(226 days)
The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondy lolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudoarthrosis, or 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. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. 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, iliac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.
The purpose of this submission is to add components to the PASS LP implant range to treat Pars interarticularis fracture.
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 hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. These components can be rigidly locked into a variety of configurations.
The provided text describes the 510(k) premarket notification for the PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for a new device's performance characteristics. Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted directly from this type of regulatory submission.
However, I can extract information regarding the performance data provided to support the substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table for device performance in the way one might expect for a new diagnostic or AI intervention. Instead, it relies on demonstrating substantial equivalence to existing predicate devices through mechanical testing. The implicit acceptance criterion is that the new components perform comparably to the predicates in standard mechanical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantially equivalent mechanical performance to predicate devices | Demonstrated substantially equivalent performance in Dynamic Compression Bending Tests (following ASTM F1717) to predicates (K123138 and K140449). |
2. Sample size used for the test set and the data provenance
The document mentions "Dynamic Compression Bending Tests, following the ASTM F1717 'Standard Test Methods for Spinal Implants Constructs in a Vertebrectomy Model' were carried out."
- Sample Size: The specific number of devices tested in the Dynamic Compression Bending Tests (
nfor each test group) is not provided in this document. - Data Provenance: The tests were "carried out" as part of the submission process, implying these were prospective bench tests conducted specifically for this regulatory submission. The country of origin for the data is implicitly France, where Medicrea® International S.A. is based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The "ground truth" for the mechanical performance of a spinal implant is determined by established engineering standards (ASTM F1717) and the physical properties observed in the bench tests, not by expert consensus in a clinical setting.
4. Adjudication method for the test set
This section is not applicable. Mechanical tests against a standard do not typically involve human adjudication in the same way clinical or image-based studies do. The results are quantitative measurements against predetermined pass/fail criteria (often, remaining within a certain deviation of predicate performance).
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
This section is not applicable. This document concerns a spinal implant system, not a diagnostic device or AI system that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. This document concerns a spinal implant system, not an AI algorithm.
7. The type of ground truth used
The ground truth used for evaluating the device's performance was:
- Mechanical performance metrics as defined by the ASTM F1717 standard for "Spinal Implants Constructs in a Vertebrectomy Model." This involves quantitative measurements of force, displacement, and cycles to failure under defined loading conditions.
- Performance of legally marketed predicate devices (CD Horizon Spinal System - K140449, and PASS LP Spinal System - K123138) against the same standard, effectively setting the "ground truth" for acceptable performance.
8. The sample size for the training set
This section is not applicable. This document concerns a spinal implant system, not a device that utilizes a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This section is not applicable. There is no "training set" in the context of this device and evaluation.
§ 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.