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CoreLink Navigation Instruments are intended to be used in the preparation and placement of CoreLink screws (Tiger and Entasis) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

CoreLink Navigation Instruments are non-sterile, reusable manual surgical instruments made of surgical stainless steel. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures.

The provided text describes the CoreLink Navigation Instruments, but it does not contain the specific information requested about acceptance criteria and the detailed study that proves the device meets those criteria.

The document is a 510(k) Premarket Notification from the FDA, which primarily focuses on establishing substantial equivalence to a legally marketed predicate device. While it mentions "Performance Data" and "Testing to ASTM F2554-10," it does not elaborate on the specific acceptance criteria, reported performance values, study design details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance), or training set information.

Therefore, I cannot fulfill your request as the necessary details are not present in the provided text.

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Foundation™ Cervical Interbody Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical some with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by pairent history and radies. Foundation™ Cervical implants are used to facilitate interverebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Foundation Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment. prior to treatment with an intervertebral cage

The Foundation™ Lumbar Interbody Devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Foundation™ Lumbar implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Foundation™ Interbody Devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the graft donation site. They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis).
The changes to the Foundation™ Interbody Devices cleared in K0733440 and included in this Special 510(k) are:
• Removal of specific surgical approaches for the lumbar devices
• Addition of additional sizes and configurations

The provided text is a 510(k) premarket notification for the "Foundation™ Interbody Devices." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information (like specific performance acceptance criteria, test set details, expert ground truth adjudication, MRMC studies, and standalone algorithm performance) is not applicable or available in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy, as it is a 510(k) submission for a physical medical device (an intervertebral body fusion device). The "performance" being evaluated here is primarily related to mechanical safety, materials, and functional equivalence to existing devices.

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

• Test Set Sample Size: Not applicable. No clinical test set involving patients or data for measuring diagnostic/clinical performance was used in this 510(k) summary. The "test set" for this device's evaluation primarily consisted of engineering analyses (Finite Element Analysis) and material characterization.
• Data Provenance: Not applicable. The evaluations were non-clinical, involving engineering simulations and material specifications.

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

• Not applicable. As no clinical data or diagnostic performance was being evaluated, there was no need for expert ground truth establishment in this context. The "ground truth" for material properties and mechanical performance would be based on established engineering standards and material science data.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication method was employed as there was no clinical test set requiring interpretation or consensus on outcomes.

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

• No, an MRMC study was not done. This evaluation is for a physical orthopedic implant, not an AI or diagnostic imaging device that would typically undergo MRMC studies.

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

• Not applicable. This device is a physical implant and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is implicitly based on engineering standards, material specifications (ASTM F2026, ASTM F560), and the established performance and safety profiles of the predicate devices. The device's substantial equivalence is a regulatory judgment based on these data points, not on clinical outcomes or pathology.

8. The Sample Size for the Training Set

• Not applicable. No machine learning algorithm or AI was involved, so there was no "training set."

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

• Not applicable. As there was no training set, no ground truth needed to be established for it.

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The TIGER® Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (TT Sifleum): degenerative discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective widence of neurological impairment, frecture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The TIGER® Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

The provided text describes a Special 510(k) Summary for the TIGER® Spine System. It focuses on the substantial equivalence of the device to existing predicate devices based on non-clinical testing. Crucially, the document explicitly states that no clinical studies were performed. Therefore, this device submission does not contain information regarding acceptance criteria for a device's performance based on clinical data, nor does it describe a study that proves the device meets such criteria through clinical outcomes.

Instead, the document details non-clinical testing performed to demonstrate mechanical safety and performance in comparison to predicate devices.

Here's a breakdown of the requested information based only on the provided text, acknowledging the absence of clinical performance data:

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

Since this is a non-clinical submission based on substantial equivalence to predicate devices, the "acceptance criteria" are implicitly meeting or exceeding the performance of the predicate device(s) in specified mechanical tests. The "reported device performance" is the conclusion that the TIGER® Spine System is equivalent.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size (number of devices or test repetitions) used for the non-clinical mechanical tests. It also does not discuss data provenance as it pertains to patient data, as no clinical studies were performed. The tests are laboratory-based mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. No ground truth based on expert clinical assessment (e.g., radiologists) was established because no clinical studies were performed. The "ground truth" for the non-clinical tests is based on established ASTM standards and comparative analysis to predicate devices.

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

This question is not applicable. No clinical test set requiring adjudication of expert opinions was created.

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 question is not applicable. No MRMC study was performed, as no clinical studies involving human readers or AI assistance were conducted.

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

This question is not applicable. No algorithm or standalone software performance was evaluated, as this submission is for a physical spinal implant system.

