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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 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.

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The Zavation Spinal System is a pedicle screw system intended to provide Immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. This document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance as one would typically find for an AI/ML medical device.

Instead, this document describes the Zavation Spinal System, its intended use, materials, predicate devices, and the basis for its substantial equivalence to those predicate devices. The "Performance Data" section specifically states:

"Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case construct. The mechanical test results demonstrated that the Zavation Spinal System performs as well as or better than the predicate devices."

This indicates a mechanical performance study for a spinal implant, which is a different type of evaluation from what is typically done for AI/ML devices regarding diagnostic accuracy or clinical effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance in the context of an AI/ML device from this document. The document primarily focuses on:

• Mechanical Safety/Performance: Comparing the mechanical strength of the Zavation Spinal System to predicate devices according to a specific ASTM standard (F1717). The acceptance criterion here is implicit: the device must perform "as well as or better than" the predicate devices in these mechanical tests.
• Substantial Equivalence: Arguing that the device is substantially equivalent to legally marketed predicate devices based on technological characteristics, performance, and intended use.

To answer your specific questions in the context of an AI/ML device, I would need a document detailing a clinical performance study or an AI algorithm validation study.

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The PSG 5.5mm Cannulated Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 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), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.

The PSG 5.5mm Cannulated Pedicle Screw System is a non-cervical spinal fixation system. Pedicle screw fixation is limited to skeletally mature patients.

The PSG 5.5mm Cannulated Pedicle Screw System is a multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.

The provided document is a 510(k) premarket notification for a medical device called the "PSG 5.5mm Cannulated Pedicle Screw System." This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance rather than clinical efficacy studies in the context of AI/software-as-a-medical-device (SaMD). Therefore, many of the requested details about acceptance criteria, clinical study design, and AI performance metrics are not applicable or available in this submission.

However, I can extract the information relevant to the device's mechanical performance and what the submission provides in place of clinical study details.

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices such as pedicle screw systems, "acceptance criteria" and "reported device performance" are typically defined by engineering standards to ensure mechanical integrity and safety. In this context, the device's performance is compared against these standards and to predicate devices.

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

The document does not specify the exact sample sizes (number of devices or test repetitions) used for the mechanical tests. It only states that the device "has been tested" according to the ASTM standards.

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

This is not applicable as the device is a mechanical implant, not an AI/SaMD that requires expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM F1717-13).

4. Adjudication method for the test set

Not applicable. Mechanical testing is objective and relies on measurements and adherence to specified test protocols, not human adjudication of results.

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 pedicle screw system, not an AI/SaMD for diagnostic imaging or decision support. No MRMC study was performed.

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

Not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this type of device is defined by engineering standards and established mechanical performance characteristics relevant to spinal implants. Specifically, the ASTM F1717-13 standard dictates the methodologies and expected performance metrics for static and dynamic mechanical integrity. Comparison to legally marketed predicate devices also serves as a benchmark for "ground truth" in terms of acceptable clinical performance and safety.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a mechanical device, not a machine learning algorithm.

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

Not applicable.

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The Lancer Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

When used as a pedicle screw system, the Lancer Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Lancer Pedicle Screw System is comprised of polyaxial pedicle screws, rods and crosslinks. The system consists of a variety of color coded top loading pedicle screws. The rods are Ø5.5mm and are available in straight and pre-lordosed (curved) configurations. The cross linkage assemblies fit over the rods to supply torsional stability to the construct.

The provided document is a 510(k) summary for the Lancer Pedicle Screw System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information you're asking for, which is typical for AI/ML device evaluations or drug trials (e.g., acceptance criteria tables with performance, sample sizes for test/training sets in an AI context, expert ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training data details), is largely not applicable to this specific document.

However, I can extract the relevant "acceptance criteria" information in the context of what is provided in a 510(k) for a device like this, which primarily relates to non-clinical performance and substantial equivalence.

Here's a breakdown of the available information:

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

For a pedicle screw system, "acceptance criteria" are not reported as clinical performance metrics (like sensitivity/specificity for an AI model). Instead, acceptance criteria are met by demonstrating a device's substantial equivalence to predicate devices in terms of intended use, design, materials, and mechanical strength, along with meeting certain recognized standards for mechanical testing.

• Static compression bending
• Static torsion
• Dynamic compression bending |

Study that proves the device meets acceptance criteria:

The study proving the device meets its "acceptance criteria" (i.e., demonstrates substantial equivalence and mechanical performance) is the non-clinical testing conducted in accordance with ASTM F1717. The document states:

• "The Lancer Pedicle Screw System is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and strength."
• "The following tests were conducted per ASTM F1717: Static compression bending, Static torsion, Dynamic compression bending."

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

• Sample Size for Test Set: This concept doesn't apply to this 510(k) in the way it would for an AI/ML device or clinical trial. The "test set" here refers to the actual physical devices (Lancer Pedicle Screw System components) that underwent mechanical testing. The specific number of physical samples tested is not reported in this summary, but device manufacturers typically test multiple units to meet ASTM F1717 standards.
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from in-vitro mechanical testing performed on the device components.

