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The EBI Omega 21™ 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; scoliosis; spondylolisthesis, fracture; previous failed fusion; or turnor 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 Omega 21™ System is a spinal fixation device that uses rods, screws, and couplers. This submission is for expanding the range of screw sizes to offer an additional 7 and 8mm expansive screw.

The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI Omega 21™ System, a spinal fixation device. This document is a regulatory submission to the FDA for market clearance, primarily focused on showing substantial equivalence to previously cleared devices.

Based on the information provided in the input, here's a breakdown of the requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document describes a reliance on substantial equivalence rather than presenting a detailed de novo clinical or non-clinical study designed with specific acceptance criteria in the manner of an AI/software device. The entire 510(k) submission itself serves as the "study" or evidence package demonstrating that the EBI Omega 21™ System, with the expanded screw sizes, meets the acceptance criteria by being "substantially equivalent" to its predicate devices (EBI Omega 21™ System, EBI SpineLink™ System).

This type of submission for a spinal fixation device typically involves:

• Bench Testing: Mechanical testing (e.g., static and fatigue testing, pull-out strength, torsional strength) of the new screw sizes and the overall system to demonstrate performance comparable to the predicate devices and relevant ASTM standards. Although not explicitly detailed in this summary, such testing would be included in the full submission.
• Material Characterization: Verification that the materials meet ASTM F136 standards.
• Comparison to Predicate Devices: A detailed comparison of design, materials, intended use, and performance characteristics between the new device (with expanded screw sizes) and the predicate devices.

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

• Sample Size: Not specified in the provided text. For mechanical testing of medical devices like spinal implants, samples would typically consist of a certain number of devices or components tested according to relevant ASTM or ISO standards to ensure statistical validity. This is not a "test set" in the context of clinical data for AI, but rather a set of physical devices subjected to engineering tests.
• Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The "studies" for this type of submission are primarily non-clinical (bench) tests and material analyses, not human clinical trials in the conventional sense for the aspect of adding new screw sizes. The provenance would be the manufacturing site and testing laboratories of Electro-Biology, Inc.

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

Not applicable in the context of the provided document. Ground truth, in this context, would be established by:

• Engineering standards (e.g., ASTM F136 for materials, other ASTM/ISO standards for mechanical performance).
• Performance data from the legally marketed predicate devices.
• Regulatory requirements for spinal fixation devices.

The "experts" involved are likely internal engineering and regulatory teams at Electro-Biology, Inc., and potentially external independent testing labs. The FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices) are the regulatory experts who evaluate the submission.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from expert readings of medical images or clinical outcomes, which is not the type of data or study described here. Acceptance is based on meeting pre-defined engineering and material standards, and demonstrating substantial equivalence.

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

No, this type of study was not done. MRMC studies are specific to evaluating the diagnostic performance of imaging devices or AI algorithms when interpreted by multiple human readers, often comparing performance with and without AI assistance. This submission is for a physical orthopedic implant.

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

No, this is not applicable. This is not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

• Engineering Standards: Compliance with ASTM F136 for materials and other relevant biomechanical standards for spinal implants.
• Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate devices, particularly the existing EBI Omega 21™ System and EBI SpineLink™ System. The new components are expected to perform comparably.
• Regulatory Requirements: Fulfillment of FDA's regulatory requirements for spinal fixation devices as outlined in 21 CFR sections pertaining to classification, manufacturing, and labeling.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of AI or machine learning for this physical medical device.

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

Not applicable, as there is no training set mentioned or implied for this physical medical device.

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The EBI X FIX® DynaFix® System Hydroxyapatite (HA) Coated Screws are intended for use in association with the external fixation of bone.

The EBI X FIX DynaFix® Hydroxyapatite® (HA) Coated Screws are intended for use in external fixation for the treatment of bone conditions including limb lengthening, corrective osteotemies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.

The bone screws have a tapered thread diameter and are available in a variety of diameters and lengths in both cortical and cancellous thread patterns. The screws will be available with and without the additional proprietary hydroxapatite surface coating on the threads, and will be sold sterile and nonsterile. The coating has been shown to enhance fixation at the pin-bone interface and to reduce the incidence of pin loosening. Furthermore, osseointegration with direct contact between the bone and the screw thread was seen on histologic examination.

The provided text describes a 510(k) summary for the EBI X FIX® DynaFix® System HA Coated Bone Screws, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed studies proving performance against specific acceptance criteria in the manner of a new drug or novel medical device requiring extensive clinical trials.

Therefore, the input does not contain the specific information required to complete tables or answer questions related to acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies. The document primarily discusses the device description, intended use, materials, comparison to predicate devices, and regulatory approval.

