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The MESA and DENALI Spinal 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 scoliosis 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.

This traditional 510(k) premarket notification is to introduce the Cannulated Power Driver Attachment instrument for use with Stryker Power Systems.

The Cannulated Power Driver Attachment is an accessory to the Everest and Range (Mesa and Denali) pedicle screw systems intended to facilitate the insertion of pedicle screws using powered instrumentation. The Cannulated Power Driver Attachment, also referred to as the power adaptor or subject device, serves as a mechanical interface between the power driver and screwdriver instrument. When the adaptor is attached, the driver (corded and cordless) provides appropriate power to rotate screw drivers for the insertion of pedicle screws. No changes have been made to the indications for use of the associated thoracolumbar spinal implant systems Everest and Range (Mesa and Denali) Spinal Systems. The indications for use of each spinal system remain consistent with their most recent 510(k) clearance.

The provided text is a 510(k) summary for the "Cannulated Power Driver Attachment". This document is for a medical device that assists in the surgical insertion of pedicle screws, not an AI/ML-driven device for diagnosis or prediction. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable.

However, I can extract information related to the acceptance criteria and how the device met them.

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

The document states that the "Cannulated Power Driver Attachment Instrument has demonstrated substantial equivalence to the predicate device." It further states: "The performance of the Cannulated Power Driver Attachment has met all acceptance criteria."

While specific numerical acceptance criteria (e.g., torque values, cycles to failure) are not provided in this summary, the general acceptance criteria can be inferred from the context of "substantial equivalence" and "verification and validation activities."

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

This device is a mechanical instrument. Testing would involve engineering evaluations (e.g., mechanical stress tests, fatigue tests) rather than data from human subjects or medical images. Therefore, the concepts of "test set sample size" and "data provenance" as typically applied to AI/ML systems are not relevant here. The "test set" would be the manufactured Cannulated Power Driver Attachment instruments subjected to various non-clinical performance evaluations. The number of units tested is not specified.

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 as the device is a mechanical instrument. Ground truth in this context would be defined by engineering standards and specifications, not expert medical opinion on clinical data.

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

Not applicable for a mechanical device.

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 as this is a mechanical medical instrument, not an AI/ML diagnostic or predictive tool.

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

Not applicable as this is a mechanical medical instrument, not an AI/ML algorithm.

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

The "ground truth" for a mechanical device would be established by engineering specifications, validated test methods, and performance benchmarks against predicate devices. The summary indicates that "Verification and validation activities" were conducted to demonstrate that the device "met all acceptance criteria" and "does not represent a new worst case for powered pedicle screw insertion," implying a comparison to established performance characteristics of the predicate device.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

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PYRENEES and BLUE RIDGE Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

OZARK Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The CAYMAN Buttress Plates are 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 Thoracolumbar Plates are indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L5-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

The previously cleared K2M PYRENEES, BLUE RIDGE, OZARK and CAYMAN plate systems consist of a variety of plates and screws designed to provide support across implanted levels of the cervical, thoracolumbar and lumbosacral spine until fusion is achieved. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants. In addition, PYRENEES, BLUE RIDGE and CAYMAN components that were previously provided non-sterile are now being optionally offered as sterile packaged devices.

The provided text does not contain information about acceptance criteria and a study proving a medical AI device meets those criteria. Instead, it describes K2M Inc.'s PYRENEES, BLUE RIDGE, OZARK, and CAYMAN spinal plate systems, which are physical medical devices (spinal fixation systems).

The document discusses:

• Indications for Use for various spinal plate systems.
• The purpose of the submission as establishing an MR Conditional labeling claim for these implants and optionally offering previously non-sterile components as sterile.
• Performance Data related to:
  • MR Compatibility testing per ASTM F2503. The text states, "The test results demonstrate that the PYRENEES, BLUE RIDGE and OZARK Cervical Plate Systems and the CAYMAN Thoracolumbar and Buttress Plate Systems performance met the prescribed acceptance criteria."
  • Bacterial endotoxin testing (BET) performed in accordance with AAMI ST72:2011. The text states, "The test results demonstrate that the sterile devices met the specified testing limit."

Therefore, I cannot provide the requested table or information regarding acceptance criteria for an AI device. The details provided in the input pertain to the testing of spinal implants.

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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 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.

Range (Mesa and Denali) and ARI 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; pseudarthrosis; 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 Range Spinal System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis when used for posterior noncervical fixation in pediatric patients. The Range 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 Caspian OCT/MESA Mini/DENALI Mini Spinal System is intended to provide immobilization and stabilization of spinal seqments 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 fusions (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 Caspian OCT/MESA Mini/DENALI Mini Spinal System is also intended to restore the 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. In order to achieve additional levels of fixation, the Caspian OCT/MESA Mini/DENALI Mini Spinal System may be connected to Range/MESA/DENALI Spinal System and Everest Spinal System components via the rod to rod connectors or transition rods.

