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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 MOSS Miami Spinal System is intended for non-cervical use in the spine.

When used with ante ior screw fixation or posterior hook, non-pedicle screw fixation the MOSS Miami Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to turnor, 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 with pedicle screw fixation, the MOSS Miami Spinal System is intended for use in patients with severe spondylolisthesis (Grades 3 and 4) at the US-S1 vertebral joint, having fusions with antogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 and below), and for whom the device system is intended to be removed after the development of a solid fusion mass.

The MOSS MIAMI System is available in cither Stainless Steel or Titanium. The screws, polygial corect are available in Stainless Steel or Titanum. The screws, polyaxial screws, reduction screws, hooks, reduction hooks, transverse connectors, axial conrectors, staple washers and sacral extenders. The following screws, books, transwice organium: longitudinal rods, monoaxial screws, polyaxial screws, hooks, transverse connectors, axial connectors, washers, staple washers, and sacral extenders. The resign, intended use, and material of these components have been cleared in previous 51 3(k) submissions.

The line extension covered in this submission are additional screw components to the existing 5mm Stainless Steel and 5.5mm Titanium alloy versions of the MOSS Miami Spinal System. The additional screws consist of Stainless Steel and Titanium 5-7mm diameter polyaxial and monoaxial screws in 5mm increments to provide screws lengths from 25mm to 90mm The additional screws also consist of Titanium 8mm diameter monoaxial screws in imm increments to provide screws lengths from 25mm to 90mm, and the addition of Stainless Steel 8mm monoaxial and polyaxial and of Titanium 8mm polyaxial screws in 1-1 lengths from 25mm to 90mm in 5mm increments. Additionally, the intended uses of the 7mm monoaxial and polyaxial screws, which were previously cleared as part of the 5mm stainless steel version of this system, were expanded to include anterior use.

The provided text does not contain information about acceptance criteria, device performance, or a study specifically designed for the DePuy Motech MOSS Miami Spinal System. The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested table and study details.

Here's why and what information is available:

• Nature of the Document: This is a regulatory submission for premarket notification (510(k)), not a clinical trial report or a detailed engineering performance study. The 510(k) process in the US allows a manufacturer to market a device by demonstrating that it is "substantially equivalent" to a legally marketed predicate device, without requiring extensive new clinical studies if the equivalence is clear.
• Focus on Substantial Equivalence: The document explicitly states, "Based on the information provided, DePuy believes that the subject additional screws in the MOSS Miami Spinal Systems and the additional indication of non-cervical anterior use of the Stainless Striel 7mm monoaxial and polyaxial screws are substantially equivalent to other currently legally marketed spinal systems' screws."
• Device Description: The "DEVICE DESCRIPTION AND INTENDED USE" sections detail the components, materials (Stainless Steel or Titanium), available sizes (diameters 5-8mm, lengths 25-90mm), and indications for use.
• Predicate Devices: The document lists several "SUBSTANTIALLY EQUIVALENT DEVICES" (e.g., DePuy Motech MOSS Miami Spinal Systems K933881, K950697, etc., and AcroMed VSP & ISOLA). The equivalence is largely based on similar design, intended use, and materials to these cleared devices, as well as the addition of different screw lengths and diameter.
• FDA Response: The FDA letter confirms the substantial equivalence with specific limitations and warnings regarding pedicle screw use, particularly for severe spondylolisthesis at L5-S1 and the requirement for device removal after fusion. This indicates that while the device was cleared, the FDA imposed strict conditions based on the existing evidence and regulatory framework for pedicle screws at the time.

In summary, the document serves to establish regulatory clearance by demonstrating equivalence, not to present novel performance data against specific acceptance criteria for a new device.

