(149 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), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates, when used for posterical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct 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. 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.
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. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.
The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of new components: Polyaxial Cannulated Pedicle Screws.
The provided text is a 510(k) Summary for a medical device (PASS LP Spinal System) and does not contain information about the acceptance criteria and a study proving the device meets those criteria in the way a performance study for an AI/ML diagnostic device usually would.
This document describes a premarket notification for a spinal implant system, which is a physical device, not an AI/ML algorithm. Therefore, the typical "acceptance criteria" and "performance study" as they pertain to AI/ML diagnostic tools (e.g., sensitivity, specificity, AUC, human reader improvement) are not applicable here.
Instead, the performance data provided focuses on:
- Biocompatibility Testing: Ensuring the materials are safe for use in the human body.
- Mechanical Testing: Demonstrating the structural integrity and strength of the physical components.
Here's an analysis of the provided information based on the typical categories for AI/ML device performance, highlighting why much of it is not present in this physical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for an AI/ML device) | Reported Device Performance (PASS LP Spinal System) | Relevance to AI/ML |
|---|---|---|
| Not applicable | Biocompatibility Testing: | Not applicable |
| (e.g., Clinical Sensitivity, Specificity, AUC) | - Cytotoxicity: Passed | |
| - Sensitization: Passed | ||
| - Irritation: Passed | ||
| - Systemic toxicity: Passed | ||
| - Pyrogen Testing: Passed | ||
| Mechanical Testing: | Not applicable | |
| - Pull out (ASTM F543): Performed, indicates mechanically sound | ||
| - Static torsion (ASTM F2193): Performed, indicates mechanically sound | ||
| - Static bending (ASTM F2193): Performed, indicates mechanically sound |
Note: The document explicitly states "No clinical studies were performed. No animal studies were performed." for this 510(k) submission, as it relies on substantial equivalence to predicate devices for its intended use.
2. Sample size used for the test set and the data provenance
- Not Applicable: This pertains to an AI/ML algorithm trained and tested on data. The PASS LP Spinal System is a physical implant. The biocompatibility and mechanical tests are performed on materials and components, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: Ground truth establishment by experts is relevant for AI/ML diagnostic devices. For a physical spinal system, the safety and performance are assessed through laboratory and material testing against established engineering standards (ASTM, ISO).
4. Adjudication method for the test set
- Not Applicable: Adjudication is for resolving discrepancies in expert interpretations for AI/ML ground truth.
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: An MRMC study is for evaluating human performance with and without an AI diagnostic aid. This device is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: Standalone performance refers to an AI algorithm's diagnostic accuracy without human interaction. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the physical device, the "ground truth" for its safety and efficacy is established through a combination of:
- Adherence to Material Standards: Conformance to ASTM F136 and ISO 5832-3 for titanium alloy and ISO 5832-12 and ASTM F1537 for cobalt-chromium molybdenum alloy.
- Biocompatibility Testing Standards: Following FDA Memorandum #G95-1 and ISO 10993-1.
- Mechanical Testing Standards: Specific ASTM standards (F543 for pull-out, F2193 for static torsion and bending).
- Substantial Equivalence: The primary basis for this 510(k) clearance is that the device is substantially equivalent to previously cleared predicate devices (K141398 and K112493) in terms of indications for use, design, material, and function. The "ground truth" for its clinical safety and effectiveness is inferred from the established track record of these predicate devices.
8. The sample size for the training set
- Not Applicable: This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable: There is no training set for this physical device.
Summary for the provided document:
The document describes the PASS LP Spinal System, an orthopedic implant. The "performance data" section in this 510(k) summary focuses entirely on the biocompatibility of the materials and the mechanical strength of the components, tested against established industry standards. The submission relies on substantial equivalence to predicate devices. The concepts of acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and training sets are specific to AI/ML diagnostic software and are not applicable to 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.