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The Lucero Medical Cervical Spacer is intended for anterior intervertebral body fusion in skeletally mature patients who have had at least six weeks of non-operative treatment. The Lucero Medical Cervical Spacer is indicated to treat cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Lucero Medical Cervical Spacer is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone to facilitate fusion and to be used with supplemental fixation cleared for use in the cervical spine.

The Lucero Medical Cervical Spacer is an additively manufactured interbody device. These cervical implants have basic keystone cross-sectional shape and an open structural architecture. A variety of height, length, width and anteroposterior angulation combinations are available to accommodate the anatomic requirements of individual patients. The devices are provided sterile.

This document describes the Lucero Medical Cervical Spacer System, an intervertebral body fusion device. The acceptance criteria and performance are based on mechanical testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific number of Lucero Medical Cervical Spacers used in the mechanical testing (the test set sample size). It refers to "worst-case Lucero Medical Cervical Spacer." The data provenance is internal testing performed by Lucero Medical, LLC, to demonstrate substantial equivalence to legally marketed predicate devices.

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

Not applicable. This is a medical device for orthopedic surgery, and the "ground truth" for mechanical testing is established by adherence to recognized ASTM standards (F2077, F2267) rather than expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements against established engineering standards.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical implant, not an AI or imaging-based diagnostic tool. The performance evaluation is based on mechanical properties and substantial equivalence to existing devices.

6. Standalone Performance Study (Algorithm Only)

No, a standalone performance study was not done as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" used for device performance is based on established engineering standards for intervertebral body fusion devices, specifically ASTM F2077 for static and dynamic compression and static torsion, and ASTM F2267 for subsidence.

8. Sample Size for the Training Set

Not applicable. Mechanical testing of physical devices does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. There is no training set for this type of device evaluation.

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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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