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The Calvary Spine 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 (T1 to S1/ilium); degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical (T1 to S1/ilum), pedicte screw fixation in pediatric patients, the Calvary Spine Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Calvary Spine Pedicle Screw System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Calvary Spine Pedicle Screw System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. Calvary pedicular screws must be used with Ø 5.5mm straight and curved rods.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Calvary Spine Pedicle Screw System:

Based on the provided FDA 510(k) summary (K201568), there is no information about acceptance criteria or a study proving the device meets specific performance criteria in terms of an AI/algorithm-based medical device.

The document describes a traditional medical device, specifically a pedicle screw system, which is a hardware implant used in spinal fusion surgery. The "acceptance criteria" discussed in this document refer to the regulatory requirements for establishing substantial equivalence to previously cleared predicate devices, primarily based on design, materials, and mechanical performance through non-clinical testing.

Therefore, I cannot populate most of the requested fields because they are specifically tailored for studies validating AI/algorithm performance.

However, I can extract the relevant information regarding the type of study and the basis for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device and not an AI/algorithm, there are no specific performance metrics like sensitivity, specificity, or AUC to list as acceptance criteria for automated diagnosis or analysis. The "acceptance criteria" for this device are broadly the demonstration of substantial equivalence to predicate devices based on:

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

• Not applicable (N/A) for an AI/algorithm test set.
• The "test set" in this context refers to the samples used in non-clinical mechanical testing, which are typically manufactured units of the device. No information on the specific number of units tested for each mechanical test is provided, but it would involve standard engineering sample sizes for material and mechanical property evaluations.
• Data Provenance: The data provenance for mechanical testing would be from internal laboratory testing of the manufactured devices. No country of origin for data in the AI sense is relevant here, nor is retrospective or prospective human data.

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

• N/A for an AI/algorithm test set.
• Ground truth for mechanical properties is established through standard engineering and materials testing protocols (e.g., ASTM standards), not by human experts adjudicating images or clinical data.

4. Adjudication Method for the Test Set

• N/A for an AI/algorithm test set.
• Mechanical test results are objective measurements against defined standards, not subject to human adjudication methods like 2+1 or 3+1.

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 not an AI/algorithm, therefore, there is no human-in-the-loop performance improvement with AI assistance to measure.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No. A standalone algorithm performance study was not done.
• This device is not an AI/algorithm.

7. The Type of Ground Truth Used

• Mechanical and Material Standards: The "ground truth" for this medical device's performance is compliance with established material specifications (e.g., ASTM F136, F67, F1582) and mechanical testing standards for spinal implants, demonstrating equivalent or superior strength to predicate devices.

8. The Sample Size for the Training Set

• N/A for an AI/algorithm training set.
• This device does not involve a training set as it's not an AI/algorithm.

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

• N/A for an AI/algorithm training set.
• Not applicable as there is no training set.

Summary of what was done (based on the provided text):

The Calvary Spine Pedicle Screw System underwent non-clinical testing to demonstrate that it is substantially equivalent to legally marketed predicate devices. This equivalence was established based on:

• Similar materials (Ti-6Al-4V ELI, CP Titanium, CoCrMo).
• Similar intended use.
• Similar design (shape, sizes, manufacturing process).
• Comparable or superior strength values, presumably measured through mechanical testing (though specific tests and methodology are not detailed in this summary).

The document explicitly states: "No clinical studies were performed." This is common for 510(k) clearances where substantial equivalence can be demonstrated through non-clinical data.

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The KHEIRON Spinal Fixation 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: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the KHEIRON System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the KHEIRON Spinal Fixation System is intended to treat pediatic patients diagnosed with spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

This system is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The KHEIRON® Spinal Fixation System may be used for a variety of conditions that affect the thoracic and lumbar spine. In cases in which the posterior elements are fractured, the pedicle screw offers an excellent means of stabilizing a specific spinal segment. KHEIRON Spinal Fixation System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. KHEIRON pedicular screws must be used with Ø 5.5mm and Ø 6mm rods.

The KHEIRON® Spinal Fixation System is a medical device and the provided document is a 510(k) summary for its premarket notification to the FDA. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a standalone study of its capabilities in a clinical setting.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not directly available in the provided text. The document states "No clinical studies were performed."

