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1. The intended use of the Malibu 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.

2. The intended use and indications of the Malibu system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System or Sublaminar Wire 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.

The system contains titanium alloy and cobalt alloy implants. This submission is intended to address the line extensions including titanium and cobalt alloy spinal rods, cap, set screw, and a sublaminar wire. All devices are supplied non-sterile. These devices are not compatible with stainless steel implants.

The SeaSpine Malibu Spinal System line additions (titanium and cobalt alloy spinal rods, cap, set screw, and a sublaminar wire) do not have specific acceptance criteria or a detailed clinical study described in the provided document that proves the device meets such criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that the manufacturer demonstrates that the new line additions are as safe, as effective, and perform as well as or better than existing, legally marketed predicate devices.

Here's an analysis based on the provided text, addressing your points:

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

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

• Sample Size for Test Set: Not applicable. No clinical test set or human study data is described. The performance data focuses on mechanical testing and comparison to predicates.
• Data Provenance: Not applicable. The data primarily stems from mechanical testing and a comparison of design, materials, and intended use to existing predicate devices.

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

• Number of Experts: Not applicable. No human expert "ground truth" or clinical efficacy/safety study requiring expert assessment is described.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No clinical test set or human study data requiring adjudication is described.

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. This submission is for spinal implants and does not involve AI or diagnostic imaging interpretation.

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

• Standalone Performance: No. This submission is for physical spinal implants, not a software algorithm.

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

• Type of Ground Truth: For the purpose of establishing substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate devices. The mechanical testing data aims to demonstrate that the new devices perform comparably to these known predicates. No clinical outcomes data for the new device is presented.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. No training set for an algorithm is described.

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

• Ground Truth Establishment for Training Set: Not applicable. No training set for an algorithm is described.

In summary: The provided document is a 510(k) summary for line additions to an existing spinal system. The primary method for demonstrating safety and effectiveness is through proving substantial equivalence to previously cleared predicate devices, supported by mechanical testing rather than clinical trials with human subjects. Therefore, many of the questions related to clinical study design, expert evaluation, and AI performance are not applicable to this type of submission.

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