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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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The intended use of the Mariner Pedicle Screw System is to provide immobilization 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,

• severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions 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 or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

• spinal tumor,

• pseudoarthrosis, and/or

• failed previous fusion.

The SeaSpine Mariner Pedicle Screw system is a system consisting of instruments and single-use implants intended to build constructs within the body to act as a temporary or permanent posterior, non-cervical pedicle fixation system, or an anterolateral fixation system to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The Mariner implants are manufactured solely from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The instruments included in the Mariner System facilitate the placement, removal, adjustment, and final locking of the system implants. The instruments also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) premarket notification from the FDA regarding the Mariner Pedicle Screw System by SeaSpine Orthopedics Corporation. It establishes substantial equivalence to previously marketed devices and does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets them because:

• This document is for a traditional medical device (pedicle screw system), not an AI/ML medical device. The questions posed are highly specific to the evaluation of AI/ML algorithms, particularly the use of test sets, ground truth establishment by experts, and analysis of AI-augmented human reader performance.
• The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further confirms that no clinical study (or AI/ML performance study) was conducted or presented in this 510(k) submission to demonstrate performance against specific acceptance criteria for an AI/ML algorithm.

The non-clinical testing mentioned refers to mechanical testing of the physical screw system components (static and dynamic cantilever mechanical testing with reference to ASTM F1717 and screw head disassociation testing), which is standard for orthopedic implants, not AI/ML software.

The document's purpose is to establish that the new pedicle screw system is substantially equivalent in design, materials, and intended use to predicate devices already on the market, thereby demonstrating safety and effectiveness without requiring new clinical trials.

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of the Malibu adjustable cross connector from SeaSpine Inc. to the Coral™ Spinal System. Cross connectors are used to connect the bi-lateral rods of a spinal construct to add torsional rigidity. The cross connectors are available in two styles, straight and contoured, the different styles offer the surgeon options intraoperatively. The straight cross connector offers the surgeon a low profile compared to the surrounding construct. The contoured cross connector offers surgeons an option that is slightly higher in profile but provides additional clearance between the cross connector and the spinal construct.

The information provided describes a medical device submission (K120047) for the Coral™ Spinal System and its expansion with the Malibu adjustable cross connector. It focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and mechanical testing, rather than presenting a study of device performance against specific clinical acceptance criteria.

Therefore, many of the requested categories for acceptance criteria and the study proving adherence cannot be directly addressed from the provided text, as they pertain to clinical or functional performance. The document primarily describes mechanical performance tests to establish substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present in the document:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified for the mechanical tests.
• Data Provenance: N/A (mechanical tests, not clinical data)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A (Ground truth is not relevant for mechanical performance testing establishing substantial equivalence.)

4. Adjudication method for the test set

• N/A (Adjudication is not relevant for mechanical performance testing establishing substantial equivalence.)

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

• MRMC Study: No.
• Effect Size: N/A (This device is a spinal fixation system, not an AI-assisted diagnostic tool.)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. (This device is a spinal fixation system, not an algorithm.)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the device's performance is its ability to meet the mechanical standards outlined in ASTM F-1717. This is based on engineering and physical testing standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• N/A (This pertains to mechanical testing and substantial equivalence, not a machine learning model's training set.)

9. How the ground truth for the training set was established

• N/A (Not applicable for this type of submission.)

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