Search Results

The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -S1) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Pioneer Lumbar Plate System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification. Implants are composed of titanium alloy Ti6Al4V (ISO 5832-3) ELI, the same as predicate device.

The provided document is a 510(k) premarket notification for a medical device called the "Pioneer Lumbar Plate System." It describes the device's intended use and demonstrates its substantial equivalence to previously marketed predicate devices.

However, the document does not contain the kind of information typically associated with complex AI/ML device evaluations, such as detailed acceptance criteria, reported performance metrics (like accuracy, sensitivity, specificity), sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.

Instead, the performance data presented focuses on mechanical testing and comparison to predicate devices' performance data, materials, indications, and design/function. This is standard for spinal implant devices where the primary concern is the physical and structural integrity and biocompatibility of the implant.

Therefore, for aspects 2 through 9 of your request, the answer will largely be "Not applicable" or "Not specified in this document" because this type of evaluation is not relevant to a spinal plate system.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Additional Information Not Relevant for this Device Type:

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device (spinal plate system), not a diagnostic algorithm or AI/ML product that uses a "test set" of data in the typical sense. Mechanical testing typically uses a certain number of physical samples to establish performance. The document doesn't specify the number of samples for mechanical testing, nor does it refer to "data provenance" in this context.
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 device performance for this product refers to established engineering standards for mechanical strength, fatigue, material properties, and clinical utility as defined by the predicate devices. It doesn't involve expert consensus on image interpretation or similar.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" for performance is defined by established mechanical engineering standards (e.g., ISO standards for implants, ASTM standards for materials testing) and the performance characteristics of the legally marketed predicate devices. The "Guidance for Spinal Systems 510(k')s" document likely outlines specific mechanical tests and performance benchmarks (e.g., fatigue strength, static strength, wear resistance).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary: The Pioneer Lumbar Plate System demonstrated substantial equivalence by meeting mechanical performance standards and by having comparable materials, indications for use, and design/function to its predicate devices (K063158 & K041167), as outlined in the "Guidance for Spinal Systems 510(k')s". The evaluation process did not involve the types of studies or criteria typically applied to AI/ML software as a medical device.

Ask a specific question about this device