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When intended to promote fusion of the cervical spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods: The hooks and rods are also intended to provide stabilization following reduction of fracture/ dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Screws/Connectors: The use of screws is limited to placement in the TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Axial and Offset Rod Connectors: The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE 2 System offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the NexLink Spinal Fixation System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Cl-T3) spine. The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

The NexLink OCT Occipital Cervical Plating System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following indications: degenerative disease (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies), spondylolisthesis, spinal stenosis, fracture/dislocation, atlantoaxial fracture with instability, occipito-cervical dislocation, revision of previous cervical spine fusion surgery and tumors.

The Cancellous and Cortical Bone Screws (3.5mm and 4mm diameters; 6mm-20mm threaded lengths) are used with the NexLink OCT Occipital Cervical Plating System to allow for occipital fixation and limited to occipital fixation only. The 4mm Cannulated Side Loading Closed Screws are limited to placement in the upper thoracic spine (T1-T3) for additional stabilization of the cervical spine for the indications specified above.

When intended for pedicle screw fixation from T1-S1, the Sequoia Pedicle Screw System is 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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion.

When used as a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.

When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.

After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

The ST360° Spinal Fixation System is intended for posterior, non-cervical 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 radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a sacral screw system, the ST360° Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for sacral screw fixation of this system are T1 to the sacrum.

The TiTLE 2 Polyaxial 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 TiTLE 2 Polyaxial Spinal System is a Pedicle Screw System intended to provide immobilization 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 TiTLE 2 Polyaxial 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, TiTLE 2 Polyaxial Spinal System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illum/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 TiTLE 2 Polyaxial Spinal System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

The Zimmer Spine Pedicle Screw-Rod System implants include pedicle, polyaxial or fixed screws of varying diameters and lengths, rods of varying lengths, hooks (anchors) in varying designs and fixed and adjustable transverse connectors (cross-links). These implants are manufactured from medical grade Ti-Al-4V ELI titanium alloy and or commercially pure titanium. The system(s) are provided to the end-user Non-Sterile. Implants and instrumentation are provided clean and must be sterilized prior to use by the end-user. The system(s) implants are designed for single-use only. The purpose of this submission was to demonstrate through testing and engineering analyses that the subject devices can be labeled as MR Conditional.

This document is a 510(k) Pre-Market Notification from Zimmer Spine, Inc. to the FDA. The purpose of this submission is not to introduce a new device or a new algorithm, but rather to update the product-specific package inserts (IFU) with MRI Conditional language only for existing pedicle screw-rod systems. Therefore, the traditional acceptance criteria and study design for a new medical device would not apply in the same way.

The "study" conducted here is a series of performance tests to demonstrate the MRI compatibility of the existing devices.

Here's a breakdown of the requested information based on the provided document:

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)

• Sample Size: The document does not specify the exact number of individual screws and rods tested from each system. It states "Magnetic Resonance Imaging (MRI) testing of screws and rods contained in the Zimmer Spine Pedicle Screw-Rod Systems were assessed and tested appropriately." This implies representative samples of the various components were used.
• Data Provenance: The testing was likely conducted in a controlled laboratory environment by Zimmer Spine or a contracted test facility in the USA (given the submitter's location in Minneapolis, Minnesota, USA, and submission to the FDA). The tests themselves are prospective in nature, as they involve actively conducting measurements on physical devices.

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 is not applicable to this submission. The "ground truth" in this context is established by adherence to recognized ASTM standards for MRI compatibility testing, which are objective, quantifiable measurements. There is no subjective expert interpretation of output data in the same way there would be for image analysis or clinical diagnosis.

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

Not applicable. This type of testing involves objective physical measurements according to standardized protocols, not subjective expert review or adjudication.

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 submission is for MRI compatibility of hardware (pedicle screw-rod systems), not an AI device or a diagnostic tool that involves human readers.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this performance testing is defined by the objective pass/fail criteria established within the referenced ASTM standards (ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213). These standards provide quantitative thresholds for magnetic field interactions (displacement, torque, heating) and qualitative assessments of image artifact.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing involved physical devices.

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

Not applicable.

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The TiTLE 2 Polyaxial 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 TiTLE 2 Polyaxial 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 TiTLE 2 Polyaxial 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, TiTLE 2 Polyaxial System, when not used with pedicle screws, is indicated for sacral screw fixation from T1 to the illium sacrum. The non-pedicle screw indications are spondylolisthesis, degeneralive 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 TiTLE 2 Polyaxial System can also be linked to the Minit® Posterior Cervical and Upper Thoracic Fixation System.

The TiTLE® 2 Polyaxial Spinal System Implants are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of screws joined with spinal rods and should be removed after fusion.

