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The EBI SpineLink™ System is a spinal fixation device screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, in the non-servical spine of skeletally mature patients, the System is intended to provide immobilization of stinal segments, 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 of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

In addition, when used as a pedice system in skeletally mature patients, it is intended for patients: (a) having severe spondylolistheis (Grades 3 and 4) of the fifth lymbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the desice fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and saxral/ibac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and illum. The System is intended for the treatment of degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; scollosis; spondylouisthesis, fracture; previous failed fusion; or tumor resection.

W hen used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosisthesis, fracture; previous failed fusion; or tumor resection.

The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links and/or rods. This submission is for the addition of rods and couplers (pinchblocks) to supplement the existing system.

The provided text is a 510(k) Summary of Safety & Effectiveness for a spinal fixation device, the EBI SpineLink™ System. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe a clinical study in the typical sense with acceptance criteria, sample sizes, ground truth establishment, or expert involvement to evaluate device performance against specific metrics like sensitivity or specificity.

Instead, the "study" mentioned is mechanical testing to demonstrate performance of the device's new components.

Here's an breakdown of the information that can be extracted or inferred from the provided text, and what cannot:

1. Table of acceptance criteria and reported device performance:

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

• Sample Size for Test Set: Not specified. This typically refers to the number of patient cases or images in an AI/diagnostic study, which is not applicable here as it's mechanical testing of a physical device.
• Data Provenance: Not applicable. The "data" comes from mechanical testing performed on device components.

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 testing is established by engineering specifications and testing protocols, not medical experts.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations in diagnostic studies, which is not relevant to mechanical 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:

• MRMC Study: No. This is a mechanical device, not an AI or diagnostic imaging device.

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

• Standalone Study: No. This is not applicable to a spinal fixation device.

7. The type of ground truth used:

• Type of Ground Truth: Engineering specifications and established mechanical testing standards. The "ground truth" for a mechanical device relates to its ability to withstand specified forces, resist corrosion, etc., as defined by relevant ASTM standards or internal design requirements.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. There is no "training set" in the context of mechanical testing of a physical device.

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does communicate:

The document focuses on establishing substantial equivalence to previously cleared devices based on:

• Intended Use: The EBI SpineLink™ System's intended use has not changed from previously cleared versions.
• Materials: Components are manufactured from Ti-6A1-4V ELI per ASTM F136.
• Function: Mechanical testing was performed on new components (rods and couplers/pinchblocks) to ensure they comply with applicable standards and meet functional requirements. This is the "study" referred to in the context of device performance. The specific standards or detailed results of this mechanical testing are not provided in this summary but would have been part of the full 510(k) submission.

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The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, 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, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links. This submission is for the addition of a modified polydirectional spondylolisthesis screw. The components of the system are manufactured from Ti-6AI-4V ELI per ASTM F136. The components will be available with and without TiN coating.

This document is a 510(k) summary for a medical device (EBI SpineLink™ System), not a study demonstrating device performance against acceptance criteria for an AI/ML product. Therefore, it does not contain the information required to answer your specific questions about acceptance criteria, study design, expert involvement, or AI/ML performance metrics.

The document describes:

• The device (EBI SpineLink™ System), which is a spinal fixation device.
• Its intended use and indications.
• The materials used.
• A comparison to predicate devices, stating that there are "no significant differences" and that it is "substantially equivalent."
• An FDA letter confirming substantial equivalence and allowing the device to be marketed.

Based on the provided text, I cannot extract the information required to populate your table and answer your questions.

Specifically:

• Acceptance Criteria & Device Performance: This document does not detail specific quantitative acceptance criteria or performance metrics derived from a study that would be relevant to an AI/ML device (e.g., sensitivity, specificity, accuracy). It only states that "Testing comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements," but no specific data or criteria are provided.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts related to the evaluation of AI/ML or diagnostic devices, which are not discussed in this 510(k) summary for a spinal fixation hardware system.

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The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, 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, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.

The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links. This submission is to revise the labeling in accordance with the FDA Final Rule dated July 27, 1998, "Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems."

The provided text does not describe the acceptance criteria or a study that proves the EBI SpineLink™ System meets acceptance criteria.

Instead, this document is a 510(k) Summary of Safety & Effectiveness for the EBI SpineLink™ System, which outlines the device's substantial equivalence to previously cleared devices. It focuses on:

1. Device Description and Intended Use: Detailing what the EBI SpineLink™ System is and the conditions it's intended to treat (spinal fixation for various instabilities and deformities).
2. Comparison to Predicate Devices: Stating that the device is substantially equivalent to other marketed spinal systems in terms of intended use, materials, and function, and complies with applicable standards and special controls.
3. Regulatory Information: Including the FDA's clearance letter for the device (K984027).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, ground truth, or MRMC studies, as this information is not present in the provided document.

The document does mention:

• Compliance with material standards.
• Compliance with mechanical testing standards.
• Compliance with biocompatibility standards.
• Labeling requirements.

These could be considered broad categories of "acceptance criteria," but no specific numerical or qualitative thresholds are provided, nor are any study results to demonstrate compliance.

Ask a specific question about this device

The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.

When used as an anterior fixation system or a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

The EBI SpineLink™ System is a spinal fixation device that uses interconnecting links. This submission is for the addition of an 8.5 mm screw, 18 mm link (standard and reverse) and availability of screws in 25 and 30 mm lengths.

The provided text is a 510(k) summary and an FDA clearance letter for the EBI SpineLink™ System, a spinal fixation device. It describes the device's indications for use and states its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or specific studies proving the device meets those criteria in terms of performance metrics.

