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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.

Device Description

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.

AI/ML Overview

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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K Number

K051663

Device Name

MALIBU SPINAL SYSTEM

Manufacturer

SEASPINE, INC.

Date Cleared

2005-07-12

(20 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K021623,K031381,K043232,K031175,K002607,K992168,K993503

Intended Use

The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.

The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, 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,
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 (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
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 intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and 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, kyphosis, and/or lordosis),
tumor,
pseudarthosis, and/or
failed previous fusion.

Device Description

The Malibu Spinal System includes titanium alloy iliac monaxial and monaxial screws. Both screw types will be offered in numerous diameters and lengths. The screw is comprised of an integrated body and housing. Both screws are designed to be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will also include titanium alloy caps, rods, and hooks. The caps will come in one size, the rods in two diameters, and the four types of hooks in a variety of sizes. All of these devices are designed to be a part of the stand alone Malibu Spinal System, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Malibu Spinal System will offer a wide variety of instruments that range from rod forks to hook pushers. These various instruments will be made primarily from various grades of stainless steel with a few components made from titanium alloy, Radel, and medical grade Pomalux. These items are supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

The acceptance criteria and study proving device performance are described below based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Substantially equivalent to predicate devices for temporary/permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization for spinal fusions.	"The intended use of the Malibu Spinal System... is substantially equivalent to the intended use of the predicate devices." (Page 3)
Indications for Use	Substantially equivalent to predicate devices for conditions like DDD, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion (with specific details for Pedicle Screw Systems/Spondylolisthesis systems and Interlaminal Fixation Orthoses/Hook Systems).	"The overall designs... are substantially equivalent to the predicate devices. See Table 1..." (Page 3)
Design	Substantially equivalent for iliac monoaxial screws, monoaxial screws, fixed locking caps, rods, hooks, and components.	"Similar" to predicate devices for each component listed. (Table 1, Page 3)
Iliac Monoaxial Screws	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Monoaxial Screws	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Caps	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Laminar Hooks	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Pedicle Hooks	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Offset Hooks	Substantially equivalent in design.	"See prints" (implies detailed design specifications match predetermined criteria or predicate designs). "Similar" to predicate. (Table 1, Page 3)
Material	Titanium alloy, similar to predicate devices.	"Titanium alloy" for Malibu Spinal System, "Similar" to predicate. (Table 1, Page 3)
Sterile	Non-sterile, similar to predicate devices.	"Non-sterile" for Malibu Spinal System, "Similar" to predicate. (Table 1, Page 3)
Method of Sterilization	High-temperature steam, similar to predicate devices.	"High-temperature steam" for Malibu Spinal System, "Similar" to predicate. (Table 1, Page 3)
Mechanical Strength	Demonstrated to be similar to predicate devices based on test results.	"See test results" for Malibu Spinal System, "Similar" to predicate. (Table 1, Page 3)

Study Details:

The provided document is a 510(k) summary for a medical device (Malibu Spinal System). It focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new performance criteria. Therefore, most of the requested information regarding "study" parameters (like sample size, experts for ground truth, adjudication, MRMC, standalone performance, training set) is not directly applicable or explicitly stated in this type of regulatory submission. The "study" here is a comparison analysis to predicate devices.

2. Sample Sizes and Data Provenance:

Test Set Sample Size: Not explicitly stated. The comparison is made against existing predicate devices, implying that their established performance and characteristics serve as the "test set" for equivalence.
Data Provenance: Not explicitly stated. The comparison is to predicate devices (Synthes Click'X Monoaxial Screw System, DePuy Acromed's Moss Miami System, and SeaSpine Inc.'s UCR Spinal System), which are legally marketed devices. The data for these predicate devices would have been generated during their own regulatory submissions or clinical use. The Malibu Spinal System itself underwent "Mechanical Strength" testing, the details of which are not provided (e.g., number of units tested, conditions, etc.).

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: Not applicable or explicitly stated. This is a comparison of technical characteristics and intended use to existing devices, not a study requiring expert readers to establish ground truth for a novel output.
Qualifications of Experts: N/A

4. Adjudication Method:

Adjudication Method: Not applicable. The process described is a regulatory review for substantial equivalence based on a comparison document and potentially internal test results, not a study involving human reader interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. This type of study is typically used for assessing the performance of diagnostic devices where human interpretation is involved. The Malibu Spinal System is an implantable surgical device.

6. Standalone Performance Study:

Standalone Study: Yes, in terms of mechanical strength. The document states "Mechanical Strength: See test results" for the Malibu Spinal System. While the full report is not included, this indicates that the device's mechanical properties were evaluated independently to demonstrate its performance, which was then compared to the predicate devices. The specific details of this testing (e.g., the exact criteria, methodology, and outcome beyond "similar") are not provided.

7. Type of Ground Truth Used:

Ground Truth: The "ground truth" for this submission is the established characteristics and performance of the predicate devices, as determined during their own regulatory approvals and market history. For the Malibu Spinal System's mechanical strength, the ground truth would be the measured physical properties and performance under specific test conditions, compared against the expected performance of the predicate devices.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This is not a machine learning or AI device that would require a training set.

9. How Ground Truth for the Training Set Was Established:

Ground Truth for Training Set Establishment: Not applicable.

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