Search Results

The DEL MAR® Monoaxial Pedicle Screw System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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 Del Mar® Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Del Mar® Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor-made to fit the patient's individual anatomy. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of length, ranging from 30 mm to 100 mm and in 5 mm, 6 mm, 7 mm, 8mm and 9 mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. Pre-bent rods are available in 10 mm increments from 30 to 120 mm in length. Additional components, such as a Single Piece Set Screw, Cobalt Chrome Rods ranging from 400 mm to 600 mm and several types of Deformity Connectors have been added. The Del Mar® Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136 and Cobalt Chrome alloy per ASTM F1058.

The provided 510(k) summary (K110679) describes a spinal fixation system, not a device that generates performance metrics like sensitivity, specificity, or AUC, which are typically associated with AI/ML-based diagnostic or prognostic devices. Therefore, a direct application of the requested structured response for AI/ML device studies is not fully appropriate.

However, I can extract the relevant information regarding acceptance criteria and the study that proves the device meets them, focusing on the mechanical and substantial equivalence aspects as presented in the document.

Acceptance Criteria and Reported Device Performance

Study Details (based on what's available for a non-AI/ML mechanical device):

The device is a mechanical spinal fixation system, and the "study" referred to in the document is a series of mechanical bench tests rather than a clinical study with human subjects, diagnostic accuracy endpoints, or AI/ML algorithm performance.

1. Sample size used for the test set and the data provenance: Not applicable in the context of human subjects or clinical data for this type of device. The "test set" would refer to the physical device samples subjected to mechanical testing. The provenance is the manufacturer (Phygen, LLC).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by adherence to ASTM standards and engineering principles, not expert medical consensus on human data.

3. Adjudication method for the test set: Not applicable. Mechanical tests have pass/fail criteria based on measured physical properties against established standards.

4. 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 a mechanical device, not an AI/ML diagnostic tool requiring human reader studies.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used:

   • For mechanical performance: Adherence to ASTM F1717-10 and ASTM F1798-97 (2008) standards for spinal implant mechanical testing. The "ground truth" is the established performance requirements within these standards.
   • For substantial equivalence: Comparison against the predicate device's previously cleared design, materials, and indications for use, as evaluated by the FDA.

7. The sample size for the training set: Not applicable. This is a manufactured medical device, not an AI/ML model that undergoes a "training set" process.

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

Ask a specific question about this device

The DEL MAR® Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: 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 DEL MAR® Monoaxial Pedicle Screw System is intended to be used with autograft and/or allograft as an adjunct to fusion.

The DEL MAR® Monoaxial Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The DEL MAR® Monoaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.

This K091219 document describes a spinal fixation system, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically in the context of AI/ML performance, cannot be extracted from the provided text.

The document discusses the Allez Spine Del Mar® Monoaxial Pedicle Screw System and focuses on its substantial equivalence to a predicate device based on material, design, and intended use for spinal fixation. The "Performance data" section (in {0}) states: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading." This indicates that the device's performance was evaluated through biomechanical testing to ensure it meets the mechanical requirements for spinal implants, but it does not involve any AI/ML components or associated acceptance criteria and study designs that would typically be described for such systems.

Therefore, I cannot provide the requested table and details as they pertain to AI/ML device performance.

Ask a specific question about this device