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SANTORINI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1), SANTORINI cages are intended for use 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. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period 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.

When used in the thoracolumbar spine (T1-L5), SANTORINI cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the Santorini Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the SANTORINI Corpectomy Cage System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA

CAPRI Corpectomy Cages are vertebral body replacement devices intended for use in the cervical and thoracolumbar spine.

When used in the cervical spine (C2-T1). CAPRI Static cages are intended for use 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. These cages are intended to restore integrity of the spinal column even in the absence of fusion for a limited time period 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.

When used in the thoracolumbar spine (T1-L5), CAPRI Static and Expandable cages are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture). These cages are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

The interior of the cages can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft as an adjunct to fusion.

When used in the thoracolumbar spine, the CAPRI Static and Expandable Corpectomy cages are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

When used in the cervical spine at one or two levels, the CAPRI Static cages are intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. When used at more than two levels, supplemental fixation should include posterior fixation which is cleared by the FDA

The SANTORINI and CAPRI Corpectomy System implants are vertebral body replacement devices that are designed in a variety of lengths, widths and heights to match the patient's anatomy. Solid and adjustable cages are available and can be implanted via posterior, anterior or lateral approaches. The implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001) and Cobalt Chrome (per ASTM F1537). The SANTORINI implants are made from PEEK OPTIMA LT1 (ASTM F2026) and tantalum (ASTM 560), with some components containing CP titanium (ASTM F67). The purpose of this submission is to expand the indications to include the cervical spine.

Function: The system is used to provide structural stability in skeletally mature individuals following a corpectomy or vertebrectomy.

This document is an FDA 510(k) clearance letter for the SANTORINI and CAPRI Corpectomy Cage Systems. It primarily deals with the substantial equivalence of medical devices, not the performance of an AI/algorithm-based device. Therefore, the detailed information about acceptance criteria, study methodologies, expert ground truth establishment, MRMC studies, or training sets for AI models is not present in this document.

The document discusses the substantial equivalence of the SANTORINI and CAPRI Corpectomy Cage Systems to legally marketed predicate devices, focusing on:

• Device description
• Intended use
• Technological comparison
• Non-clinical performance evaluation via in vitro testing (static/dynamic compression and torsion, subsidence)
• Clinical evaluation via literature review.

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm-based devices, and this document pertains to physical surgical implants, I cannot extract the requested information as it is not relevant to this type of medical device clearance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to biomechanical testing and clinical literature review for the physical cage systems, not performance metrics of an AI model.

Therefore, I am unable to populate the table and answer the specific questions related to AI/algorithm performance.

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The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

The purpose of this 510(k) submission is to add modified screws, rods, hooks and rod to rod connectors.

The provided text is a 510(k) Summary for the Everest Spinal System, which is a medical device. This document focuses on the regulatory submission for clearance of a spinal fixation system and its substantial equivalence to predicate devices, primarily through mechanical testing. It does not contain information on clinical studies involving human patients, AI/human reader performance, or ground truth establishment relevant to the questions asked.

Therefore, many of the requested items cannot be extracted from this document, as they pertain to clinical or AI-related performance studies that were not part of this 510(k) submission.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Note: The document only refers to mechanical performance based on bench testing (ASTM F1717) for the medical device's structural integrity, not clinical performance or AI diagnostic accuracy.

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

• Sample Size for Test Set: Not applicable. The "test set" here refers to mechanical testing of implants, not a clinical data set. The document does not specify the number of implants tested, only that "worst case implants" were tested.
• Data Provenance: Not applicable. This refers to bench testing of physical devices, not patient data.

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

• Not applicable. Ground truth in this context would refer to clinical diagnoses or pathology. The submission focuses on device mechanics, assessed against ASTM standards, not clinical ground truth.

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

• Not applicable. This pertains to clinical assessment or AI performance, not mechanical testing.

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 document does not mention any MRMC study or AI assistance.

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

• No. This document does not describe any algorithm or standalone performance study.

