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VEO is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. VEO is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.

VEO is a radiolucent PEEK interbody fusion implant comprised of various heights to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The lateral access technique allows a large cage to be implanted similar to marketed lateral lumbar interbody fusion sized cages. It is designed for use to provide structural stability in skeletally mature individuals.

Here's a breakdown of the acceptance criteria and study information for the TranS1 VEO device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a medical device, the TranS1 VEO, which is an intervertebral fusion device, and details its mechanical testing. The acceptance criteria are defined by various ASTM standards for mechanical testing. The reported device performance is that it met or exceeded these requirements.

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

The document describes confirmatory mechanical testing and does not refer to clinical studies with patient data. Therefore, information regarding "sample size used for the test set" (in terms of patient numbers), "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The "test set" in this case refers to the physical devices undergoing mechanical tests. The specific number of devices tested for each mechanical test is not provided in the summary.

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

This information is not applicable as the study is a mechanical engineering test on a medical device, not a diagnostic or AI-driven evaluation that would require human expert ground truthing. The "ground truth" for these tests is the physical performance of the device against established engineering standards.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as above. Adjudication methods are typically relevant for clinical studies or image interpretation, not for mechanical device testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. The document describes mechanical testing of an intervertebral fusion device, not a diagnostic or interpretative AI system where human readers would be involved or assisted by AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used:

The ground truth used for these tests is the established requirements and specifications within the referenced ASTM (American Society for Testing and Materials) standards. These are engineering benchmarks for material properties, structural integrity, and performance under various loads.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning study or a clinical trial with a patient training cohort. The device's design and manufacturing are based on established engineering principles and materials science.

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

This information is not applicable for the same reasons as above. The "ground truth" for the device's design and manufacturing is derived from engineering principles and regulatory requirements for such implants.

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The TranS1 Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Interbody Fusion System is designed to be used with autogenous bone graft and a supplemental spinal fixation system that is cleared for use in the lumbar spine.

The TranS1® Interbody Fusion System is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also interfaces with Class I access instruments and disc preparation instruments. The TranS1® Interbody Fusion System provides anterior, transforaminal or posterior approaches to the spine. The access techniques allow a large cage to be implanted similar to marketed anterior, transforaminal, or posterior lumbar interbody fusion devices. It is designed for use with supplemental fixation to provide structural stability in skeletally mature individuals.

The provided document describes the 510(k) Pre-market Notification for the TranS1® Interbody Fusion System. This submission focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not involve a study related to AI or a software device, and therefore many of the requested criteria are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device is a physical interbody fusion implant, not a software or AI-driven diagnostic device. Therefore, the "acceptance criteria" are related to mechanical performance for safety and effectiveness as defined by ASTM standards.

Note: The document states "All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards." This indicates that the device's performance satisfied the established benchmarks for mechanical integrity.

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

• Test Set: The "test set" in this context refers to the samples of the TranS1® Interbody Fusion System that underwent mechanical testing. The document does not specify the exact number of units tested for each mechanical test.
• Data Provenance: The mechanical testing was "performed per ASTM standards," implying controlled laboratory conditions. There is no information regarding country of origin for "data" in the sense of patient data, as this was not a clinical study. It was a pre-market submission based on engineering and materials testing. The study was not retrospective or prospective in the clinical sense, but rather a series of laboratory experiments.

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

• Not Applicable (N/A): For mechanical testing of an implant, the "ground truth" is defined by the objective physical properties and performance against established ASTM standards. There are no human experts involved in establishing a "ground truth" for interpretive data in this type of submission. The standards themselves, and the engineers verifying compliance, serve this role.

4. Adjudication Method for the Test Set

• Not Applicable (N/A): Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical readings or image analysis. This is not relevant for mechanical testing.

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

• Not Applicable (N/A): An MRMC study is a clinical study format involving multiple human readers interpreting cases, often with and without AI assistance, to assess diagnostic performance. This submission is for a physical medical implant and does not involve AI or diagnostic interpretation.

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

• Not Applicable (N/A): This question pertains to AI algorithm performance. The TranS1® Interbody Fusion System is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Standards and Performance Metrics: The "ground truth" for the device's performance is adherence to the validated mechanical test standards (ASTM F2077-11, ASTM F2267-04, etc.) and meeting the predefined requirements within those standards. This is an objective and quantitative ground truth established by engineering principles.

8. The Sample Size for the Training Set

• Not Applicable (N/A): There is no "training set" in the context of mechanical testing for a medical implant like this. Training sets are relevant for machine learning algorithms.

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

• Not Applicable (N/A): As there is no training set, this question is not applicable.

