(78 days)
The SeaSpine Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion; Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Deformities (i.e., scoliosis, kyphosis, and/or lordosis); Spinal tumor; Pseudoarthrosis; and/or Failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Daytona Small Stature Spinal System is indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Daytona® Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants including polyaxial and monoaxial pedicle screws as well as connecting spinal rods and a separate locking element. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and Cobalt Chrome alloy (Co-28Chromium-6Molybdenum per ASTM F1537).
This document is a 510(k) premarket notification for a medical device called the "SeaSpine Daytona Small Stature Spinal System." The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a new premarket approval application (PMA).
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with specific numerical thresholds that the device must meet for clinical performance. Instead, the "acceptance criteria" are implied by the regulatory standard of "substantial equivalence" to predicate devices, as demonstrated through mechanical testing.
| Acceptance Criteria (Implied by Substantial Equivalence and Mechanical Testing) | Reported Device Performance |
|---|---|
| Similar performance to predicate systems in static compression bending | Demonstrated similar performance to predicate systems per ASTM F1717 |
| Similar performance to predicate systems in dynamic compression fatigue | Demonstrated similar performance to predicate systems per ASTM F1717 |
| Similar performance to predicate systems in static torsion | Demonstrated similar performance to predicate systems per ASTM F1717 |
| Similar components to predicate devices | Components are similar to cited predicate devices |
| Similar device description to predicate devices | Device description is similar to cited predicate devices |
| Similar intended use/indications for use to predicate devices | Intended use/indications for use are similar to cited predicate devices |
| Similar technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) to predicate devices | Technological characteristics are similar to cited predicate devices |
| Similar basic design concept for safety and effectiveness to predicate devices | Represents a basic design concept in terms of safety and effectiveness, differing only in design details, not functionality |
2. Sample Size Used for the Test Set and Data Provenance
- Test set sample size: Not applicable. The "test set" in this context refers to mechanical testing rather than a clinical dataset. The document states "The SeaSpine® Daytona® Small Stature Spinal System demonstrated similar performance to the predicate systems through static compression bending, dynamic compression fatigue, and static torsion mechanical testing per ASTM F1717." It does not specify the number of devices or components tested, as is common for mechanical bench testing summaries in 510(k)s.
- Data provenance: Not applicable in the context of clinical data. The performance data comes from non-clinical (mechanical) laboratory testing conducted according to ASTM F1717. The country of origin for such testing is not specified, but it's typically performed by the manufacturer or a contracted lab. This is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For this type of mechanical bench testing, ground truth is established by standardized testing protocols (ASTM F1717) and engineering measurements, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human readers or assessments that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." Therefore, no MRMC study was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical spinal implant system, not a software algorithm or AI tool. Performance is evaluated through mechanical testing, not algorithm performance.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical testing is implied by the technical specifications and performance characteristics defined by the ASTM F1717 standard for spinal implant systems, against which the device's mechanical performance is measured and compared to predicate devices. It is based on engineering standards and measurements.
8. Sample Size for the Training Set
Not applicable. This refers to the training of an algorithm, which is not relevant for this physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an algorithm, there is no training set or ground truth established in that context.
§ 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.