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

• For the mechanical testing, the "ground truth" was adherence to performance levels established by ASTM F1717 and comparison to predicate devices, interpreted by engineering rationale. This is not clinical ground truth.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this document describes a physical medical device, not an AI or algorithm.

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

• Not applicable.

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The Denali Deformity System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Denali Deformity System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

The Denali Deformity System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking set screws, offset connectors and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar or sacral spine.

The Denali Deformity System received 510(k) clearance based on substantial equivalence to predicate devices, rather than meeting specific performance criteria through a clinical study. The provided documentation focuses on biomechanical testing against existing devices and a comparison of design features and materials.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) submission was substantial equivalence to predicate devices. This means the device's performance, indications for use, and technological characteristics were compared to existing, legally marketed devices.

2. Sample Size for the Test Set and Data Provenance

The provided document does not describe a clinical test set of patients or data in the way a diagnostic AI device would. The "test set" here refers to the biomechanical testing performed on the device itself.

• Sample Size for Test Set: Not specified in terms of number of device units, but refers to "biomechanical testing" and "ASTM testing to F1717." This likely involves multiple iterations and samples of the device components.
• Data Provenance: The testing was done on the manufactured device components. The document doesn't specify a country of origin for the data beyond implying it was part of the K2M, LLC development process. It is not retrospective or prospective patient data.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the clearance was based on substantial equivalence and biomechanical testing, not on comparison to expert-established ground truth from patient data. There were no human experts establishing ground truth for a clinical test set in this context.

4. Adjudication Method for the Test Set

This is not applicable as there was no clinical test set requiring adjudication.

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

An MRMC study was not conducted or referenced. This type of study is relevant for evaluating the impact of an AI device on human reader performance, which is not the basis for clearance of a spinal implant system.

6. Standalone Performance Study

A standalone (algorithm-only) performance study was not conducted or referenced in the context of an AI device. The "standalone performance" for this device would be its mechanical performance as measured by ASTM standards.

7. Type of Ground Truth Used

The "ground truth" for this submission was based on established engineering standards (ASTM F1717) for spinal implant testing and comparison to the characteristics of predicate devices that have already been deemed safe and effective.

8. Sample Size for the Training Set

This information is not applicable. Medical device clearances based on substantial equivalence and biomechanical testing do not involve "training sets" in the context of machine learning or AI models.

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

This information is not applicable for the reasons stated above.

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Indicated for use in anterior screw fixation to the cervical spine ( C2 - C7 ) for the following indications: degenerative disc disease ( DDD ), spondylolisthesis, trauma ( including fractures ), spinal stenosis and tumors ( primary and metastatic ), failed previous fusions (pseudarthrosis ) and deformity ( defined as scoliosis, kyphosis or lordosis ).

The Pyrenees Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Commercially Pure Titanium and titanium allov per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

The provided text describes a medical device, the Pyrenees Cervical Plate System, and its regulatory clearance process, including an "Indications For Use" statement. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample sizes, expert qualifications, adjudication methods, or ground truth establishment).

The document is a "Summary of Safety and Effectiveness" and a 510(k) clearance letter from the FDA. These documents primarily focus on demonstrating substantial equivalence to a predicate device based on design, function, material, and intended use, rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other study-related details based on the provided text. The text explicitly states: "There are no significant differences between the Pyrenees Cervical Plate System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." This language indicates a reliance on substantial equivalence rather than a new performance study with explicit acceptance criteria.

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The Mesa Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Mesa Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe 'pondylolisthesis ( grades 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by utogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

The Mesa Spine System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, hooks, and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.

The provided document is a 510(k) Summary for the Mesa Spinal System, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed device. It describes the device's intended use, materials, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance against such criteria in the context of clinical or diagnostic efficacy.

Instead, the document primarily focuses on biomechanical testing to demonstrate equivalence to predicate devices, which is typical for spinal fixation systems. Here's a breakdown of why the requested information cannot be fully provided from the given text:

1. Acceptance criteria and reported device performance (Table 1): The document states: "The Mesa Spine System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717." This indicates a type of performance standard (ASTM F1717) was used, and the device met or exceeded it. However, specific numerical acceptance criteria (e.g., "must withstand X N of force," "fatigue life must exceed Y cycles") and the exact reported performance values are not detailed in this summary. The table below reflects the limited information available.