Explanation of Missing Information:

• Acceptance Criteria and Reported Device Performance: This device is a bone screw. The "performance" in this context would typically relate to mechanical strength (fatigue, pull-out strength), biocompatibility, and perhaps evidence of enhanced bone integration. While the summary mentions "biocompatibility, fatigue, and effectiveness testing," it does not provide the specific quantitative acceptance criteria or the reported results from these tests to compare against such criteria. For example, it doesn't say "fatigue strength must be X, and our device achieved Y."
• Sample Size, Ground Truth, Adjudication for Test Set: These details are relevant for studies involving diagnostic or AI-powered devices where a "test set" of data is evaluated against a "ground truth" established by experts. This is not applicable to a physical implant like a bone screw in the context of this 510(k) summary.
• MRMC Comparative Effectiveness Study: An MRMC study is used to evaluate the impact of a diagnostic aid (e.g., AI) on human reader performance. This is not relevant to a bone screw.
• Standalone Performance: "Standalone performance" refers to the algorithm's performance without human intervention, again applicable to AI/diagnostic tools, not a physical implant.
• Type of Ground Truth: The concept of "ground truth" in the context of a bone screw's performance evaluation would involve objective measures from mechanical testing (e.g., stress-strain curves, failure points), histological analysis (for osseointegration), or potentially animal model outcomes. The summary mentions "osseointegration with direct contact between the bone and the screw thread was seen on histologic examination," but this is a general statement, not a detailed ground truth methodology for a formal study.
• Training Set Sample Size and Ground Truth Establishment (Training Set): The bone screw does not involve a "training set" in the sense of machine learning. Its development would involve material science, engineering design, and biomechanical testing, not data-driven model training.

Summary of Available Information (and lack thereof for your specific questions):

The 510(k) summary identifies the predicate device, states that the device underwent "biocompatibility, fatigue, and effectiveness testing," and mentions "osseointegration with direct contact between the bone and the screw thread was seen on histologic examination." However, it does not provide the granular detail requested about acceptance criteria, numerical performance data, sample sizes, expert involvement, or specific study methodologies typical for AI/diagnostic devices.

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The EBI XFIX DFS® Rail System is a unilateral external fixation device intended for use in the treatment of bone conditions including limb lengthening, corrective osteotomies, arthrodesis, fracture fixation, acute or gradual multiplanar correction and other bone conditions amenable to treatment by use of the external fixation modality.

The system consists of fixation components and implantable bone screws. The EBI XFIX DFS Rail System is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS Rail System is attached to the shanks of the bone screws.

The provided text is a 510(k) summary for a medical device called the "EBI XFIX DFS® Rail System," an external fixation device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that the new device meets specific performance acceptance criteria through a clinical study or a standalone algorithm study in the way modern AI/ML devices do.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this 1999 510(k) submission for a physical medical device. These elements are typically associated with performance studies for software as a medical device (SaMD) or AI-powered diagnostics.

Here's a breakdown of what can be extracted and what is not applicable based on the provided document:

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

• Not Applicable. This document is a 510(k) summary demonstrating substantial equivalence to predicate devices, not a report of performance against specific acceptance criteria in a study for a new device type (like an AI/ML product). The FDA's determination of substantial equivalence means the device is as safe and effective as a legally marketed predicate device.

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

• Not Applicable. No test set or associated data provenance is described in this 510(k) summary. The submission relies on a comparison of technological characteristics to predicate devices.

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 mention of a test set, ground truth, or expert involvement for performance evaluation described in this 510(k) summary.

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

• Not Applicable. No test set or adjudication method is 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 device is a physical external fixation system, not an AI or diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is irrelevant and not mentioned.

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

• Not Applicable. This is a physical medical device, not a standalone algorithm.

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

• Not Applicable. Ground truth is not established or used as part of this 510(k) submission, which is based on demonstrating substantial equivalence to existing devices.

8. The sample size for the training set

• Not Applicable. There is no training set for an algorithm mentioned in this submission.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided document is a regulatory submission demonstrating the substantial equivalence of a physical medical device (EBI XFIX DFS® Rail System) to existing predicate devices based on its intended use, materials, and technological characteristics. It does not describe performance studies involving acceptance criteria, test sets, ground truth, or AI/ML evaluations.

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The EBI SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

The EBI SpineLink™ System is a cervical spinal fixation device that uses interconnecting links. This submission is for the addition of a 4.5mm diameter bone anchor screw.

