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The PediGuard is indicated for use during pedicle screw pilot hole drilling to provide feedback to the surgeon via visual and audible alerts that indicate a change in impedance at the tip of the probe and may indicate contact of the tip with soft tissues and possible vertebral cortex perforation. The PediGuard also is specifically indicated for use in intraoperative electromyographic ("EMG") surveillance to assist in the location and evaluation of spinal nerves during surgery of the spine, by administration of low voltage electrical energy to tissues and nerves at the operative site, and EMG monitoring of muscle groups associated with those nerves.

The PediGuard System is a hand held, battery operated bi-polar probe that is comprised of the following components: (1) a stainless steel shaft; (2) a hollow plastic handle; and (3) an electronic cartridge. Its components are manufactured from stainless steel and plastics according to ASTM and USP requirements.

The provided 510(k) summary for the PediGuard™ Nerve Detector System does not contain the detailed information necessary to complete most of the requested sections regarding acceptance criteria and study design.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical or statistical acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, response time, threshold values for impedance change).
• Quantifiable results of the device's performance against any established criteria.

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

Missing Information:

• Sample Size: The document does not mention any specific test set, number of cases, or even the type of study (e.g., animal, cadaver, human).
• Data Provenance: Not mentioned. It's unclear if any data used for "testing" was retrospective or prospective, or the country of origin.

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

Missing Information:

• No mention of a "test set" in the context of expert review or ground truth establishment. Therefore, no information on the number or qualifications of experts.

4. Adjudication Method for the Test Set

Missing Information:

• Given the absence of a described test set with expert review, there is no information on any adjudication method.

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

Missing Information:

• The document does not indicate that an MRMC comparative effectiveness study was performed. It focuses on substantial equivalence to predicate devices, but not on human reader improvement with or without AI assistance. This device is a nerve stimulator, not an AI-powered diagnostic tool, so such a study would not typically be applicable.

6. Standalone Performance Study (Algorithm Only)

Missing Information:

• This device is a hardware probe with electronics for impedance sensing and electrical stimulation. It is not an "algorithm-only" device that would typically have a standalone performance study in the AI/software context. The "testing" mentioned is likely related to its functional performance and material equivalence, not an algorithm's diagnostic accuracy. No specific standalone performance study results are provided.

7. Type of Ground Truth Used

Missing Information:

• No specific ground truth establishment method (e.g., pathology, outcomes data, expert consensus) is described, as the detailed testing methodology is absent. The "testing for equivalence" likely relied on comparing electrical outputs or functional behaviors to predicate devices, rather than a diagnostic ground truth.

8. Sample Size for the Training Set

Missing Information:

• This device is not described as an AI/machine learning device that would typically have a "training set." Therefore, no information on training set sample size is provided.

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

Missing Information:

• As no training set is mentioned (see point 8), there is no information on how its ground truth was established.

Summary of what can be gleaned from the document:

The 510(k) summary focuses on establishing substantial equivalence to predicate devices based on:

• Similar design and materials: "components of the PediGuard Nerve Monitoring System are similar in design, material, and intended use to other nerve monitoring systems..."
• Intended use: The indications for use are similar to predicate devices.
• Functional testing for equivalence: "Testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." (No details about this testing are provided).
• Compliance with material standards: "Its components are manufactured from stainless steel and plastics according to ASTM and USP requirements."

The provided text is a high-level summary for regulatory filing, not a detailed scientific study report. It demonstrates that the device's fundamental design, materials, and intended functions are comparable to existing cleared devices, which is the cornerstone for 510(k) clearance.

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The Spacevision™ Cage System is intended for use as partial replacement (i.e. partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body in the thoracolumbar spine (T1-L5). The Spacevision Cage System is also indicated in the treatment of trauma/fractures of the thoracic and lumbar spine.

The Spacevision cage implant is an oval shaped device with teeth on the upper and lower portions. The implant is hollow and can be used with bone graft when implanted. The implant is manufactured from PEEK Optima® LT1 and contains tantalum beads for location on radiographs. A variety of sizes are available, and the implants may be inserted individually or in pairs.

This document is a 510(k) summary for the "Spacevision™ Cage System," a medical device intended for vertebral body replacement. The key takeaway from this document is that the device's acceptance criteria and its demonstration of meeting these criteria are solely based on mechanical testing for substantial equivalence to previously cleared predicate devices.

