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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

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

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

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.

Ask a specific question about this device