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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 and Expandable 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 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 and Expandable 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 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. Static (titanium) and expandable (titanium and cobalt chrome) cervical cages are available and are implanted via an anterior approach. The cervical implants of the CAPRI Corpectomy Cage Systems are manufactured from Titanium (per ASTM F3001 and ASTM 136) and Cobalt Chrome (per ASTM F1537). The purpose of this Traditional 510(k) submission is to introduce a new 12x14mm cervical expandable footprint size to the previously cleared CAPRI Corpectomy Cage System.

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

The provided text describes the 510(k) premarket notification for the K2M, Inc. CAPRI Corpectomy Cage System. This submission introduces a new 12x14mm cervical expandable footprint size to an already cleared system. As such, the study focuses on demonstrating the substantial equivalence of this new footprint to the predicate device, rather than proving a new device's performance against specific clinical acceptance criteria for effectiveness or safety in a clinical trial setting. The studies conducted are mechanical tests to ensure the new footprint maintains the same structural integrity and performance characteristics as the predicate.

Here's the information extracted from the provided text, addressing your points:

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

The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for each test, but it lists the mechanical tests performed to demonstrate substantial equivalence to the predicate device. The performance is implied to be "met" if the device demonstrates substantial equivalence.

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

The document does not specify sample sizes (number of devices tested) for the mechanical tests. It also does not mention data provenance in terms of country of origin or whether a retrospective/prospective study was conducted, as these were benchtop mechanical tests, not clinical studies involving patient data.

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

This is not applicable to the type of study described. The study involves mechanical testing against ASTM standards and comparison to a predicate device, not expert-based ground truth establishment as would be seen in diagnostic imaging or clinical effectiveness studies.

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

This is not applicable as the study involves mechanical testing against defined standards, not human evaluation requiring adjudication.

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. The device is a spinal implant, not an AI-assisted diagnostic tool.

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, not an algorithm.

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

For mechanical testing, the "ground truth" is typically defined by adherence to established engineering standards (e.g., ASTM F2077-18, ASTM F2267-04 R18) and meeting performance characteristics comparable to the predicate device. There is no expert consensus, pathology, or outcomes data used as ground truth for this type of submission.

8. The sample size for the training set

This is not applicable. There is no training set mentioned, as this is a submission for a medical implant, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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K2M Navigation Instruments are intended to be used in the preparation and placement of K2M screws (Denali, Mesa, Everest, and Yukon) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. MESA screw navigation is intended for open procedures only. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Navigated Screw Inserters are also compatible with the Medtronic IPC POWEREASE System. The K2M Navigation Instruments are not intended for navigation of occipital screws.

K2M Navigation Instruments are nonsterile, reusable surgical instruments (inserters, taps, probes, and awls) and single use drill bits intended be used when implanting previously cleared components of Mesa, Denali, Everest, and Yukon Spine Systems. These instruments are designed to interface with the Medtronic StealthStation® System when used for navigation during cervical and thoracolumbar spinal surgery.

The provided text is a 510(k) summary for the K2M Navigation Instruments. It discusses the device's indications for use, its substantial equivalence to predicate devices, and the design validation testing conducted. However, it does not contain the specific information required to answer the questions about acceptance criteria for an AI/ML powered device, associated performance data, test set details (sample size, provenance, ground truth establishment, adjudication), training set details, or any multi-reader multi-case (MRMC) comparative effectiveness study.

The document states:

• "Design validation testing was conducted to ensure the K2M Navigation Instruments are acceptable for their intended use, to ensure functionality and compatibility with the Medtronic StealthStation® using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instruments."

This indicates that performance testing was done for the navigational instruments themselves, focusing on their functionality and compatibility with a navigation system, rather than evaluating the performance of an AI/ML algorithm that predicts or diagnoses. The device described, "K2M Navigation Instruments," appears to be physical surgical instruments (inserters, taps, probes, and awls) designed to work with a stereotactic navigation system (Medtronic StealthStation® System) to assist surgeons with screw placement. It is not an AI/ML powered diagnostic or predictive device.

Therefore, since the device is not an AI/ML system, the requested information regarding AI/ML acceptance criteria and study results (including AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training set details, etc.) is not applicable to the content of this 510(k) summary.