The TiTLE® 2 Polyaxial Spinal System is designed to aid in the surgical correction of several types of spinal conditions, as stated in the section below. The TiTLE® 2 Polyaxial Spinal System consists of screws, rods, connection components that are intended to be used as a temporary construct that assists in normal healing and are not intended to replace normal body structures. The system is intended to stabilize the spinal operative site during posterior fusion procedures, attaching to the spine by means of screws joined with spinal rods and should be removed after fusion. The polyaxial spinal system is a rod and top-loading screw fixation system. This system can be placed surgically using either open or endoscopic surgical techniques. The system is provided non-sterile, for single use only.

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

The Zimmer Spine TiTLE® 2 Polyaxial Spinal System is a medical device and its "acceptance criteria" and "study" refer to the performance testing and resulting substantial equivalence determination by the FDA, rather than clinical efficacy studies often associated with AI/software devices. Therefore, the information provided corresponds to the regulatory requirements for medical devices.

Acceptance Criteria and Device Performance

The acceptance criteria for the TiTLE® 2 Polyaxial Spinal System are based on establishing substantial equivalence to its predicate devices concerning design, materials, function, and intended use. The device's performance was evaluated through various types of testing, the results of which confirmed its suitability for its intended use and its substantial equivalence to the predicate.

• Static Axial Compression (Bending) per ASTM F1717-12
• Static Torsion per ASTM F1717-12
• Axial Compression (Bending) Fatigue per ASTM F1717-12
• Static Axial Gripping Capacity per ASTM F1798-97 (Reapproved 2008)
• Static Torsion Gripping Capacity per ASTM F1798-97 (Reapproved 2008)
• Static Flexion-Extension Moment per ASTM F1798-97 (Reapproved 2008)
• Dynamic Flexion-Extension Moment per ASTM F1798-97 (Reapproved 2008) |
  | Human Factors (Cadaver Lab Testing) | Confirmed substantial equivalence of design changes (instrument and labeling) and interaction with implants compared to predicate devices. |
  | Biocompatibility | Ensured materials are biocompatible after manufacturing, based on minor design changes compared to predicate devices. |
  | Sterilization & Dry Time | Ensured steam sterilization and dry time requirements and instructions are substantially equivalent to the predicate devices. |
  | Overall Substantial Equivalence | Considered substantially equivalent to predicate devices due to no changes in product performance specifications or device functional scientific technology. This determination was reviewed and accepted by the FDA (K133086). |

Study Information (Applicable to medical device regulatory context)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of AI or software performance evaluation. Instead, testing was conducted on manufactured components of the TiTLE® 2 Polyaxial Spinal System.

• Bench Testing: The sample size for mechanical testing (implants, screws, rods, and connection components) is not explicitly stated in terms of number of units tested, but it refers to "components of the subject TiTLE® 2 Polyaxial Spinal System" being reviewed and tested.
• Cadaver Lab Testing: The sample size (number of cadavers or tests) for evaluating human factors is not specified.
• Data Provenance: The studies were conducted by Zimmer Spine, Inc. for regulatory submission to the FDA. This indicates the testing was performed internally or by contracted labs for the manufacturer, in the context of a prospective submission for marketing authorization.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this device's regulatory review. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F1717-12, ASTM F1798-97) and internal design specifications, not by expert consensus on clinical data. For human factors, the evaluation likely involved surgical or relevant medical professionals, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This concept is not directly applicable to the type of performance testing described for this medical device. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or for establishing ground truth in AI/software evaluations, particularly when human expert disagreement needs to be resolved. The performance testing here follows established engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of AI on human reader performance for diagnostic or screening tasks. The TiTLE® 2 Polyaxial Spinal System is a physical implantable medical device, not an AI or diagnostic software.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This concept is relevant for AI/software devices. The performance testing for the TiTLE® 2 Polyaxial Spinal System focused on the physical and mechanical properties of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this medical device generally refers to:

• Engineering Standards: Compliance with established ASTM standards (F1717-12, F1798-97) for mechanical properties.
• Biocompatibility Standards: Compliance with standards for material safety.
• Design Specifications: Meeting internal design requirements for function and form.
• Predicate Device Performance: The predicate device itself served as a benchmark for "substantially equivalent" performance.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the way it would be defined for AI/software or diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. The TiTLE® 2 Polyaxial Spinal System is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for this type of medical device.

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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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The Endius® TITLE 2™ Polyaxial 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™Polyaxial 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™ Polyaxial 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™ Polyaxial 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™ Polyaxial 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.

The provided text is a 510(k) summary for the Endius® TITLE 2™ Polyaxial Spinal System, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a study against acceptance criteria for algorithm performance.

Therefore, the requested information regarding acceptance criteria, study details (sample size, provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set), and effect size cannot be extracted from the provided text.

The 510(k) summary outlines the device description, indications for use, and claims substantial equivalence to a previously cleared device (Endius TiTLE Spinal Fixation System: K021881). It does not contain information about clinical performance studies with specific statistical acceptance criteria for a new device's performance against a defined ground truth, nor does it include details on AI/algorithmic performance or human reader studies.

In summary, the provided document is a regulatory submission for device clearance based on substantial equivalence, not a clinical study report of a device's performance against pre-defined acceptance criteria.

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