| Sufficient for in vivo loading (implies adequate strength/durability) | "sufficient for in vivo loading" |
Explanation:
For a 510(k) submission based on substantial equivalence for a pedicle screw system, the "acceptance criteria" are not explicitly stated in numerical terms like sensitivity/specificity for AI, but are implied by the requirement to demonstrate that the new device performs as safely and effectively as a legally marketed predicate device. This is typically shown through comparative biomechanical testing. The performance data states that the Laguna™ system's biomechanical test results were equivalent to other similar implants and sufficient for in vivo loading, thus meeting the implicit acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: This information is not provided in the document. Biomechanical testing typically involves a specific number of samples of the device components (e.g., screws, rods, constructs) tested under various loading conditions, but the exact number of components tested is not detailed here.
- Data Provenance: Not applicable in the human data sense. Biomechanical tests are laboratory-based studies performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth for biomechanical tests is established by engineering standards and measurements, not expert clinical interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Biomechanical tests are analytical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-interpretation software where human readers' performance with and without AI assistance is evaluated. This device is a surgical implant.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Study: No, a standalone algorithm performance study was not done. This concept applies to AI/ML software; the device described is a physical implant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for biomechanical testing is based on engineering principles, material science standards (e.g., ASTM F136 or ISO 5832-3 or 5832-2 for materials), and established mechanical testing protocols. "Equivalence" is determined by comparing measured properties (e.g., strength, stiffness, fatigue resistance) against the predicate device's known performance or against accepted industry standards for spinal implants deemed sufficient for in vivo loading.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This concept applies to machine learning models, not physical medical devices undergoing biomechanical testing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
Summary in Context of the Device:
The Allez Spine Laguna™ Pedicle Screw System is a physical implant, not an AI/ML-based software. The "performance data" refers to biomechanical tests conducted to demonstrate that its physical properties and mechanical performance are equivalent to predicate devices already on the market, ensuring its safety and effectiveness for its intended use as an adjunct to spinal fusion. The acceptance criteria are therefore implicit in proving substantial equivalence through these physical tests as opposed to clinical or diagnostic performance criteria.
§ 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.