(30 days)
The LAGUNA® Polyaxial Pedicle Screw 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® Polyaxial 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 for the individual case Multi axial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes All sizes are able to receive 5 5mm connecting rods only. The LAGUNA® Polyaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
This document describes the Allez Spine Laguna Polyaxial Pedicle Screw System, a spinal fixation system. However, the provided text does not contain acceptance criteria for specific performance metrics (like accuracy, sensitivity, or specificity) or detailed study results directly proving the device meets certain quantitative acceptance criteria in the way an AI/ML device submission would.
Instead, the submission focuses on substantial equivalence to a previously marketed predicate device and mentions general biomechanical tests.
Therefore, I cannot generate a table of acceptance criteria and reported device performance or answer most of the specific questions about clinical study design, as this information is not present in the provided 510(k) summary and FDA letter.
I can, however, extract what is mentioned regarding performance and study type:
Performance Data Mentioned:
- "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."
This statement indicates that the device underwent non-clinical performance testing (biomechanical tests) to demonstrate its mechanical properties and safety for its intended use. The acceptance criteria for these tests would typically involve meeting specific strength, fatigue, and other mechanical property thresholds established for similar spinal fixation devices. The specific thresholds are not provided in this summary.
Given the nature of the device (a physical medical implant, not an AI/ML diagnostic or predictive tool), the questions related to sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable as they pertain to clinical or AI/ML performance evaluation studies.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biomechanical equivalence to similar implants and sufficiency for in vivo loading | "The test results were equivalent to other similar implants and are sufficient for in vivo loading." |
| Material properties (per ASTM F136) | Components fabricated from "medical grade titanium alloy per ASTM F136." |
| Functional equivalence to predicate device | "substantially equivalent to the original Laguna® Pedicle Screw System" |
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 / Not Provided. The document refers to biomechanical tests, not a clinical test set in the context of diagnostic accuracy. Biomechanical tests typically involve a defined number of device units tested under specific conditions to assess mechanical properties. The specific 'sample size' (number of units tested) is not provided, nor is the data provenance in this context applicable.
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 / Not Provided. This type of information is relevant for clinical studies involving expert interpretation, which is not described here for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. This is relevant for clinical studies with expert reviewers, not for biomechanical performance 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:
- Not Applicable. This is a physical implant device, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the biomechanical tests, the "ground truth" would be the engineering standards and specifications (e.g., ASTM F1717 for static and fatigue testing of spinal implant constructs, or similar standards relevant to pedicle screw systems) that define acceptable mechanical performance. The device's performance is measured against these established engineering standards.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, it's not an AI/ML algorithm.
§ 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.