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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 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 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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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/iliac spine (T1 - S1/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 tumor, and failed previous fusion (pseudarthrosis).

The TIGER™ Spine System is comprised of polyaxial pedicle screws, rods and crosslinks. The TIGER The System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors. The implants are manufactured from Ti6Al4V alloy.

This 510(k) summary describes a spinal implant system, not an AI/ML device, therefore, the requested information regarding acceptance criteria, study details, and ground truth establishment, which are specific to AI/ML device evaluations, cannot be provided.

The TIGER™ Spine System is a pedicle screw spinal system used for spinal immobilization and stabilization. The submission is for an expansion of its Indications For Use to include Degenerative Disc Disease (DDD).

The device's performance was evaluated through mechanical testing and comparison to predicate devices, not through a study involving AI/ML performance metrics.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and 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)

This information is not applicable as this is a mechanical medical device, not an AI/ML device that uses a test set of data. The "testing" refers to mechanical integrity and performance as per ASTM standards for spinal implants.

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. The device's "ground truth" is defined by its mechanical properties and performance against established ASTM standards for spinal implants, not by expert interpretation of data.

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

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, not for mechanical testing of hardware.

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. This is a spinal implant system, not an AI-assisted diagnostic or clinical decision-making tool.

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

This information is not applicable. This is a physical medical device (spinal implant), not an algorithm.

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

The "ground truth" for this device's performance is established by adherence to mechanical testing standards (ASTM F1717), not expert consensus, pathology, or outcomes data in the context of an AI/ML model. The comparison is against previously cleared devices and their established performance and safety profiles.

8. The sample size for the training set

This information is not applicable as this is a mechanical medical device, not an AI/ML device that uses a training set.

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

This information is not applicable as this is a mechanical medical device, not an AI/ML device.

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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 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™ Spine System 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 comprised of polyaxial pedicle screws, rods and crosslinks. The TIGER™ Spine System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-iordosed (curved) configurations. The system has variable length cross connectors.

The provided text describes the TIGER™ Spine System, a pedicle screw system, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of the requested AI/medical device performance evaluation framework.

The document is a 510(k) summary for a medical device (TIGER™ Spine System), which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This process typically relies on demonstrating substantial equivalence rather than meeting pre-defined performance acceptance criteria in the way an AI algorithm might have.

Here's a breakdown of why many of your requested points cannot be answered from the provided text:

• Acceptance Criteria & Device Performance: The document outlines the device's characteristics and compares them to predicate devices to establish substantial equivalence. It does not define performance metrics, thresholds, or acceptance criteria in the sense of accuracy, sensitivity, specificity, or other performance measures that would be relevant for an AI device.
  • The "performance" described is in terms of the device's physical properties, materials, and intended function, not diagnostic or predictive performance.
• Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document explicitly states: "No clinical studies were performed." This means there are no details about a test set, training set, experts, ground truth, or any other elements related to performance evaluation studies for an AI/diagnostic device.
• Training Set Sample Size & Ground Truth: Since no clinical studies were performed, there is no mention of a training set or how ground truth for such a set would have been established.

Summary based on the provided document:

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

   • Acceptance Criteria: Not explicitly defined in terms of measurable performance thresholds for a diagnostic device. The acceptance criteria for its 510(k) approval are based on demonstrating "substantial equivalence" to predicate devices in terms of intended use, design, materials, and function.
   • Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity) are reported. The performance described is its function as a posterior pedicle screw system for temporary stabilization.

2. Sample sized used for the test set and the data provenance: None, as no clinical studies were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: None, as no clinical studies were performed.

4. Adjudication method for the test set: None, as no clinical studies were performed.

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, as this is a physical spinal implant system, not an AI diagnostic device, and no clinical studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical spinal implant system.

7. The type of ground truth used: Not applicable, as no clinical studies requiring ground truth for performance evaluation were performed.

8. The sample size for the training set: Not applicable, as no clinical studies were performed.

9. How the ground truth for the training set was established: Not applicable, as no clinical studies were performed.

What the document does provide regarding "performance" and "studies":

• Non-clinical Test Summary: Mentions "Static and dynamic compression and static torsion per ASTM F1717." These are mechanical tests to ensure the physical integrity and strength of the implant, not performance as a diagnostic or AI device. The results of these tests (e.g., meeting ASTM F1717 standards) would be the "performance" data, but specific numerical outcomes are not detailed in this summary.
• Conclusion: States that the TIGER™ Spine System is "substantially equivalent to the predicate devices in terms of indications for use, design, material, and function." This "substantial equivalence" is the primary basis for its acceptance (510(k) clearance).

In essence, the provided document is for a traditional medical device (implant) and not an AI-powered diagnostic tool, therefore the requested information fields related to AI performance evaluation are not relevant or present in this context.

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