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

For the non-clinical tests, the "ground truth" is based on established engineering standards (ASTM F1717, ASTM F1798) and the performance characteristics of legally marketed predicate devices. This is a technical, rather than clinical, ground truth.

8. The sample size for the training set

This question is not applicable. There was no training set, as no algorithms requiring training were involved in this submission.

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

This question is not applicable. There was no training set.

Summary of Study (Based on Provided Document):

The submission describes a non-clinical study involving mechanical and dimensional testing of the TIGER® Spine System. The study's purpose was to demonstrate substantial equivalence to existing predicate devices (e.g., Expedium™/Viper™ Spine System, Scient'x Polyaxial LP) for the addition of new components. The study involved:

• Tests performed: Static and dynamic compression (ASTM F1717), static torsion (ASTM F1717), static axial and torsional grip (ASTM F1798), and dimensional comparison.
• Conclusion: The results indicated that the TIGER® Spine System is equivalent to the predicate device(s) in terms of principles of operation, technology, materials, and indications of use.
• Sample Size and Ground Truth: Not explicitly detailed for the specific tests, but generally refers to standard testing protocols. The "ground truth" for this equivalence claim is the established performance and safety profile of the predicate devices.
• Clinical Studies: Explicitly stated as not performed. Therefore, no clinical acceptance criteria or performance studies were conducted or reported in this submission.

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The CoreLink ANODYNE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scollosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

The Anodyne™ Anterior Cervical Plate System is comprised of an assortment of cervical plates and screws that act to stabilize the spine during the intervertebral fusion process. The cervical plate has a rotatable anti-backout "lock" for each screw position to prevent back-out of the screw.

The plate is available in single and double plate configurations with multiple lengths ranging from 13 mm – 22 mm (1 level) and 26 mm – 40 mm (2 level) for the single plates. The double plates include 1 level (13 mm - 30 mm), 2 level (26 mm - 46 mm), 3 level (46 mm - 70 mm), and 4 level (60 mm -100 mm). The screws are available in various lengths from 12 mm - 20 mm, with major thread diameter options of 4.6 mm or 5.2 mm.

The Anodyne™ Anterior Cervical Plate System is a medical device intended for anterior fixation of the cervical spine. The device's acceptance criteria and the study proving it meets these criteria are outlined in the 510(k) summary.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Anodyne™ Anterior Cervical Plate System are based on the mechanical performance of the device, specifically its ability to withstand static and dynamic loads and torsion, as compared to predicate devices. The study demonstrates that the device performs equivalently to previously cleared devices.

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

• Sample Size: Not explicitly stated as a number of devices tested. Instead, the testing refers to "the ANODYNE™ Anterior Cervical Plate System" as the subject of the tests, implying a representative sample of its components (plates and screws across various sizes and configurations).
• Data Provenance: The tests are described as "Non-Clinical Test Summary" and were likely conducted in a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these are non-clinical (mechanical) tests rather than clinical studies on human subjects.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

Not applicable. This device underwent non-clinical mechanical testing, not clinical studies involving human patients or expert interpretation of medical images. Therefore, no medical experts were involved in establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. As described above, there was no clinical test set requiring adjudication. The assessment was based on objective mechanical testing results against industry standards.

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

No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. Standalone Performance Study:

No. Since no clinical studies were performed, there was no standalone algorithm performance study (the device is a physical medical implant, not an AI or digital diagnostic tool). The "standalone performance" in this context refers to the device's mechanical integrity as tested in a lab setting, independent of human interaction during real-world use, which was indeed evaluated through the non-clinical tests.

7. Type of Ground Truth Used:

The ground truth for the non-clinical tests was established by recognized industry standards (ASTM F1717) for mechanical testing of spinal implants. The performance of the Anodyne™ system was compared against the established mechanical properties and performance of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. The device is a physical medical implant, not an AI algorithm. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a physical medical implant.

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Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). The system is intended to be used in skeletally mature patients as an adjunct to fusion using autograft and allograft for the following conditions: degenerative disc disease (DDD): defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; spondylolisthesis; spinal stenosis; fracture/dislocation; atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumor.

The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use from C1-C7. The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3). They are not intended to be placed in the cervical spine.

The Tiger® Occipital-Cervical-Thoracic Spinal Fixation System can be connected to the Tiger® Spine System using the side by side and end to end rod to rod connectors.

The CoreLink Tiger® OCT System consists of occipital plates, occipital bone screws, cervical hooks, upper thoracic pedicle screws, rods in both titanium and cobalt chrome, transverse connectors, and other various connectors. These components are manufactured from Ti-6Al-4V ELI in accordance with ASTM F136.

