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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 F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, noncervical pedicle fixation (T1-S1) 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: severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal tumor, Schuermann's disease, and failed previous fusion.

The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The F1-MPS is also intended for posterior, non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

The F1-Modular Pedicle Screw System is composed of cannulated and non-cannulated pedicle screws which are designed to accept a 5.5mm rod and are available in various sizes. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 or cobalt-chromium-molybdenum per ASTM F1537.

This document is a 510(k) premarket notification for a medical device called the "F1-Modular Pedicle Screw System". It's not a study proving device performance against acceptance criteria in the way you're asking about for an AI/software device. This document is for a mechanical implant, and the "acceptance criteria" and "study" described are for non-clinical mechanical testing to demonstrate substantial equivalence to existing devices.

Therefore, many of your requested points (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the non-clinical performance testing and substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this mechanical device, "acceptance criteria" are typically defined by recognized standards such as ASTM F1717 and ASTM F543, and the performance is demonstrated by meeting or exceeding the performance of predicate devices. Specific quantitative acceptance criteria are not provided in this summary, but the conclusion states the device meets or exceeds the performance of predicate devices.

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

• Sample Size: Not explicitly stated in this summary. For mechanical testing per ASTM standards, specific sample sizes are prescribed, but the exact number of screws/constructs tested is not given here.
• Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical testing.

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

Not applicable. Ground truth in this context refers to established mechanical testing standards and the comparison to predicate devices, not expert human interpretation of data for an AI.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical testing against engineering standards.

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

No. This is not an AI/diagnostic imaging device.

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

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established ASTM mechanical testing standards (F1717, F543) and the performance of existing, legally marketed predicate devices. The goal is to show substantial equivalence, meaning it performs at least as well as, if not better than, comparable devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of mechanical device.

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

Not applicable. There is no "training set."

Summary for this specific document related to your request:

This document describes a non-clinical performance testing study for a mechanical pedicle screw system. The purpose of the study was to demonstrate substantial equivalence to existing predicate devices based on recognized ASTM standards for mechanical testing. The "acceptance criteria" are implied by these standards and the performance of the predicate devices, which the subject device was found to meet or exceed. There are no elements related to AI, software performance, human reader studies, or ground truth derived from expert consensus on clinical data.

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The Aversion Pedicle Screw System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion

The Aversion Pedicle Screw System consists of straight and curved rods, polyaxial pedicle screws and crosslink connectors. These are available in a variety of sizes to accommodate differing patient anatomy.

This is a 510(k) premarket notification for a medical device called the "Aversion Pedicle Screw System." It is not an AI/ML device, therefore the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, or standalone performance) related to AI/ML device testing is not applicable.

The document describes a traditional medical device, a pedicle screw system, and focuses on demonstrating its substantial equivalence to a legally marketed predicate device based on:

1. Technological characteristics: Basic design (rod-based fixation), material (titanium alloy), anatomic location (non-cervical spine), and sizes.
2. Performance Data: Mechanical testing (static compression bending and torsion, dynamic compression bending, and pullout testing) performed according to ASTM F1717 and ASTM F543 standards. The results demonstrated substantial equivalence in performance to the predicate devices.

Therefore, I cannot fulfill the request for information on acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC, or standalone performance as these concepts are specifically relevant to AI/ML device evaluations, which this document does not describe.

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The Athena Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The system is intended for posterior, pedicle fixation 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 (DDD) (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 Athena Pedicle Screw System is comprised of polyaxial pedicle screws in various diameters and lengths, spinal rods in various lengths, cross-connectors and set screws. The Athena Pedicle Screw System can be used for single or multiple level fixations. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, 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

The provided text describes non-clinical mechanical testing of the device components. It does not refer to a "test set" in the context of patient data or clinical trials. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable to this type of study as described. The testing involves physical samples of the pedicle screw system components.

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

Given this is a non-clinical mechanical performance study rather than a clinical study evaluating diagnostic or treatment outcomes, there were no experts used to establish ground truth in the way one would for clinical data interpretation. The "ground truth" for this study is defined by the established standards of ASTM F1717 for mechanical testing. Compliance with these standards is objectively measured.

4. Adjudication Method

Since no experts were establishing ground truth for a clinical test set, an adjudication method is not applicable. The testing involves objective physical measurements against established engineering standards.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical substantial equivalence of a medical implant, not the effectiveness of a diagnostic or treatment method involving human readers.

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

No, a standalone "algorithm only" performance study was not done. This is a physical medical device, not a software algorithm. The "standalone performance" here refers to the mechanical integrity of the device components in isolation (i.e., without being implanted in a patient, but using standardized test fixtures). The study conducted was precisely that – standalone mechanical testing of the device components.

7. The Type of Ground Truth Used

The "ground truth" used for this study is based on established engineering standards (ASTM F1717) for mechanical performance and material specifications (ASTM F136). The performance of the Athena Pedicle Screw System was compared directly against these standards and to the mechanical performance of predicate devices that previously met these standards.

8. The Sample Size for the Training Set

Since this is a non-clinical mechanical study rather than a machine learning or clinical study, the concept of a "training set" is not applicable. The device's design is developed through engineering principles, not through training on a dataset.

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

As the concept of a "training set" does not apply to this type of study, the question of how ground truth was established for a training set is not applicable. The design and manufacturing processes are validated against engineering specifications and industry standards.

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The flamenco™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.

When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.

When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the flamenco™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

The flamenco™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.