However, the document does provide information on non-clinical testing to demonstrate the physical performance and safety of the device:

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

Since no specific numerical acceptance criteria (e.g., minimum strength values) are given, and only a comparative statement is made regarding performance against predicates, a direct table of acceptance criteria and the reported device performance as typically expected for an AI/diagnostic device is not applicable here.

Instead, the non-clinical test summary states:

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

• Test Set Sample Size: Not specified as clinical studies were not performed. For non-clinical tests (mechanical tests), the sample sizes for the devices tested were not provided.
• Data Provenance: Not applicable as no clinical data was used. Mechanical testing is typically done in a laboratory setting. No country of origin for the mechanical test data is mentioned.

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, as no clinical studies requiring expert consensus for ground truth were performed.

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

• Not applicable, as no clinical studies requiring ground truth adjudication were performed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "No clinical studies were performed." This device is a mechanical spinal fixation system, not an AI or diagnostic tool that would typically involve human "readers."

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 (expert consensus, pathology, outcomes data, etc):

• For the non-clinical mechanical tests, the "ground truth" would be the engineering standards (e.g., ASTM F1717 and ASTM F1798) and the performance characteristics of the predicate devices. The device's strength was directly measured against these established benchmarks.

8. The sample size for the training set:

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device that requires a training set.

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

• Not applicable, as this is a mechanical spinal fixation system and not an AI/machine learning device.

Summary of Non-Clinical Testing:

The KHEIRON® Spinal Fixation System underwent the following non-clinical mechanical tests:

• Static and dynamic compression bending (according to ASTM F1717)
• Static torsion (according to ASTM F1717)
• Torsional and axial gripping capacity (according to ASTM F1798)

The results of these evaluations indicated that the KHEIRON Spinal Fixation System is "substantially equivalent to legally marketed predicate devices" and specifically noted that its "strength values" were "greater or equivalent" compared to other cleared devices for thoracolumbosacral spine use.

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The DePuy PULSE Thoracolumbar Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The DePuy PULSE Thoracolumbar Screw System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation 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, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are pedicle screw systems 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ISOLA, VSP, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are 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 ISOLA, MOSS MIAMI, TiMX, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems are also a hook and sacral/iliac screw fixation system of the 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 ISOLA, VSP, CrossOver Cross Connectors, E-Z Link Cross Connectors, and MONARCH Spine Systems when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.

The ISOLA and MOSS MIAMI Spine Systems when used as anterior thoracic/lumbar screw fixation systems, are 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 MONARCH Spine System Dual Rod Connectors can be used to connect MONARCH Spine System Rods to rods of other DePuy Spine 4.75mm, 5.5mm, and 6.35mm diameter rod systems.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in posterior spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM, VIPER, VSP, ISOLA, MONARCH, MOSS MIAMI, and TiMX Spine Systems. Please refer to the labeling of the aforementioned spinal systems indications for use.

The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic. Iumbar and sacral spine.

The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System, VIPER SAI, and VIPER PRIME is intended for noncervical pedicle fixation 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, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, VIPER PRIME is intended for noncervical pedicle fixation and nonpedicle fixation 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); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER 2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, VIPER System, VIPER 2 System, and VIPER PRIME are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM Growing System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM Growing System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM Spine Systems. The EXPEDIUM Growing Spine System is not intended to be used with 4.0mm diameter screws.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the VIPER and EXPEDIUM Fenestrated Screw Systems are 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER and EXPEDIUM Fenestrated Screw Systems augmented with the CONFIDENCE High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The Cross over and E-Z Link Cross Connectors are designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. The CrossOver and E-Z Link Cross Connectors are indicated as part of the ISOLA Spinal System.

The DePuy PULSE Thoracolumbar Screw System consists of a variety of rods, pedicle screws, connectors, setscrews and other connection components used to build a spinal construct. The DePuy PULSE Thoracolumbar Screw System is offered in titanium material in sizes ranging from 4.35mm to 12.0mm in shank diameter and 20mm to 130mm in length. Screw shanks with 7.0mm and smaller are assembled from the top of the outer head, while screws with 7.5mm and larger are assembled from the bottom using a flex ball. The implant components can be rigidly locked into a variety of configurations, with each construct being made for the individual case.

