(58 days)
The PERLA® posterior occipito-cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the crania-cervical junction. the cervical spine (Cl to C7) and the thoracic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The PERLA® posterior occipito-cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the cervical spine (Cl to C7) and the thoracic spine (Tl to T3).
In order to achieve additional levels of fixation, the PERLA® posterior occipito-cervico-thoracic fixation system may be connected to the ROMEO®2 and PERLA® TL Posterior Osteosynthesis Systems with rod connectors. Transition rods mav also be used to connect the PERLA® posterior occipito-cervico-thoracic fixation system to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems. Refer to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems packages inserts for a list of the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems indications of use. PERLA® posterior occipito-cervico-thoracic fixation system is indicated for skeletally mature patients.
The PERLA® 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® system is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® 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 on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PERLA® Posterior Occipito-Cervico-Thoracic Fixation System.
Important Note: This document is a 510(k) summary for a medical device. It describes the device as "substantially equivalent" to predicate devices based on non-clinical testing. It does not contain information about software performance, AI algorithms, clinical study outcomes for human readers, or ground truth establishment in the ways typically expected for AI/ML device submissions. The questions asked are highly relevant for AI/ML medical devices, but the provided text describes a traditional orthopedic implant. Therefore, many of your questions cannot be answered from this document.
Explanation of Device: The PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is a surgical implant designed to provide immobilization and stabilization of spinal segments. It consists of various components like screws, rods, and connectors, made of medical-grade titanium alloy and cobalt chromium. The 510(k) submission is for a line extension of the PERLA® system to include components for occipital fixation.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a hardware orthopedic implant and not an AI/ML device, the "acceptance criteria" and "device performance" are related to mechanical and material properties, rather than diagnostic accuracy metrics (e.g., sensitivity, specificity).
| Acceptance Criteria (Study Type) | Reported Device Performance |
|---|---|
| Static Compression Bending per ASTM F2706-18 | Results demonstrate comparable mechanical properties to the predicate devices. |
| Static Torsion per ASTM F2706-18 | Results demonstrate comparable mechanical properties to the predicate devices. |
| Dynamic Compression Bending per ASTM F2706-18 | Results demonstrate comparable mechanical properties to the predicate devices. |
| Dynamic Torsion per ASTM F2706-18 | Results demonstrate comparable mechanical properties to the predicate devices. |
| Bacterial Endotoxin Testing | Achieved Endotoxin limit of 20 EU / device (as specified in USP standard for pyrogenicity testing). |
| Material Composition | Medical grade titanium alloy and medical grade cobalt chromium conforming to standards ASTM F136 and ASTM F1537, respectively. |
| Sterilization | Delivered non-sterile or sterile (gamma sterilization). |
2. Sample Size Used for the Test Set and Data Provenance
The study described is non-clinical bench testing (mechanical and material testing), not a clinical study involving patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this device. The "test set" would refer to the physical samples of the device components subjected to the mechanical tests. The document does not specify the number of individual components tested but states that "non-clinical tests were conducted on the PERLA® components for occipital fixation."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to an orthopedic implant submission based on non-clinical bench testing. "Ground truth" in this context would be the measured physical properties of the materials and constructs, determined by laboratory equipment and standard mechanical testing protocols, not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. As explained above, the "test set" is physical device components, and the "adjudication method" does not apply to non-clinical mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, this type of study was not done. An MRMC study is relevant for AI/ML diagnostic devices where human readers interpret medical images or data. The PERLA® system is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The device is a physical surgical implant, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing:
- Mechanical Performance: The "ground truth" is the quantitative results (e.g., load to failure, fatigue life) obtained from standardized mechanical tests (ASTM F2706-18). This is based on objective physical measurements according to established engineering standards.
- Material Composition: The "ground truth" is that the materials conform to specific ASTM standards (F136, F1537) for medical-grade titanium alloy and cobalt chromium, verified through material characterization tests.
- Pyrogenicity: The "ground truth" is that the device meets the endotoxin limit of 20 EU/device, as measured by bacterial endotoxin testing following USP standards.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML model or "training set" for this physical implant device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.