2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and ground truth establishment for a clinical/diagnostic study: These questions are entirely not applicable to the type of information presented in this 510(k) summary. The document describes a biomechanical study, not a clinical study involving human patients, image analysis, or diagnostic accuracy where such details would be relevant.

Therefore, most of the requested fields cannot be filled based on the provided text.

Here's the closest possible answer based only on the provided text, with explanations where information is absent:

Acceptance Criteria and Device Performance

Explanation: The document explicitly states that the device was biomechanically tested against the ASTM F1717 standard and compared to predicate devices. The acceptance criterion was implicitly defined as performing "equal to or better than" these established systems. Specific numerical thresholds for this ASTM standard and the exact results are not provided in this 510(k) summary.

Details of the Study

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

   • Sample Size: Not specified. (This likely refers to the number of devices or components tested in the biomechanical study).
   • Data Provenance: Not applicable, as this was a biomechanical study, not a clinical data collection from patients or specific countries.

2. 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. This was a biomechanical test of physical properties, not a study requiring expert clinical "ground truth" establishment.

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

   • Not Applicable. (Again, this pertains to clinical/diagnostic studies, not biomechanical tests).

4. 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. An MRMC study was not done. This device is a spinal fixation system, not a diagnostic AI tool, so this type of study is irrelevant.

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

   • Not Applicable. This is a physical medical device, not an algorithm.

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

   • Not Applicable. The "ground truth" for a biomechanical study would typically be the physical properties and performance standards defined by the ASTM F1717 standard and the performance of the predicate devices.

7. The sample size for the training set:

   • Not Applicable. This device is hardware; there is no "training set" in the machine learning sense.

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

   • Not Applicable. As there is no training set for this type of device and study.

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Indicated for use in anterior screw fixation to the cervical spine ( C2 - C7 ) for the following indications : degenerative disc disease ( DDD ), spondylolisthesis, trauma ( including fractures ), spinal stenosis and tumors ( primary and metastatic ), failed previous fusions (pseudarthrosis ) and deformity ( defined as scoliosis, kyphosis or lordosis ).

The Tectonic Cervical Plate System is a spinal fixation system which consists of cervical screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Titanium Alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of cervical segments of the spine.

After reviewing the provided document, I cannot identify any information regarding acceptance criteria, device performance, results from a study, or details about ground truth establishment.

This document is a 510(k) Premarket Notification summary and approval letter for the Tectonic Cervical Plate System. It focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a detailed clinical study with specific performance metrics against pre-defined acceptance criteria.

The key points from the document are:

• Device: Tectonic Cervical Plate System
• Intended Use: Anterior screw fixation to the cervical spine (C2-C7) for various indications (degenerative disc disease, trauma, tumors, etc.).
• Comparison: The device is deemed "substantially equivalent" to predicate devices (Cervical Spine Locking Plate System, Codman Anterior Cervical Plate System, Blackstone Anterior Cervical Plate System) in design, function, material, and intended use. The document explicitly states: "There are no significant differences between the Tectonic Cervical Plate System and other systems currently being marketed which would adversely affect the use of the product."
• Regulatory Outcome: The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot fulfill your request for the Acceptance Criteria, Reported Device Performance, Study Details, or Ground Truth information based on this document. Such information would typically be found in detailed clinical study reports, performance testing reports, or validation summaries, which are not part of this 510(k) summary.

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The Aleutian Spacer System is indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System is designed to restore the integrity of the spinal column even in the absence of fusion for a prolonged period.

The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental internal fixation intended to be used with this implant is the K2M Denali Spinal System.

The Aleutian Spacer System consists of a hollow tube structure manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient anatomy and which are designed to engage with the vertebral body end plates.