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TranSl AxiaLIF® Plus System is intended to provide anterior stabilization of the L5-S1 or 14-S1 spinal segment (s) as an adjunct to spinal fusion. The AxiaLIF® Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion) spinal stenosis, spondylolisthesis (Grade 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at LS-SI or L4-SI in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF:

The TranS1® AxiaLJF® Plus system is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 - S1 or L4-S1 disc space(s). The device's instruments are used for independently distracting the L5 - S1 or L4-S1 vertebral bodies and inserting bone grafi material (DBM, autograft or autologous blood) into the disc space. The device includes an anterior fixation rod that is implanted through the same approach and is used to lock the construct together.

This document describes the Premarket Notification (510(k)) Summary for the TranS1® AxiaLIF Plus system, which is a medical device for spinal fusion. The study described focuses on demonstrating substantial equivalence to predicate devices through mechanical, biomechanical, and system testing. This is not a study assessing the clinical performance or diagnostic accuracy of an AI/ML device. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

Acceptance Criteria and Device Performance (Mechanical/Biomechanical Testing)

Study Details:

1. Sample size used for the test set and the data provenance: Not applicable. This study involved mechanical and biomechanical testing of physical implants, not a test set of patient data. The "test set" in this context refers to the physical devices and testing conditions.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM 1717) and pre-defined test protocols, not by expert consensus in the typical sense of clinical or diagnostic studies.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication is not relevant for mechanical and biomechanical testing. The results are quantitative and compared against established engineering thresholds.
4. 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 a clinical study involving human readers or AI.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a study of an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this study was established by engineering standards (ASTM 1717) and specific test protocols that define acceptable performance limits for spinal implant devices under various mechanical stresses (Static Compression Bending, Static Torsion, and Fatigue Compression Bending).
7. The sample size for the training set: Not applicable. There is no training set for mechanical and biomechanical testing.
8. How the ground truth for the training set was established: Not applicable.

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The TranS1 Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The TranS1 Lateral Interbody Fusion Device is designed to be used with autogenous graft.

The TranS1® Lateral Interbody Fusion Device is a radiolucent PEEK interbody fusion implant comprised of various heights and footprints to accommodate individual patient anatomy and graft material size. It also includes curved access instruments and disc preparation instruments. The TranS1® Lateral Interbody Fuson Device provides a lateral approach to the spine from a posterior angle while the patient is in a prone position. The lateral access technique allows a larger cage to be implanted similar to an anterior lumbar interbody fusion sized cage and the patient is already in the prone position which eliminates the need to flip the patient for supplemental posterior fixation. It is designed for use to provide structural stability in skeletally mature individuals.

The provided document is a Premarket Notification [510(k)] Summary for the TranS1® Lateral Interbody Fusion Device. It details the device's indications, description, and claims of substantial equivalence to predicate devices, supported by mechanical testing. However, it does not include information about acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

Summary of Testing (as provided):

The document states:
"Mechanical testing for the TranS1 Lateral Interbody Fusion Device was performed per ASTM standards and included Static Axial Compression Strength (ASTM 2077-03), Static Subsidence (ASTM 2267-04), Static Push-out (ASTM Draft Standard F-04.25.02.02 and ASTM 2077-03) and Dynamic Axial Compression (Fatigue) (ASTM 2077-03). All static and dynamic testing met or exceeded the requirements as established by the test protocol and applicable ASTM standards. No new safety or effectiveness questions were raised as a result of the testing."

This indicates that the acceptance criteria for the mechanical testing were established by ASTM standards and the test protocol, and the device met or exceeded these requirements. However, specific numerical acceptance criteria and reported performance values are not detailed in this summary.

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TranS1® AxiaLIF® 2L System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2L System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.

The AxiaLIF® 2L System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2L System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

The TranS1® AxiaLIF® 2L System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial tract to the LC-1.5-S 1 disc spaces. The track and the device's instruments are used for distracting the L4 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes implantable anterior fixation rods that are implanted through the same tract.

The provided text is a 510(k) Premarket Notification for the TranS1 AxiaLIF 2L System. This document describes a medical device (spinal intervertebral body fixation orthosis) and its intended use, but it does not contain information about acceptance criteria, study methodologies, or performance data comparing the device to these criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the provided text. The document focuses on establishing substantial equivalence to a predicate device (TranS1 AxiaLIF II, K073643) rather than presenting detailed clinical or performance study results against specific acceptance criteria.

The FDA's letter states that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This determination is typically based on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, often without requiring extensive new clinical studies that establish performance against explicit acceptance criteria in the way you've outlined.

**To answer your request, I would need a different type of document, such as a full clinical study report, a specific performance testing report, or a more detailed submission that includes: **

• Performance goals or acceptance criteria for the device.
• The methodology of a study designed to test these criteria.
• Results of that study.
• Details about sample sizes, ground truth establishment, expert qualifications, etc.

