(63 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 TI-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 radios, 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 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.
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 Perla® system can also be linked to the cleared Spineart Romeo®2 spinal system (K151695) using the specific Perla® Axial and Parallel Rod to Rod connectors 3.5/5.4mm or the Perla® Transition Rods 3.5/5.4mm which are part of this submission.
The provided document is a 510(k) summary for the PERLA® Posterior Cervico-Thoracic Fixation System. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML device.
The information provided describes a traditional medical device (implantable fixation system for spinal segments) and its FDA clearance process. It does not involve AI or algorithms, and therefore, the requested information about AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not applicable or present in this document.
Therefore, the table below will be filled with "Not Applicable" or "Information Not Provided" as the document pertains to a physical medical device and not an AI/ML system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for AI/ML device) | Reported Device Performance (from document, if applicable to AI/ML) |
|---|---|
| Not Applicable (no AI/ML device) | Not Applicable (no AI/ML device) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Information Not Provided (Not applicable to a physical spinal fixation system)
- Data Provenance: Information Not Provided (Not applicable to a physical spinal fixation system)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Information Not Provided (Not applicable to a physical spinal fixation system)
- Qualifications of Experts: Information Not Provided (Not applicable to a physical spinal fixation system)
4. Adjudication method for the test set
- Adjudication Method: Information Not Provided (Not applicable to a physical spinal fixation system)
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
- MRMC Study Conducted?: No (Not applicable; this is a physical spinal fixation system, not an AI/ML system for image interpretation or diagnosis by human readers.)
- Effect Size: Not Applicable
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study Conducted?: No (Not applicable; this is a physical spinal fixation system, not an AI/ML algorithm.)
7. The type of ground truth used
- Type of Ground Truth: Information Not Provided (Not applicable to a physical spinal fixation system. For this device, "ground truth" would refer to manufacturing specifications, material properties, and mechanical testing results, which are detailed in the document but not in the context of diagnostic "ground truth" for AI.)
8. The sample size for the training set
- Training Set Sample Size: Information Not Provided (Not applicable to a physical spinal fixation system)
9. How the ground truth for the training set was established
- Ground Truth Establishment: Information Not Provided (Not applicable to a physical spinal fixation system)
Summary of Device Performance (from the document, relevant to a physical device):
The document states that "Published literature and bench testing per ASTM F1717 demonstrate that the PERLA® posterior cervico-thoracic fixation system is substantially equivalent to the predicate devices."
The following non-clinical tests were conducted:
- Static Compression Bending, Static Torsion, and Dynamic Compression Bending according to ASTM F1717.
- Static flexion-extension testing, Static axial gripping, and Static torsion gripping according to ASTM F1798.
- Axial pullout strength and Torque to failure according to ASTM F543.
The conclusion is that "Design comparisons and non-clinical performance testing demonstrate that the PERLA® posterior cervico-thoracic fixation system is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function."
These tests and their results are used to establish substantial equivalence for a traditional spinal implant, not to evaluate the performance of an AI/ML algorithm against predefined acceptance criteria for diagnostic accuracy or similar metrics.
§ 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.