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The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

The Medicon Epiplating System is an implant system consisting of various plates used as the foundation for anchoring prostheses or epitheses in the craniofacial region. The system offers various implant sizes to fit the anatomical needs of a wide variety of patients. Components are manufactured from pure titanium (ASTM F67) or Ti6Al4V alloy (ASTM F136).

The provided text describes a 510(k) premarket notification for the "Medicon Epiplating System" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of its performance against specific acceptance criteria for an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided document.

The document is a regulatory submission for a physical medical device (an implant system), not an AI/ML software device. The "Performance Data" section discusses mechanical testing, sterilization validation, cleaning validation, and biocompatibility, which are standard for such devices, but not the type of performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML solutions and their acceptance criteria.

Summary of what can be extracted based on the provided text:

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

• Not applicable/Not found. The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics that would be relevant for an AI/ML device (e.g., sensitivity, specificity). Instead, it refers to mechanical testing standards (ASTM F382) and biocompatibility standards (ISO 10993-1). The results are qualitative ("demonstrate substantial equivalence") rather than quantitative against specific clinical performance thresholds.

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

• Not applicable/Not found. This section is irrelevant for the type of device described. No "test set" of clinical data (images, patient records) is mentioned. "Performance data" refers to bench testing on 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 found. This information pertains to studies with human expert interpretation, typically in the context of AI/ML evaluation. This document describes a physical implant system.

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

• Not applicable/Not found. This is for clinical data interpretation, not for evaluating a physical implant.

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/Not found. This is specific to AI/ML devices that assist human readers.

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

• Not applicable/Not found. This is specific to AI/ML algorithm performance.

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

• Not applicable/Not found. For this physical device, "ground truth" would be related to material properties meeting standards, mechanical performance under specified loads, and biocompatibility, which are evaluated against established engineering and biological standards, not clinical ground truth derived from expert consensus or pathology.

8. The sample size for the training set:

• Not applicable/Not found. There is no AI/ML training set.

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

• Not applicable/Not found. There is no AI/ML training set.

Information that is mentioned in the document (but not directly addressing the AI/ML specific questions):

• Device Type: Medicon Epiplating System, an implant system.
• Purpose: Attachment of an external restoration prosthesis for physical defects in the maxillo-craniofacial region (ear, nose, eye).
• Regulatory Mechanism: 510(k) premarket notification.
• Substantial Equivalence: Demonstrated through comparison of technological characteristics (design, intended use, material composition, function) to predicate devices.
• Performance Data (for this device type):
  • Mechanical Testing: Performed in accordance with ASTM F382 (proof of load, bending strength, bending stiffness, structural bending stiffness).
  • Sterilization Validation: Pre-vacuum (steam) sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013.
  • Cleaning Validation: Manual and machine cleaning validation in accordance with AAMI TIR30:2011.
  • Biocompatibility: Based on previously cleared devices with identical material and manufacturing methods, tested according to ISO 10993-1.

The document entirely pertains to a physical medical device and does not involve AI/ML technology, which is why the specific questions about AI/ML acceptance criteria and study design cannot be answered from the provided text.

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The MediRod Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar. and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the MediRod Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the MediRod Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The MediRod Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws and rods manufactured from titanium alloy. All the components are available in a variety of sizes to match more closely the patient's anatomy.

This document is a 510(k) summary for the "MediRod Pedicle Screw System." It does not describe a study involving device performance metrics, accuracy, or human reader involvement in the context of AI or diagnostic systems. Instead, this document focuses on the mechanical performance testing of a physical medical device (pedicle screws) to demonstrate substantial equivalence to predicate devices for FDA clearance.

Therefore, the requested information regarding acceptance criteria for device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment, as typically applied to AI/diagnostic devices, is not available or applicable in this document.

The document states:

• Performance Testing: "Static and dynamic testing of the MediRod Pedicle Screw System was performed in accordance with ASTM F1717 (static and dynamic compression bending, and static torsion testing) and ASTM F1798 (static flexion-extension testing)."
• Conclusion: "Results of the testing demonstrate the substantially equivalent mechanical performance of the subject device."

This indicates that the acceptance criteria are based on meeting the standards set forth in ASTM F1717 and ASTM F1798 for mechanical properties, and the study "proves" the device meets these criteria by demonstrating substantial equivalence in mechanical performance to legally marketed predicate devices. However, no specific numerical acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the text.

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The MediExpand Cervical Expandable VBR System is intended for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. Use of the MediExpand Cervical Expandable VBR System is limited to single-level or two-level corpectomy and the device is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.

