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The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The PEEK CAS is a curved implant constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LT1) as described by ASTM F-2026. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for additional bone growth through the device. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.

This 510(k) submission (K050861) for the PEEK CAS device does not include a study describing acceptance criteria, device performance, or ground truth establishment based on clinical data or expert evaluations.

Instead, this submission focuses on demonstrating substantial equivalence to existing predicate devices (Interpore Cross Expandable PEEK VBR (K040928) and Interpore Cross NEXUS (K040168)) through:

• Same indications for use: The device targets the same clinical conditions and anatomical region as the predicates.
• Intended use: The purpose of the device (partial vertebral body replacement) aligns with the predicates.
• Similarity in materials of construction: It uses PEEK OPTIMA™ LT1, a medical-grade material, also used in similar devices.
• Equivalent biomechanical performance: This typically implies that the device has undergone non-clinical (e.g., in-vitro mechanical) testing to demonstrate its structural integrity and mechanical properties are comparable to the predicate devices and suitable for its intended use. However, the specific details or results of such tests (acceptance criteria, performance data) are not provided in this summary.

Therefore, I cannot populate the table or answer most of your specific questions as the provided text does not contain that information.

Here's what can be inferred or explicitly stated from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable / Not provided: The document describes a substantial equivalence submission based on device characteristics and intended use, not a clinical study with 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

• Not applicable / Not provided: No clinical ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable / Not provided: No clinical 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

• No: This is a medical device for vertebral body replacement, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with human readers and AI assistance is not applicable.

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

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

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

• Not applicable / Not provided in the context of clinical performance evaluation: The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior approval and marketing. The PEEK CAS aims to meet this "ground truth" through equivalence in design, materials, and biomechanical performance.

8. The sample size for the training set

• Not applicable / Not provided: No computational model or AI training is described.

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

• Not applicable / Not provided: No computational model or AI training is described.

Summary of Device and Submission Type:

This 510(k) submission for the PEEK CAS is for a physical implantable medical device used for vertebral body replacement. The primary method for gaining market clearance is by demonstrating substantial equivalence to already approved predicate devices, rather than conducting new clinical trials that would involve the kind of performance data, acceptance criteria, and ground truth establishment you are asking about. The "study" mentioned would primarily consist of engineering and materials testing to show equivalent biomechanical performance.

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InterGro DBM products are to be used for filling bony voids or gaps in the extremities, and pelvis that are not intrinsic to the bony stability of the structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to bone. The device may also be used for filling craniofacial defects and craniotomies that are no larger than 25cm². The amount of InterGro DBM products to be used should be based on the type of procedure and size of the graft site.

InterGro® DBM products contain human tissue (allograft bone) and are intended for transplantation. The allograft bone has been granulated, demineralized and provided in a lipid carrier. Some versions contain porous ceramic granules that are a composite of highly resorbable calcium carbonate with a slower resorbing 2 to 10 um outer layer of calcium phosphate.

InterGro DBM products have been processed aseptically and are ready to use. They do not require rehydration or any special preparation. InterGro DBM is intended for single patient use only.

The provided 510(k) summary for InterGro® DBM describes a bone graft substitute and its assessment for substantial equivalence. It does not contain information about an AI/ML powered medical device, therefore many of the requested categories related to such systems (e.g., AI assistance, MRMC studies, training set details) are not applicable.

Here's an analysis of the provided text based on your request, focusing on the available information:

Acceptance Criteria and Device Performance for InterGro® DBM (K031399)

This 510(k) pertains to a bone graft substitute. The acceptance criteria and "performance" are framed around biological equivalence and safety rather than diagnostic accuracy metrics typically associated with AI/ML devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Viral Inactivation Validation: "A select panel of viruses representing various virus types, sizes, shapes, and genomes were evaluated." (Specific number of viruses not provided). Data provenance is not specified but the nature of the test suggests laboratory-based validation.
• Osteoinductive Potential (In Vivo Correlation): 25 donor lots of DBM were used for correlation with athymic rat muscle implantation. Data provenance for these donor lots is not specified but implies human tissue.
• Osteoinductive Potential (Clinical Results): "Clinical results using DBM..." (Number of patients or specific studies not provided explicitly for this summary). The context implies human clinical data, but provenance (e.g., country, retrospective/prospective) is not given.
• Product Performance Testing (Animal Models): "evaluated in rabbit and sheep models." (Specific number of animals or studies not provided). This is prospective animal study data.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This device is a material (bone graft substitute) not an AI diagnostic device. Ground truth is established through laboratory assays, animal studies, and clinical observations of healing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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

• Not Applicable. This is not an AI-powered diagnostic device, so MRMC studies comparing human readers with and without AI assistance are irrelevant.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This is not an algorithm. The in-vitro SAOS assay and in-vivo athymic rat model can be considered "standalone" in vitro/in vivo tests of the DBM's osteoinductivity, independent of human clinical application, but they are not algorithm performances.

