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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 an anterior cervical spinal fixation device that uses interconnecting links. This submission is for the addition of a 3.5mm diameter screw to the existing System.

This submission is a 510(k) Pre-market Notification for a medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial to prove safety and effectiveness from scratch. Therefore, the information provided focuses on comparative performance rather than extensive standalone studies with detailed acceptance criteria and expert reviews as would be expected for novel devices or those undergoing PMA.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The 510(k) summary does not typically include a detailed list of quantitative acceptance criteria as would be present in a design verification and validation report. The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence.

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

The document does not describe a clinical "test set" in the context of human data. The "testing" mentioned is mechanical.

• Sample size for mechanical testing: Not specified.
• Data Provenance: The mechanical testing would have been conducted by the manufacturer, EBI, L.P. The location is Parsippany, NJ, USA. It's a laboratory-based test, not human-specific data, and would be considered prospective for the specific device modification.

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

This information is not provided in the 510(k) summary, as the nature of the submission (510(k) for a modification to an existing device) relies on mechanical testing and comparison to legally marketed predicates. There's no mention of a test set requiring expert ground truth establishment in this context.

4. Adjudication Method for the Test Set:

This information is not provided. Given the type of submission (510(k) for mechanical substantial equivalence), adjudication by multiple experts for a clinical test set is not applicable.

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

No. The document does not describe an MRMC study. This type of study is far more common for AI/imaging devices where human interpretation is a key component to be improved. This submission is for an orthopedic implant.

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

No. This question is not applicable. This is not an algorithm-based device. The "device" is a physical spinal fixation system. However, if one were to interpret "standalone performance" as the performance of the device itself (mechanical integrity, material properties), then the "Mechanical testing" mentioned would represent this.

7. The Type of Ground Truth Used:

For the mechanical testing, the "ground truth" would be the established engineering standards (e.g., ASTM F136 for materials) and internal design specifications for functional requirements. For the substantial equivalence argument, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of machine learning or AI algorithms, as this is a physical medical device.

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

This information is not applicable for the same reasons as #8.

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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.

Warning: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The EBI SpineLink™ System is a cervical spinal fixation device that uses interconnecting links. This submission is for design modifications to the previously cleared 4.5mm, 5.5mm, 6.5mm bone anchor screws, the cervical lock nut, and the associated instrumentation.

The provided document, K993822, is a 510(k) summary for a medical device (EBI SpineLink™ Anterior Cervical Spinal System). It is a regulatory submission for pre-market notification of a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria. This type of submission does not typically include the detailed information requested in your prompt regarding acceptance criteria, study design, ground truth establishment, or sample sizes related to performance evaluation in the way you might expect for an AI/CADe device.

Therefore, many of your requested points cannot be extracted from this document, as they are not relevant to a 510(k) for a spinal fixation system that relies on substantial equivalence.

Here's an analysis based on the information available in the document:

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

This document does not specify quantitative "acceptance criteria" or report "device performance" in terms of clinical outcomes or diagnostic metrics. Instead, it demonstrates substantial equivalence to predicate devices. The "performance" aspect is addressed by an "Engineering Analysis comparing the modifications to the previous system," which "demonstrated that the device complies with applicable standards and meets all of its functional requirements." However, the specific standards, functional requirements, and the results of this analysis are not detailed in this summary.

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

Not applicable. This is a spinal fixation system, not a diagnostic device evaluated with test sets of data. The submission relies on engineering analysis and comparison to predicate devices, not clinical data sets in the context you describe.

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. Ground truth, in the context of diagnostic or AI studies, is not established for this type of device submission.

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

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

Not applicable. This is a spinal fixation system, not an AI or diagnostic tool.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set

Not applicable. This document is not about an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary of what is provided in the document related to "acceptance criteria" and "study":

The document states that an Engineering Analysis was performed to compare the modified device components (4.5mm, 5.5mm, 6.5mm bone anchor screws, the cervical lock nut, and associated instrumentation) to the previous cleared system.

• Acceptance Criteria (Implied): The device complies with "applicable standards" and "meets all of its functional requirements." The specific standards and functional requirements are not detailed but would be related to mechanical strength, biocompatibility (materials: Ti-6A1-4V ELI per ASTM F136), and design integrity for a spinal implant.
• Study: The "Engineering Analysis" serves as the "study." This would involve mechanical testing, material characterization, and design review to ensure the modifications do not adversely affect safety or effectiveness compared to the predicate. The document states: "An Engineering Analysis comparing the modifications to the previous system demonstrated that the device complies with applicable standards and meets all of its functional requirements."

In conclusion, this 510(k) summary for a spinal fixation device focuses on substantial equivalence based on engineering analysis and material comparisons, not detailed clinical trial data or performance against diagnostic acceptance criteria as is common for AI/CADe devices.

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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 SpineLink™ Anterior Cervical Spinal System is intended for anterior interbody screw fixation of the cervical spine at levels C3-C7. The System is indicated fogense in the temporary stabilization of the anterior spine during the development of cervical spinal fusions 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, or scoliosis), pseudarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachments of the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The EBI SpineLink™ Anterior Cervical Spinal System is an anterior cervical spinal fixation system.

The provided 510(k) summary (K973923) for the EBI SpineLink™ Anterior Cervical Spinal System focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended use, and materials. It explicitly states that "Bench testing comparing the system to a predicate system demonstrated that the device complies with applicable standards and meets all of its functional requirements."

However, this document does not contain specific acceptance criteria, reported device performance metrics (e.g., in a table), sample sizes for test or training sets, details on ground truth establishment, expert qualifications, adjudication methods, or results of MRMC studies common for AI/diagnostic devices.

This type of submission predates the common requirements for AI-based diagnostic devices or those involving clinical studies with detailed performance metrics. The focus is on mechanical and material equivalence.

Therefore, many of the requested fields cannot be filled from the provided text.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The study involved "bench testing."
• Data Provenance: Not applicable in the context of bench testing for a mechanical device.

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

• Not applicable. This was bench testing of a mechanical device, not a diagnostic or AI device requiring expert-established ground truth.

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

• 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

• No. This is a spinal fixation system, not an AI or diagnostic device that would typically involve MRMC studies.

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

• Not applicable. This refers to a mechanical device.

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

• Not applicable. The "ground truth" for bench testing would be engineering specifications, material properties, and mechanical load limits, not clinical "ground truth."

8. The sample size for the training set

• Not applicable. There is no training set for a mechanical device undergoing bench testing.

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

• Not applicable.

Summary based on the provided document:

The EBI SpineLink™ Anterior Cervical Spinal System's acceptance criteria were primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices. This was achieved through:

• Comparison of intended use, materials, and functional characteristics.
• Bench testing to show compliance with applicable standards and functional requirements when compared to a predicate system.

The document K973923 is a 510(k) summary from 1997 for a medical device (a spinal fixation system), not a diagnostic algorithm or AI product. Therefore, the detailed information typically requested for AI/diagnostic studies (like expert consensus, sample sizes for training/test sets, MRMC studies) is not present in this type of submission. The "study" mentioned is "bench testing" which demonstrated mechanical and material performance consistent with predicate devices and established standards.

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