The provided text describes the "flamenco™ spinal fixation system," a Class II medical device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for standalone performance or comparative effectiveness with AI.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are implied to be achieving performance at least on par with the predicate devices under the specified ASTM F1717 mechanical tests.

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

The document reports mechanical performance data, not clinical performance data from a test set of patient cases. Therefore, information regarding "sample size used for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The testing was laboratory-based mechanical testing of "worst case" device constructs.

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

As this is a mechanical testing study, there were no human experts involved in establishing "ground truth" in the clinical sense. The "ground truth" for the mechanical tests would be the physical properties and performance measured by standardized mechanical testing equipment.

4. Adjudication Method for the Test Set:

Not applicable, as this was a mechanical test, not a clinical study requiring adjudication of expert interpretations.

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

No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI diagnostic or therapeutic software that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.

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

Yes, in spirit, a standalone performance was done for the device's mechanical properties. The mechanical tests were performed on the device "constructs" themselves, independent of human interaction during the test. This is not "standalone algorithm performance" in the context of AI, but rather standalone performance of the physical device.

7. The Type of Ground Truth Used:

The "ground truth" for the mechanical performance study was physical measurements and adherence to engineering standards (ASTM F1717). The performance was compared against the measured performance of predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant, not an AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for a physical device.

Summary of Study:

The study described is a mechanical performance study conducted according to ASTM F1717. This standard specifies methods for static and dynamic testing of spinal implant constructs. The "flamenco™" system's "worst case" construct was subjected to static compression bending, torsion, and dynamic compression bending. The objective of the study was to demonstrate that the mechanical performance of the flamenco™ system is equivalent to or superior to that of legally marketed predicate devices. The study concluded that the "flamenco™ performs as well as or better than the predicate devices," thereby meeting the implied acceptance criteria for mechanical equivalence.

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When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the Moss Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).

When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the Moss Miami Spinal System is indicated for deqenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Moss Miami Spinal System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5 -- S1 vertebral joint, having fusions with autogenous bone graft. with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 - S1), and for whom the device system is intended to be removed after solid fusion is attained.

The Moss Miami Spinal System Polyaxial Screws and Polyaxial Reduction Screws are designed to accept a 5.5mm rod and are available in various sizes.

The Moss Miami Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.

The provided text describes a 510(k) premarket notification for the Moss Miami Spinal System Polyaxial Screws, a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance tables, study details (sample sizes, data provenance, expert involvement, adjudication, MRMC studies, standalone performance), or ground truth establishment.

Instead, the submission relies on the established safety and effectiveness of predicate devices. The FDA determines "substantial equivalence" based on factors like:

• Intended Use: The Moss Miami Spinal System Polyaxial Screws share similar intended uses with the predicate devices.
• Technological Characteristics: The device is described as Polyaxial Screws designed to accept a 5.5mm rod, which is compared to existing Moss Miami Spinal System components.
• Performance Data: While not explicitly detailed, 510(k) submissions typically include non-clinical performance testing (e.g., mechanical testing, biocompatibility) to demonstrate that the new device performs as safely and effectively as the predicate device and meets established engineering standards. However, these specific test results are not part of this summary document.

In summary, this document is a regulatory approval notice based on substantial equivalence, not a study report demonstrating acceptance criteria and device performance as would be found in a clinical trial.

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The ISOBAR 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The provided document is a 510(k) summary for the ISOBAR Spinal System Additional Components. This document pertains to a medical device (pedicle screw spinal system) and its mechanical performance, not an AI/ML-based device. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or cannot be extracted from this type of documentation.

However, I can extract the acceptance criteria and the study performed based on the information provided, focusing on the mechanical aspects of the device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. Testing according to ASTM F1717-96 would involve a specific number of samples, but this summary does not provide that detail.
• Data Provenance: The testing was "performed according to ASTM F1717-96." This implies laboratory testing of the physical device components. Data provenance in terms of country of origin or retrospective/prospective is not applicable for this mechanical testing.

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

• Not applicable. This is mechanical performance testing against an engineering standard, not clinical data requiring expert human review or ground truth establishment.

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

• Not applicable. This refers to consensus methods for clinical assessment, which is not relevant for 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:

• Not applicable. This is a medical device for spinal fixation, not an AI-based diagnostic or assistive technology.

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

• Not applicable. This is not an algorithm.

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

• The "ground truth" for this device's performance is compliance with the ASTM F1717-96 standard for static and fatigue compression testing, and the ASTM F136 standard for material composition. These are engineering standards, not clinical ground truths.

8. The sample size for the training set:

• Not applicable. This is mechanical performance testing, not an AI/ML model that requires a training set.

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

• Not applicable. There is no training set for this type of device and study.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed to demonstrate the device meets acceptance criteria involved mechanical testing of the ISOBAR Spinal System Additional Components. The specific standard cited for this testing is ASTM F1717-96, which covers static and fatigue compression testing of metallic spinal implant ensembles. Additionally, the material used, titanium alloy (Ti-6Al-4V), was confirmed to conform to ASTM F136, a standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications.

The 510(k) submission states that these tests were "performed according to" the specified standards. This implies that the device and its components successfully met the performance requirements and material specifications outlined in those ASTM standards, thus establishing its substantial equivalence to predicate devices (Moss Miami Polyaxial Screw and ISOBAR U-Line Spinal System) that also rely on compliance with such standards for their mechanical integrity. The document does not provide a detailed report of the exact numerical results or the pass/fail thresholds for these tests, as is typical for a 510(k) summary which focuses on demonstrating substantial equivalence rather than a full engineering report.

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