7. Type of Ground Truth Used

• Viral Inactivation: Laboratory assay results demonstrating a reduction in viral titre.
• Osteoinductive Potential:
  • In-vitro: Proliferation of SAOS human osteosarcoma cells (a cellular assay).
  • In-vivo correlation: Histological evidence of bone formation in athymic rat muscle following DBM implantation.
  • Clinical: Radiographic evaluation of healing in human patients following DBM implantation.
• Product Performance Testing: Radiographic and histological methods in animal models.

8. Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not Applicable. See point 8.

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The Titanium Mesh Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for total replacement of diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and ncural tissues, and to restore the height of a collapsed vertebral body. The Titanium Mesh Implant is also indicated for total vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The Titanium Mesh Implant is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

The Titanium Mesh Implant is intended to be used with supplemental internal fixation. The supplemental fixation system that must be used with this implant is the Synergy Spinal System. In addition, the Titanium Mesh Implant is intended for use with bone graft.

The Titanium Mesh Implant is a hollow cylindrical tube made from commercially pure (CP) titanium (ASTM F-67). The sides of the cylinder implants contain concentric oval patterned openings. These openings allow the surgeon to trim the cylinder to the desired length at a pre-specified angle relative to the longitudinal axis of the cylinder. The external surface of the implant contains concentric circular grooves perpendicular to the axis of the cylinder which provides a guide in the event that a perpendicular end is desired.

The provided text is for a 510(k) summary for a medical device called the "Titanium Mesh Implant." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a traditional clinical study.

Therefore, many of the requested categories (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable in the context of this 510(k) submission as it is presented. The FDA's review for such a device primarily relies on comparing its design, materials, and intended use to an already legally marketed device to ensure it is equally safe and effective.

Here's how the available information relates to your request:

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

• Not Applicable. This document does not specify acceptance criteria or report performance data in the way a clinical study would for a new AI or diagnostic device. The basis for clearance here is "substantial equivalence."

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. No test set or associated data provenance is described. The approval is based on comparison to a predicate device.

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. No ground truth establishment by experts is mentioned, as this is not a diagnostic device undergoing performance validation with a test set.

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

• Not Applicable. No 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

• Not Applicable. This is a physical implant, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

• Not Applicable. This is a physical implant.

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

• Not Applicable. No specific ground truth is referenced for this type of device submission. The "ground truth" for its safety and effectiveness is implicitly derived from the existing predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. There is no training set described.

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

• Not Applicable. There is no training set described.

Summary of what the document does provide regarding "proof":

The "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which aims to demonstrate substantial equivalence to an already legally marketed predicate device, rather than proving performance against new acceptance criteria.

The key points from the document that serve this purpose are:

• Predicate Device: DePuy Acromed Surgical Titanium Mesh (K003043 and K020522)
• Comparison Statement: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Titanium Mesh Implant is considered substantially equivalent to the legally marketed predicate devices."
• Intended Use: The Titanium Mesh Implant's intended use (thoracolumbar spine (T1 to L5) for total replacement of diseased vertebral bodies due to tumors or fractures, to achieve anterior decompression and restore height, with supplemental fixation and bone graft) is explicitly stated to be the same as the predicate device.
• Device Description: The device is a hollow cylindrical tube made from commercially pure (CP) titanium (ASTM F-67), with specific design features (concentric oval openings, concentric circular grooves) which presumably are similar to or justify equivalence to the predicate device.
• FDA Clearance: The FDA's letter (DEC 29, 2004) states they have "determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the "proof" is the successful demonstration of substantial equivalence based on a comparison of intended use, materials, and biomechanical performance to an existing cleared device, as reviewed and accepted by the FDA.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Altius OCT System is indicated for:

• . DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis .
• Spinal stenosis t
• . Fracture/dislocation
• . Atlantoaxial fracture with instability
• Occipitocervical dislocation .
• Revision of previous cervical spine surgery
• . Tumors

The occipital bone screws are limited to occipital fixation only.

