(285 days)
The LAGUNA™ Spinal System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical pedicle 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™ Size 8 Pedicle Screws are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine LAGUNA™ Polyaxial Pedicle Screw System. 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. The Allez Spine LAGUNA™ Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The LAGUNA™ Size 8 Pedicle Screws are available in eleven sizes ranging from 30 mm to 100 mm are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
The provided text describes a medical device, the LAGUNA™ Size 8 Pedicle Screw, and its clearance through the FDA 510(k) process. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML device evaluations.
The document primarily focuses on:
- Identifying the device and its manufacturer.
- Classifying the device and specifying its product codes.
- Describing the device and its intended use as an adjunct to fusion for various spinal conditions.
- Declaring substantial equivalence to a previously cleared device (LAGUNA™ Pedicle Screw System K050060).
- Mentioning that "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."
This is a regulatory filing for a physical medical implant (a pedicle screw), not an AI/ML-based diagnostic or therapeutic software device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, are not applicable to this document.
Therefore, many of your requested fields will be filled with "Not Applicable" or similar, as the provided document pertains to a physical medical device and not an AI/ML-based system.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated as pass/fail metrics within this document (e.g., minimum tensile strength, fatigue cycles). | Biomechanical tests performed, results "equivalent to other similar implants" and "sufficient for in vivo loading." |
| Substantial Equivalence to predicate device (LAGUNA™ Pedicle Screw System K050060). | The FDA found the device substantially equivalent. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document refers to "biomechanical tests" without detailing the number of units tested.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests are described generally as "biomechanical tests."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device, not an AI/ML system requiring expert ground truth for classification/detection. Performance is assessed through mechanical testing.
4. Adjudication method for the test set
- Not Applicable. Biomechanical tests typically involve laboratory measurements against engineering specifications, not 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 a physical device, not an AI/ML system for diagnostic assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an AI/ML algorithm.
7. The type of ground truth used
- For biomechanical tests, the "ground truth" would implicitly be the established engineering standards and performance expectations for spinal fixation devices, as well as comparison to the predicate device's performance. There isn't a "ground truth" in the AI/ML sense (e.g., pathology, expert consensus).
8. The sample size for the training set
- Not Applicable. This is a physical device; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical device; there is no "training set" or corresponding ground truth establishment process related to AI/ML.
§ 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.