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The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device must be used with a cleared supplemental fixation system.

The ENDURAMESH is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device must be used with a cleared supplemental fixation system.

The EDURAMESH vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions diameters and heights are available to accommodate variability among patients.

The provided text is a 510(k) Summary for a medical device called ENDURAMESH, a spinal intervertebral body fixation orthosis. This document focuses on demonstrating substantial equivalence to a predicate device for FDA clearance. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document primarily covers:

• Device Description: What the ENDURAMESH is and its purpose.
• Indications for Use: The medical conditions and spinal locations for which the device is intended.
• Substantial Equivalence Information: A comparison of the ENDURAMESH with a predicate device (an earlier version of ENDURAMESH K093207) to show that it is similar in design, material, and intended use. The only notable difference highlighted is the addition of new height options (35mm, 37mm, 39mm) for the modified ENDURAMESH.
• FDA Clearance Letter: Official communication from the FDA confirming substantial equivalence based on the submitted information.

Therefore, I cannot provide the requested table or answer questions 2 through 9 because the provided text does not contain any details about acceptance criteria, specific performance studies (like clinical trials or standalone algorithm evaluations), sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies. The clearance was based on substantial equivalence, material information, and analysis data (which are not detailed here), rather than a separate study proving against specific acceptance criteria.

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The ENDURAMESH is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.

The ENDURAMESH is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.

The ENDURAMESH vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions. Various diameters and heights are available to accommodate variability among patients.

The provided text describes a 510(k) submission for a medical device called ENDURAMESH, a spinal intervertebral body fixation orthosis. Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets specific performance criteria in a clinical or AI-assisted context.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DePuy Harms Mesh Cage (K003043)) through non-clinical mechanical testing.

Therefore, many of the requested information points cannot be extracted from the given text.

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

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

• Cannot be provided: The document does not define specific clinical acceptance criteria (e.g., success rates, complication rates, image quality metrics) or report performance against such criteria. The "performance" reported refers solely to mechanical testing results comparing it to a 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 / Cannot be determined: There is no clinical "test set" in the traditional sense described. The "testing" referred to is mechanical testing of the physical device, not a study involving patient data.

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

• Not applicable: As there's no clinical test set or diagnostic task, there's no ground truth established by experts.

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

• Not applicable: No clinical test set.

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 submission for a physical medical implant, not an AI/software device. Therefore, no MRMC study or AI assistance is relevant here.

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

• No: This device is a physical implant, not an algorithm.

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

• Not applicable: No clinical ground truth is established for this mechanical device submission.

8. The sample size for the training set:

• Not applicable: No AI algorithm or training set is mentioned as this is a physical implant.

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

• Not applicable: No AI algorithm or training set is mentioned.

Summary of Non-Clinical Tests (from the document):

The only "studies" mentioned are non-clinical mechanical tests to demonstrate substantial equivalence to the predicate device.

• Tests Performed: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion.
• Standards Used: ASTM F2077 and ASTM F2267.
• Outcome: "The device functioned as intended and the performance results show that the ENDURAMESH is substantially equivalent to the predicate device."

Conclusion:

The provided K093207 submission for the ENDURAMESH device is a 510(k) Pre-market Notification focusing on demonstrating substantial equivalence to a predicate device through non-clinical mechanical testing. It does not involve AI, clinical efficacy studies with human subjects, or the establishment of ground truth for diagnostic purposes. Therefore, the majority of the requested information points, which are typically relevant for AI/diagnostic device submissions, are not present in this document.

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