The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

The Altius OCT System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bone screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.

The provided text is a 510(k) summary for the Altius OCT System, which is a spinal interlaminal orthosis fixation device. This type of device is an implant used in surgery and does not typically involve AI or software components requiring the kind of acceptance criteria, performance studies, and ground truth establishment detailed in your request.

The 510(k) process for such a device focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through comparing indications for use, materials, and biomechanical performance, rather than evaluating AI algorithm performance.

Therefore, I cannot extract the information required in your request (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from the provided text because it describes a physical medical device (spinal implant) and not an AI or diagnostic software device. The document states:

"{1} COMPARISON TO THE PREDICATE DEVICE
Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Altius OCT System is considered substantially equivalent to the legally marketed predicate device."

This explicitly indicates the type of evaluation performed, which does not align with the questions about AI performance metrics.

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The C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

The C-TEK C-Thru Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole or slotted hole design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. It is a 510(k) summary for the C-TEK C-Thru Anterior Cervical Plate System, detailing its classification, predicate device, indications for use, and a comparison to the predicate device. The document states that the device is considered substantially equivalent to a legally marketed predicate device based on similar indications, intended use, materials, and equivalent biomechanical performance.

Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies. This type of information is typically found in performance studies, clinical trials, or validation reports, which are not present in the provided 510(k) summary.

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The Expandable PEEK VBR Implant is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Expandable PEEK VBR Implant is also indicated for treating fractures of the thoracic and lumbar spine. The Expandable PEEK VBR Implant is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The Expandable PEEK VBR Implant is an expandable device constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LTI) as described by ASTM F-2026. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The Expandable PEEK VBR Implant is inserted between vertebral bodies in the posterior thoracolumbar spine from T1 to LS. Following insertion into the surgical site, the implant may be left undistracted or may be expanded via a ratcheting mechanism. When expanded, a reinforcement clip is inserted into the implant to aid in maintaining height. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.

This document is a 510(k) Summary for the Expandable PEEK VBR Implant, submitted to the FDA in 2004. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving that the device meets specific performance criteria through clinical data.

Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML medical devices, is not present in this type of submission for a traditional implantable medical device.

However, I can extract the information that is available and indicate where the requested details are not provided.

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

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not provide a table of acceptance criteria with corresponding device performance metrics in the way you'd expect for an AI/ML device (e.g., sensitivity, specificity, accuracy thresholds). For implantable devices like the Expandable PEEK VBR, "acceptance criteria" are generally met through:

• Substantial Equivalence to Predicate Devices: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by comparing:
  • Indications for Use: Must be the same.
  • Technological Characteristics: Must be the same or substantially similar. If different, the differences must not raise new questions of safety and effectiveness.
  • Performance Data: Often includes bench testing (biomechanical), material testing, and sometimes animal studies, but rarely human clinical trials for a 510(k) orthopedic device unless significant new questions of safety/effectiveness arise.

The text states: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Expandable PEEK VBR Implant is considered substantially equivalent to the legally marketed predicate devices."

Therefore, the tacit acceptance criteria are that the device performs equivalently to its predicates in terms of:

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

• Sample Size for Test Set: Not applicable/not provided for a traditional biomechanical equivalence study. The "test set" would typically refer to the samples used in bench testing. The 510(k) summary only states "equivalent biomechanical performance," which implies testing was done, but does not provide details on sample sizes of implanted devices/materials, nor "data provenance" (country of origin, retrospective/prospective) as these are not clinical trial results.
• Data Provenance: Not applicable/not provided. Biomechanical testing is usually performed in a lab setting, not using patient data in the sense of AI/ML device validation.

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

• Number of Experts: Not applicable. For an implantable device's biomechanical testing, "ground truth" is established through engineering principles, material science, and established ASTM standards, not typically by expert consensus of clinical cases.
• Qualifications of Experts: If any experts were involved in test design or review, they would typically be biomechanical engineers, material scientists, or orthopedic surgeons, but their number and specific qualifications are not detailed in this summary.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This concept is relevant for reconciling discrepancies in human expert labeling/diagnosis in AI/ML studies. For a medical implant, "adjudication" would refer to reviewing and interpreting test results against predetermined engineering specifications, not expert consensus on medical cases.

