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The Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

The Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided non-sterile.

The Posterior Spinal Fixation System includes the following sets:
RS8 LEGEND (designed for open surgery) RS8 LONG (designed for minimally invasive surgery)

Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option.

The provided text describes a 510(k) premarket notification for a Posterior Spinal Fixation System, which is a medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, and training/test set sample sizes for an AI/ML model are not applicable here.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, Medtronic Sofamor Danek USA, Inc.'s CD HORIZON® Spinal System (K130646). The acceptance criteria are implicit in the comparison to the predicate device and relevant standards.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable for a medical device):

The acceptance criteria are generally that the subject device performs comparably to the predicate device and meets applicable industry standards. The performance is assessed through bench testing and material characterization.

• Dynamic Compression: Experienced more fractures than predicate.
• Static Tensile: Tensile bending ultimate load lower than predicate.
• Static Torsion: Yield torque and torsional stiffness lower than predicate.
  (Note: Despite some lower values, the conclusion states these differences do not raise new questions of safety and effectiveness, implying overall equivalence or acceptable performance within design limits.) |
  | Sterilization | Provided non-sterile with validated cleaning and sterilization instructions. | Provided non-sterile; validated manual cleaning and steam sterilization instructions provided. (Same as predicate.) |
  | Surgical Instrument Materials | Acceptable materials for surgical use. | Stainless steel (17-4 PH), Silica gel, Polyformaldehyde (POM), Aluminum alloy. (Predicate materials unknown for comparison). |
  | Physical Dimensions (e.g., rods, screws) | Dimensions comparable to predicate device to ensure interchangeability or functional equivalence where applicable. | Rods: Subject: 5.5-6.0mm diameter. Predicate: 3.5-6.0mm diameter.
  Set Screws: Subject: 9.5-10mm diameter. Predicate: 6.0-10mm diameter.
  Crosslinks: Subject: 5.0-6.0mm diameter, 23-80mm length. Predicate: 3.5-6.0mm diameter, 13-120mm length.
  Polyaxial Reduction Screws: Subject: 4.5-7.5mm diameter, 25-90mm length. Predicate: 4.0-8.5mm diameter, 20-115mm length.
  MISS Polyaxial Reduction Screws: Subject: 4.5-10mm diameter, 25-110mm length. Predicate: 4.0-8.5mm diameter, 20-115mm length. |
  | MR Safety and Compatibility | Not explicitly stated as a criterion for the subject device. | Not evaluated for the subject device. Predicate is MR conditional. |

Study Proving Acceptance Criteria:

The device's acceptance is proven through non-clinical bench testing and adherence to recognized consensus standards for material characterization and biocompatibility, as compared to a legally marketed predicate device. The study aims to demonstrate substantial equivalence, not superior or absolute performance against new criteria.

2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device, and the testing involved bench studies rather than testing on human or animal data sets for AI/ML performance evaluation. The provenance would be the test conditions and materials used in the lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of an AI/ML device for diagnostic or prognostic purposes is not relevant here. The "truth" for this device is its mechanical properties, material composition, and biocompatibility as determined by standardized physical and chemical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication for bench testing of a physical medical device. The results are quantitative measurements against predefined standards or comparative measurements against the predicate device.

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. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is established through:

• Physical and Chemical Standards: ASTM, ISO, and GB/T standards for material properties, mechanical strength, and biocompatibility.
• Predicate Device Comparison: The performance and characteristics of the legally marketed predicate device (CD HORIZON® Spinal System) serve as a de facto "ground truth" for demonstrating substantial equivalence.

8. The sample size for the training set: Not applicable. This is not an AI/ML device. The device itself is manufactured, and its properties are tested.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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