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When intended to promote fusion of the cervical spine and the thoracic 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 to promote fusion 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 T1-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 and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.

The provided text is a 510(k) Premarket Notification for the Endius Minit Posterior Cervical and Upper Thoracic Fixation System. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria for a new device's performance. Therefore, many of the requested categories of information are not present in the document.

Here's an assessment based on the provided text:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the device's clinical application. Instead, it relies on demonstrating substantial equivalence to a 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)

The document does not describe a clinical "test set" in the context of human data. The assessment for substantial equivalence appears to be based on:

• Mechanical Test Results: The document mentions "mechanical test results" were provided to demonstrate substantial equivalence. No sample size for these tests is given, nor is their provenance.
• Comparison to Predicate Device: The primary "data" seems to be a comparison to the predicate device (Endius Minit Posterior Cervical and Upper Thoracic Fixation System, K070282) regarding design, materials, and indications for use.

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. No clinical test set with a "ground truth" established by experts is mentioned. The submission is a 510(k) for a spinal fixation system, not a diagnostic or AI device requiring expert ground truth for performance evaluation in a clinical setting.

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

Not applicable. No clinical test set requiring adjudication is described.

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 is not an AI or diagnostic imaging device.

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)

Not applicable. The ground for the "proof" of the device is its substantial equivalence to a previously cleared predicate device, based on similar design principles, materials, indications, and mechanical performance.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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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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When intended to promote fusion of the cervical spine and the thoracic 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 to promote fusion 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 T1-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 and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium alloy that complies with ASTM F136.

The provided text is a 510(k) Premarket Notification for the Endius Minit Posterior Cervical and Upper Thoracic Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device through general device description, indications for use, and a statement about mechanical test results. It does not contain information about specific acceptance criteria, a detailed study design with sample sizes, expert involvement, or adjudication methods for establishing ground truth, which are typically found in studies evaluating device performance against pre-defined criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided 510(k) summary. Acceptance criteria and specific performance metrics would typically be detailed in a separate test report or study. The document only generally states: "Documentation, including mechanical test results, has been provided which demonstrates that the proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System components are substantially equivalent to legally marketed similarly indicated predicate devices which have been tested in a similar manner."

2. Sample size used for the test set and the data provenance:
This information is not provided. The document mentions "mechanical test results" but does not specify the sample size of the components tested or the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Expert involvement in establishing ground truth (e.g., for clinical outcomes) is not mentioned as this document primarily concerns mechanical equivalence.

4. Adjudication method for the test set:
This information is not provided.

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 type of study is irrelevant and not mentioned. The device is a spinal fixation system, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a medical implant, not an algorithm.

7. The type of ground truth used:
This information is not provided. For a mechanical device, "ground truth" would typically relate to established engineering standards or performance benchmarks for similar devices, but these are not detailed in this summary. The document mentions "mechanical test results" as evidence of substantial equivalence.

8. The sample size for the training set:
This is not applicable as this is a medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established:
This is not applicable as this is a medical device.

Ask a specific question about this device

Ask a specific question about this device

When intended to promote fusion of the cervical spine and the thoracic 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 to promote fusion 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 T1-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 and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.

The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.

The provided document is a 510(k) Premarket Notification for the Endius Minit Posterior Cervical and Upper Thoracic Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through clinical studies with performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The "study" mentioned in the document is a mechanical test that demonstrates substantial equivalence:

1. Table of acceptance criteria and the reported device performance:
Not applicable. The document states "Documentation, including mechanical test results, has been provided which demonstrates that the proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System components are substantially equivalent to legally marketed similarly indicated predicate devices which have been tested in a similar manner." It does not provide specific acceptance criteria or reported performance data for these mechanical tests.

2. Sample sized used for the test set and the data provenance:
Not applicable. The study refers to mechanical testing, not a clinical test set with data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically understood in the context of clinical studies (e.g., for AI/diagnostic devices) is not relevant for this type of mechanical testing for substantial equivalence.

4. Adjudication method 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 is for a spinal fixation system, not an AI or diagnostic device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is for a spinal fixation system.

7. The type of ground truth used:
Not applicable. For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device.

8. The sample size for the training set:
Not applicable. There is no training set mentioned.

9. How the ground truth for the training set was established:
Not applicable. There is no training set mentioned.

Ask a specific question about this device

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 Atavi System is indicated for use for posterior access and visualization in the surgical area of cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi system would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include: an endoscope, a light source, light guide, a camera control unit, and a camera head.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) summary for the Endius Atavi System does not contain any information related to specific acceptance criteria or a study designed to prove the device meets those criteria.

The document is a regulatory submission focused on demonstrating substantial equivalence to previously cleared predicate devices. It describes the device, its intended use, and confirms that the FDA has reviewed the submission and found the device to be substantially equivalent to existing marketed devices.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, ground truth establishment, or expert involvement because this information is not present in the provided text.

Here's why:

• No Acceptance Criteria: The document does not define any quantitative or qualitative performance metrics that the device is intended to meet.
• No Study Details: There are no descriptions of any performance studies, clinical trials, or validation tests. The submission hinges on substantial equivalence, meaning it relies on the safety and efficacy of its predicate devices, rather than presenting new performance data for the modified device.
• Focus on Substantial Equivalence: The core of this 510(k) is the assertion that the "proposed Endius Atavi System is substantially equivalent to the current Endius Atavi System" (Section 5.8). This regulatory pathway often means that detailed performance studies might not be required if the device is sufficiently similar to a legally marketed predicate.

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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

When intended to promote fusion of the cervical spine and the thoracic 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 to promote fusion 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 T1-T3 in treating thoracic conditions only, Screws are not intended to be placed in the cervical spine.

The Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.

This 510(k) premarket notification for the Endius Minit Posterior Cervical and Upper Thoracic Fixation System does not describe an AI/ML device, nor does it present a study with acceptance criteria and device performance in the way requested. This document is for a medical device (spinal fixation system) and relies on demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical testing and comparison of design and materials, rather than clinical performance metrics in a study involving human data.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from the provided text.

Here's an attempt to answer the relevant parts, highlighting what is missing due to the nature of the submission:

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

• Medtronic VERTEX Reconstruction System (K052180)
• Synthes Spine Cervifix (K991089, K001864)
• Starlock Systems |

Note: The specific numerical acceptance criteria (e.g., minimum load to failure, fatigue cycles) for the mechanical tests are not detailed in this summary. The stated performance is that the device meets the equivalence standard implied by these tests.

2. Sample sized 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. The submission focuses on mechanical testing of components, not human-patient-derived 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)

This information is not provided. The "ground truth" here is the substantial equivalence demonstrated through mechanical testing against predicate devices. This typically involves engineering and biomechanical expertise in the testing and analysis.

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

Not applicable. This device relies on mechanical testing for substantial equivalence, not retrospective human data requiring 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 is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" used for proving substantial equivalence appears to be mechanical test data compared against performance of predicate devices. This type of device relies on engineering and biomechanical principles rather than clinical outcomes for its 510(k) clearance in this context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Endius Atavi System is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi™ System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).

The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The overying tobace, as were of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.

The provided text is a 510(k) summary for the Endius® Atavi System, which is an endoscopic spinal access system. It describes the device, its indications for use, and states its substantial equivalence to previously cleared devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway that often relies on comparison of design, materials, and intended use, rather than extensive performance studies with acceptance criteria in the same way a de novo or PMA application might require.

Therefore, I cannot provide the requested information based on the input text. The sections of your request (1-9) would typically be found in detailed verification and validation reports, clinical study reports, or specific performance testing summaries, which are not present in this 510(k) filing.

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