The provided text describes a 510(k) summary for the Tiger® OCT System, a spinal fixation system. It details the device's indications for use, description, predicate devices, and performance standards. However, it does not contain information regarding an AI/ML device or a study comparing device performance against acceptance criteria in the way typically expected for an AI/ML diagnostic or assistive tool.

The "Performance Standards" section refers to mechanical testing of the implantable device against ASTM F2706 standards, not a clinical performance study with human subjects, ground truth, or expert readers.

Therefore, many of the requested categories for AI/ML device evaluation are not applicable or cannot be extracted from this document.

Here's a breakdown of the information that can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Not Applicable. This document describes mechanical testing of an implantable device, not a performance study on a test set of data (e.g., medical images) to evaluate an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No human experts were involved in establishing ground truth for mechanical device testing.

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

• Not Applicable. No adjudication method is relevant for mechanical device testing.

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 not an AI/ML device. No MRMC study was performed.

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. No standalone algorithm performance was assessed.

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

• For the mechanical performance testing, the "ground truth" would be the engineering specifications and requirements outlined in ASTM F2706.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device. No training set was used.

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

• Not Applicable. This is not an AI/ML device. No training set ground truth was established.

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The TIGER® Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic. lumbar. and sacral spine (T)-S1/Ileum): degenerative disc discase (defined as discogenic back pain with degeneration of disc confirmed by history of and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment. fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The TIGER® Spine System is a multiple component, posterior spinal fixation system which consists of pedicle screws, cannulated pedicle screws, posted pedicle screws, rods, crossconnectors, locking cap screws, hooks, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.

This document describes a 510(k) premarket notification for the TIGER® Spine System, a medical device for spinal fixation. Let's break down the acceptance criteria and the supporting study, focusing on the requested information.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes physical performance testing rather than algorithm-based acceptance criteria for a medical imaging device. However, we can infer the "acceptance criteria" as meeting the specified ASTM standards and the "reported device performance" as having been tested to those standards.

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

This information is not available in the provided text. The document refers to mechanical testing of physical device components, not a study involving human subjects or image data. Therefore, concepts like a "test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are inapplicable in this context.

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

This information is not applicable/available. The study described is mechanical testing of medical device components, not a clinical study involving experts establishing ground truth for diagnostic or prognostic purposes.

4. Adjudication Method for the Test Set

This information is not applicable/available as the study did not involve a test set requiring adjudication in the context of expert review.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes mechanical performance testing of spinal fixation components, not a study evaluating human reader performance with or without AI assistance.

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

No, a standalone study in the context of an algorithm's performance was not done. This device is a physical spinal fixation system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance testing was the engineering specifications and established test methods defined by ASTM standards (ASTM F1717-11a and ASTM F1798-97). The device components were tested to see if they met the performance requirements outlined in these standards for static axial compression, static torsion, dynamic axial compression, and torsion grip.

8. The Sample Size for the Training Set

This information is not applicable/available. The device is a physical product, not an AI or algorithm that requires a training set.

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

This information is not applicable/available as there is no training set for a physical medical device like the TIGER® Spine System.

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The CoreLink ANODYNE® Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 - T1.

The ANODYNE® Anterior Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The ANODYNE® Anterior Cervical Plate System is manufactured from anodized Ti-6AI-4V ELI in accordance with ASTM F136. The two-screw per level plates are available in lengths of 13-30mm (1-level), 26-46mm (2-level), 46-70mm (3-level), and 60-100mm (4-level).

The provided text describes the 510(k) summary for the ANODYNE® Anterior Cervical Plate System, focusing on its substantial equivalence to predicate devices rather than a standalone clinical study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested sections regarding acceptance criteria, performance metrics, ground truth, sample sizes, and expert adjudication are not applicable or cannot be extracted from the provided document, as it pertains to a mechanical device and a substantial equivalence review, not an AI/diagnostic software study.

Here's a breakdown based on the provided text, indicating what can and cannot be answered:

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

Explanation: The "acceptance criteria" here are defined by adherence to ASTM F1717 performance standards, which cover mechanical testing for spinal implant assemblies. The reported performance is that the device met these standards, demonstrating substantial equivalence to its predicate devices in terms of mechanical behavior. Specific quantitative values for these tests are not provided in this summary.

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

• Sample Size: Not applicable in the context of this device's mechanical testing for 510(k) clearance. The "test set" refers to the physical devices undergoing mechanical tests, not patient data.
• Data Provenance: Not applicable. The "data" comes from engineering and mechanical testing, not clinical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not applicable. Ground truth for mechanical performance is established through standardized testing protocols (ASTM F1717) and engineering analysis, not expert consensus on clinical data.
• Qualifications of experts: Not applicable.

