(216 days)
The PASS LP Spinal System includes 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 or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae 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 includes hooks, rods and sacral/iliac 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 stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, illac screws, clamps, rods, nuts, rod plates and crosslink members. 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 cobalt-chrome alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537. The purpose of this submission is to add an axial connector and to deliver the implants of the PASS LP Spinal System sterile.
Here's an analysis of the provided 510(k) summary, specifically addressing the requested information about acceptance criteria and the study proving the device meets them:
Acceptance Criteria and Device Performance Study for the PASS LP Spinal System (K110497)
This 510(k) submission is for the addition of an axial connector and delivering existing implants of the PASS LP Spinal System as sterile, rather than a fundamentally new device. Therefore, the "acceptance criteria" and "study" are focused on demonstrating that these modifications do not compromise the safety and effectiveness established for the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance | ASTM F1798 Dynamic flexion/extension | "The results of these tests indicate that the PASS LP Spine System is equivalent to predicate devices in terms of mechanical strength..." |
| ASTM F1717 Dynamic compression bending, static compression bending, static torsion | "The results of these tests indicate that the PASS LP Spine System is equivalent to predicate devices in terms of mechanical strength..." | |
| Sterilization | ISO 11737 "Sterilization of medical devices: Estimation of the population of microorganisms on product" | "The results of these tests indicate that the PASS LP Spine System is equivalent to predicate devices in terms of...sterilization." |
| ISO 11137-1 (2006) Sterilization of health care products Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. | "The results of these tests indicate that the PASS LP Spine System is equivalent to predicate devices in terms of...sterilization." | |
| ISO 11137-2:2008, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | "The results of these tests indicate that the PASS LP Spine System is equivalent to predicate devices in terms of...sterilization." |
Summary of the Study:
The study proving the device meets the acceptance criteria is a non-clinical testing program. No clinical studies were performed. The core of the demonstration is showing substantial equivalence to the predicate device in terms of mechanical strength and sterilization effectiveness.
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of axial connectors, number of sterilized implants) used for the mechanical and sterilization tests listed. It only states that the "results of these tests indicate..." equivalence. No information about data provenance (e.g., country of origin, retrospective/prospective) is applicable since these are laboratory-based engineering and sterilization tests, not patient data studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for non-clinical performance (mechanical strength, sterility) is established through standardized engineering and microbiological testing methods (ASTM and ISO standards), not through expert consensus on cases. The interpretation of the test results would be performed by qualified engineers and microbiologists.
4. Adjudication Method for the Test Set
Not applicable. This concept applies primarily to clinical studies where patient outcomes or diagnoses are being evaluated, often involving multiple readers. For non-clinical, objective laboratory tests, "adjudication" in this sense is not relevant.
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 device is a mechanical implant (spinal system), not a diagnostic or AI-powered system designed to assist human readers. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant; there is no algorithm or AI component to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Established mechanical properties: Defined by ASTM F1798 and ASTM F1717 standards, which are engineering benchmarks for spinal implant performance. The expectation is that the modified device performs comparably to the predicate and meets these standards.
- Established sterilization efficacy: Defined by ISO 11737, ISO 11137-1, and ISO 11137-2 standards, which ensure the device achieves an acceptable sterility assurance level.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The design, material, and manufacturing process of the device are based on established engineering principles and data from the predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 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.