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

• MRMC Comparative Effectiveness Study: No, this type of study was not done. MRMC studies are specific to evaluating diagnostic imaging devices or AI-assisted diagnostic tools and measuring their impact on human reader performance. The Expandable PEEK VBR Implant is an orthopedic implant, not a diagnostic or AI device.
• Effect Size of AI Improvement: Not applicable, as no AI component is involved.

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

• Standalone Performance Study: No, this refers to algorithm-only performance for AI/ML devices. The Expandable PEEK VBR is an implantable medical device and does not have an algorithm.

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

• Type of Ground Truth: The "ground truth" for demonstrating substantial equivalence for this device primarily relies on:
  • Material Standards: Adherence to ASTM F-2026 (for PEEK) and ASTM F-560 (for tantalum).
  • Biomechanical Test Standards/Engineering Principles: Testing according to relevant standards (though not specified in the summary) to demonstrate "equivalent biomechanical performance" to predicate devices.
  • Established Clinical Practice: The indications for use are established treatments for spinal conditions.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use machine learning, so there is no "training set."

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of medical device.

In summary, this 510(k) submission is for a traditional, non-digital, implantable medical device. Its "acceptance criteria" and "study" for marketing clearance are centered around demonstrating substantial equivalence to an existing predicate device through comparisons of indications for use, technological characteristics, material compliance, and biomechanical performance (typically verified through bench testing). The concepts of test sets, training sets, ground truth by experts, MRMC studies, and standalone algorithm performance are not relevant to this type of device and submission.

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The C-TEK Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C2 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

The INTERPORE CROSS C-TEK C-Thru Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastatic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

The C-TEK Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates and screws manufactured from surgical implant grade titanium alloy as described by ASTM F 136 (Ti 6Al 4V ELI). The plates are provided in a fixed hole (C-TEK and C-TEK C-Thru) or slotted hole (C-TEK) design and are available in 1 to 5 level plates. The screws are supplied color coded to identify their respective lengths. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach.

The provided document is a 510(k) summary for a medical device called the "C-TEK Anterior Cervical Plate System." This filing focuses on establishing substantial equivalence to a predicate device, primarily through material composition, indications for use, and biomechanical performance. It does not describe a study involving an AI/algorithmic device or its performance against acceptance criteria in the manner requested.

The questions in your prompt are geared towards evaluating an AI-powered diagnostic or assistive device, which requires details about:

• Statistical performance metrics (sensitivity, specificity, accuracy).
• Test and training datasets (size, provenance, ground truth establishment).
• Expert involvement (number, qualifications, adjudication).
• Comparative effectiveness studies (MRMC, standalone).

Since the C-TEK Anterior Cervical Plate System is a physical implant (spinal intervertebral body fixation orthosis) made of titanium alloy, these types of evaluations are not applicable. The substantial equivalence for this device would be demonstrated through mechanical testing (e.g., fatigue, static strength), biocompatibility, and sterilization validations, rather than diagnostic performance metrics against a medical imaging dataset.

Therefore, I cannot fulfill your request as the provided text does not contain the information necessary to describe acceptance criteria or a study proving device performance for an AI/algorithmic device. The document is about a hardware medical implant.

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The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.

As a pedicle screw system, the Synergy Spinal System is intended only for 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 screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.

In addition, the pedicle screw system may also be used 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the Synergy Spinal System are:

• 1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• 2. Idiopathic scoliosis.
• Kyphotic deformities of the spine. 3.
• Paralytic scoliosis and/or pelvic obliquity.
• Lordotic deformities of the spine.
• Neuromuscular scoliosis associated with pelvic obliquity. 6.
• Vertebral fracture or dislocation. 7.
• 8. Tumors.
• 9. Spondylolisthesis.
• 10. Stenosis.
• 11. Pseudarthrosis.
• 12. Unsuccessful previous attempts at spinal fusion.

For posterior, non-pedicle, screw use, the Synergy screws and lateral connectors are intended for sacral/iliac attachment only, and the Synergy hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.

The Adjustable Length Rod is intended for in situ adjustment of the hooks or screws during spinal fusion surgery.

For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.

