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The EQUATION™ Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATION™ Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the EQUATION™ Fixation System is indicated for skeletally mature 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.

The Medtronic Sofamor Danek EQUATION™ Fixation System consists of a variety of shapes and sizes of screws, nuts, and rods and cross connectors. The implant components can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. The implants are made of medical grade titanium alloy, and are also offered in medical grade stainless steel. Stainless steel and titanium implant components must not be used together in a construct. The purpose of this submission is to include an additional 3.5mm rod and associated components to the system.

Here's an analysis of the provided text regarding the Medtronic Sofamor Danek EQUATION™ Fixation System, focusing on acceptance criteria and supporting studies:

Assessment of the Provided Information:

The provided document is a 510(k) summary for a medical device (spinal fixation system) seeking clearance for an additional component. Crucially, 510(k) submissions for Class II devices generally do not involve clinical studies with human participants to establish performance against acceptance criteria in the way described in your request. Instead, the primary method for demonstrating safety and effectiveness in such cases is through substantial equivalence to a previously cleared predicate device. This is explicitly stated in the document: "The EQUATION™ Fixation System is substantially equivalent to itself (K013962, SE 06/20/02)." and "Mechanical testing was performed on the subject components. Results indicated that the subject components were substantially equivalent to the previously cleared EQUATION™ Fixation System device."

Therefore, the typical metrics, sample sizes, expert involvement, and statistical analyses relevant to clinical trials (as implied by your questions 1-9) are not applicable or not present in this type of regulatory submission and will not be found herein.

The "acceptance criteria" here relate to the mechanical properties of the new component compared to the previously cleared system, and the "study" is mechanical testing.

Here's a breakdown based on the information available and what can be inferred for a 510(k) for a spinal fixation system:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified quantitatively in the summary. For mechanical testing of medical devices, "sample size" refers to the number of individual components tested for each specific mechanical property (e.g., 3-6 samples for static tests, 12+ for fatigue tests, per ISO/ASTM standards). This information is typically detailed in the full test report, not the 510(k) summary.
• Data Provenance: The mechanical testing was performed on the "subject components" (the newly added 3.5mm rod and associated components). This would be prospective testing specifically conducted for this 510(k) modification. The country of origin of the data would be the testing laboratories, likely in the USA, given the submitter's location.

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

• Not applicable in the human clinical sense. For mechanical testing, the "ground truth" is established by validated testing methods and engineering standards (e.g., ASTM F1717 for spinal implant constructs, ISO 12189). The "experts" would be the biomedical engineers and technicians performing and interpreting these standardized tests, ensuring they follow protocols to generate reliable data. Their qualifications would be in mechanical engineering, materials science, or related fields, with experience in medical device testing.

4. Adjudication Method for the Test Set

• Not applicable in the clinical sense. For mechanical testing, adjudication would involve standard peer review and verification of test results by other qualified engineers or a quality assurance department to ensure compliance with protocols and accurate reporting. There is no "adjudication method" in the sense of reconciling differing expert opinions on a patient case.

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 such study was performed or is relevant. This device is a mechanical spinal implant, not an AI-powered diagnostic or assistive tool for human readers. MRMC studies are for evaluating AI's impact on human interpretation tasks.

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

• No such study was performed or is relevant. Again, this is a mechanical implant, not an algorithm.

7. The Type of Ground Truth Used

• Established mechanical testing standards and performance specifications. The "ground truth" for the mechanical testing is the expected performance (e.g., ultimate tensile strength, fatigue cycles to failure) as defined by relevant ISO and ASTM standards for spinal implant components, and crucially, the performance of the predicate device's components. The testing aims to demonstrate the newly added components meet or exceed these established benchmarks.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning context.

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

• Not applicable. As there is no training set for an AI algorithm.

In summary: The 510(k) process for this type of device (a modification to an existing mechanical implant) relies on demonstrating substantial equivalence through mechanical testing against established engineering standards and comparison to the predicate device's performance. It does not involve the clinical trial methodologies or AI evaluation metrics described in your comprehensive set of questions.

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The EQUATION™ Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATION™ Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the EQUATION™ Fixation System is indicated for skeletally mature 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.

The Medtronic Sofamor Danek EQUATION™ Fixation System consists of a variety of shapes and sizes of screws, nuts, and 3.6mm rods and cross connectors. The implant components can be rigidly locked in a variety of configurations, with each construct being tailormade for the individual case. The implants are made of medical grade titanium alloy. Stainless steel and titanium implant components must not be used together in a construct. The purpose of this submission is to provide the surgeon with an alternative minimally invasive surgical technique.

This document is a 510(k) premarket notification for the Medtronic Sofamor Danek EQUATION™ Fixation System, a spinal implant. It describes the device, its intended use, and its substantial equivalence to itself (meaning a previous version of the same device).

