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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.

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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