Based on the provided text, I can only extract these general facts:

• Device: TranS1 AxiaLIF 2L System
• Intended Use: Anterior stabilization of L4-S1 spinal segments as an adjunct to spinal fusion; minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy, or for assistance in the performance of L4-S1 interbody fusion.
• Indications for Use: Patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease.
• Predicate Device: TranS1 AxiaLIF II (K073643)

The document explicitly states: "The technological characteristics of the TranS1® AxiaLIF® 2L System have not changed," which is a key part of demonstrating substantial equivalence to the predicate device in a 510(k) submission. This usually implies that the performance is expected to be similar to the predicate, but it does not detail specific performance studies of the new device against new acceptance criteria.

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TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL System is also intended for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectorny, or for assistance in the performance of L4-S1 interbody fusion.

The AxiaLIF® 2-LEVEL System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2-LEVEL System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

The Trans1® AxiaLIF® II System is made of medical grade titanium alloy conforming to such standards as ASTM F-136.

The provided text is a 510(k) Premarket Notification summary for a medical device called the "TranS1® AxiaLIF® II System." It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the indications for use.

Crucially, this document does NOT describe specific acceptance criteria and a study demonstrating the device meets those criteria, as typically found in clinical trials or performance studies that assess a device's accuracy or efficacy.

Instead, the submission is focused on regulatory clearance by demonstrating substantial equivalence to an already legally marketed device (TranS1® AxiaLIF® System). This means the FDA found the new device to be as safe and effective as the predicate device, based on shared technological characteristics and indications for use.

Therefore, many of the requested details such as sample sizes for test and training sets, expert qualifications, ground truth establishment, or specific performance metrics (like accuracy, sensitivity, specificity for diagnostic devices, or specific outcome measures for therapeutic devices) are not present in this type of regulatory submission. This document is a summary of the 510(k) application, not a detailed study report.

Here's an attempt to answer the questions based only on the provided text, while acknowledging its limitations:

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

This document does not provide a table of acceptance criteria or reported device performance in the context of a study demonstrating numerical compliance to those criteria. The primary "acceptance criterion" for this 510(k) submission was to demonstrate substantial equivalence to a predicate device.

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

Not applicable / Not provided. This document does not describe a test set or data from a study designed to evaluate performance metrics. The submission focuses on substantial equivalence based on technological characteristics and intended 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 / Not provided. The concept of "ground truth" for a test set, as it relates to accuracy or performance assessment, is not detailed in this regulatory summary.

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

Not applicable / Not provided. Adjudication methods are relevant for studies that require expert review of cases to establish ground truth, which is not the type of study described here.

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. The TranS1® AxiaLIF® II System is an anterior spinal fixation system, not a diagnostic device involving human readers or AI assistance. Therefore, an MRMC comparative effectiveness study is not relevant to this device's regulatory submission as described.

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

Not applicable. As a spinal fixation system, this device is a surgical implant and does not involve an "algorithm only" performance.

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

Not applicable / Not provided. This document does not detail a study that uses a "ground truth" for evaluating device performance as would be relevant for diagnostic or AI-driven systems. For a surgical implant, "ground truth" might refer to clinical outcomes, but no such study is presented here.

8. The sample size for the training set

Not applicable / Not provided. This document does not describe a training set, as it is not a machine learning or AI device.

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

Not applicable / Not provided. This question is irrelevant for the type of device and regulatory submission described in the provided text.

Summary of what IS stated in the document regarding "acceptance" for regulatory purposes:

• Substantial Equivalence: The primary "acceptance criterion" for the 510(k) process is demonstrating substantial equivalence to a legally marketed predicate device.
• Predicate Device: The TranS1® AxiaLIF® II System was deemed substantially equivalent to the TranS1® AxiaLIF® System.
• Regulatory Action: The FDA issued a letter allowing the device to be marketed, signifying that it met the requirements for substantial equivalence.

The provided text is a regulatory filing summary, not a scientific study report describing performance against acceptance criteria.

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The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion.

The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint (usually) at a single level and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process. Bone graft must be used for both fixation methods.

For both techniques, the system is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

The TranS1® Facet Screws are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3 or ASTM F-138 Stainless Steel.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific criteria. The document is a 510(k) Premarket Notification for TranS1® Facet Screws, which primarily focuses on establishing substantial equivalence to predicate devices and defining the device's intended use and technological characteristics.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details as this information is not present in the provided text.

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The TranS1® AxiaLiF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet or pedicle screw systems.

The intended use of the instrumentation kit is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5 - S1 interbody fusion.

The TranS1® AxiaLIF® System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral axial track to the L5 -- S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.

