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The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:

· 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
• · pseudoarthrosis
• · and failed previous fusion

The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws, rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.

The systems components are manufactured using standard manufacturing processes. The tulips, screw shafts, and one family of rods are of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications. The push plate is of Commercially Pure Grade4 Titanium (CP Ti) per ASTM F67 - Standard Specifications for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50500 & R50700). The other family of rods are of Cobalt Chromium (CoCr) per ASTM F75 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).

The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by Spine Smith Holdings. LLC, as well as the instructions provided by the Autoclave manufacturer.

The provided text is a 510(k) summary for the CorticaLINK Spinal Fusion Platform, a medical device for spinal fixation. It describes the device's intended use, materials, and equivalence to a predicate device. However, it does not contain information regarding the acceptance criteria, specific device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) typically associated with software or AI device clearances.

The document primarily discusses mechanical performance testing against a predicate device, as per ASTM F1717, which is standard for orthopedic implants.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of what can and cannot be answered:

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

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 (Test Set): Not specified. The document refers to "the worst-case subject device" being tested, implying a single or limited number of devices for mechanical testing, not a data sample.
• Data Provenance: Not applicable, as this refers to mechanical testing of physical orthopedic implants, not data analysis for software/AI.

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. Ground truth and expert review are typically associated with performance studies for diagnostic or AI-driven devices, not mechanical testing of implants.

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

• Not applicable. This refers to adjudication of expert opinions for ground truth establishment, which is not relevant to 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, an MRMC study was not done. This device is an orthopedic implant, not an AI or diagnostic tool that involves human readers.

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

• Not applicable. This device is an orthopedic implant, not a standalone algorithm.

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

• Not applicable. For mechanical testing, the "ground truth" is defined by the physical properties and performance benchmarks specified in the ASTM standard.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" as it is not a machine learning or AI-driven device.

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

• Not applicable. This device does not involve a "training set."

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The device's acceptability is proven through performance testing conducted in accordance with ASTM F1717. This standard evaluates the mechanical performance of spinal implant systems. The testing included static and dynamic compression bending, as well as static torsion. The conclusion states that "Results of the testing demonstrate substantially equivalent mechanical performance as compared to the predicate(s)." This means the CorticaLINK Spinal Fusion Platform met the implicit acceptance criterion of performing mechanically equivalently to legally marketed predicate devices.

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The CorticaLINK Fusion System is intended for noncervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:

· 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:
• · pseudoarthrosis;
• · and failed previous fusion.

The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws, rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.

The systems components are manufactured using standard manufacturing processes of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136 - Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, Commercially Pure Grade4 Titanium (CP Ti) per ASTM F67 - Standard Specifications for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, R50400, R50500 & R50700) and Cobalt Chromium (CrCo) per ASTM F75 - Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075).

The implant components are provided clean and non-sterile. These devices are supplied in a rigid sterilization tray and are to be sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by LinkSPINE, Inc., as well as the instructions provided by the Autoclave manufacturer.

This document is a 510(k) premarket notification for a medical device called the "CorticaLINK Spinal Fusion Platform." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing details of a study that proves the device meets specific acceptance criteria through a performance study.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment cannot be fully addressed from the provided text because these elements are not present in a 510(k) for a device like this, which relies on substantial equivalence to a previously cleared predicate.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

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

The document does not specify quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" assessment focuses on the modifications substantially meeting established criteria for the cleared parent device.

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

The document describes a submission for demonstrating substantial equivalence, not a clinical trial with a "test set" of patients or data in the typical sense. Therefore:

• Sample size for test set: Not applicable (no test set of clinical data described).
• Data provenance: Not applicable (no specific clinical data provenance mentioned for a new study). The comparison is primarily based on device characteristics and the predicate.

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

Not applicable. As there's no described clinical "test set" requiring ground truth establishment by experts for performance evaluation, this information is not provided. The submission focuses on engineering and material equivalence.

4. Adjudication method for the test set

Not applicable. There is no described test set of clinical cases or data requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or described in this document. This is a 510(k) for a spinal fusion platform, which typically demonstrates substantial equivalence through mechanical testing and comparison of design/materials, not through MRMC studies.

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

Not applicable. This device is a physical medical implant (spinal fusion platform), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The type of ground truth used

Not applicable. There is no described clinical study or algorithm where "ground truth" (e.g., pathology, outcomes data) would need to be established for performance evaluation. The "ground truth" in this context refers to the characteristics and performance of the predicate device to which the new device is being compared for substantial equivalence.

8. The sample size for the training set

Not applicable. This is a physical implant, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical implant and does not involve AI/ML or a training set.

Ask a specific question about this device

The CorticaLINK Spinal Fusion Platform is intended for non-cervical pedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients:

• 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;
• pseudoarthrosis;
• and failed previous fusion.

The CorticaLINK Spinal Fusion Platform is a comprehensive suite of fixation implants which can be used to stabilize the spine as an adjunct to fusion following surgical decompression. The platform is comprised of screws. rods and locking caps, with the screws being offered in several different lengths, diameters, and thread pitches to accommodate varying anatomies, pathologies, and surgeon preferences.

The provided document is a 510(k) premarket notification for the CorticaLINK Spinal Fusion Platform. It describes the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices. However, it does not contain acceptance criteria or detailed results of a study demonstrating the device meets specific performance criteria in a clinical context that would require ground truth, human readers, or AI.

This document describes a medical device called the "CorticaLINK Spinal Fusion Platform," which is a system of implants used to stabilize the spine. The performance data provided is for non-clinical mechanical testing of the device's components (screws, rods, and locking caps), not a study involving human or AI performance.

Therefore, I cannot fulfill the request to provide details about acceptance criteria and a study proving the device meets those criteria, as the information required (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for training and test sets) is not present in the given text.

The document only states that the device was tested mechanically according to ASTM standards and found to be substantially equivalent to predicate devices for its intended use, indicating sufficient strength.

Here's what I can provide based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions ASTM F1717-14 standards, which are general test methods for spinal implant constructs. However, specific numerical acceptance criteria (e.g., minimum bending strength in Nm) and the corresponding reported device performance values are not detailed in this summary. It only states that the results "show that the strength of the CorticaLINK Spinal Fusion Platform is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Missing Information (Not Available in the Document):

2. Sample size used for the test set and the data provenance: Not applicable, as this was mechanical testing, not a clinical study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable, as this was mechanical testing, not a study requiring ground truth for diagnostic or expert agreement.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device