Materials: The devices are manufactured from Medical Grade PEEK (Polyetherether): OPTIMA I T1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads to be Grade UNS R05200 according to ASTM F560.

Function: The system functions as a vertebral body replacement device to assist in fusion and to provide stabilization of the thoraco-lumbar segments of the spine.

The provided text is a 510(k) summary for the Aleutian Spacer System, a vertebral body replacement device. It establishes substantial equivalence by comparing it to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Such information would typically be found in a performance study or clinical data section, which is absent from this summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

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The Denali Spinal System is a non-cervical spinal fixation device intended for posterior, non-pedicle fixation for the following indications: degenerative disc disease ( DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Denali Spinal System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid fusion.

The Denali Spine System is a top-loading, multiple component, posterior system which consists of periety of periety I he Dellar Spite Systems a top-loading, matchers components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar and / or sacral spine.

The provided 510(k) summary for the Denali Spinal System does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

This 510(k) submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo acceptance criteria and then proving the device meets them through a specific clinical study with granular details like sample size for test sets, expert qualifications, or MRMC studies.

Here's a breakdown of why the requested information cannot be extracted from the provided document:

• Nature of 510(k) Submissions: 510(k)s are primarily premarket notifications to demonstrate that a new device is as safe and effective as (i.e., substantially equivalent to) a legally marketed predicate device. They typically rely on comparisons of technological characteristics, materials, and intended use, often supported by bench testing (biomechanical, material compatibility) rather than extensive clinical efficacy trials with acceptance criteria in the manner requested.

Information that could be inferred/stated from the document:

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

• Acceptance Criteria (Implied): The implied acceptance criterion for this 510(k) is "substantial equivalence" to the listed predicate devices in terms of design, function, materials, and intended use.

• Reported Device Performance (Implied): The document states "The Denali System was biomechanically tested and compared to its predicate devices... The Denali System found to be substantially the same as these systems." and "It's components were manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems."

  Acceptance Criterion (Implied for 510(k))	Reported Device Performance
  Substantially equivalent in design	Found to be substantially the same as predicate devices.
  Substantially equivalent in function	Performed equal to predicate devices.
  Substantially equivalent in materials	Manufactured from the same FDA recognized materials.
  Substantially equivalent in intended use	Indicated for the same intended uses as predicate systems.
  Biomechanical performance	Biomechanically tested and compared favorably to predicate devices.

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

• Not provided. The document mentions "biomechanically tested" but does not specify sample sizes for these tests, nor the data provenance (country, retrospective/prospective). This is typically detailed in engineering reports, not summarized in the 510(k) in this level of detail.

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

• Not applicable/Not provided. For a 510(k) based on substantial equivalence and biomechanical testing, "ground truth" related to clinical outcomes or expert consensus on observations isn't typically established in this manner. The "truth" is based on established engineering principles and comparison to predicate devices.

4. Adjudication method for the test set:

• Not applicable/Not provided. This is relevant for studies involving human interpretation or clinical endpoints, which is not the focus of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is not mentioned or implied. MRMC studies are specific to evaluating the diagnostic performance of imaging devices/algorithms with multiple human readers, often comparing performance with and without AI assistance. This device is a spinal implant, not an imaging device.

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

• No. This refers to AI algorithms for diagnosis or analysis. The Denali Spinal System is a physical medical device (implant), not an algorithm.

7. The type of ground truth used:

• The "ground truth" for demonstrating substantial equivalence for this device would be:
  • Engineering specifications and material standards: Adherence to ASTM and ISO standards for materials (Ti6Al-4V ELI alloy).
  • Bench test results: Biomechanical performance data showing comparability to predicate devices.
  • Functional comparison: Direct comparison of design features and sizing to predicate devices.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" in the context of this 510(k) for a spinal implant. This term relates to machine learning models.

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

• Not applicable/Not provided. As there's no training set, there's no ground truth establishment for it.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/software device. Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth establishment (especially those related to human readers, experts, and AI algorithms) are not present and are not typically required for this type of submission.

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