Therefore, the following information regarding AI/algorithm performance, ground truth, expert opinions, and multi-reader studies is not applicable to this submission, as it predates and does not involve AI or diagnostic algorithms.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to the Spacevision™ Cage System itself undergoing mechanical testing, not a dataset for an algorithm. The data provenance is mechanical test results.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a mechanical device is established through engineering and material science principles, typically evaluated by qualified engineers or test facilities. The document does not specify the number or qualifications of individuals who performed or reviewed the mechanical testing.

4. Adjudication method for the test set: Not applicable. Adjudication methods are relevant for subjective assessments or when reconciling differing expert opinions, which is not the case for mechanical testing of a medical device's physical properties.

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 device is a physical implant, not an AI or diagnostic algorithm.

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

7. The type of ground truth used:

• Mechanical Testing Results: The "ground truth" for the device's performance is established by its ability to meet the defined mechanical performance specifications that demonstrate equivalence to predicate devices. This typically involves biomechanical tests to assess strength, fatigue, and stability.

8. The sample size for the training set: Not applicable. This device is a physical implant, not an AI or diagnostic algorithm, and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established: Not applicable, for the same reason as above.

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The Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:

• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.

In addition, the Uni-Thread Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• Degenerative spondylolisthesis with objective evidence of neurologic impairment
• fracture
• dislocation
• scoliosis
• kyphosis
• spinal tumor
• failed previous fusion (pseudoarthrosis)

The Uni-Threaad Spinal System instrumentation consists of screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The Uni-Thread System components are available in titanium alloy manufactured according to ASTM-F136.

The Uni-Thread™ Spinal System is a pedicle screw spinal system. The provided text, a 510(k) summary, indicates that this device received clearance based on its substantial equivalence to previously cleared devices. This means that the device's safety and effectiveness were demonstrated through comparison to predicate devices rather than a standalone clinical study with predefined acceptance criteria.

Therefore, the typical structure for reporting acceptance criteria and a study proving their fulfillment is not directly applicable here in the way it would be for a de novo device or one requiring a PMA.

Here's a breakdown of the available information based on your request, with an emphasis on how "substantial equivalence" impacts the answers:

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

Since the clearance is based on substantial equivalence, there are no specific, quantitative acceptance criteria for clinical performance in the provided document that the device had to meet in a standalone study. Instead, the "acceptance criteria" were demonstrating equivalence in design, materials, and mechanical performance to predicate devices.

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

No clinical or human-based test set with a specified sample size is mentioned in the 510(k) summary. The "test set" in this context refers to the mechanical testing samples. The document does not specify the sample size, country of origin, or whether the mechanical testing data was retrospective or prospective.

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 as there was no clinical study described that required expert-established ground truth. The device's equivalence was based on engineering and material comparisons, not diagnostic or therapeutic outcomes requiring expert review.

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

Not applicable for the same reasons as point 3.

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 device is a mechanical implant (pedicle screw system), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is irrelevant.

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

No standalone clinical performance study was conducted or reported in this summary. The device was cleared based on substantial equivalence and mechanical testing, not a clinical trial.

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

For the mechanical testing, the "ground truth" would be the established performance standards or specifications for predicate devices or relevant ASTM standards for spinal implants. This is based on engineering principles and material science, not clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

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

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

Not applicable for the same reasons as point 8.

In summary: The provided 510(k) summary for the Uni-Thread™ Spinal System indicates clearance through the substantial equivalence pathway. This pathway primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through design, material, and mechanical performance comparisons, rather than extensive new clinical trials with predefined acceptance criteria and human subject data analysis.

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When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

• degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• spondylolisthesis
• fracture
• spinal stenosis
• deformities (i.e. scoliosis, kyphosis, lordosis)
• tumors
• failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.

In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• Degenerative spondylolisthesis with objective evidence of neurologic impairment
• fracture
• dislocation
• scoliosis
• kyphosis
• spinal tumor
• failed previous fusion (pseudoarthrosis)

The PI.US Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and The 11100 Proceed be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.

The document is a 510(k) summary for the PLUS™ Pivot Link Universal System for spinal instrumentation. This type of submission is for medical devices, not AI/ML-driven software, and therefore the concepts of acceptance criteria related to algorithmic performance, ground truth, expert adjudication, or MRMC studies do not apply.

The basis of substantial equivalence for this device is primarily through mechanical testing which demonstrates its equivalence in terms of design, material, and intended use to other FDA-cleared spinal instrumentation systems.

Therefore, I cannot provide the requested information as it pertains to an entirely different type of device evaluation than what is described in the provided text.