I am sorry, but the provided text does not contain any information regarding acceptance criteria, study details, or device performance metrics. The document consists of a 510(k) summary for the TranS1® AxiaLIF® Fixation System, primarily detailing its intended use, device description, and substantial equivalence to predicate devices, along with the FDA's clearance letter.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

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The TranS1® Facet Screws are to be used in conjunction with the TranS1® AxiaLIFTM System which includes the TranS1® 3D Axial Rod™, in order to create an anterior/posterior fixation construct as an aid to fusion.

The AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIFTM System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor, or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 in conjunction with legally marketed facet and pedicle screw systems.

The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.

The TranS1® Facet Screws are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3 or ASTM F-138 Stainless Steel.

The provided document is a 510(k) summary for the TranS1® Facet Screws, which aims to demonstrate substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing.

Instead, the submission focuses on establishing substantial equivalence based on:

1. Intended Use and Indications for Use: The document clearly states the intended use of the TranS1® Facet Screws in conjunction with the TranS1® AxiaLIFTM System for spinal fusion, including specific conditions they are indicated to treat and those they are not.
2. Technological Characteristics: It mentions that the screws are made of medical-grade titanium alloy or stainless steel conforming to ASTM and ISO standards.
3. Comparison to Predicate Devices: The core of the submission is to demonstrate that the TranS1® Facet Screws are "substantially equivalent" to two predicate devices: the Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System (K003928) and the Sofamore Danek Transfacetpedicular Screw Fixation System (K953076). This equivalence is claimed for "intended use, level of attachment, materials, labeling, sterilization, and technological characteristics." The range of sizes is also stated to be identical to or a subset of the predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as such details are not present in the provided text. The 510(k) process for this device relies on demonstrating equivalence to existing legally marketed devices, rather than presenting a de novo study with specific performance acceptance criteria.

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The TranS1® AxiaLIFTM System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1@ AxiaLIFTM is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet and pedicle screw systems.

The TranS1® AxiaLIFTM System is a multi-component system including titanium alloy implantable devices and instrumentation made of titanium alloy and stainless steel. This device includes instruments for creating a small pre-sacral. axial track to the 1.5 - S1 disc space. The track and the device's instruments are used for distracting the L5 - S1 vertebral bodies and inserting bone graft material into the disc space. The device also includes an anterior fixation rod that is implanted through the same track.

The information provided does not contain a specific study designed to prove the device meets acceptance criteria. Instead, it describes a 510(k) premarket notification for a medical device (TranS1® AxiaLIF™ System) where a modification to its indication statement is being sought.

Here's a breakdown based on the provided text, addressing your questions where possible:

Acceptance Criteria and Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format (e.g., a specific success rate, accuracy, sensitivity, or specificity). The core of this 510(k) is a claim of substantial equivalence to a previously cleared device. Therefore, the "acceptance criteria" for the modified indication is that the device, with its new indication, is considered as safe and effective as the predicate device.

The "device performance" is implicitly based on the substantial equivalence argument, which hinges on the fact that:

• Technological Characteristics: "The technological characteristics of the TranS1® AxiaLIFTM System have not changed."
• Biomechanical/Clinical Testing: "A significant amount of biomechanical and clinical testing of facet screws, and of facet screws in comparison to pedicle screws, appearing in the literature and as performed by TranS1®, establish that facet screw fixation will provided adequate posterior stabilization when used with the anterior stabilization of the AxiaLIF™ 3D Axial Rod™ (which is part of the AxiaLIFTM System)."

Therefore, a table of acceptance criteria and reported device performance directly from this document is not possible as it would be for a typical performance study. The "performance" is that its use with facet screws is "adequate" for posterior stabilization, based on existing literature and testing.

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

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

The document refers to "biomechanical and clinical testing" but does not specify sample sizes, data provenance (e.g., country of origin), or whether it was retrospective or prospective for the specific data submitted to support the expanded indication. It mentions "appearing in the literature" which suggests published studies.

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 application relies on existing literature and prior testing, not a new reader study to establish ground truth for a test set.

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

This information is not provided, as a specific "test set" and a corresponding adjudication process are not described in the context of this 510(k) submission.

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 not mentioned. The device is a surgical implant, not an AI-based diagnostic tool for human readers.

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

This question is not applicable. The device is a surgical implant, not an algorithm.

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

The "ground truth" for the claim of "adequate posterior stabilization" appears to be based on:

• Biomechanical testing (likely cadaveric or in-vitro models to measure forces, stability, etc.).
• Clinical testing (likely outcomes data from studies involving facet screws, or comparative studies of facet vs. pedicle screws).
  The document does not detail specific methods for establishing this ground truth.

8. The sample size for the training set:

This concept (training set) does not apply here as the device is not an AI algorithm requiring 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 mentioned for this medical device submission.

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