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The Endius TiTLE 2® Poly Axial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Endius TiTLE 2° Poly Axial Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Endius TiTLE 2® Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, the Endius TiTLE 2® Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

The Endius TiTLE 2® Poly Axial Spinal System can also be linked to the Minit Posterior Cervical and Upper Thoracic Fixation System.

The proposed Endius TiTLE 2% Poly Axial Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.

This document is a 510(k) summary for the Endius TiTLE 2® Poly Axial Spinal System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for a new, unproven device. Therefore, much of the requested information about acceptance criteria and study details for a new device's performance will not be found.

Here's an analysis based on the provided text:

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

The document does not specify quantitative acceptance criteria or device performance metrics as would be expected for a novel AI/software device. Instead, the "performance" described is in the context of demonstrating substantial equivalence to an existing predicate device.

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

This information is not provided in the document. The substantial equivalence argument relies on "mechanical test results" and documentation, not on clinical data or a "test set" of patient data in the sense of an AI/software study.

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)

This information is not applicable/not provided. The assessment is based on mechanical testing and comparison to an existing device, not on expert-adjudicated ground truth for a clinical dataset.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. There is no mention of a test set requiring adjudication in the context of human expert review.

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

This information is not applicable/not provided. This is a 510(k) submission for a physical medical device (spinal system), not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would have been performed or required for this type of submission.

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

This information is not applicable/not provided. This device is a physical pedicle screw system, not an algorithm.

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

The "ground truth" in this context is the performance and safety established for the predicate device (Endius TiTLE 2® Poly Axial Spinal System, K072840) and the demonstrated equivalence of the modified device to that predicate through mechanical testing and material compliance. There isn't a "ground truth" derived from patient-specific data, pathology, or outcomes in the way one would describe for a diagnostic or prognostic medical device.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.

Summary of Device and Evidence:

The Endius TiTLE 2® Poly Axial Spinal System is a physical medical device (spinal fixation system) seeking 510(k) clearance by demonstrating substantial equivalence to a previously cleared device (Endius TiTLE 2® Poly Axial Spinal System, K072840). The primary evidence for this claim comes from:

• Mechanical test results: These tests would compare the physical properties and performance (e.g., strength, fatigue life) of the new components to the predicate device to ensure they perform equivalently.
• Material compliance: The device is manufactured from titanium that complies with ASTM F136, a standard for implantable materials.
• Indications for Use comparison: The indications for the new device are consistent with or a minor modification of those for the predicate device.

The 510(k) process for such a device does not typically involve clinical studies with human participants comparing device performance against "ground truth" established by experts, nor does it involve AI algorithms with training and test sets.

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The Endius TiTLE 2 Poly Axial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.

The Endius TiTLE 2 Poly Axial Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Endius TiTLE 2 ° Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

In addition, the Endius TiTLE 2 Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The nonpedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.

The proposed Endius TiTLE 2® Poly Axial Spinal System that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.

The provided text is a 510(k) Premarket Notification for the Endius TiTLE 2® Poly Axial Spinal System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical studies with specific acceptance criteria and detailed performance metrics as one might find for a novel device or a PMA submission.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.

Instead, the submission relies on demonstrating substantial equivalence through:

1. Comparison to a Predicate Device: The predicate device is the "existing Endius TiTLE 2® Poly Axial Spinal System, K041808."
2. Mechanical Test Results: The document states, "Documentation, including mechanical test results, has been provided which demonstrate that the proposed Endius TiTLE 2® Poly Axial Spinal System components are substantially equivalent to the existing Endius TiTLE 2® Poly Axial Spinal System, K041808."

Without a detailed study report provided in this 510(k) summary, it's impossible to fill out the table and answer the specific questions about acceptance criteria and study particulars. The information about the type of assessment (mechanical testing for substantial equivalence) is present, but not the details of its execution or results in the way requested.

Ask a specific question about this device