The provided text describes a 510(k) summary for the EBI SpineLink™ Anterior Cervical Spinal System, which is a medical device for spinal fixation. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market rather than providing detailed clinical study data with specific acceptance criteria and performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in the provided text. The text primarily addresses regulatory compliance and safety/effectiveness through comparison to predicate devices, rather than a de novo clinical trial demonstrating performance against quantitative acceptance criteria.

However, I can extract the information that is present:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria or quantitative performance metrics typically seen in a clinical study report. Instead, the "acceptance criteria" can be inferred as demonstrating "substantial equivalence" to predicate devices and complying with applicable standards.

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

• Sample size for test set: Not applicable/Not provided. The submission relies on comparative testing to demonstrate equivalence rather than a clinical trial with a "test set" of patients. The "testing comparing the modifications" likely refers to bench testing rather than human subject data.
• Data provenance: Not applicable/Not provided in terms of human subjects. The testing described would primarily involve mechanical or material testing of the device itself.

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

Not applicable/Not provided. Ground truth, typically established by experts in clinical studies, is not mentioned as this relates to a comparative device submission based on product characteristics and previous approvals.

4. Adjudication method for the test set

Not applicable/Not provided. Adjudication methods are relevant for clinical trials or studies involving expert review of outcomes, which are not detailed here.

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

Not applicable. This is a medical device for spinal fixation, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI enhancement 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 spinal fixation device, not an algorithm or software.

7. The type of ground truth used

Not applicable/Not provided. The concept of "ground truth" as used in diagnostic or AI studies (e.g., pathology, outcomes data) does not apply to this device submission, which focuses on mechanical equivalence and safety.

8. The sample size for the training set

Not applicable/Not provided. Training sets are relevant for machine learning models, which this device is not.

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

Not applicable/Not provided. See point 8.

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The EBI Ornega 21™ System is a spinal fixation device for pedicle screw fixation and a nombedicle 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 of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (psuedarthrosis).

In addition, when used as a pedicle system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first saxral (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 spine (1,3 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/iliar screw fixation system, the levels of attachment are the lumbar and thoracc spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scollosis; 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; spondylolisthesis, fracture; previous failed fusion; or tumor resection.

The EBI Omega 21™ System is a spinal fixation device that uses rods, screws, and couplers. 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", and introduce the availability of two shorter length rods.

This document is a 510(k) summary for the EBI Omega 21™ System, a spinal fixation device. It describes the device, its intended use, and its substantial equivalence to previously cleared devices.

Here's an analysis of the document concerning acceptance criteria and supporting studies, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of discrete performance metrics (e.g., accuracy, sensitivity, specificity, mechanical strength thresholds, etc.) nor does it present a study demonstrating the device meets such criteria with reported performance values.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implied by the regulatory requirements for spinal fixation devices and the comparison to established predicate devices.

Implied Acceptance Criteria and Device Characteristics:

Study Details (Based on available information in the K990303 document):

The document does not describe a clinical study or a standalone performance study with a test set, ground truth, or expert involvement. The primary "study" or evidence presented for this 510(k) submission is a comparison to predicate devices and adherence to recognized standards.

Here's an attempt to address the requested points based solely on the provided text, noting where information is absent:

1. Sample size used for the test set and the data provenance: Not applicable. No specific test set data is mentioned for performance evaluation in a clinical or standalone study. The substantiation is based on material compliance, mechanical testing standards, and predicate device equivalence.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No specific test set requiring ground truth establishment by experts is described.

3. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic or analysis tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. Standalone performance, in this context, would refer to mechanical testing, which is mentioned as a "special control" that the device "meets", but no specific study results are provided in this summary.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a performance study for this device as described in the summary. For a spinal implant, "ground truth" might refer to long-term clinical outcomes or successful fusion, but this document does not present such data for this submission; it relies on the predicate device's established safety and effectiveness.

7. The sample size for the training set: Not applicable. This is not an algorithm requiring a training set.

8. How the ground truth for the training set was established: Not applicable. This is not an algorithm requiring a training set.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The K990303 submission for the EBI Omega 21™ System demonstrates safety and effectiveness primarily through substantial equivalence to predicate devices. This means the manufacturer argues that:

• The device's materials, design, and function are highly similar to devices already legally marketed.
• Its intended use is identical or very similar to the predicate device.
• It complies with relevant consensus standards for materials and mechanical testing (though specific results are not detailed in this summary).
• Its labeling meets current regulatory requirements.

The mention of "Compliance with mechanical testing standards" indicates that such testing was done, and the device met those standards, serving as the primary technical performance "study" for a device of this type in a 510(k) submission. However, the details of those tests (e.g., number of samples, specific loads, pass/fail criteria, actual performance results) are not included in this high-level summary.