The EXPEDIUM, VIPER and VIPER PRIME screws with fenestrations are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end and may be used in conjunction with, or without the CONFIDENCE High Viscosity Spinal Cement. The cannulation and fenestrations allow for the injection of bone cement through the screws into the vertebral body in patients with severe osteoporosis or pathological fractures due to osteoporosis and tumor in the thoracic, lumbar and sacral spine.

The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in constructs comprising spinal instrumentation components. It features an advanced top-loading design and unique snap-fit feature that simplify initial placement and tightening procedures which helps avoid impingement of surrounding anatomy. The EXPEDIUM SFX Cross Connector system incorporates a broad range of implant options in both and adjustable configurations for an optimal balance between dural clearance and implant profile.

The EXPEDIUM VERSE Spine System is designed to provide intraoperative polyaxial to monoaxial conversion. It facilitates easier rod capture and provides a powerful and precise reduction mechanism. EXPEDIUM VERSE is a reduced profile thoracolumbar implant for use for with wide range of patient statures. EXPEDIUM VERSE is a selfcontained, efficient, and intuitive instrument system that is compatible with EXPEDIUM 5.5 rods, hooks and mono screws to enhance versatility.

The ISOLA Spine 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. The ISOLA Spine System consists of connectors, open and closed iliac screws, iliac bolts, and angled closed iliac screws. These components have been designed to allow for rigid fixation of the sacral and pelvic regions of the spine.

The MONARCH Spine System is both a rod-based and plate-based system designed to interface with various spinal anatomies. The plate-based system consists of pedicle screws, spine plates, transverse connectors. J-hooks, washers, nuts and set screws. The rod-based system consists of spinal rods, pedicle screws, set screws, various slotted connectors, and transverse connectors.

The TiMX Low Back System is a construct that consists of pedicle and sacral screws, spine plates, nuts, washers, and transverse connectors. The TiMX Low Back System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of chronic instabilities and deformities of the thoracic, lumber, and sacral spine.

The MOSS MIAMI Spine System is a closure mechanism which secures the rod to the screw in one single, simple step. The unique square threads balance the forces vertically, creating a secure assembly. It consists of anatomic hooks, monoaxial screws, polyaxial screws and a dual closure mechanism.

The VIPER PRIME System is novel technique for percutaneous pedicle screw placement and posterior stabilization. This innovative technique eliminates the need for guidewires, Jamshidi needles and pedicle preparation instruments; utilizing a stylet that is fully controlled by the screwdriver. The VIPER PRIME System enables surgeons to target pedicles and insert the screw, without the need for instrument exchanges or reconfirmation of their trajectory.

The VIPER Sacral-Alar-Iliac Screw is an implant designed for sacropelvic fixation. The VIPER SAI Screw is optimized for Sacral-Alar-Iliac placement vis-à-vis a favored angle polyaxial head, smooth shank and robust drive feature. The in-line nature of this anchor allows not only stabilization but also correction of pelvic sagittal or coronal deformities.

The EXPEDIUM Spine System, VIPER System, and VIPER 2 System are metallic implants intended to provide immobilization and stabilization of spinal segments. They can be used for skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine; or for posterior non-cervical pedicle screw fixation in pediatric patients as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The EXPEDIUM Spine System consist of longitudinal rods, monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers. The VIPER and VIPER 2 Systems consist of cannulated polyaxial screws, monoaxial screws, uni-planar screws, reduction screws, and rods used in a percutaneous approach.

The VSP Spine System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion. Levels of fixation are for the thoracic, lumbar and sacral spine. The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion us attained. Levels of fixation are from L3-S1.

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to previously cleared devices. Therefore, the information provided focuses on comparative data rather than a standalone clinical study with acceptance criteria in the same manner as a de novo or PMA submission might require.

