(84 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 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 (13 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, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The Medicrea PASS LP Spinal System consists of pedicle screws, hooks, sacral plates, 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
Here's an analysis based on the provided text:
This document is a 510(k) summary for a medical device called the PASS LP Spinal System. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and clinical performance studies of the type described in the prompt. The provided text primarily focuses on comparing the new device to existing legally marketed predicate devices and outlining the mechanical testing performed.
Therefore, the requested information about acceptance criteria and studies demonstrating that the device (i.e., AI/software) meets these criteria cannot be fully extracted from this document, as it pertains to a mechanical spinal implant system, not a software device.
However, I can extract what is available regarding the mechanical aspects of the device and structure it to the best of my ability according to your request, while highlighting the absence of information relevant to software performance studies.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for spinal implant) | Reported Device Performance (from text) |
|---|---|
| Mechanical soundness, comparable to commercially available devices. | Mechanical tests such as static torsion, static and dynamic compression bending (according to ASTM F1717), static axial sliding, static torsion, and dynamic flexion/extension (according to ASTM F1798) have been performed. |
| The purpose of these tests was "to indicate that the products are as mechanically sound as other devices commercially available." | |
| Material conformity | Manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. |
| Geometric similarity | The new device and previously cleared PASS LP devices "have the same geometry." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the mechanical tests.
- Data Provenance: Not specified, but generally, mechanical testing is performed in a lab setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This information is for medical device software performance evaluations involving expert interpretation. The provided document describes mechanical testing of a spinal implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This information is for medical device software performance evaluations involving expert interpretation. The provided document describes mechanical testing of a spinal implant.
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
- No MRMC study was done. This device is a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a mechanical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical performance, the "ground truth" would be the standards set by ASTM (e.g., F1717, F1798) for mechanical properties and the ASTM F136 standard for titanium alloy material properties. The device's performance is compared against these engineering standards and to the performance of predicate devices.
8. The sample size for the training set
- Not applicable. This document describes a mechanical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is for a mechanical implant, not a machine learning model.
Summary of Device and Study:
The device is the PASS LP Spinal System, an orthopedic implant designed for spinal fixation. This 510(k) submission is for an "Additional components" to the already cleared system, specifically noting the "PASS MIS" product as having the same material and geometry as existing PASS LP devices, but with restrained indications for use.
The "study" or performance data presented focuses on mechanical testing:
- Tests Performed: Static torsion, static and dynamic compression bending (per ASTM F1717), static axial sliding, static torsion, and dynamic flexion/extension (per ASTM F1798).
- Purpose of Testing: To demonstrate that the additional components are "as mechanically sound as other devices commercially available."
- Material Conformance: The device is manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
The document does not contain information related to AI/software performance studies, human reader performance, or clinical efficacy trials beyond the statement that mechanical tests were performed to demonstrate mechanical soundness compared to predicates. The 510(k) clearance (K112493) confirms substantial equivalence to the predicate devices based on the information provided, including the mechanical testing.
§ 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.