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The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The MOJAVE Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for bone ingrowth and engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F1472, ASTM F136, ASTM F3001) and cobalt chromium alloy (ASTM F1537) and are available in a variety of heights to accommodate anatomical variations.

The provided document describes an FDA 510(k) clearance for the MOJAVE Expandable Interbody System. This is a medical device, not an AI/software product, and the information provided does not include acceptance criteria or a study proving that an AI/software device meets acceptance criteria.

The document discusses the substantial equivalence of the MOJAVE Expandable Interbody System to predicate devices based on:

• Technological Comparison to Predicate: Minor modifications to enhance user experience, comparable in design, function, intended use, materials, and size.
• Non-clinical Performance Evaluation: Risk assessment, including benchtop and mechanical testing, to confirm no new issues of safety or effectiveness.

Therefore, I cannot provide the requested information for an AI/software device from this text as it is not applicable.

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The YUKON OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3); traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusion (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The YUKON OCT Spinal System is also intended to restore the integrity of the spinal column even in the absences 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.

In order to achieve additional levels of fixation, the YUKON OCT Spinal System may be connected to EVEREST, MESA, and DENALI Spinal System components via the rod to rod connectors or transition rods.

The YUKON OCT Spinal System is a top-loading, multiple component, posterior (occipital-cervical-thoracic) spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components. The system functions as an adjunct to fusion to provide stablilization of the posterior cervical and thoracic spine.

I apologize, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria.

The document is an FDA 510(k) clearance letter for the "Yukon OCT Spinal System." It details the device's classification, indications for use, and a summary of technological characteristics and non-clinical performance evaluation, which states:

• Non-clinical Performance Evaluation: "The subject implants were compared to the predicates using engineering rationales in addition to static compression, static torsion and dynamic compression testing (ASTM F1717) and performed equivalent to or better than the predicates."

This statement indicates that the device underwent non-clinical (mechanical) testing based on ASTM F1717 standards and demonstrated performance equivalent to or better than predicate devices. However, it does not specify:

• Quantitative acceptance criteria (e.g., specific load endurance, displacement limits).
• The raw performance data of the device against these criteria.
• Details about a clinical study, including sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC, standalone algorithm performance).

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text.

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Brainlab Compatible K2M Navigation Instruments are intended to be used in the preparation and placement of K2M pedicle screws (DENALI, MESA, EVEREST, YUKON) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Brainlab Navigation system, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The Brainlab Compatible K2M Navigation Instruments are not intended for navigation of occipital screws.

Brainlab Compatible K2M Navigation Instruments are manual surgical instruments intended be used when implanting previously cleared components of MESA, DENALI, EVEREST and YUKON Spinal Systems. These instruments are designed to interface with the Brainlab Navigation system when used for navigation during spinal surgery. The subject instruments feature a modification of the connection mechanism geometry and material to enhance user experience.

The provided FDA 510(k) summary for the "Brainlab Compatible K2M Navigation Instruments" does not contain information typically found in a study proving a device meets specific acceptance criteria for performance, especially not in the context of an AI/algorithm-based medical device.

This document describes a conventional surgical instrument that interfaces with an existing navigation system. The "Non-clinical Performance Evaluation" section mentions a risk assessment and rotational testing, which are standard for mechanical devices. It does not refer to any clinical studies, AI performance metrics, or ground truth establishment as would be required for an AI/ML medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or details about MRMC studies. This is because the device in question is a surgical instrument and not an AI/ML-driven diagnostic or treatment planning system that would necessitate such detailed performance evaluation against ground truth.

The relevant sections state:

• Non-clinical Performance Evaluation: "A risk assessment including sterilization, biocompatibility, and additional rotational testing was conducted to confirm that the subject Brainlab Compatible K2M Navigation Instruments do not introduce new issues of safety or effectiveness."
• Conclusion: "There are no significant differences between the Brainlab Compatible K2M Navigation Instruments and other legally marketed systems. It is substantially equivalent to these other devices in design, function, material and intended use."

These statements indicate that the submission relies on demonstrating substantial equivalence to a predicate device through engineering and safety testing, rather than an AI performance study.