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 question is not applicable. There is no "ground truth" in the clinical AI sense for this device as no clinical data or image interpretation by experts was involved for regulatory submission. Mechanical tests are typically performed by engineers/technicians in a laboratory setting according to established standards.

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

• This question is not applicable. Adjudication methods are relevant for clinical endpoints, especially in situations involving human interpretation or subjective assessments. Mechanical tests are objective measurements.

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 question is not applicable. An MRMC study is a type of clinical study used to evaluate diagnostic imaging systems or AI devices. The Lancer Pedicle Screw System is a physical implant, not an imaging or diagnostic device.

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

• This question is not applicable. This is not an AI algorithm.

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

• The "ground truth" for the mechanical performance of the device is defined by the acceptance criteria within the ASTM F1717 standard (e.g., minimum loads, fatigue life, etc.). The device passes if it meets or exceeds these pre-defined mechanical benchmarks, which are typically derived from historical data on predicate devices and clinical expectations for device durability.

8. The sample size for the training set

• This question is not applicable. There is no "training set" for physical mechanical devices in the context of this 510(k). The device's design and manufacturing process are informed by engineering principles and prior device knowledge, but not by a data-driven "training" process in the AI sense.

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

• This question is not applicable.

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The Renovis S 100 Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion {pseudoarthrosis}, spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.

When used as a pedicle screw system, the Renovis S 100 Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

As a posterior pedicle screw system designed for temporary stabilization of the anterior spine during the development of spinal fusion, the Renovis S 100 Pedicle Screw System is comprised of polyaxial pedicle screws, rods, and crosslinks. The S 100 System can be used for single or multiple level fixations

The screws are a top loading tulip design and are available in multiple diameters and lengths. Reduction screws are available for cases of spondylolisthesis where the short arms of the standard screw are not long enough to engage the rod. The rods are available in straight and pre-lordosed (curved) configurations. The system also has variable and fixed crosslinks.

The provided text describes a 510(k) summary for the Renovis S 100 Pedicle Screw System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies that would establish acceptance criteria and device performance in the same way as an AI/ML medical device.

Therefore, many of the requested categories are not applicable to this document. The "acceptance criteria" here refers to demonstrating equivalence to predicate devices through mechanical testing and comparison of design and materials.

Here's a breakdown of the information as it relates to the provided text:

Acceptance Criteria and Device Performance (as applicable for a 510(k) of this nature)

• Testing per ASTM F1717
• Testing per ASTM F1798
• Component dissociation testing
  The results “were equal or higher than the predicate system” (ZODIAC™ Polyaxial Spinal Fixation, and other predicates for specific components). This indicates the device meets or exceeds the mechanical performance of established similar devices. |

Study Information (Based on the provided K101682 document):

Because this is a 510(k) for a pedicle screw system, the "study" is primarily a non-clinical, mechanical testing comparison to predicate devices, rather than a clinical trial or AI/ML model validation.

1. Sample size 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 the exact sample sizes (e.g., number of screws, rods, or crosslinks) used for the mechanical tests (ASTM F1717, ASTM F1798, component dissociation testing).
   • Data Provenance: The tests conducted are standard ASTM (American Society for Testing and Materials) standards, implying laboratory-based mechanical testing. No geographical origin of the data is specified beyond the company's location (Redlands, CA, USA). The testing is prospective for this device, comparing its new components against existing standards and predicates.

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

   • Not Applicable. For mechanical performance testing of a physical medical device, "ground truth" is established by adherence to recognized national/international standards (like ASTM) and comparison to the published properties/performance of legally marketed predicate devices. Expert consensus in the clinical sense is not directly relevant here. The manufacturing and testing would be performed by qualified engineers and technicians.

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

   • Not Applicable. Mechanical testing under ASTM standards typically involves precise measurements and quantitative outcomes. There isn't an "adjudication" process in the sense of resolving disagreements among human observers for image interpretation or diagnosis. The "acceptance" is based on meeting the quantitative performance metrics relative to the predicate devices and applicable 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:

   • Not Applicable. This device is a pedicle screw system, a physical orthopedic implant. It is not an AI/ML-driven diagnostic or assistive technology, so MRMC studies involving human "readers" or AI assistance are irrelevant.

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

   • Not Applicable. As above, this is a physical implant, not an algorithm or software device.

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

   • The "ground truth" for this 510(k) submission is based on established mechanical engineering principles, recognized industry standards (ASTM F1717, F1798), and the performance characteristics of legally marketed predicate devices. The claim of "substantial equivalence" is the central "truth" being established through these comparisons.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of a physical medical device like a pedicle screw system. This term is relevant for AI/ML models.

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

   • Not Applicable. As there is no training set, this question is not relevant.

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