The YUKON OCT Spinal System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations: instability or deformity: failed previous fusions (e.q., 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 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. In order to achieve additional levels of fixation, the YUKON OCT Spinal System may be connected to Everest Spinal System components via the rod to rod connectors or transition rods.

The previously cleared K2M EVEREST, RANGE (MESA and DENALI), CASPIAN OCT (MESA Mini and DENALI mini) and YUKON OCT Spinal Systems are top-loading, multiple component posterior spinal fixation implants consisting of pedicle screws, hooks, rods and connectors, intended to provide support during spinal fusion procedures. The primary purpose of this submission is to establish an MR Conditional labeling claim for these implants. In addition, CASPIAN components that were previously provided non-sterile are now being optionally offered as sterile packaged devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EVEREST, RANGE, CASPIAN OCT, and YUKON OCT Spinal Systems:

Based on the provided FDA 510(k) summary, the primary purpose of this submission is not to introduce a new device with novel performance criteria, but rather to:

1. Establish an MR Conditional labeling claim for existing, previously cleared spinal systems.
2. Optionally offer previously non-sterile CASPIAN components as sterile packaged devices.

Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating the safety and compatibility of the devices in an MRI environment, and that their core technological characteristics remain equivalent to their predicates.

It is important to note that this document is a 510(k) summary for modifications to existing devices (primarily MR compatibility and sterilization options), not for the initial clearance of the spinal systems themselves. The original studies for the biomechanical and clinical performance of the spinal systems would have been part of their initial 510(k) submissions. This document focuses on the new testing related to the modifications.

Acceptance Criteria and Reported Device Performance

Study Details (Relevant to this 510(k) submission)

The primary study mentioned in this document is related to MR Compatibility testing.

1. Sample size used for the test set and the data provenance:

   • The document does not specify a "sample size" in terms of number of patients or cases for this particular testing. MR compatibility testing (per ASTM F2503) typically involves testing the physical devices themselves (e.g., assessing heating, artifact generation, and displacement forces), not patient data.
   • Data provenance: Not applicable in the context of device testing for MR compatibility. The tests would be conducted in a controlled laboratory environment.

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

   • Not applicable as this is a device performance test, not an AI or diagnostic expert review study. MR compatibility testing is conducted by engineers and technicians following established ASTM protocols.

3. Adjudication method for the test set:

   • Not applicable for device performance testing. Results are typically determined by measurements against predefined ASTM standards.

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. This document pertains to spinal implants (physical medical devices), not AI software or diagnostic imaging analysis. Therefore, no MRMC study, AI integration, or human reader improvement assessment was performed or is relevant to this submission.

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

   • No. This is not an algorithm or software device.

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

   • Not applicable as this concerns the physical properties of the device for MR compatibility. The "ground truth" would be the measured physical interactions (e.g., temperature rise, deflection) of the implant components in an MRI electromagnetic field compared to acceptable limits defined by ASTM F2503.

7. The sample size for the training set:

   • Not applicable. There is no software or AI model involved that would require a training set.

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

   • Not applicable. There is no software or AI model involved.

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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 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 (thoracic/lumbar/sacral) spinal fixation system consisting of pedicle screws, hooks, rods and connectors.

This document describes a 510(k) premarket notification for the EVEREST Spinal System, which is a medical device for spinal fixation. It details the device's indications for use and states that the current 510(k) submission is specifically for adding a set screw to the existing system.

Based on the provided text, the specific information requested in the prompt regarding acceptance criteria and a study proving device performance (especially related to AI or a software-driven device) is not available. The document focuses on the regulatory clearance process for a physical medical device (spinal system components), not a software or AI-based diagnostic tool.

The "Performance Data" section explicitly states: "The modified device was evaluated via finite element analyses. The results demonstrated the performance of the modified set screw is substantially equivalent to the predicate." This indicates an engineering analysis rather than a clinical study with human data.

Therefore, I cannot fulfill the request to provide details about acceptance criteria, test set sample size, expert ground truth establishment, or multi-reader multi-case studies, as these concepts are not applicable to the information provided about the EVEREST Spinal System.

If your request pertains to a different document or scenario where AI/software performance is being evaluated, please provide that relevant text.

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Ozark™ Cervical Plate System is indicated for use in anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).

The Ozark Cervical Plate System consists of variable and fixed screws having self-tapping and self-starting tips, and one- through five-level plates. The implants are offered both sterile and non-sterile.

This document describes the Ozark™ Cervical Plate System, a Class II medical device used for anterior screw fixation to the cervical spine. The Food and Drug Administration (FDA) has determined that this device is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the mechanical tests. It only mentions that "Mechanical testing of the Ozark Cervical Plate System constructs was performed according to ASTM F1717". The data provenance refers to laboratory testing of device constructs according to a recognized standard rather than clinical data from human subjects. Therefore, there is no information on country of origin or whether the data was retrospective or prospective in the context of patient data.

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

Not applicable. The "ground truth" for this device is based on standardized mechanical testing according to ASTM F1717, not on expert clinical interpretation of images or patient data. The results of these tests are objective measurements of the device's physical properties.