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

• Not applicable. Mechanical testing results are objectively measured and analyzed against predetermined standards, not adjudicated by human readers.

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 a medical device (spinal plate system), not AI software or an imaging diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is a physical medical device.

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

• Type of Ground Truth: The ground truth for this device's performance is established by validated mechanical testing methodologies and engineering principles as defined by the ASTM F1717 standard. The "truth" is that the device withstands specified loads and forces according to these standards, demonstrating mechanical equivalence to previously cleared devices.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence.

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

• Not applicable.

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The CoreLink ZOUTM Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterior lateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels.

The CoreLink ZOU™ Anterior Lumbar Plate System is designed to provide temporary stability until fixation is achieved. It is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Zou® Anterior Lumbar Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Zou® Anterior Lumbar Plate System is manufactured from Ti-6A1-4V ELI in accordance with ASTM F136.

This is a 510(k) summary for a spinal fixation device, not a report about an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and human reader performance with AI assistance is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the Zou® Anterior Lumbar Plate System to previously cleared predicate devices based on:

• Indications For Use: Identical to predicate devices.
• Design, Function, and Materials used: Similar to predicate devices.
• Performance Standards: The device underwent testing based on a modified ASTM F1717 protocol, which included static compression bending, static torsion, and dynamic compression bending. The conclusion is that all substantial equivalence requirements were met.

There is no mention of an algorithm or AI being used, nor any studies involving human readers or ground truth for diagnostic purposes.

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The TIGER™ Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral/iliac spine (TI Si/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The TIGER™ Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

The purpose of this premarket notification is twofold: 1) the addition of new components to the TIGER™ Spine System, 2) Size range expansion and 3) expand the Indications For Use statement to include Degenerative Disc Disease (DDD) for previously cleared components of the system.

The provided text describes a Special 510(k) Summary for the Tiger™ Spine System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or safety through extensive clinical trials. Therefore, the information typically requested in your prompt (especially related to AI/algorithm performance, ground truth, and expert consensus for a separate study) is not applicable to this document.

However, I can extract the relevant information regarding the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" as presented in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The tests were "non-clinical" and likely involved a number of manufactured devices/components for mechanical testing.
• Data Provenance: Not applicable in the context of clinical data. The tests were laboratory-based mechanical performance tests.

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

This is not applicable. The "ground truth" for mechanical testing is established by the specified ASTM standards and the physical properties of the materials and design. No humans were involved in interpreting data for ground truth in this context.

4. Adjudication Method

Not applicable. Mechanical tests have objective pass/fail criteria based on physical measurements against established standards.

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

No. This document explicitly states, "No clinical studies were performed." and details non-clinical mechanical testing. MRMC studies are for evaluating human reader performance, often with AI assistance, which is not relevant here.

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

No. This document describes a physical medical device (pedicle screw system), not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by the ASTM standards (ASTM F1798 and ASTM F1717) which define the test methodologies and acceptance parameters for spinal implant constructs. Equivalence was demonstrated through engineering rationale comparing the test results to the predicate device's performance, as per these standards.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. (See #8)

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The TIGER™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, the TIGER™ is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The TIGER™ Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.

This document does NOT describe a study that uses AI/ML to detect or diagnose a condition and does not contain the requested information. The document describes a Special 510(k) submission for the Tiger™ Spine System, which is a medical device (pedicle screw system) used for spinal fixation.

Here's why the requested information cannot be provided from this document:

• Acceptance Criteria and Reported Device Performance (Table): The document reports non-clinical test results (static and dynamic compression, static torsion) and states that the results "indicate that the TIGER™ is equivalent to predicate device(s)." It does not provide specific numerical acceptance criteria or detailed performance metrics in the way one would for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). The "performance" here relates to mechanical strength and equivalence.
• Sample Size for Test Set and Data Provenance: Not applicable as no clinical study or AI/ML model evaluation involving human data was performed.
• Number of Experts and Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The document explicitly states, "No clinical studies were performed." Therefore, no MRMC study was conducted.
• Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device, not an algorithm.
• Type of Ground Truth Used: Not applicable. The "ground truth" for this device's evaluation was based on mechanical test standards (ASTM F1717) and demonstrating equivalence to predicate devices, not clinical outcomes or expert consensus on a diagnosis.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable, as no AI/ML model was developed or trained.

In summary, this document is a regulatory submission for a physical medical device, not a diagnostic algorithm. The "study" referenced is non-clinical mechanical testing to demonstrate substantial equivalence to existing devices.

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