(41 days)
The PERLA® posterior cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic spine from Tl-T3: traumatic 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 cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the 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. In order to achieve additional levels of fixation, the PERLA® posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior Osteosynthesis System with rod connectors. Transition rods may also be used to connect the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.
The Spineart Perla® system is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and the upper thoracic spine. Perla® system consists of a variety of shapes and sizes of rods, hooks, multi-axial screws, set screws, rod connectors and transverse connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The multi-axial screws are available with diameters 3.5mm and 4.0 mm with lengths ranging from 08 mm up to 52 mm. The purpose of this Special 510(k) application is to introduce an additional range of multi-axial screw with 4.5 mm diameter and lengths ranging from 08 mm up to 52 mm to the Perla® spinal system.
The provided document is a 510(k) summary for the SPINEART Perla® Posterior Cervico-Thoracic Fixation System. It describes a device modification, specifically the introduction of an additional range of multi-axial screws with a 4.5 mm diameter.
Here's an analysis of the acceptance criteria and study information, based solely on the provided text:
Key Takeaway: This 510(k) is for a modification to an existing device (Perla® Posterior Cervico-Thoracic Fixation System, cleared under K153386). The modification is the introduction of a new screw diameter (4.5mm). The submission leverages previous testing and an engineering analysis to demonstrate substantial equivalence, rather than conducting new performance studies for the specific modification. As such, the information you requested regarding acceptance criteria and performance data for a new study is largely not present for this specific submission because it was deemed unnecessary due to the nature of the modification.
1. A table of acceptance criteria and the reported device performance
Based on the provided document, there are no specific numeric acceptance criteria for device performance reported for this specific 510(k) submission (K190071). Instead, the submission relies on the existing performance data and acceptance for the predicate device (Perla® Posterior Cervico-Thoracic Fixation System, K153386).
The document states: "An engineering analysis was performed and determined the new 4.5 mm multi-axial screws do not constitute a new worst-case design in the Perla spinal system. No additional testing has been performed for the Perla® 4.5 mm multi-axial screws."
It then lists non-clinical tests that were conducted on the predicate devices:
| Test Type | Standard | Acceptance Criteria (Not explicitly stated for this submission, inferred from standards) | Reported Device Performance (Not explicitly stated for this submission) |
|---|---|---|---|
| Static Compression Bending | ASTM F1717 | Device should meet specified strength/integrity requirements of the standard | Implied to have met requirements for predicate device |
| Static Torsion | ASTM F1717 | Device should meet specified strength/integrity requirements of the standard | Implied to have met requirements for predicate device |
| Dynamic Compression Bending | ASTM F1717 | Device should meet specified strength/integrity requirements of the standard | Implied to have met requirements for predicate device |
| Static flexion-extension testing | ASTM F1798 | Device should meet specified strength/integrity requirements of the standard | Implied to have met requirements for predicate device |
| Static axial gripping | ASTM F1798 | Device should meet specified strength/integrity requirements of the standard | Implied to have met requirements for predicate device |
| Static torsion gripping | ASTM F1798 | Device should meet specified strength/integrity requirements of the standard | Implied to have met requirements for predicate device |
| Axial pullout strength | ASTM F543 | Device should meet specified strength requirements of the standard | Implied to have met requirements for predicate device |
| Torque to failure | ASTM F543 | Device should meet specified strength requirements of the standard | Implied to have met requirements for predicate device |
| Bacterial endotoxin testing (Pyrogenicity testing) | USP standard (for Endotoxin limit of 20 EU / device) | Endotoxin limit of 20 EU / device | Implied to have met this limit for predicate device |
2. Sample size used for the test set and the data provenance
As no new performance testing was conducted for the 4.5 mm multi-axial screws due to the engineering analysis, there is no "test set" and thus no sample size or data provenance specified for this particular modification. The previous testing for the predicate device would have had its own sample sizes, but those are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new clinical or performance test set (requiring expert ground truth) was performed for this specific 510(k) submission.
4. Adjudication method for the test set
Not applicable, as no new clinical or performance test set (requiring adjudication) was performed for this specific 510(k) submission.
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 device is a mechanical implant (spinal fixation system), not an AI-driven diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new performance studies requiring ground truth were conducted for this submission. The "ground truth" for mechanical testing is the physical measurement against the standard.
8. The sample size for the training set
Not applicable, as no AI/algorithm is involved, and no new training set was mentioned for mechanical testing.
9. How the ground truth for the training set was established
Not applicable, as no AI/algorithm is involved, and no new training set or corresponding ground truth establishment was discussed.
§ 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.