(28 days)
The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.
The predicate CapSure® PS System consists of a selection of non-sterile, single use, titanium alloy screws and connectors, and titanium alloy and cobalt chrome rod components that are assembled to create a rigid spinal construct. The components of the predicate CapSure® PS System are attached to the non-cervical spine of skeletally mature patients in order to stabilize the spine during fusion of vertebral bodies, and are intended to be removed after spinal fusion is achieved.
This document describes a 510(k) premarket notification for a medical device called the CapSure® PS System, a pedicle screw spinal system. The submission seeks clearance for additional components to an already cleared system. As such, the information provided focuses on the substantial equivalence to a predicate device rather than on novel acceptance criteria and a detailed clinical study demonstrating performance against those criteria as would be required for a de novo submission or a new device with significant technological differences.
Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as detailed study information often associated with AI/software devices, cannot be fully generated. This document pertains to a hardware medical device (pedicle screw system), and therefore, the type of "acceptance criteria" and "study" are different from what one might expect for a software or AI-based device.
However, I can extract the available information related to performance data and the rationale for claiming substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from testing) | Reported Device Performance / Rationale |
|---|---|---|
| Mechanical Performance | Static Compression | "The modified implants were compared to constructs previously tested in static compression... in accordance with ASTM F1717." |
| Static Torsion | "The modified implants were compared to constructs previously tested in... static torsion... in accordance with ASTM F1717." | |
| Dynamic Compression | "The modified implants were compared to constructs previously tested in... dynamic compression in accordance with ASTM F1717." | |
| Safety and Effectiveness | Substantial Equivalence | "An engineering rationale determined that the proposed implants do not represent a new worst case and were therefore determined to be substantially equivalent to the predicate devices." |
| No new issues of safety or effectiveness | "Based on the indications for use, technological characteristics and comparison to a predicate, the subject CapSure® PS System... does not present any new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of human subjects or a large dataset often associated with AI/software studies. Instead, it refers to "modified implants" and "constructs previously tested." This implies an engineering test setup with a limited number of physical components for mechanical testing. No specific number is given.
- Data Provenance: Not applicable in the context of clinical data or country of origin. The data provenance is from mechanical testing conducted in accordance with ASTM F1717. The document does not specify where these tests were performed, but given the manufacturer is US-based and seeking FDA clearance, it's presumed to be from a reputable testing facility, likely within the US, or a recognized international body. The tests are "retrospective" in the sense that the modified implants are compared to "constructs previously tested" rather than new testing being exclusively performed for the new components (though some testing was likely done to ensure the comparison is valid).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a hardware medical device; the "ground truth" is established by adherence to recognized mechanical testing standards (ASTM F1717) and engineering principles, not through expert consensus on medical images or clinical outcomes in the same way an AI device would. The "experts" involved would be mechanical engineers and test technicians responsible for performing and interpreting the mechanical tests.
4. Adjudication Method for the Test Set
- Not Applicable. As this is mechanical testing of hardware, there is no expert adjudication process in the manner of multiple medical professionals independently reviewing cases and reaching a consensus. The "adjudication" is based on whether the devices meet the specified parameters of the ASTM F1717 standard and if the engineering rationale for substantial equivalence is sound.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for evaluating the performance of AI/software in a clinical context (e.g., how AI assistance impacts human readers' diagnostic accuracy). This document pertains to a physical implantable device, so an MRMC study was not conducted or required for this type of submission.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- No. This is a hardware device. There is no standalone algorithm to evaluate.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance is the mechanical test results obtained by following recognized industry standards (ASTM F1717) for spinal implant performance, alongside an engineering rationale demonstrating that the updated components do not negatively impact these established performance characteristics and are equivalent to the predicate.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set for this hardware device.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.