(236 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 fusion of the Occipital, Cervical, and Thoracic regions of the spine (Occiput-T3). The system consists of a variety of rods, occipital plates, occipital screws, polyaxial screws, cross-connectors, lateral offset, domino connectors, and hooks to achieve an implant construct that closely matches patient anatomy. The Reform POCT System implants are fabricated from titanium, 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 alloy, and medical grade cobalt chromium may be used together, however, should not be used with stainless steel. The system also includes the instruments 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.
Based on the provided K172495 document for the Precision Spine Reform® POCT System, here's a description of the acceptance criteria and the study that proves the device meets them:
Important Note: The provided document is a 510(k) summary for a spinal fixation system, which is a medical implant. The "acceptance criteria" and "study" described in this document refer to mechanical and material performance testing for substantial equivalence against predicate devices, not a clinical study involving human patients or an AI algorithm’s performance. Therefore, many of the typical questions for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies) are not applicable to this type of device submission and thus cannot be answered from the provided text.
Acceptance Criteria and Device Performance for Precision Spine Reform® POCT System (K172495)
The acceptance criteria for the Reform® POCT System are not explicitly listed with numerical targets in the document. Instead, the study's goal was to demonstrate substantial equivalence to legally marketed predicate devices based on technological characteristics and mechanical performance. The implicit acceptance criterion is that the device's mechanical performance is "substantially equivalent" to the specified predicate devices.
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:
| Feature/Test Mode | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Material | Compatible with standards (ASTM F136, ASTM F1537, ISO 5832-3) and similar to predicates. | Fabricated from titanium, titanium alloy, or cobalt chromium alloys as described by these standards, similar to predicates. |
| Sterility | Non-sterile, single-use only, similar to predicates. | Supplied clean and "NON-STERILE." Single use only. Similar to predicates. |
| Indications for Use | Similar to predicate devices listed in Table 5-1. | Stated indications for use are similar to those of predicates K162300, K151755, and K153631. |
| Principles of Operation | Similar to predicate devices. | Similar to predicate devices. |
| Dynamic Axial Compression (per ASTM F2706) | Strength is substantially equivalent to legally marketed predicate devices. | Tested, and results show "strength... is substantially equivalent to legally marketed predicate devices." |
| Dynamic Torsion (per ASTM F2706) | Strength is substantially equivalent to legally marketed predicate devices. | Tested, and results show "strength... is substantially equivalent to legally marketed predicate devices." |
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 dynamic axial compression and dynamic torsion. It only states that "The Reform® POCT System has been tested in the following test modes." For mechanical testing, this typically involves a sufficient number of samples to generate statistically meaningful data for comparison.
- Data Provenance: The testing was "non-clinical testing" and was conducted to support the 510(k) submission. The document does not provide details on the location of the testing facility (e.g., country of origin), nor does it describe data as retrospective or prospective (as this terminology applies to clinical studies, not mechanical bench testing).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This is a mechanical device, not an AI/ML diagnostic tool. Ground truth in this context is established by standardized mechanical testing protocols (e.g., ASTM F2706) and the physical properties and performance of the device itself compared to predicate devices, not by expert interpretation of images or data.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is mechanical bench testing, there is no "adjudication method" in the sense of multiple human experts reviewing results. The results are quantitative measurements obtained through standardized test methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is relevant to diagnostic devices and AI algorithms where human readers interpret medical images or data. It is not applicable to a spinal implant system like the Reform® POCT System, which is evaluated based on its mechanical and material properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI algorithm. Its performance is tested as a standalone mechanical device.
7. The Type of Ground Truth Used:
- The ground truth for this device's performance is established through standardized mechanical engineering tests (e.g., ASTM F2706 for dynamic axial compression and dynamic torsion) performed on the device components and constructs. The performance is then compared to the known performance of predicate devices or to established industry standards to demonstrate "substantial equivalence."
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. There is no training set for this type of device.
§ 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.