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When used for anterior screw fixation or as a posterior, non-pedicle system of the nohcervical spine, the PLUS™ Pivot Link Universal System is indicated for:

• degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history . and radiographic studies)
• spondylolisthesis .
• fracture ●
• spinal stenosis ◆
• deformities (i.e. scoliosis, kyphosis, lordosis) ●
• tumors
• failed previous fusion (pseudoarthrosis) .

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

• . have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to ● sacrum); and
• . have the device removed after the development of a solid fusion.

In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• . Degenerative spondylolisthesis with objective evidence of neurologic impairment
• fracture .
• dislocation ●
• scoliosis
• kyphosis ●
• . spinal tumor
• failed previous fusion (pseudoarthrosis) .

The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.

This 510(k) premarket notification for the PLUS™ Pivot Link Universal System describes a spinal instrumentation system and seeks to establish its substantial equivalence to previously cleared devices. It does not contain information about an AI device or a study involving an AI algorithm and human readers.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device conformance for an AI device. The document primarily focuses on:

• Device Description: Components (hooks, screws, rods, connectors) and materials (stainless steel, titanium alloy, pure titanium).
• Intended Use/Indications for Use: Various spinal disorders for both anterior/posterior non-pedicle fixation and pedicle screw applications.
• Basis of Substantial Equivalence: Stated as "identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA" and mechanical testing to demonstrate equivalence to currently marketed spinal systems.

There is no mention of an AI component, performance metrics, clinical study design, ground truth establishment, or human reader studies in this document. The "study that proves the device meets the acceptance criteria" refers to mechanical testing in this context, demonstrating the physical properties and performance of the spinal implants, not an AI efficacy study.

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When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

• degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history and radiographic studies)
• spondylolisthesis .
• fracture ●
• spinal stenosis ●
• deformities (i.e. scoliosis, kyphosis, lordosis) ●
• tumors
• failed previous fusion (pseudoarthrosis) ●

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and ●
• have the device removed after the development of a solid fusion. .

In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• . Degenerative spondylolisthesis with objective evidence of neurologic impairment
• fracture ●
• dislocation .
• scoliosis ●
• . kyphosis
• spinal tumor
• failed previous fusion (pseudoarthrosis) ●

The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.

This document is a 510(k) summary for the PLUS™ Pivot Link Universal System, a spinal instrumentation system. It's a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study in the way modern AI/ML device submissions might.

Therefore, many of the requested numbered points are not directly applicable or available in this type of document. I will extract what is present and explicitly state when information is not provided.

Device: PLUS™ Pivot Link Universal System (Rod, Hook, and Screw Spinal Instrumentation)

1. Table of acceptance criteria and the reported device performance

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

This document describes a submission for a spinal implant, which relies on mechanical testing and material compliance, not clinical data in the sense of patient test sets.

• No "test set" of patient data is described for performance evaluation.
• The "testing" mentioned is mechanical testing of physical device constructs. The sample size for these mechanical tests (e.g., number of constructs tested) is not provided in this summary.
• Data provenance for mechanical testing (e.g., location of a lab) is not specified.

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. There is no patient-data-based "test set" or ground truth requiring expert consensus to establish. This is a physical device approval, not an AI/ML diagnostic or prognostic tool.

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

Not applicable. No patient-data-based "test set" or adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device that assists human readers.

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

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

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

For this type of device, "ground truth" is typically established through:

• Engineering Standards: Adherence to established ASTM standards for materials (F138, F1586, F136, F67).
• Biomechanical Testing Principles: Ensuring mechanical performance (fatigue, strength) meets or exceeds that of predicate devices, often based on recognized test methods.
• Predicate Device Performance: The primary "ground truth" for a 510(k) is often the demonstrated safety and effectiveness of an already legally marketed, substantially equivalent predicate device.

No medical expert consensus, pathology, or outcomes data is mentioned as a "ground truth" source in this summary for the purpose of device validation.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. No training set for an AI/ML algorithm.

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The UNI-T Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:

• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
• receive fusions using autogenous bone graft only; .
• · have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion. .

In addition, the UNI-T Uni-Thread Spinal System is a pedicle screw system intended to provide In addition, the UNF-1 Unl-Tiread Spinal System is a pkelers on on adjunct to fusion in fusion in fusion in immobilization and Sabilization of Spiralis in Skolouny Industry Industry of the thoracic, lumbar, and sacral spine:

• Degenerative spondylolisthesis with objective evidence of neurologic impairment .
• fracture ◆
• . dislocation
• scoliosis .
• kyphosis .
• spinal tumor .
• failed previous fusion (pseudoarthrosis) .

