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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 Inertia® Pedicle Screw and Deformity Correxxion™ System is intended for pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion 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, cyphosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pediatic patients, the Inertia® Pedicle Screw and Deformity Correxxion™ System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Inettia® Pedicle Screw and Deformity Correxxion™ System is to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Inertia® Pedicle Screw and Deformity Correxxion™ System consists of longitudinal members (rods), anchors (screws and hooks), interconnections (offset, rod-rod and crosslink) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The Inertia® Pedicle Screw and Deformity Correxxion™ System implants are sold sterile and non-sterile.

The provided text describes a 510(k) premarket notification for the "Inertia® Pedicle Screw and Deformity Correxxion™ System," a medical device for spinal stabilization and immobilization. However, the document does not contain information regarding an AI/Machine Learning-enabled device or a study proving its performance against specific acceptance criteria for such a device.

The acceptance criteria described in the document, and the study conducted, pertain to the mechanical performance of the pedicle screw system itself, not to the performance of an AI algorithm.

Therefore, I cannot provide the details requested in your prompt regarding AI/ML device performance, such as:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size for the test set and data provenance for an AI/ML device.
• Number of experts and their qualifications for establishing ground truth for an AI/ML device.
• Adjudication method for an AI/ML device.
• MRMC comparative effectiveness study results or effect size for AI assistance.
• Standalone performance for an AI/ML device.
• Type of ground truth used for an AI/ML device.
• Sample size for the training set for an AI/ML device.
• How ground truth for the training set was established for an AI/ML device.

What the document does describe (related to mechanical device performance):

The document implicitly defines acceptance criteria by stating that the device's performance needs to be "substantially equivalent" to predicate devices.

1. A table of acceptance criteria and the reported device performance (for the mechanical device):

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

• Sample Size: Not explicitly stated as a number of devices, but refers to "worst case Inertia® Pedicle Screw and Deformity Correxxion™ System constructs."
• Data Provenance: The tests are described as mechanical testing, implying in-vitro lab testing rather than human patient data.

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 "ground truth" here refers to established engineering standards (ASTM F1717) for mechanical performance, not expert clinical interpretation.

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

• This is not applicable, as it refers to a clinical or AI-based assessment, not mechanical testing.

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

• No, this type of study was not done, as the document concerns a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic tool.

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

• Not applicable; this is not an AI device.

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

• The "ground truth" for the mechanical device's performance is established by ASTM F1717 standards for static and dynamic compression bending and static torsion.

8. The sample size for the training set:

• Not applicable; mechanical testing doesn't involve a "training set" in the context of AI/ML.

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

• Not applicable.

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The Libra Pedicle Screw System is intended for immobilization of the posterior thoracic, lumbar and sacral/iliac spine (TI-S1/Ilium) in skeletally mature patients as an adjunct to 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

The Libra Pedicle Screw System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document describes the FDA's clearance of the Libra Pedicle Screw System (K151770) based on substantial equivalence to predicate devices, rather than a study and acceptance criteria for a novel device's performance. Therefore, the requested information about device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not directly available in this text.

However, I can extract information related to the performance data provided for substantial equivalence and the acceptance criteria implicitly met through comparison with predicates.

Implicit Acceptance Criteria and Reported Device Performance (Table)

Since this is a 510(k) summary for a substantial equivalence determination for a medical device (pedicle screw system), the "study" is primarily focused on bench testing to demonstrate that the new device performs as safely and effectively as legally marketed predicate devices, not clinical studies with human performance metrics as one might see for AI/software devices. Therefore, many of your specific questions are not directly applicable or answerable from this document.

Here's an attempt to address your other points based on the provided text, acknowledging the nature of a 510(k) submission for a physical implantable device:

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

• Test Set Sample Size: The document does not specify the exact number of Libra Pedicle Screw System constructs tested for mechanical performance. It generally refers to "worst case Libra Pedicle Screw System constructs." For a 510(k) for a physical device, this typically involves a representative number of samples (e.g., typically 3 to 5 per test condition) to satisfy the standard (ASTM F1717). The specific number is usually detailed in the full 510(k) submission, not summarized at this level.
• Data Provenance: The data is from bench testing (mechanical testing), conducted by the manufacturer, Spinal Balance Inc., to evaluate the physical components of the device. It is not clinical data, and thus concepts like "country of origin of the data" or "retrospective/prospective" do not apply in the same way they would for clinical or AI data.

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

• Not applicable in this context. For mechanical bench testing, "ground truth" is established by the specifications and pass/fail criteria of the referenced ASTM standards (ASTM F1717). Engineers and technicians conduct the tests and determine if the results meet the criteria, comparing them against the performance of similar predicate devices. There isn't "expert adjudication" of test results in the sense of clinical image review for diagnostic accuracy.

4. Adjudication method for the test set

• Not applicable. See point 3. Testing against an industry standard (ASTM F1717) provides objective pass/fail criteria.

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 physical spinal implant, not an AI software. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this submission.

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

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

7. The type of ground truth used

• For mechanical testing, the "ground truth" is adherence to the performance standards and specifications outlined in ASTM F1717, and the comparative performance to predicate devices as demonstrated by their own cleared mechanical testing data. The goal is to show equivalent, safe, and effective mechanical properties.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense.

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

• Not applicable. See point 8.

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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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The Ti-TaMED Spinal System is intended for immobilization and stabilization of the spine as an adjunct to fusion for use in anterior, anterolateral, or posterior non-cervical pedicle and non-pedicle fixation for spinal conditions in skeletally mature patients with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Ti-TaMED Spinal System consists of a variety of rods, hooks, screws, cross connectors and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The System consists of four types of screws all manufactured out of Titanium (6A 1-4V ELI). 1. Poly Axial Screws: These screws have a poly axial articulation that allows angulations of the head in all directions, but once the cap or grub screw and ring are tightened the position becomes locked. 2. Rigid screws. The Ti-TaMED Spinal system consists of two different types of rods: Round both ends and Round and hexagonal ends. The Ti-TaMED Spinal system also consists of the following: Cross Connector and Hooks. The Ti-TaMED screws and rods may be used posteriorly or anteriorly to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or lumbar spine. The Ti-TaMED spinal implant components can be rigidly locked into a variety of configurations, with each case being tailor made for the individual. The Ti-TaMED hooks and cross connectors are intended for posterior only, where as all other components may be used anteriorly or posteriorly.

This document is a 510(k) summary for the Ti-TaMED Spinal System, a spinal fixation device. It describes the device, its components, indications for use, and declares substantial equivalence to predicate devices. It does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than performance study results against specific acceptance criteria.

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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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