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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of the Malibu adjustable cross connector from SeaSpine Inc. to the Coral™ Spinal System. Cross connectors are used to connect the bi-lateral rods of a spinal construct to add torsional rigidity. The cross connectors are available in two styles, straight and contoured, the different styles offer the surgeon options intraoperatively. The straight cross connector offers the surgeon a low profile compared to the surrounding construct. The contoured cross connector offers surgeons an option that is slightly higher in profile but provides additional clearance between the cross connector and the spinal construct.

The information provided describes a medical device submission (K120047) for the Coral™ Spinal System and its expansion with the Malibu adjustable cross connector. It focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and mechanical testing, rather than presenting a study of device performance against specific clinical acceptance criteria.

Therefore, many of the requested categories for acceptance criteria and the study proving adherence cannot be directly addressed from the provided text, as they pertain to clinical or functional performance. The document primarily describes mechanical performance tests to establish substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present in the document:

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

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

• Sample Size: Not specified for the mechanical tests.
• Data Provenance: N/A (mechanical tests, not clinical data)

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

• N/A (Ground truth is not relevant for mechanical performance testing establishing substantial equivalence.)

4. Adjudication method for the test set

• N/A (Adjudication is not relevant for mechanical performance testing establishing substantial equivalence.)

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No.
• Effect Size: N/A (This device is a spinal fixation system, not an AI-assisted diagnostic tool.)

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

• No. (This device is a spinal fixation system, not an algorithm.)

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

• The "ground truth" for the device's performance is its ability to meet the mechanical standards outlined in ASTM F-1717. This is based on engineering and physical testing standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• N/A (This pertains to mechanical testing and substantial equivalence, not a machine learning model's training set.)

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

• N/A (Not applicable for this type of submission.)

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of cobalt chrome rods to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.

I am sorry, but the provided text from K091266 does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies that are typically found in a clinical study report.

The document is a 510(k) summary for the Coral™ Spinal System, which focuses on demonstrating substantial equivalence to previously cleared predicate devices for the addition of cobalt chrome rods to the system. It primarily discusses:

• Device Description: The components and their materials.
• Intended Use: The medical conditions the device is designed to treat.
• Predicate Devices: Previously cleared devices it is similar to.
• Substantial Equivalence Argument: How the new components are similar to existing ones in terms of indications for use, operating principle, biocompatible materials, surgical techniques, manufacturing, sterilization, and packaging.
• Regulatory Information: Classification and product codes.

The key phrase "sufficient evidence exists to reasonably conclude that the additional components are substantially equivalent to the predicate device...This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, preproduction quality assurance planning and engineering analysis" indicates that the evaluation was based on bench testing (mechanical testing) and a comparison of design and materials, rather than clinical efficacy studies with patient data.

Therefore, I cannot provide the requested table or answer the questions related to clinical study design, acceptance criteria, sample sizes, ground truth establishment, or human reader performance. This type of information is not typically part of a 510(k) submission focused on substantial equivalence for a device modification where prior clinical data on the predicate device is assumed to be sufficient.

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is to add rod to rod connectors and lateral rod connectors to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.

This document describes a 510(k) premarket notification for the Coral™ Spinal System by Theken Spine, LLC. It aims to add rod-to-rod and lateral rod connectors to an already approved system. The submission emphasizes substantial equivalence to existing predicate devices based on design, materials, indications for use, and manufacturing processes.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets such criteria. The document is a regulatory submission for a medical device that focuses on demonstrating substantial equivalence to previously approved devices, primarily through comparison of design, materials, and intended use, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The sections below will indicate that the information is not available in the provided document.

Acceptance Criteria and Device Performance Study Information

The provided document is a 510(k) summary for a medical device (Coral™ Spinal System) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria and results. Therefore, the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

• Information Not Available in the Provided Text. The document does not describe specific acceptance criteria or report performance metrics for the Coral™ Spinal System beyond declaring it substantially equivalent to predicate devices.

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

• Information Not Available in the Provided Text. No test set, data provenance, or sample sizes related to a performance study are mentioned. The submission relies on design, material, and functional comparisons for substantial equivalence.

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

• Information Not Available in the Provided Text. The document does not describe a performance study involving ground truth establishment by experts.

4. Adjudication method for the test set

• Information Not Available in the Provided Text. No adjudication method for a test set 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

• Information Not Available in the Provided Text. This device is a mechanical spinal fixation system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.

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

• Information Not Available in the Provided Text. This device is a mechanical spinal fixation system. Performance is assessed through mechanical testing and comparison to predicate devices, not through standalone algorithm performance.

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

• Information Not Available in the Provided Text. No ground truth for a performance study is mentioned as no such study is detailed.

8. The sample size for the training set

• Information Not Available in the Provided Text. No training set is mentioned as the document is not describing a machine learning or AI-based device.

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

• Information Not Available in the Provided Text. No ground truth for a training set is mentioned.

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The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Coral™ Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, cross-connectors, and connecting components. Coral™ Spinal System components can be rigidly locked creating a rigid construct for promoting fusion. Coral™ Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67, ASTM F136, ISO 5832-3, and ISO 5832-2. Alternatively, the entire system may be made out of medical grade stainless steel described by such standards as ASTM F138, ISO 5832-1, and ISO 5832-9. Caution use of dissimilar metals, i.e. stainless steel and titanium must not be used in combination, but must be used independently.

The provided document is a 510(k) summary for the Coral™ Spinal System. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on mechanical testing. This document does not contain information typically found in a study proving a device meets acceptance criteria related to diagnostic accuracy or clinical performance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving performance in the context of diagnostic or AI/ML device evaluation. The information provided is for a traditional medical device (spinal implant) where substantial equivalence is primarily demonstrated through mechanical testing and comparison to existing devices.

However, I can extract the information provided about the device's substantial equivalence and general description:

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

The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be applicable to a diagnostic device or AI/ML system. Instead, it references substantial equivalence to predicate devices. For a spinal implant, this typically means demonstrating comparable mechanical properties and safety.

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

This information is not applicable and not provided in the document as it refers to mechanical testing data, not a clinical or diagnostic performance test set.

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 information is not applicable and not provided. Ground truth in the context of diagnostic accuracy, clinical outcomes, or AI labeling is not relevant for the type of substantial equivalence demonstrated here (mechanical testing of a spinal implant).

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

This information is not applicable and not provided.

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 information is not applicable and not provided. This is for an orthopedic implant, not an AI/ML-assisted diagnostic device.

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

This information is not applicable and not provided. This is not an AI/ML device.

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

The closest concept to "ground truth" here would be the established standards for mechanical testing (e.g., ASTM F-1717) and the characteristics of the predicate devices. The "ground truth" for the device's safety and effectiveness is inferred through its mechanical equivalence to devices already on the market.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/ML device.

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

This information is not applicable and not provided. This is not an AI/ML device.

Summary of why most fields are N/A:

The provided document is a 510(k) summary for a spinal surgical implant (Coral™ Spinal System). The primary method for demonstrating substantial equivalence for such devices is through mechanical testing against established standards (like ASTM F-1717) and comparison to legally marketed predicate devices. The request's questions are designed for evaluating diagnostic devices, particularly those that might use AI/ML, which involve clinical performance studies, ground truth establishment, expert review, and statistical measures like sensitivity and specificity. These concepts are not relevant to the information presented in this 510(k) filing for a spinal fixation system.

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