However, based on the provided text, we can infer some "acceptance criteria" related to magnetic resonance compatibility and how the study "proves" the device meets them.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are indirectly established by the selection of specific ASTM standards for magnetic resonance compatibility. The study "proves" the device meets these criteria by performing tests according to these standards and reporting that the "results demonstrated compatibility conditions." While the exact quantitative thresholds are not provided in this summary, the FDA's clearance implies that the performance met the requirements set by these recognized standards for MR safety.

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

• Sample Size for Test Set: Not specified. The document states that "non-clinical testing was conducted in alignment with the following standards." This usually means a set of representative devices or components are tested, but the specific number is not provided in this summary.
• Data Provenance: The nature of the tests (magnetic resonance compatibility) indicates laboratory testing of the devices themselves, rather than human subject data. Therefore, "country of origin of the data" and "retrospective or prospective" do not directly apply in the traditional sense of clinical studies. The tests were performed to demonstrate that the device materials and design are safe within an MR environment.

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

This submission is for device clearance based on non-clinical (laboratory) testing for MR compatibility. Therefore, there were no experts used to establish ground truth for a test set in the clinical sense. The "ground truth" is governed by the objective measurements defined by the ASTM standards for MR compatibility.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical laboratory testing, there is no adjudication method involving human interpretation or consensus. The data points are quantitative measurements against predefined ASTM standard limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on diagnostic performance with human readers, which is not the purpose of this submission. This submission is for the clearance of physical medical devices (spinal systems) and their magnetic resonance compatibility labeling.

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

No. A standalone algorithm-only performance study was not done. This submission concerns physical medical devices and their MR compatibility, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was defined by the specifications and limits within the cited ASTM standards (ASTM F2213, ASTM F2052, ASTM F2119, ASTM F2182) for magnetic resonance compatibility. These standards outline methodologies and acceptable thresholds for torque, displacement force, image artifacts, and heating.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this 510(k) submission, as it relates to physical device testing for MR compatibility, not machine learning or AI algorithm development.

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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The PASS LP Spinal System is a pedicle screw fixation system intended for immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in 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, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when used for posterior non-cervical pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to treat adolescent idiopathic scollosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 and ISO 5832-3.

A subset of PASS LP components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP range, with the addition of those new components:

• TULIP GENESIS Non-cannulated Pedicle Screws
• TULIP GENESIS Non-cannulated Iliac Screws
• TULIP GENESIS Cannulated Pedicle Screws
• TULIP GENESIS Cannulated Iliac Screws
• TULIP GENESIS Breakable Setscrew

This document is a 510(k) Pre-Market Notification from the FDA for the PASS LP Spinal System. It is an approval letter and a summary of the device and its intended use, not a study evaluating its performance against acceptance criteria in the context of an AI/ML medical device.

Therefore, I cannot provide the requested information as the document does not contain details about:

1. Acceptance criteria and reported device performance related to an AI/ML model. This document is for a medical implant (spinal fixation system), not a software device that relies on performance metrics like accuracy, sensitivity, or specificity.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Stand-alone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
8. Sample size for a training set.
9. How ground truth for the training set was established.

The "Performance Data" section (g) only mentions mechanical testing according to ASTM F1717-18 for static compression bending, static torsion, and dynamic compression bending tests, concluding that the products are "as mechanically sound as other devices commercially available." This refers to the physical properties of the spinal implants, not the performance of an AI or Machine Learning algorithm.

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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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When used as a pedicle screw fixation system in the non-cervical posterior spine (TI-SI) in skeletally mature patients, the VICEROY Spine 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 the thoracic, lumbar and sacral spine: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis, (7) turnor, (8) failed previous fusion (i.e. pseudarthrosis).

The VICEROY Spine System consists of four or more pedicle screws and two VICEROY solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The VICEROY rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The VICEROY Spine System is fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for a medical device called the VICEROY Spinal System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies or extensive standalone algorithm evaluation. The "performance summary" section refers to mechanical testing of the device, not a study of its clinical or diagnostic accuracy.

Therefore, many of the requested fields regarding acceptance criteria related to diagnostic performance or clinical outcomes, and the type of study that proves it, are not applicable or cannot be extracted from this document.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Device Performance (Mechanical Testing)

The document states: "Testing was performed to support the equivalence of the proposed pedicle screw system in accordance with FDA Guidance 'Guidance for Industry and FDA Staff: Spinal System 510(k)s.' The following testing was performed in accordance with ASTM F1717: static compression bending, static torsion, and dynamic compression bending."