The UNI-T Uni-Thread Spinal System instrumentation consists of screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The UNI-T System components are available in titanium alloy, manufactured according to ASTM F136.

The provided text is a 510(k) summary for the UNI-T™ Uni-Thread Spinal System. This document describes a medical device (spinal instrumentation) and its indications for use, and it declares substantial equivalence to existing devices.

The information you are requesting, specifically acceptance criteria and a study proving a device meets acceptance criteria, is typically associated with performance studies for diagnostic devices or those with quantifiable performance metrics that are clinically assessed. For a spinal implant system like this, the "acceptance criteria" and "study" are primarily focused on mechanical testing to demonstrate equivalence and safety, rather than a clinical performance study with specific sensitivity, specificity, or similar metrics.

Based on the provided text, here's an attempt to extract relevant information according to your request, but please note that some of your requested categories are not directly applicable or explicitly detailed for this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. "Mechanical testing" typically involves a specific number of constructs tested under various loading conditions, but the exact number of samples is not detailed in this summary.
• Data Provenance: Not specified, but likely refers to laboratory testing data (in-vitro mechanical tests) rather than clinical patient data.

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

This category is not applicable for this type of device and submission. "Ground truth" established by experts in the context of diagnostic performance (e.g., radiologists interpreting images) is not relevant for a mechanical implant. For mechanical testing, the "ground truth" is defined by established engineering standards and test protocols.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation or outcome assessment by multiple experts, which is not described for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

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

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

Not applicable. This is not an algorithm/diagnostic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for mechanical performance is established through adherence to recognized mechanical testing standards and protocols (e.g., ASTM standards for medical implants). This involves measuring properties like fatigue strength, pull-out strength, and bending stiffness according to predefined methods, and comparing these results to predicate devices or established minimum performance criteria. The text explicitly mentions "Mechanical testing was performed to demonstrate the equivalence."

8. The Sample Size for the Training Set

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

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

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

Summary of the Study Discussed (Mechanical Testing):

The primary "study" mentioned to support the UNI-T™ Uni-Thread Spinal System's safety and effectiveness is mechanical testing.

• Objective: To demonstrate the equivalence of the construct design to currently marketed spinal systems.
• Methodology (implied): The mechanical testing would have involved subjecting samples of the UNI-T System components (screws, rods, connectors) and assembled constructs to various mechanical loads and conditions (e.g., static and dynamic loading, fatigue testing) as specified by relevant industry standards (e.g., ASTM F1717 for Spinal Implant Constructs, ASTM F1798 for fatigue testing of pedicle screw spinal systems).
• Conclusion: The tests demonstrated the device's equivalence, implying that its mechanical performance characteristics are comparable to the predicate devices (SCS Claris Spinal System, Orthotec, Inc., and CD Horizon Sofamor Danek) which have already been cleared by the FDA. This equivalence in mechanical performance provides the scientific basis for demonstrating the device's safety and effectiveness for its intended use, as it suggests the device can withstand the physiological forces it will encounter in the body.

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When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:

• degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
• spondylolisthesis
• fracture
• spinal stenosis
• deformities (i.e. scoliosis, kyphosis, lordosis)
• tumors
• failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:

• have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
• have the device removed after the development of a solid fusion.

In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• Degenerative spondylolisthesis with objective evidence of neurologic impairment
• fracture
• dislocation
• scoliosis
• kyphosis
• spinal tumor
• failed previous fusion (pseudoarthrosis)

The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel, manufactured according to ASTMs F138 and F1586.

The provided text does not contain information about acceptance criteria for a device, nor does it describe a study proving a device meets such criteria. Instead, it is a 510(k) summary of safety and effectiveness for a spinal instrumentation system.

The document focuses on:

• Device Description: The components of the PLUS™ Pivot Link Universal System (hooks, screws, rods, connectors).
• Indications for Use: The specific spinal disorders and conditions the system is intended to treat, both as a posterior, non-pedicle system and as a pedicle screw system.
• Basis of Substantial Equivalence: A statement that the device is similar in design, material, and indications to other FDA-cleared spinal instrumentation systems, with mechanical testing performed to demonstrate equivalence.
• FDA Clearance Letter: The formal letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because that information is not present in the provided text.

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