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510(k) Data Aggregation
(51 days)
The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is 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.
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,
- · spondylolisthesis,
- · trauma (i.e., fracture or dislocation),
· spinal stenosis,
- · deformities or curvatures (i.e., scoliosis, and/or lordosis),
- · spinal tumor,
- pseudarthrosis, and/or
- · failed previous fusion.
The Mariner Pedicle Screw System is a non-cervical spinal fixation system used to build constructs within the body to act as temporary or permanent non-cervical spinal fixation devices and is intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle fixation system, and/or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusion to occur.
The Mariner Pedicle Screw System includes a variety of non-sterile, single-use implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and/or cobalt chrome alloy (Co-28Cr-6Mo per ASTM F1537 or Co-35Ni-20Cr-10Mo per ASTM F562) and is comprised of fixed, uni-axial, uni-planar, and polyaxial and motion-limiting modular pedicle screws, as well as connecting spinal rods, hooks, connectors, crossbars, and a separate locking element. The instruments included in the Mariner Pedicle Screw System facilitate the placement, adjustment, final locking, and removal, if necessary, of the system implants, and accessories to the system include trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
The Mariner RDX System provides additional implants and instruments to expand the functionality of the Mariner platform and provide surgeons with reduction-integrated implants to allow for implant-based reduction techniques with an open or minimally invasive approach. Additional implants include a locking cap and a variety of modular standard tab, and MIS screw heads, as well as additional instruments and accessories.
The provided text describes a medical device, the Mariner RDX System, and its clearance by the FDA based on substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for a new type of performance or diagnostic capability. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted.
However, I can provide the following:
1. A table of acceptance criteria and the reported device performance
The provided document describes the non-clinical testing for the Mariner RDX System as follows:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent mechanical performance to predicate systems established via static and dynamic mechanical testing with reference to ASTM F1717. | The Mariner RDX System demonstrated equivalent mechanical performance to the predicate systems through static and dynamic mechanical testing with reference to ASTM F1717. |
2. Sample sized used for the test set and the data provenance
Not applicable. The clearance is based on non-clinical mechanical testing, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth from experts is not relevant for this type of mechanical testing.
4. Adjudication method for the test set
Not applicable. Adjudication methods are not relevant for this type of mechanical testing.
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
Not applicable. The document explicitly states: "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This is a mechanical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
For the non-clinical testing, the "ground truth" or standard for comparison was the mechanical performance of the predicate systems as defined by ASTM F1717.
8. The sample size for the training set
Not applicable. This is not an AI or algorithm-based device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(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.
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