This indicates that the acceptance criteria are adherence to ASTM F1717 standards for the specified mechanical tests, and the device performs in a manner equivalent to predicate devices under these tests. However, specific numerical acceptance values or detailed performance results (e.g., specific bending moment values, torsion limits) are not provided in this summary. The document only states that the testing supports equivalence.

Study Details (Mechanical Testing)

1. Sample size used for the test set and the data provenance: Not specified in the document. Mechanical testing typically uses a certain number of device samples, but this information is not provided. The data provenance is implied to be from the manufacturer's internal testing as part of the 510(k) submission process.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is mechanical testing of a physical device, not related to expert interpretation or ground truth establishment for diagnostic purposes.
3. Adjudication method for the test set: Not applicable.
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 spinal system, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
6. The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics defined by ASTM F1717, to which the device's measured performance is compared.
7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this type of mechanical testing.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document does convey:

• The VICEROY Spinal System is a medical device intended for spinal stabilization.
• The manufacturer is seeking substantial equivalence to existing predicate devices (ACME Spinal System, Moss Miami, and Expedium Spinal System).
• Substantial equivalence is claimed based on materials, design, indications for use, operational principles, and mechanical testing.
• Mechanical testing was performed according to ASTM F1717 standards for static compression bending, static torsion, and dynamic compression bending.
• The document implies the device met the requirements of these standards and demonstrated performance equivalent to the predicate devices.

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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of designs that interface to 5.5mm and 6.35mm rods and are available in various geometries and sizes.

This document describes a 510(k) premarket notification for the EXPEDIUM Spine System, a medical device for spinal fixation. It is not a traditional AI/ML device approval, therefore much of the requested information about AI model performance, training sets, and ground truth establishment is not applicable.

Here's the relevant information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document states that "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification." This implies that the acceptance criteria are tied to the standards outlined in ASTM F 1798. However, the specific quantitative acceptance criteria (e.g., maximum deflection, fatigue life, strength) and the reported performance values are not provided in the summary. The document only confirms that data was submitted, not the results themselves.

Note: For medical devices like spinal fixation systems, acceptance criteria typically involve detailed mechanical testing (e.g., static and dynamic compression, bending, torsion), biocompatibility, and material characterization to ensure safety and effectiveness. The ASTM F 1798 standard specifically deals with the fatigue testing of intervertebral body fusion devices.

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

The document describes mechanical performance testing, not data analysis or human subject testing in the traditional sense of a "test set" for an AI model. Therefore, the concept of sample size for a "test set" and "data provenance" (country of origin, retrospective/prospective) as it applies to an AI/ML device is not applicable here. The "test set" for this device would refer to the physical components subjected to mechanical tests. The specific number of components tested is not provided in the summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as this is a physical medical device (spinal fixation system) and not an AI/ML product. The "ground truth" for such a device is established through adherence to engineering specifications, material science principles, and mechanical testing standards (like ASTM F 1798). Experts involved would be engineers, material scientists, and potentially surgeons for clinical relevance, but their role is not in establishing a data "ground truth" as it would be for an AI model.

4. Adjudication Method for the Test Set

This concept is also not applicable as this is a physical medical device. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert labeling or diagnoses for AI/ML training or evaluation datasets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-analysis AI/ML systems where human readers interpret cases with and without AI assistance to measure improved performance. This device is a physical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable as the device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and mechanical test results. Specifically, the summary states "Performance data per ASTM F 1798 were submitted." ASTM F 1798 is a standard specification for fatigue test performance of spinal artificial disc prostheses and components. Therefore, the ground truth is derived from objective mechanical testing outcomes compared against established engineering standards.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML product. There is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative engineering and testing, but not in the sense of an AI training set.

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

This information is not applicable for the same reasons as #8.