The document focuses on the regulatory clearance process rather than a detailed performance study report. It mentions "Engineering analysis comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements," but it does not provide details about this analysis, such as acceptance criteria, specific performance results, or study methodologies.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present.
• Sample size used for the test set and the data provenance: This information is not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present.
• Adjudication method for the test set: This information is not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This type of study is not mentioned. Spinal fixation devices are typically evaluated through bench testing, mechanical testing, and clinical outcomes, not MRMC studies.
• If a standalone performance (algorithm only without human-in-the-loop performance) was done: This information is not present. This is not an AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not explicitly stated. The "engineering analysis" would likely rely on mechanical properties and design specifications.
• The sample size for the training set: This information is not present.
• How the ground truth for the training set was established: This information is not present.

The document is a regulatory submission for a medical device focusing on its design, materials, and intended use, and its substantial equivalence to already approved devices. It is not a clinical or performance study report in the way AI/software devices often require.

Ask a specific question about this device

The EBI SpineLink™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine.

When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.

When used as an anterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

The EBI SpineLink™ System with Link Tie is a spinal fixation device for the interconnection of two links.

The provided text describes a 510(k) premarket notification for a medical device (EBI SpineLink™ System with Link Tie), not a study analyzing device performance against acceptance criteria. A 510(k) is a submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process does not typically involve detailed studies with acceptance criteria in the manner requested for a new device's efficacy or accuracy.

Therefore, most of the requested information (such as acceptance criteria, reported performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from the provided document. The document focuses on establishing substantial equivalence through comparison of technological characteristics, intended use, and materials, rather than presenting a performance study with detailed statistical outcomes.

Here's what can be gathered from the text, indicating the type of assessment rather than the specifics of a performance study:

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

Explanation: The "acceptance criteria" here are not numerical performance thresholds but rather the regulatory requirement of demonstrating substantial equivalence to predicate devices, supported by bench testing results that show compliance with standards and functional requirements. Specific numerical performance metrics are not provided.

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/Not mentioned. The document refers to "bench testing," which typically involves mechanical testing of device components, not a clinical "test set" in the context of diagnostic or AI performance evaluation.
• Data Provenance: Not applicable/Not mentioned.

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):

• Number of Experts: Not applicable/Not mentioned. This type of information is pertinent to studies involving human interpretation or clinical data, which is not the subject of this 510(k) summary.
• Qualifications of Experts: Not applicable/Not mentioned.

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

• Adjudication Method: Not applicable/Not mentioned.

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:

• MRMC Study: No, an MRMC study was not done. This is a medical device for spinal fixation, not an AI or diagnostic imaging device.

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

• Standalone Performance: Not applicable. This is a physical medical implant, not an algorithm.

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

• Type of Ground Truth: Not applicable. The "bench testing" mentioned compares the device to a predicate system against "applicable standards" and "functional requirements," indicating objective engineering and material property measurements rather than clinical "ground truth."

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/Not mentioned. This pertains to machine learning models, not mechanical devices.

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

• Ground Truth Establishment for Training Set: Not applicable/Not mentioned.

Summary:

The provided text is a 510(k) submission for a physical spinal fixation device. Its purpose is to demonstrate substantial equivalence to existing devices through comparison of intended use, materials, and general function, supported by "bench testing." It does not contain the detailed performance study information typically requested for AI-enabled diagnostic devices or software, such as clinical test sets, expert ground truth, or statistical performance metrics.

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The EBI SpineLink™ System, a spinal fixation device for the noncervical spine, is indicated for (a) anterior fixation, (b) posterior hook and sacral/iliac screw fixation and ® pedicle screw fixation.

When used as an anterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

When used as a pedicle screw fixation system, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only, ® who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1.

The EBI SpineLink™ System is a spinal fixation device for the noncervical spine consisting of fixed and polydirectional pedicle/sacral screws (available in diameters from 5,5 to 7.5 mm), various types of interconnecting links, lock nuts, and different types of washers.

The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI SpineLink™ System. This document describes a medical device (a spinal fixation system) and compares it to predicate devices. It focuses on intended use, materials, and technological characteristics to establish substantial equivalence.

However, the text does not contain any information about acceptance criteria or a study that evaluates an AI/ML device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the detailed table and information points you asked for, as the provided input does not relate to an AI/ML device.

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The EBI SpineLink™ System (severe spondylolisthesis indication) is intended for patient: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation.

The EBI SpineLink™ System is a posterior pedicle system consisting of fixed and polydirectional pedicle/sacral screws (available in diameters from 5.5 to 7.5 mm), various types of interconnecting links, lock nuts, and different types of washers.

The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI SpineLink™ System. This document focuses on establishing substantial equivalence to predicate devices and describes the device, its intended use, and materials.

It does not contain the information necessary to describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based medical device.

The document describes a mechanical spinal fixation system, not an AI or algorithm-based device. Therefore, typical metrics like "device performance" (e.g., sensitivity, specificity, accuracy), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance for AI are not applicable or discussed here.

The "study" mentioned is "Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements." This refers to biomechanical testing, not clinical performance or AI algorithm validation.

Therefore, I cannot fulfill your request based on the provided input.

To answer your question, I would need a document related to an AI or algorithm-based medical device that includes:

• Specific performance metrics (e.g., accuracy, sensitivity, specificity, F1-score).
• Defined acceptance criteria for these metrics.
• Details of a clinical or analytical validation study (including sample size, data provenance, ground truth methodology, expert qualifications, etc.).

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