Search Results

It is intended for patients with severe spondylolisthesis (Grades 3 and 4) having fusions at the L5-S1 joint using autogenous bone graft, to be fixed/attached to the lumbar and sacral spine. The components are intended to be removed after development of a solid fusion mass. The screws are limited to L3-S1 or iliac screw fixation.

The DDS Spinal System is a multi-component system consisting of pedicle screws, rods and spacers. The screws are available in five lengths and one diameter; the rods in twelve lengths and the spacers in three thicknesses. The screws are fabricated from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136 The screws have a 6,5 mm thread diameters and are available in five lengths, 35, 40, 45, 50 and 55 mm. The rods are also manufactured from Ti-6Al-4V and are 5 mm in diameter. The rods are available in 12 lengths ranging from 40 mm to 600 mm. Round, smooth spacers of three different heights (2, 4, and 6 mm) slide over the threaded portion of the screw to facilitate implantation of neighboring screws at the same level. The spacers are also made of Ti-6Al-4V.

The provided text describes the DDS Spinal System, a medical device, and presents test results. However, it does not contain the information required to answer your specific questions related to acceptance criteria, device performance, study details, expert involvement, or ground truth establishment in the context of an AI/algorithm study.

The document is a Summary of Safety and Effectiveness for a physical medical device (spinal fixation system) cleared in 1996. The "Test Results" section refers to mechanical testing of the device components (e.g., axial compression, bending, torsion), not an evaluation of an artificial intelligence algorithm or its diagnostic/predictive performance.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Device Performance Table: The provided "Test Results" table details mechanical properties of the spinal system (Max. Load, Deformation, Stiffness) which are acceptance criteria for the physical device's structural integrity, not for an AI algorithm's performance (e.g., sensitivity, specificity, AUC).

   • Device Performance (as per document):
     • Axial Compression: $1403.2\pm90.6$ N (Max. Load), $2.69\pm.61$ mm (Deformation), $929.2\pm117.6$ N/mm (Stiffness)
     • Bending: $24.38\pm.63$ Nm (Max. Load), $20.86\pm1.67$ mm (Deformation), $3.07\pm.53$ Nm/mm (Stiffness)
     • Torsion: $42.30\pm2.44$ Nm (Max. Load), 38 degrees (Deformation), $2.58\pm.09$ Nm/deg (Stiffness)
     • Screw Pullout* (Unembedded): $818.5\pm341.8$ N (Max. Load)
     • Screw Pullout** (Wrapped, embedded): $785.0\pm289.7$ N (Max. Load)
   • Acceptance Criteria: The document implies that these performance values were acceptable for clearance but does not explicitly state the numerical targets or thresholds that constituted the "acceptance criteria" for each test.

2. Sample size for test set and data provenance: Not applicable to an AI study. The "test set" here refers to the number of physical specimens tested (e.g., 5 for axial compression, 16 for unembedded screw pullout). Data provenance is not relevant in this context.

3. Number of experts and qualifications: Not applicable. These tests were mechanical engineering tests, not human expert evaluations of an algorithm's output.

4. Adjudication method: Not applicable. There was no need for expert adjudication.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI algorithm.

6. Standalone (algorithm only) performance: Not applicable. This is a physical device.

7. Type of ground truth: Not applicable. The "ground truth" for mechanical tests would be the measured physical properties themselves, not expert consensus or pathology.

8. Sample size for training set: Not applicable as there is no AI algorithm being "trained."

9. How ground truth for training set was established: Not applicable.

In summary, the provided document describes a physical medical device and the mechanical testing performed on its components to demonstrate its safety and effectiveness. It does not pertain to an AI/algorithm, and therefore, most of your questions cannot be answered from this text.

Ask a specific question about this device