Based on the provided text, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as typically understood for AI/ML-driven medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth) is not applicable to this submission.

Here's why and what information is provided:

• Device Type: The EQUATION™ Fixation System is a physical medical device (spinal implant components like screws, rods, and nuts), not a software-as-a-medical-device (SaMD) or an AI/ML diagnostic/interpretive tool.
• Regulatory Pathway: This is a 510(k) submission, specifically demonstrating "substantial equivalence" to a predicate device. For physical devices like this, substantial equivalence is typically demonstrated through engineering testing (e.g., mechanical strength, biocompatibility), materials testing, and sometimes benchtop or animal studies, rather than clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy.
• "Study" Described: The only "study" mentioned is a "Risk Analysis." This is a regulatory requirement for medical devices to identify potential hazards and mitigate them, not a performance study in the context of diagnostic accuracy.

Therefore, the requested information elements related to diagnostic performance (acceptance criteria table, sample size for test set, ground truth, experts, adjudication, MRMC, standalone performance, training set) do not apply to this 510(k) submission as the device is not an AI/ML diagnostic or interpretive device.

Information applicable from the provided text:

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

   • N/A. This device is a physical implant. The "performance" assessment is based on demonstrating substantial equivalence to a predicate device, primarily through engineering and materials testing, and a risk analysis. No quantifiable diagnostic performance metrics (e.g., sensitivity, specificity) are relevant or provided.
   • The "reported device performance" is essentially that a "Risk Analysis was performed... and it was determined that the proposed changes do not present any additional risks." This indicates safety.

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

   • N/A. No "test set" in the context of diagnostic performance testing is described.

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

   • N/A. No diagnostic ground truth establishment is described.

4. Adjudication method for the test set:

   • N/A. No diagnostic test set or adjudication process 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:

   • N/A. This is not an AI/ML device.

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

   • N/A. This is not an AI/ML device.

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

   • N/A. No diagnostic ground truth is used as this is a physical implant. The "ground truth" for a physical implant's safe and effective use is typically established through engineering standards, biocompatibility testing, and preclinical cadaveric or animal studies, none of which are detailed here beyond the mention of a risk analysis.

8. The sample size for the training set:

   • N/A. No "training set" in the context of AI/ML is used.

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

   • N/A. No AI/ML training set or ground truth establishment is mentioned.

In summary: The provided 510(k) submission pertains to a physical spinal implant system. The regulatory review focuses on demonstration of substantial equivalence to an existing (predicate) device, primarily through engineering and materials considerations, and a risk analysis. It does not involve performance studies typical for AI/ML diagnostic devices, and therefore, the requested information regarding acceptance criteria, ground truth, expert review, and training/test sets is not relevant to this specific submission.

Ask a specific question about this device

The EQUATION™ Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATION™ Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the EQUATION™ Fixation System is indicated for skeletally mature 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.

The Medtronic Sofamor Danek EQUATION™ Fixation System consists of a variety of shapes and sizes of screws, nuts, and 3.6mm rods and cross connectors. The implant components can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. The implants are made of titanium alloy (Ti-6Al-4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.

The Medtronic Sofamor Danek EQUATION™ Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state a "test set" in the context of clinical data or human subjects. The evaluation was primarily based on mechanical testing.

• Sample size for the test set: Not explicitly stated for mechanical testing, but the implication is that sufficient units of the EQUATION™ Fixation System components were tested to make a comparison with the predicate device.
• Data Provenance: The data is from mechanical testing of the device and its components. The country of origin for this testing is not specified, but the submitter is Medtronic Sofamor Danek USA, Inc. The data is prospective in the sense that the testing was conducted specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" for this device's performance is established through mechanical engineering principles and testing standards, not through expert clinical consensus on images or patient data. No human experts were used to establish ground truth in the way it is typically understood for diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable. As the evaluation was based on mechanical testing, there was no need for an adjudication method as would be used with human readers or clinical data. The results of mechanical tests are usually objective measurements.

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

Not applicable. This device is a surgical implant, not a diagnostic or AI-assisted system requiring a MRMC study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (spinal fixation system), not a software algorithm.

7. Type of Ground Truth Used

The ground truth used was objective mechanical test results that demonstrate the physical performance, strength, and durability of the device components, comparing them against the established performance of the legally marketed predicate device (CD HORIZON® Spinal System). The safety and effectiveness are inferred from demonstrating equivalent mechanical properties to a device already deemed safe and effective.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI/algorithm. For a physical device, the development and manufacturing process involves iterative design and testing, but these are not referred to as "training sets."

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

Not applicable as there is no training set. Design specifications and engineering requirements guide the development of such a device, and compliance with these, along with comparison to predicate devices, forms the basis of its "ground truth" for regulatory approval.

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