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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 20 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 spondylolisthesis (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 spondylolisthesis, 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 describes a 510(k) premarket notification for a medical device, the Endius TiTLE 2 Poly Axial Spinal System. This type of submission by the FDA focuses on establishing substantial equivalence to a predicate device, rather than conducting new clinical trials to prove safety and effectiveness from scratch. As such, the information you're requesting regarding acceptance criteria, study details, and AI performance metrics is not available in this document.

Here's a breakdown of why and what information is present:

Why the requested information is not available in this document:

• Premarket Notification (510(k)) Context: A 510(k) submission primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparative testing (e.g., mechanical testing in the case of a spinal system) and analysis of existing clinical data for the predicate, rather than new, large-scale clinical studies with specific performance metrics and ground truth establishment as would be required for a PMA (Premarket Approval) or certain novel devices.
• Device Type: The Endius TiTLE 2 Poly Axial Spinal System is a spinal implant system (pedicle screw system, rods, connection components). The "performance" of such a device is typically assessed through mechanical properties (strength, fatigue, torsional stiffness, etc.) relative to the predicate, and biocompatibility, rather than diagnostic accuracy metrics.
• Date: The submission is from 2007. The methodologies for evaluating AI in medical devices (e.g., MRMC studies, specific ground truth protocols, training/test set provenance) are much more recent developments and would not be relevant to a spinal implant submission from this era.

Information that is present in the document:

• Acceptance Criteria (Implied by Substantial Equivalence): The implicit acceptance criterion is "substantial equivalence" to the predicate device, the existing Endius TiTLE 2 Poly Axial Spinal System (K060990). This means the modified device must perform equivalently in mechanical tests and have the same indications for use.
• Study Proving Acceptance Criteria: "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, K060990."
  • Nature of the "Study": This refers to mechanical testing. The document does not provide specifics about the methodology, sample sizes, or the actual results of these mechanical tests beyond stating they were performed and demonstrated substantial equivalence.
• Device Performance: The document states that the mechanical test results demonstrate substantial equivalence to the predicate device. No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical load values) are reported in the summary provided.

Therefore, I cannot populate the table or answer most of your detailed questions because the provided text is for a 510(k) submission of a spinal implant system prior to the widespread application of AI in medical devices and focuses on substantial equivalence through mechanical testing, not diagnostic performance or AI-specific evaluation metrics.

Based on the provided text, here is what can be inferred and explicitly stated:

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

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

   • Not provided. The text only mentions "mechanical test results" without detailing the specific tests, sample sizes, or methodology. This is typical for a 510(k) summary focused on substantial equivalence rather than a full study report.

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/Not provided. For a spinal implant system, "ground truth" as it relates to expert consensus or pathology is typically not established for mechanical testing. The "truth" in this context would be the physical properties and performance measured against established mechanical standards or predicate device performance.

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

   • Not applicable/Not provided. Adjudication methods are relevant for subjective interpretations, often in clinical evaluations or image analysis, which is not the type of assessment described for this device.

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:

   • No. This is a spinal implant system from 2007, not an AI/diagnostic imaging device. An MRMC study would not be relevant.

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

   • No. This is a physical medical device, not an algorithm.

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

   • Not applicable/Not provided in detail. For mechanical testing, the "ground truth" would be the objective measurements of material properties and performance under stress, compared against a predefined standard or the predicate device's measured performance. The document does not specify these details.

8. The sample size for the training set:

   • Not applicable. This relates to AI/machine learning models, which are not described here.

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

   • Not applicable. This relates to AI/machine learning models, which are not described here.

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