(61 days)
The PERLA® TL posterior osteosynthesis system is 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL posterior osteosynthesis system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL posterior osteosynthesis system is intended to be used with autograft and/or allograft.
Pediatric pedicle screw fixation is limited to a posterior approach.
The PERLA® TL posterior osteosynthesis 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 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 osteosynthesis implants are delivered either non sterile or sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile except for the drill supplied as sterile or not sterile). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
This document pertains to the PERLA® TL posterior osteosynthesis system, a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets are not applicable.
However, based on the provided text, I can extract information regarding the device's acceptance criteria and the study conducted to prove it meets these criteria, focusing on the mechanical aspects relevant to this type of medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing per ASTM Standards) | Reported Device Performance (PERLA® TL System) |
|---|---|
| Static Axial Gripping per ASTM F1798: Must meet or exceed the performance of the predicate device. | Results demonstrate comparable mechanical properties to the predicate device (ROMEO® 2 Posterior Osteosynthesis System). |
| Static Axial Torque Gripping per ASTM F1798: Must meet or exceed the performance of the predicate device. | Results demonstrate comparable mechanical properties to the predicate device (ROMEO® 2 Posterior Osteosynthesis System). |
| Static Compression Bending per ASTM F1717: Must meet or exceed the performance of the predicate device. | Results demonstrate comparable mechanical properties to the predicate device (ROMEO® 2 Posterior Osteosynthesis System). |
| Static Torsion per ASTM F1717: Must meet or exceed the performance of the predicate device. | Results demonstrate comparable mechanical properties to the predicate device (ROMEO® 2 Posterior Osteosynthesis System). |
| Dynamic Compression Bending per ASTM F1717: Must meet or exceed the performance of the predicate device. | Results demonstrate comparable mechanical properties to the predicate device (ROMEO® 2 Posterior Osteosynthesis System). |
| Bacterial Endotoxin Limit: Not explicitly stated as "acceptance criteria" but mentioned for pyrogenicity testing. The device must achieve an Endotoxin limit of 20 EU/device as specified in USP standard. | Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the mechanical tests (Static Axial Gripping, Static Axial Torque Gripping, Static Compression Bending, Static Torsion, and Dynamic Compression Bending). These are typically bench tests conducted on a sufficient number of device samples to ensure statistical validity and demonstrate equivalence to the predicate device.
Data provenance: The tests were conducted according to ASTM standards, which are internationally recognized. The data is from non-clinical testing performed by Spineart to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the objective measurement of mechanical properties against established ASTM standards and comparison to a legally marketed predicate device.
4. Adjudication method for the test set
Not applicable. Mechanical testing governed by ASTM standards uses objective measurements and predefined pass/fail criteria, often through comparison to a predicate device, rather than expert adjudication.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used
For the mechanical tests, the ground truth is established by the specified ASTM standards (e.g., F1798, F1717) themselves, which define methodologies for measuring specific mechanical properties. The performance of the predicate device (ROMEO® 2 Posterior Osteosynthesis System) also serves as a benchmark for demonstrating substantial equivalence. For bacterial endotoxin, the USP standard defines the acceptable limit. A "cadaver lab trial" was also conducted, which provides real-world functional insights, but its "ground truth" would be observational and qualitative regarding surgical handling and fit rather than a strict quantitative measure against a "ground truth" in the diagnostic sense.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device. There is no concept of a "training set" in the context of mechanical performance testing for this type of implant.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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.