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The SAHARA Stabilization System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the SAHARA implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis
Hyperlordotic (angles > 15°) and Lateral implants must be used with supplemental fixation (i.e., posterior pedicle screw and rod system) cleared for use in the lumbar spine, in addition to the bone screws provided. Additional supplemental fixation (i.e. pedicle screw and rod system) is needed when used as an adjunct to fusion for degenerative scoliosis. Otherwise, the Sahara Stabilization System implants may be used as a stand-alone device, which is intended to be used with the bone screws provided.

The subject of this 510(k) submission is the addition of lateral implants to the previously cleared SAHARA Stabilization System. The implants function as an expandable intervertebral body fusion device to provide support and stabilization to the lumbar segments of the spine through a lateral approach. The system includes lateral interbody devices as well as bone screws for integrated fixation. The implants are manufactured from Titanium (ASTM F67), Titanium Alloy (ASTM F136, ASTM F1472, ASTM F3001) and Cobalt Chrome (ASTM F1537). The implants contain components that are additively manufactured.

This document describes the SAHARA Stabilization System, an intervertebral body fusion device. The acceptance criteria and supporting study are related to the mechanical performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that "mechanical tests were performed" and that the system "has demonstrated substantial equivalence to the identified predicate devices" based on material, design, and mechanical performance. It does not provide specific numerical values for the acceptance criteria or the reported performance for each test. The acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning the device's performance must be at least as safe and effective as the legally marketed predicate devices.

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

This information is not provided in the document. The study described is a series of mechanical tests, not a clinical study involving human data.

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

This information is not applicable as the described study involves mechanical testing, not a clinical study requiring expert assessment of ground truth.

4. Adjudication method for the test set

This information is not applicable as the described study involves 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a series of mechanical tests of an intervertebral body fusion device, not an AI-assisted diagnostic or imaging system.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established through industry standards and mechanical testing protocols (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these criteria and the performance of predicate devices to demonstrate substantial equivalence.

8. The sample size for the training set

This information is not applicable. The device is a physical implant and does not involve a training set as would be used for an AI algorithm.

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

This information is not applicable.

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The CAYMAN LP Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The CAYMAN LP Plate System are non-load bearing devices, each consisting of a plate and screw for attachment to the vertebral body. The plates are designed to be used as additions to spinal fusion procedures from the lateral and anterior approaches, forming a preventative barrier to intervertebral cage movement. Materials: The devices are manufactured from Ti6Al4V per ASTM and ISO standards. Function: The plates are designed to be used in a spinal fusion procedures to provide stabilization and buttressing of tissue in the intervertebral space.

The provided text describes the CAYMAN LP Plate System, a spinal implant, and its 510(k) summary for FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical testing. No information is provided in the document regarding acceptance criteria for an AI/ML device, nor any study proving an AI/ML device meets such criteria.

The document describes a medical device, the CAYMAN LP Plate System, which is a physical implant used in spinal fusion procedures. It is not an AI/ML device, and thus, the concepts of a "test set," "training set," "ground truth," "human readers," or "AI assistance" do not apply to the information presented.

Therefore, I cannot provide a table of acceptance criteria, details on sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.

The study described in the document is a nonclinical mechanical test to demonstrate the ability of the physical plates to resist migration or expulsion of graft material, and to show mechanical superiority to a legacy predicate device. This is a performance test for a physical medical device.

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The K2M Expandable Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment. The K2M Expandable Interbody System is interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The K2M Expandable Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The K2M Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F136)

The provided text is a 510(k) Summary for the K2M Expandable Interbody System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in this document.

Here's an breakdown based on the information available in the provided text:

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

The document does not explicitly state acceptance criteria for device performance in the context of clinical outcomes or diagnostic accuracy. Instead, it details non-clinical performance evaluations to show equivalence to predicate devices.

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. The document describes non-clinical laboratory testing, not a clinical study with a "test set" of patients. The sample size would refer to the number of implants tested, but this detail is not provided.

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 clinical study establishing ground truth is described.

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

Not applicable. No clinical study with a "test set" and adjudication 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 device is a physical interbody fusion system, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical interbody fusion system, not a diagnostic algorithm.

