Search Results

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components are designed to accept a 6.35mm rod and are available in various geometries and sizes. The EXPEDIUM Spine System also contains Class I manual surgical instruments, trays and cases and are exempt from premarket notification.

The provided text describes a 510(k) summary for the EXPEDIUM™ Spine System. This submission is for a medical device (spinal implant system), not an AI/ML powered device. As such, the typical acceptance criteria and study designs relevant to AI/ML software (e.g., diagnostic accuracy, reader studies, ground truth establishment) do not apply here.

The performance data for this device refers to mechanical testing of the implant, not clinical or diagnostic performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualification, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found or is not applicable in the context of this 510(k) summary.

However, I can extract the relevant performance data mentioned:

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

Note: ASTM F 1798 is a standard specification for the mechanical testing of spinal implant constructs. The 510(k) summary states that data was submitted according to this standard, implying the device met the mechanical performance requirements outlined therein, although specific numerical acceptance values and results are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not specified as this relates to mechanical testing, not a clinical study involving a test set of data.

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 for mechanical testing is based on engineering specifications and measurements, not expert clinical consensus.

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 device is a physical implant, not an AI/ML diagnostic tool.

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

• Not applicable.

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

• For mechanical testing, the "ground truth" would be the physical properties and mechanical behavior of the materials and constructs as measured by standardized engineering tests, compared against the specifications of ASTM F 1798.

8. The sample size for the training set

• Not applicable.

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

• Not applicable.

Ask a specific question about this device