Search Results

The Denali Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (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; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Denali Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

The Denali Spine System is a top-loading, multiple component, posterior system which consists of periety of periety I he Dellar Spite Systems a top-loading, matchers components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.

The provided 510(k) summary for the Denali Spinal System does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

This 510(k) submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo acceptance criteria and then proving the device meets them through a specific clinical study with granular details like sample size for test sets, expert qualifications, or MRMC studies.

Here's a breakdown of why the requested information cannot be extracted from the provided document:

• Nature of 510(k) Submissions: 510(k)s are primarily premarket notifications to demonstrate that a new device is as safe and effective as (i.e., substantially equivalent to) a legally marketed predicate device. They typically rely on comparisons of technological characteristics, materials, and intended use, often supported by bench testing (biomechanical, material compatibility) rather than extensive clinical efficacy trials with acceptance criteria in the manner requested.

Information that could be inferred/stated from the document:

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

• Acceptance Criteria (Implied): The implied acceptance criterion for this 510(k) is "substantial equivalence" to the listed predicate devices in terms of design, function, materials, and intended use.

• Reported Device Performance (Implied): The document states "The Denali System was biomechanically tested and compared to its predicate devices... The Denali System found to be substantially the same as these systems." and "It's components were manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems."

  Acceptance Criterion (Implied for 510(k))	Reported Device Performance
  Substantially equivalent in design	Found to be substantially the same as predicate devices.
  Substantially equivalent in function	Performed equal to predicate devices.
  Substantially equivalent in materials	Manufactured from the same FDA recognized materials.
  Substantially equivalent in intended use	Indicated for the same intended uses as predicate systems.
  Biomechanical performance	Biomechanically tested and compared favorably to predicate devices.

2. Sample sized used for the test set and the data provenance:

• Not provided. The document mentions "biomechanically tested" but does not specify sample sizes for these tests, nor the data provenance (country, retrospective/prospective). This is typically detailed in engineering reports, not summarized in the 510(k) in this level of detail.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. For a 510(k) based on substantial equivalence and biomechanical testing, "ground truth" related to clinical outcomes or expert consensus on observations isn't typically established in this manner. The "truth" is based on established engineering principles and comparison to predicate devices.

4. Adjudication method for the test set:

• Not applicable/Not provided. This is relevant for studies involving human interpretation or clinical endpoints, which is not the focus of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is not mentioned or implied. MRMC studies are specific to evaluating the diagnostic performance of imaging devices/algorithms with multiple human readers, often comparing performance with and without AI assistance. This device is a spinal implant, not an imaging device.

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

• No. This refers to AI algorithms for diagnosis or analysis. The Denali Spinal System is a physical medical device (implant), not an algorithm.

7. The type of ground truth used:

• The "ground truth" for demonstrating substantial equivalence for this device would be:
  • Engineering specifications and material standards: Adherence to ASTM and ISO standards for materials (Ti6Al-4V ELI alloy).
  • Bench test results: Biomechanical performance data showing comparability to predicate devices.
  • Functional comparison: Direct comparison of design features and sizing to predicate devices.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" in the context of this 510(k) for a spinal implant. This term relates to machine learning models.

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

• Not applicable/Not provided. As there's no training set, there's no ground truth establishment for it.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/software device. Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth establishment (especially those related to human readers, experts, and AI algorithms) are not present and are not typically required for this type of submission.

Ask a specific question about this device