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

Not applicable. The ground truth for non-clinical testing is typically defined by standardized methods and measurements, not clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The MESA and DENALI Systems (including ARI Staples) and the EVEREST Spinal System are cleared for the following indications:

Posterior 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; pseudoarthosis; and/or failed previous fusion.

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

Except for the ARI staples, the MESA. DENALI and EVEREST Spinal Systems are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis when used for posterior non-cervical fixation in pediatric patients. The MESA, DENALI and EVEREST Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Range (Denali and Mesa) Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation systems consisting of pedicle screws, rods, hooks and rod connectors. The purpose of this 510(k) is to add revision connectors and rods to the system.

Function: The systems function as spinal fixation devices to provide support and stabilization of the posterior thoracic and lumbar spine.

This FDA 510(k) summary describes the Range (Denali and Mesa) Spinal Systems. However, it does not contain the kind of detailed information about acceptance criteria and a study that proves the device meets those criteria, as typically found in submissions for AI/ML-driven medical devices.

The document pertains to a traditional medical device (spinal fixation system) and thus the "acceptance criteria" and "study" refer to mechanical performance evaluations, not AI/ML performance.

Based on the provided text, the answer is that the document does not contain the requested information regarding acceptance criteria and a study proving an AI/ML device meets them.

Here's a breakdown of why the requested information cannot be extracted from this document, and what is present:

• 1. A table of acceptance criteria and the reported device performance: This document reports that "Mechanical testing in accordance with ASTM F1717 (including static torsion, static compression and dynamic compression bending) was conducted on constructs representing the worst case components." It states, "The test results revealed that the proposed implants were substantially the same as the predicate devices."
  • Missing: Specific numerical acceptance criteria (e.g., minimum torque, maximum displacement) and the corresponding numerical results from the K2M device. The report only states "substantially the same."
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
  • Missing: This information is not relevant to a mechanical test of a spinal implant and is therefore not provided.
• 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):
  • Missing: This information is not relevant to mechanical testing, which relies on physical measurements and established ASTM standards, not expert interpretation.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Missing: Not applicable for a mechanical performance study.
• 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:
  • Missing: This is relevant for AI/ML diagnostic or assistive devices, not for a spinal fixation system.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • Missing: Not applicable for a traditional medical device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
  • Existing (for mechanical testing): The "ground truth" would be the established acceptable ranges or performance levels defined by the ASTM F1717 standard for spinal implant mechanical properties and comparison to predicate devices' performance.
• 8. The sample size for the training set:
  • Missing: No training set is involved for a mechanical implant.
• 9. How the ground truth for the training set was established:
  • Missing: No training set or ground truth in the AI/ML sense is established for this device.

In summary, the provided document is for a traditional spinal implant and reports mechanical testing for substantial equivalence, not performance criteria or studies related to AI/ML algorithms, expert review, or clinical data interpretation.

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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:

Posterior non-cervical fixation as an adjunct to 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 pediale 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.

K2M Spinal Systems are top-loading, multiple component, posterior (thoracic-lumbar) spinal fixation systems consisting of pedicle screws, rods, hooks and rod connectors. The subject 510(k) offers patient specific rods.

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

The provided document is a 510(k) summary for the K2M Patient Specific Rods, which are part of the EVEREST Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices based on design features, materials, sizes, and mechanical testing, rather than clinical performance or AI/software validation. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, expert involvement, or ground truth related to AI/software.

The document states:

• Non-clinical Performance Evaluation: "Mechanical testing was performed in accordance with ASTM F1717 (including static torsion, static compression, and dynamic compression bending) and the results were comparable to previously cleared devices."

This indicates that the acceptance criteria for this device are likely related to mechanical properties as defined by the ASTM F1717 standard, and the study showing it meets these criteria is the mechanical testing itself, with "comparable" results to predicates meaning it met those mechanical performance benchmarks.

However, the specific numerical acceptance criteria, the reported device performance, and details like sample size for these mechanical tests are not provided in this summary. Furthermore, all other points in your request (related to test sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training sets/ground truth for AI) are not applicable as this document pertains to a physical medical device (spinal rods) and its mechanical performance, not a digital health product or AI algorithm.

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