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When used with a fiberoptic endoscope, the EBI VueCath™ Spinal Endoscopic System can be used in the lumbar and sacral spine for observing epidural anatomy, pathology and delivery of drugs approved for epidural indications.

In addition, the system may be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.

The EBI VueCath™ Endoscopic Spinal System is an arthroscope consisting of several components and different accessories for viewing the lumbar and sacral spinal anatomy. This system includes a fiberscope, disposable catheter, and various accessories. The fiberscope is designed to connect to any compatible commercially available endoscopic video imaging system by using a camera coupler and light cord adapters.

This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the EBI VueCath™ Spinal Endoscopic System. It is a submission to the FDA (Food and Drug Administration) to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

The request asks for information related to acceptance criteria and a study proving the device meets these criteria. However, this 510(k) summary does not contain the level of detail typically found in a clinical study report for AI/software-as-a-medical-device (SaMD) products. This submission is for an endoscopic system, which is a physical medical device, not a diagnostic AI algorithm. Therefore, many of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," or "sample size for training set," are not applicable to this type of device and submission.

The "study" referenced in this document is primarily a comparison to predicate devices and bench testing to confirm functional requirements.

Here's the closest possible answer based on the provided text, acknowledging the limitations:

Acceptance Criteria and Device Performance Study

As this is a submission for a physical medical device (an endoscopic system), not an AI/SaMD product, the concept of "acceptance criteria" and "study" differs significantly from what might be expected for an AI algorithm. The primary "acceptance criteria" for this device, as implied by the 510(k) process, is substantial equivalence to existing legally marketed predicate devices, along with meeting its functional requirements through bench testing.

1. A 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 information is not provided in the 510(k) summary. For a physical device, "test set" and "data provenance" as described typically refer to clinical data. This document relies on bench testing and comparison to predicates, not a clinical trial with a "test set" in the context of diagnostic accuracy.

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

This information is not provided and is not applicable to this type of device submission. Ground truth for diagnostic accuracy is not the focus here.

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

This information is not provided and is not applicable.

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 provided and is not applicable. This is a physical endoscopic system, not an AI-assisted diagnostic tool.

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

This information is not applicable. This describes a physical endoscopic system, not an algorithm.

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

For the "bench testing" mentioned, the "ground truth" would be the engineering specifications and functional requirements of the device. For example, if a criterion is "light output intensity," the ground truth is the specified intensity in lumens, and the device is tested against that. For safety, this would involve material compatibility and sterility testing, where "ground truth" is established through industry standards and regulatory requirements for biocompatibility and sterilization.

8. The sample size for the training set

This information is not provided and is not applicable. This is not an AI algorithm that requires a "training set."

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

This information is not applicable.

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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.

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The EBI VueCath™ Spinal Endoscopic System is intended to be used by physicians for the illumination and visualization of tissues of the epidural space in the lumbar and sacral spine for the purpose of assisting in the diagnosis of disease utilizing a caudal approach via the sacral hiatus.

The EBI VueCath™ Endoscopic Spinal System is an arthroscope consisting of several components and different accessories for viewing the lumbar and sacral spinal anatomy. This system includes a fiberscope, disposable catheter, and various accessories. The fiberscope is designed to connect to any compatible commercially available endoscopic video imaging system by using a camera coupler and light cord adaptors.

The provided document is a 510(k) summary for the EBI VueCath™ Spinal Endoscopic System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, studies proving device performance against those criteria, sample sizes for testing, ground truth establishment, or human-in-the-loop studies.

Instead, the document primarily focuses on establishing substantial equivalence to existing legally marketed devices based on design, materials, and intended use, and mentions "bench testing demonstrates that the device meets its functional requirements" without providing specifics of that testing.

Therefore, much of the requested information cannot be extracted from this document. I will fill in the requested sections with "Not provided in the document" where the information is absent.

Acceptance Criteria and Device Performance

Study Information

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

   • Not provided in the document. The document only vaguely refers to "bench testing."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not applicable/Not provided. The document does not describe studies involving human interpretation or ground truth establishment by experts. The "bench testing" likely refers to engineering or materials testing.

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

   • Not applicable/Not provided.

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

   • No MRMC study was mentioned. This device is an arthroscope, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

   • Not applicable/Not provided. This device is a physical medical instrument, not an algorithm.

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

   • Not applicable/Not provided. The document refers to "bench testing" for functional requirements, not clinical ground truth.

7. The sample size for the training set

   • Not applicable/Not provided. No training set is mentioned as this is a physical device, not a machine learning model.

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

   • Not applicable/Not provided.

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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.

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