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The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

When used as a pedicle screw fixation system of the posterior lumbar spine in skeletally mature patients, the SLPSS is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment. (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the SLPSS is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

The Savannah Lumbar Percutaneous Stabilization System (SLPSS) is also intended to provide immobilization and stabilization of the spinal segments of the lumbar and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The Savannah Lumbar Percutaneous Stabilization System is comprised of a variety of pedicle screws sizes, couplers, a ball swivel, rods and locking nuts that can be uniquely fitted for each individual case. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-Eli).

The provided text is a 510(k) summary for the Savannah Lumbar Percutaneous Stabilization System (SLPSS). It describes the device, its indications for use, and how it demonstrates substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.

Instead, the document states:

"The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."

This implies that the device's performance was compared to existing, legally marketed devices (predicates) rather than against specific, predefined acceptance criteria through a standalone clinical or performance study with detailed metrics. The regulatory pathway chosen, a 510(k), relies on demonstrating "substantial equivalence" to a predicate device, which often involves comparing technical characteristics and performance data to show that the new device is as safe and effective as the predicate.

Therefore, for your request, the following information is largely not present in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance metrics are listed.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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, as this is a surgical implant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a surgical implant.
7. The type of ground truth used: Not applicable, as it's not a diagnostic device.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Summary of available information:

• Device Name: Savannah Lumbar Percutaneous Stabilization System (SLPSS)
• Regulatory Pathway: 510(k) Premarket Notification (K072116)
• Claim of Performance: "The pre-clinical testing performed indicated that the Savannah Lumbar Percutaneous Stabilization System is substantially equivalent to predicate devices."
• Predicate Devices Listed:
  • Synthes USS Pedicle Screw System (K022949, K010108, K010658, K994121, K982987)
  • DePuy Moss Miami Spinal System (K022623, K983583, K964024, K955348, K933881)
  • U&I Optima Spinal System (K031585)
  • Stryker Spine Xia Spinal System (K001319, K984251, K951725)
• Nature of Testing: "Pre-clinical testing" was performed to demonstrate substantial equivalence, but details of this testing (e.g., in-vitro, mechanical, benchtop) are not provided in this summary.

Conclusion:

The provided document relies on showing substantial equivalence to predicate devices based on pre-clinical testing, rather than presenting a study with specific acceptance criteria as you've requested for a device that might involve diagnostic performance or AI. Therefore, most of the detailed information you are seeking is not available in this 510(k) summary.

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The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

• Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
• Spondylolisthesis
• Fracture
• Spinal deformities such as scoliosis, kyphosis, lordosis
• Tumor
• Revision of failed fusion attempts
• Pseudarthrosis
• Spinal stenosis

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

The subject ISSYS LP Polyaxial Spinal Fixation System includes 5.5 mm diameter rods (preformed rod or straight rod configuration) in addition to the selection of the cleared 6.0 mm and 6.35 mm diameter rods. It is to be used with both the Polyaxial and Monoaxial screws.

This is a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, much of the requested information regarding AI device performance, such as sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies, is not applicable. The provided document focuses on demonstrating substantial equivalence to predicate devices through material, design, and performance data for a new component (5.5 mm diameter rod) of an existing spinal fixation system.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission is for a physical medical device (spinal fixation system component), not a diagnostic algorithm that uses a "test set" of data in the typical sense. The "testing" refers to mechanical and material characterization.
• Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance refers to materials testing and engineering analysis performed according to recognized standards (ASTM F-136, ASTM F 1717). This would typically be conducted in a laboratory setting by the manufacturer or contracted labs.

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

• Not applicable. This is not an AI/ML device requiring expert-established ground truth from clinical data. The "ground truth" for this device relates to established engineering standards for material properties and mechanical performance.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication method" as would be used for clinical data interpretation. Compliance is assessed against engineering standards.

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 is not an AI/ML device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is based on:

• Established engineering and material standards: Specifically, ASTM F-136 for material composition (implant grade titanium alloy) and ASTM F 1717 for mechanical performance of spinal implant constructs.
• FDA Guidance: The device's design and testing adhered to the "FDA's Guidance For Spinal System 510(k) May 3, 2004."
• Predicate Device Characteristics: The core of a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices in terms of material, design, and indications for use. The characteristics of these predicate devices serve as a benchmark.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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