(194 days)
The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the PERLA® TL Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The PERLA® TL Posterior Thoraco-lumbar Fixation System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL Posterior Thoraco-lumbar Fixation System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL Posterior Thoraco-lumbar Fixation System implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
The provided text describes a 510(k) premarket notification for the PERLA® TL Posterior Thoraco-lumbar Fixation System. This submission is an "Extension of the range" and an "MRI update" for an already cleared device.
Crucially, the document explicitly states that this is an extension of an existing device and focuses on mechanical testing of new components (rods, rod connectors) and MRI safety evaluations. It does NOT describe a study evaluating the clinical performance or diagnostic accuracy of an AI or software device. Therefore, many of the requested points related to AI performance, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.
However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this specific device extension.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Standard/Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ASTM F1798 | Results demonstrate that no new worst case has been added into the range for the added components (rod connectors and Z-rods). |
| MRI Safety Evaluation | ASTM F2052-2021 | MR Conditional (Magnetically Induced Displacement Force) |
| ASTM F2213-17 | MR Conditional (Magnetically Induced Torque) | |
| ASTM F2119-07 | Evaluation of MR Image Artifacts from Passive Implants conducted. Result: MR Conditional. | |
| ASTM F2182-19e2 | Measurement of Radio Frequency Induced Heating conducted. Result: MR Conditional. | |
| Material/Manufacture | ASTM F136 | Medical grade titanium alloy conforms to standard. |
| ASTM F1537 | Medical grade cobalt chromium conforms to standard. | |
| USP standard | Bacterial endotoxin testing meets pyrogenicity standard (Endotoxin limit of 20 EU / device). |
Explanation: The acceptance criteria for this device extension are primarily focused on the safety and performance of the added mechanical components and their compatibility with MRI environments, as well as adherence to material and manufacturing standards.
Regarding the points not applicable to this specific submission (as it's a hardware extension and MRI update, not an AI/software performance study):
- 2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document describes mechanical and MRI safety testing, not clinical data analysis. For mechanical testing, samples are typically physical devices.
- 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. No expert ground truth was established as this is not a diagnostic AI device.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method was used as this is not a diagnostic AI device.
- 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 is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for diagnostic accuracy is not relevant here. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM).
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.
§ 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.