(123 days)
The PASS LP Spinal Systems include a pedicle 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 of thoracic, lumbar, and sacral spine:
- Fractures
- Dislocation
- Failed previous fusion (Pseudoarthrosis)
- Spinal stenosis
- Degenerative spondylolisthesis with objective evidence of neurological impairment
- Spinal deformations such as scoliosis or kyphosis.
- Loss of stability due to tumors.
The PASS LP Spinal Systems are also indicated for pedicle screw fixation 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 spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The PASS LP also include hooks and rods and sacralitiiac screws indicated for degenerative disc disease (ddd) 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 deformities or curvatures (i.e., scollosis, kyphosis, and/or lordosis), turnor, stenosis. pseudoarthrosis and failed previous fusion.
Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allografi and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.
The system consists of pedicle screws, hooks, sacral plates, illac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-SAI-4V ELI) that conforms to ASTM F136 or cobalt-chromiummolybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. Similarly to the PASS LP implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case.
Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy
Function: The PASS LP was developed as an implant:
- To provide immobilzation and stabilization of posterior spinal segments
- to augment the development of a solid spinal fusion
- to provide stability to ease fusion
- to be mechanically resistant to allow the fusion of the operated level
The provided text describes a 510(k) summary for the MEDICREA® INTERNATIONAL PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of features, rather than a study proving the device meets specific acceptance criteria in a clinical setting.
Therefore, many of the requested elements regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract information related to the non-clinical tests performed to demonstrate mechanical equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Conformance to ASTM F1717 & F1798 | Established via comparison to previously cleared devices |
| (Specific values are not provided as this is a summary of equivalence to predicate devices, not performance against specific clinical metrics.) | (Specific values are not provided in the document.) | (Specific values are not provided in the document.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The "test set" in this context refers to mechanical testing of components, not a clinical data set. The document states "mechanical testing... was conducted following the ASTM F1717" and "additional components... tested following the ASTM F1798". No specific sample size (number of constructs tested) is provided in the summary.
- Data Provenance: Not applicable in the context of clinical data. The mechanical tests were performed on the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the clinical sense, is not established for mechanical testing.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable for 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. The document explicitly states: "No clinical studies were performed." This is a regulatory submission for a medical device implant, not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No. This device is a spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the mechanical performance, the "ground truth" is adherence to established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the mechanical performance of previously cleared devices. This is a technical/engineering "ground truth," not a clinical one.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no AI component or machine learning model described as part of this device or its evaluation.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. There is no AI component or machine learning model described.
§ 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.