(90 days)
The PASS Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 spines: spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the PASS Spinal System is intended 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.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the PASS Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), deformities (scoliosis, kyphosis), tumor, pseudarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.
The subjects of this submission are the addition of polyaxial crosslink components for the PASS Spinal System. The subjects of this submission are the addition of polyaxial crosslink components for the PASS Spinal System. The polyaxial crosslink components are manufactured from titanium alloy per ASTM F136.
The hooks can be used for single or multiple level fixation. The polyaxial hooks have the same attachment mechanism of the PASS Spinal System polyaxial components cleared in K001024 and K012175.
The laminar hooks are inserted inferior and superior around the pedicles. The hooks are available in standard and double lamination with a superior offset. The double lamination hooks can be inserted inferior and superior around the pedicles with a pedicle screw assembly without any problem of superimposition.
The laminar hooks are inserted under the lamina and the polyaxial hooks are inserted under the pedicle. The polyaxial hooks are available from 0 to 30 degrees and the double lamination hooks can be inserted under the lamina with a pedicle screw assembly without any problem of superimposition.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Encore Orthopedics PASS Spinal System, formatted to answer your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., minimum tensile strength, fatigue life cycles) or their corresponding reported device performance values. Instead, it indicates that the device's performance was evaluated against a standard.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to ASTM F1717-96 Standards | The performance claims of the PASS Spinal System was performed according to ASTM F1717-96. |
Note: ASTM F1717-96 is a standard specification for spinal implant constructs in vitro static and fatigue testing. This implies that the device's performance was found to be within the acceptable parameters defined by this standard, though the specific numerical results are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "The performance claims of the PASS Spinal System was performed according to ASTM F1717-96." This standard outlines methods for in vitro testing of spinal implant constructs, which typically involves a specified number of samples for static and fatigue tests, but the exact number used in this specific study is not provided in the summary.
- Data Provenance: Not applicable in the context of clinical data for human or retrospective/prospective studies. The testing was in vitro (laboratory-based) according to an ASTM standard, not derived from human patients or clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to an in vitro mechanical performance study. "Ground truth" in this context would refer to the physical and mechanical properties of the device, established through standardized testing procedures, not through expert consensus or clinical evaluation.
4. Adjudication Method for the Test Set
This question is not applicable, as the study described is an in vitro mechanical performance test, not a clinical study requiring human adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The provided document describes the mechanical performance testing of an orthopedic implant (PASS Spinal System), not an AI-assisted diagnostic or therapeutic device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The product is a physical spinal implant system, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for this mechanical study is the physical properties and mechanical integrity of the spinal system components, as determined by standardized in vitro testing methods outlined in ASTM F1717-96. The "truth" is whether the device meets the mechanical performance requirements specified by that standard (e.g., in terms of bending stiffness, torsional stiffness, fatigue life).
8. The Sample Size for the Training Set
This question is not applicable. There is no mention of a "training set" as this is a mechanical performance study of a physical device, not a machine learning or AI model development.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as no training set was used.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.