The Synergy™ Spinal System components are grouped as follows:

Posterior Application:

• Integral™ Open, Closed, Angled Closed and Reduction Screws, Variable Locking Screws with 1. Variable Locking Seats and Iliac Screws with Hex Nuts and Set Screws. Caution: Only the Integral™ Open, Closed, Reduction and Variable Locking Screws are intended for pedicle fixation.
• Open and Closed Spinal Hooks with Sliders, C-rings and Set Screws. 2.
• Adjustable and Fixed Transverse Connectors with Set Screws. 3.
• 4. Closed and Axial Rod Connectors with Set Screws.
• Lateral Connectors with Set Screws. 5.
• Rods and Adjustable Length Rods and Set Screws. 6.
• 7. Instruments.
• 8. Sterilizer case(s).

Anterior Application:

• 1. Integral™ Open and Closed Screws and Variable Locking Screws with Variable Locking Seats, with Hex Nuts and Set Screws.
• 2. Vertebral Washers.
• 3. Fixed Transverse Connectors with Set Screws.
• 4. Rods.
• 5. Instruments.
• 6. Sterilizer case(s).

NOTE: While the Variable Locking Screws and some fasteners (nuts and set screws) are used for both the 6.35mm and 4.75mm rod sizes, the remaining components (except for those connector components that are designed to join the two rod sizes) are designed for specific rod diameters.

NOTE: The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.

The Adjustable Length Rod is intended for use as part of either a single or double rod assembly. The Adjustable Length Rod allows for distraction at a central location once the bone anchors have been secured.

The provided text is a 510(k) summary for a medical device (Spinal Intervertebral Body Fixation Orthosis - Synergy™ Spinal System) and details its indications for use and comparisons to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, I cannot provide the requested table and study details. This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than presenting performance data from a clinical or technical study against specific acceptance criteria.

The key phrase that indicates the nature of this submission is:
"Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Synergy Spinal System is considered substantially equivalent to the legally marketed predicate device."

This means the device's approval is based on its similarity to an already approved device, rather than new, independent performance testing against defined acceptance criteria.

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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Altius OCT System is indicated for:

• DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient . history and radiographic studies)
• Spondylolisthesis .
• ◆ Spinal stenosis
• ◆ Fracture/dislocation
• Atlantoaxial fracture with instability .
• . Occipitocervical dislocation
• . Revision of previous cervical spine surgery
• . Tumors

The occipital bone screws are limited to occipital fixation only.

The Altius OCT System can be linked to the Synergy Spinal System using the Transitional Rods and Rod Connectors from the Altius OCT System.

The Altius OCT System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bonc screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.

The provided text is a 510(k) summary for the Altius OCT System, a spinal interlaminal orthosis fixation device. It details the device description, indications for use, and its comparison to a predicate device for substantial equivalence.

Based on the information provided, no specific acceptance criteria or results from a study proving the device meets those criteria are described.

Instead, the document states:

• Comparison to the Predicate Device: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Altius OCT System is considered substantially equivalent to the legally marketed predicate device."

This indicates that the FDA granted clearance based on the device's substantial equivalence to an already legally marketed predicate device, rather than requiring a standalone study with specific performance acceptance criteria. The "equivalent biomechanical performance" mentioned suggests that some biomechanical testing was likely performed to demonstrate similarity to the predicate, but specific acceptance criteria or detailed study results are not included in this summary.

Therefore, for your requested information, the following applies:

1. A table of acceptance criteria and the reported device performance: Not provided. The basis for clearance is substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance: Not provided. No specific test set for clinical performance is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set requiring ground truth establishment is described.
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 implant device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant device, not an AI-powered algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical test set requiring ground truth is described. The assessment focused on similarity to a predicate device based on indications, materials, and biomechanical performance.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GEO Structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The GEO Structure is a vertebral body replacement device manufactured from surgical implant grade titanium alloy as described by ASTM F-1108 (Ti 6Al 4V). The implant has a satin finish surface and is available in various shapes and sizes. The GEO Structure is provided either sterile or nonsterile.

The provided text is a 510(k) summary for the GEO Structure, a vertebral body replacement device. It primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, intended use, materials, and biomechanical performance.

Crucially, this document does NOT contain information about specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The document states: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the GEO Structure is considered substantially equivalent to the legally marketed predicate device." This indicates that the regulatory approval was based on demonstrating equivalence, not on a new clinical study with specific performance metrics against pre-defined acceptance criteria as would be the case for novel AI/software devices or those requiring new clinical evidence.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study details, and performance metrics because that information is not present in the provided 510(k) summary. These summaries typically do not contain the detailed study results that would satisfy the prompt's requirements.

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