4. Adjudication Method for the Test Set

Not applicable. As mechanical tests, the results do not require adjudication by human experts in the same way clinical diagnostic interpretations would. The tests generate quantitative data that are compared against predefined limits within the ASTM F1717 standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 surgical implant (cervical plate system), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for demonstrating the device's performance is established by validated mechanical testing standards, specifically ASTM F1717. This standard defines the methodologies and acceptable performance limits for spinal implant constructs under various mechanical loads (static and dynamic compression, static torsion).

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant and does not involve machine learning or AI models that require a "training set" of data.

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

Not applicable. As explained above, no training set is relevant for this type of device.

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When used as a cervical intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radies), The cervical device is intended to be used in patients who have had six weeks of non-operative treatment. When used as a lumbar intervertebral body fusion device, the CHESAPEAKE Stabilization System implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

The hyperlordotic lumbar implants (i.e., > 15°) 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. Otherwise, the Chesapeake Stabilization System implants (i.e., ≤ 15°) may be used as a stand-alone device, which is intended to be used with the bone screws provided (i.e., 2 or 3 screw and 3-screw implants, respectively),

The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA ® LT1 (Invibio™) per ISO 10993-1 USP Class VI, and ASTM F2026 and CP titanium per ASTM F67. Tantalum beads /rods to be Grade UNS R05200, UNS R05400 according to ASTM F560. The screws are fabricated from Ti6Al4V per ASTM 1472.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

The purpose of this 510(k) submission is primarily to add additional cervical and lumbar lordotic implants.

This document is a 510(k) premarket notification for the K2M Chesapeake Stabilization System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance evaluations (mechanical testing). Therefore, it does not contain the type of information typically found in a study proving a device meets acceptance criteria related to clinical performance or AI/software analysis.

Based on the provided text, the device is a medical implant, and the approval is based on demonstrating substantial equivalence to predicate devices, primarily through non-clinical mechanical testing. There is no mention of a "study" in the sense of a clinical trial or a dataset-based performance evaluation as would be done for an AI/software device.

Here's an analysis based on the information that is present in the document, and what is absent:

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

• Acceptance Criteria (Implicit from Mechanical Testing Standards): The document states that mechanical testing was performed "per ASTM F2077" (static compression, static compression shear, dynamic compression, dynamic torsion) and "per ASTM F2267" (expulsion, subsidence). For a device to be "substantially equivalent" based on these tests, it must meet the performance requirements or be comparable to the predicate devices when tested to these standards. The specific quantitative acceptance criteria (e.g., minimum load to failure, maximum deformation) are not explicitly stated in this summary document but would be defined within the referenced ASTM standards and often compared directly to the predicate's performance.
• Reported Device Performance: The document only states that "the proposed implants were determined to be substantially equivalent to predicate devices." It does not provide numerical results for the mechanical tests.

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

• Sample Size: For mechanical testing, this refers to the number of test specimens. This information is not provided in the summary.
• Data Provenance: Not applicable in the context of mechanical testing for a 510(k) submission.

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

• This question is not relevant to this document. The "ground truth" for mechanical testing is derived from the physical properties and behavior of the materials and device design when subjected to specified loads, evaluated against engineering standards, not through expert human assessment of images or clinical outcomes.

4. Adjudication method for the test set

• This question is not relevant to this document. Adjudication methods like 2+1 or 3+1 are used for clinical or image interpretation studies where there's a need to resolve discrepancies among human readers/experts.

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

• No. This document describes a medical device (spinal stabilization system) and a 510(k) submission primarily based on non-clinical mechanical testing. MRMC studies are typically performed for diagnostic devices, particularly those involving human interpretation of medical images, often comparing human readers with and without AI assistance.

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

• No. This question is not relevant to this document as it relates to an algorithm/AI performance, which is not what this submission is about.

7. The type of ground truth used

• Mechanical Properties and Standards Conformance: The "ground truth" for this device's performance evaluation is implicit in the internationally recognized ASTM standards (ASTM F2077, ASTM F2267) which define methodologies for testing spinal implants. The device's physical performance (e.g., strength, stability, resistance to expulsion) under simulated physiological conditions is the "truth" being assessed for substantial equivalence.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device (implants) and mechanical testing, not an AI or software device that would require a training set.

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

• Not applicable. As above, there is no training set for a physical device.

In summary:

This 510(k) summary report details the premarket notification for a physical medical device, the Chesapeake Stabilization System, which is an intervertebral body fusion device. The primary method of demonstrating substantial equivalence for this submission was non-clinical mechanical testing according to established ASTM standards. The document does not describe a clinical study or an AI/software performance study with acceptance criteria, sample sizes, expert adjudication, or ground truth establishment as would be typically requested for software as a medical device (SaMD) or AI-enabled diagnostics. The acceptance criteria are implicitly meeting the performance requirements of the referenced ASTM standards and demonstrating equivalence to predicate devices in those mechanical tests, though specific numerical results are not provided in this summary.

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