(98 days)
The Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-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 Precision Spine Reform® POCT 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 Reform® POCT System is a posterior spinal fixation system intended for use in all the Occipital, Cervical and Thoracic regions of the spine (Occiput - T3). The system consists of a variety of rods, occipital plates, occipital screws, cross connectors, pedicle screws, domino connectors, and hooks to achieve an implant construct that matches adjacent anatomy. The Reform® POCT Implants are from titanium alloy, or cobalt chromium alloys as described by standards such as ASTM F136, ASTM F1537, or ISO 5832-3. Implants made from medical grade titanium, medical grade titanium, medical grade cobalt chromium may be used together, however, should not be used with stainless steel. The system also includes the instrument necessary for inserting and securing the implants. The components are supplied clean and "NON-STERILE". All implants are single use only and should not be reused under any circumstances.
This document is a 510(k) premarket notification from the FDA, specifically concerning the Reform® POCT System for spinal fixation. It details the device's indications for use and compares its technological characteristics and performance data to predicate devices to establish substantial equivalence.
Based on the provided text, here's a breakdown of the requested information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on mechanical performance testing to demonstrate substantial equivalence to predicate devices. It does not provide a table with specific numerical acceptance criteria (e.g., minimum load bearing capacity in kN) and corresponding numerical performance results for the Reform® POCT System. Instead, it states that the testing "show that the strength of the Reform® POCT System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
The tests performed are:
| Acceptance Criteria (Stated) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength for Intended Use | The test results show that the strength of the Reform® POCT System is sufficient for its intended use. |
| Substantial Equivalence to Predicate Devices | The test results show that the Reform® POCT System is substantially equivalent to legally marketed predicate devices. |
Specific Test Modes Performed:
- Static axial compression bending per ASTM F1717-14
- Static torsion per ASTM F1717-14
- Dynamic axial compression bending per ASTM F1717-14
- Static axial compression bending per ASTM F2706-08 (2014)
- Static axial tension bending per ASTM F2706-08 (2014)
- Static torsion per ASTM F2706-08 (2014)
- Dynamic axial compression bending per ASTM F2706-08 (2014)
- Dynamic torsion per ASTM F2706-08 (2014)
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of devices or constructs tested for each of the mechanical tests performed. The tests are listed by standard (ASTM F1717-14, ASTM F2706-08), which typically define the minimum sample sizes for such testing.
- Data Provenance: This is a non-clinical performance study (mechanical testing), not a study involving patient data. The testing was conducted by Empirical Testing Corp. (presumably in Colorado Springs, Colorado, USA, based on the submitter's address). This is likely prospective testing conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of study (mechanical performance testing) does not involve experts establishing "ground truth" in the way a clinical study or AI model validation would. The "ground truth" is based on established engineering principles and the specified ASTM standards themselves, which define methodologies for evaluating mechanical properties. There are no radiologists or other clinical experts involved in this aspect.
4. Adjudication Method for the Test Set
Not applicable. As a mechanical performance study, there is no "adjudication" between human readers or experts. The results are quantitative measurements against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document describes mechanical performance testing, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is a physical device, not an AI algorithm. The performance is the device's inherent mechanical properties.
7. The Type of Ground Truth Used
For this mechanical performance study, the "ground truth" is defined by the ASTM standards (F1717-14 and F2706-08 (2014)) themselves. These standards specify the methods, test conditions, and acceptable ranges (or comparisons to predicates) for evaluating spinal implant strength. The "ground truth" is rooted in engineering principles and established benchmarks for spinal fixation device performance.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a mechanical device. The design and manufacturing processes are validated against engineering specifications, and the device's performance is then verified through the described mechanical tests.
§ 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.