These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The MediExpand Cervical Expandable VBR System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The MediExpand Cervical Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The devices can be adjusted to the required height after implantation. Once it is adjusted to the desired height the device is mechanically locked in place with fixation screws. The devices have a rectangular space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic anqles. The devices have threaded holes for anchor screws which can be inserted into the adjacent vertebral bodies. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.

The provided text describes the MediExpand Cervical Expandable VBR System, a device intended for use in the cervical spine. However, the document does not provide specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested. Instead, it offers a summary of premarket notification for FDA clearance, focusing on substantial equivalence to predicate devices.

The "Performance Testing" section mentions "Clinical data from Europe have shown the clinical performance and support the use of the MediExpand Cervical Expandable VBR System." It also references "Real World Data (RWD) ... from three sites in Germany" and states, "There were no instances of implant failure, and none of the patients suffered from implant associated damages/injuries." While this suggests positive outcomes, it does not present quantifiable acceptance criteria or a structured study for evaluating those criteria.

Therefore, many of the requested elements cannot be definitively extracted or are not present in the provided text.

Here's a breakdown of what can be a gathered from the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly list acceptance criteria in a quantitative or qualitative manner. It states "There were no instances of implant failure, and none of the patients suffered from implant associated damages/injuries" as a reported performance, but this is a broad statement rather than a specific measure against a predefined criterion.

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

• Sample size: 338 patients.
• Data provenance: Retrospective Real World Data from three sites in Germany (University Hospital of Ludwig-Maximilians-University (LMU) in Munich, Central Clinic in Bad Berka, Schoen Clinic Hamburg Eilbek, Hamburg).

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 in the text. The RWD mentions outcomes like "no instances of implant failure" or "no implant associated damages/injuries," which would likely be determined by medical professionals, but the number or qualifications of these experts are not detailed.

4. Adjudication method for the test set

This information is not provided in the text.

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 is not applicable as the device is a medical implant (Spinal Intervertebral Body Fixation Orthosis) and not an AI-assisted diagnostic tool or imaging system.

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

This is not applicable as the device is a medical implant and not an algorithm.

7. The type of ground truth used

The "ground truth" for the reported performance appears to be clinical outcomes and observations from the "Real World Data" provided by the three German sites, indicating "no instances of implant failure" and "none of the patients suffered from implant associated damages/injuries." This would implicitly involve expert clinical assessment by treating physicians.

8. The sample size for the training set

This is not provided in the text. The document refers to "Real World Data" used to support substantial equivalence, but it doesn't describe a separate "training set" in the context of machine learning or algorithm development.

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

This information is not provided as there is no mention of a "training set" or its ground truth establishment.

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The MediExpand TL Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore the height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neutral tissues. The MediExpand TL Expandable VBR System is intended to be used with supplemental internal spinal fixations systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft material may be used at the surgeon's discretion.

The MediExpand TL Expandable VBR System is an adjustable vertebral body replacement device that is implanted into the vertebral body space to improve stability of the spine. The system comprises of vertebral body devices of various heights, sizes and footplates to fit the anatomical needs of a wide variety of patients. The columns can of the device can be adjusted to the exact length required by the patient's anatomy after implantation. Once it is adjusted to the desired length the columns are mechanically locked in place. The devices have a cylindrical space to allow grafting material to be packed inside the devices. Spikes on the footplates improve the anchoring of the implant to the vertebral body. The footplates are available in various lordotic angles. Components are manufactured from titanium alloy (Ti6Al4V) per ASTM F-136 and ISO 5832-3.

The provided document is a 510(k) premarket notification for a medical device called the "MediExpand TL Expandable VBR System." This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through a standalone clinical study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not available in this document.

The document primarily details the performance testing done according to ASTM F2077 to demonstrate that the device performs equivalently to the predicate devices, particularly under static and dynamic loading. This type of testing is mechanical, not clinical, and does not involve human readers, expert ground truth, or patient outcome data as would be found in a clinical study for AI performance validation.

Here's an assessment based on the available information:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail numerical thresholds for clinical performance in the provided text. The implicit acceptance criterion is "substantial equivalence" to predicate devices, supported by mechanical testing.
   • Reported Device Performance: "Static and dynamic testing of the MediExpand TL Expandable VBR System was performed in accordance with ASTM F2077 as recommended by the FDA Guidance for Spinal System 510(k)'s." However, specific numerical results of this testing (e.g., load capacity, fatigue life) are not detailed in this summary.

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

   • This information is not applicable as the study described is mechanical testing, not a clinical study involving a test set of 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 this is mechanical device testing, not a study requiring expert ground truth for interpretation of patient data.

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 device is a physical medical implant, not an AI diagnostic or assistive 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 consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the mechanical testing would be the specified performance requirements of ASTM F2077 and the performance characteristics of the predicate devices. This involves engineering specifications and materials science data, not clinical ground truth.

8. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

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