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The Titanium MX Plate Based Low Back System is intended for use in Grade 3 and 4 spondylolisthesis at L5-S1, when affixed to the lumbosacral spine, utilizing autologous bone graft, and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The TiMX Plate Based Low Back System is a variation of the existing titanium alloy VSP Spinal System previously cleared under K944736. The TiMX Plate Based Low Back System is a construct that consists of pedicle and sacral screws, spine plates, nuts, washers and a transverse connector. This modified system provides increased pedicle screw strength, increased construct fatigue performance, increased construct stiffness, improved geometry and lower profile than its predecessor, the titanium alloy VSP Spinal System.

The document describes a medical device called the "TiMX Plate Based Low Back System" and its substantial equivalence to a previously cleared device. It is a 510(k) premarket notification, which assesses substantial equivalence to a predicate device rather than establishing new acceptance criteria and conducting studies to prove the device meets those criteria from scratch.

Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of typical AI/software device evaluation (e.g., sensitivity, specificity, F1-score) is not directly applicable to this type of medical device submission.

Instead, the document details performance data in comparison to its predicate device to demonstrate substantial equivalence.

Here's how to frame the information based on the provided text, focusing on the equivalence study presented:

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

Since this is a 510(k) demonstrating substantial equivalence, the "acceptance criteria" are implied to be that the new device (TiMX) is "generally superior or equivalent" to the predicate device (standard titanium VSP system) in terms of its mechanical performance.

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

• Sample Size: Not specified in terms of distinct units or number of tests conducted, but refers to "a full battery of testing" on "both the TiMX and standard titanium VSP systems." This implies testing on physical prototypes of the components and systems.
• Data Provenance: Not specified, but given it's a 510(k) submission in the US, the testing would typically be performed by the manufacturer or a certified lab, likely in the US, for regulatory submission to the FDA. The study is prospective in the sense that the testing was performed on the new device designs to gather data for the submission.

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

This is not applicable. The "ground truth" here is objective mechanical engineering measurements (e.g., torque, bending force, fatigue cycles) from physical testing, not expert interpretation of medical data. Therefore, no human experts as described are involved in establishing ground truth for mechanical testing.

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

Not applicable, as this is objective mechanical testing. The results would be quantitative measurements, not subjective evaluations requiring adjudication.

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 document describes a physical medical implant (spinal system), not an AI/software device that assists human readers.

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

Not applicable. This is not an algorithm or software. It is a physical device.

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

The "ground truth" for the performance claims is objective mechanical engineering measurements obtained from physical laboratory testing (e.g., static compression bending, static torsion, dynamic compression bending, torque to failure, endurance limit) comparing the new device components and system to the predicate device components and system.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set. The "training" in manufacturing comes from design iterations and engineering experience.

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

Not applicable, as there is no training set in the context of an AI/ML algorithm for this device.

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The AcroMed 4.75 mm Pedicle Screw is designed to be utilized with the VSP Spinal Fixation System. The VSP Spinal Fixation System is intended for use in grade 3 or 4 spondylolisthesis at LS-S1, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The AcroMed Pedicle Screw is composed of two sections: a long cancellous section with an integral fixed lower nut, and a machine threaded section topped with an hexagonal drive head. The integral nut serves two purposes: it creates a stronger bolt connection between the screw and plate and it eliminates the "claw hammer" effect associated with other screw designs. The upper surface of the integral nut is a transverse flat smooth surface to provide maximum contact area with the underside of the VSP spine plate.
The AcroMed Pedicle Screw is supplied with an adjustable tapered nut and an optional lock nut, which enables a pedicle screw and a slotted connector to be adjoined utilizing a locking nut system. The junction point of the adjustable integral nut and machine thread portion of the pedicle screw is also rounded to reduce potential stress concentration.
The screw is available in cancellous thread lengths from 25 mm to 50 mm, in 5 mm increments.
The AcroMed Pedicle Screw is manufactured from implant grade stainless steel conforming to ASTM F1314 specifications.

Here's an analysis of the provided text regarding acceptance criteria and study information for the AcroMed Pedicle Screw (4.75 mm):

The provided text ("K965102") describes a 510(k) summary for the AcroMed Pedicle Screw. However, it does not contain the detailed information requested regarding specific acceptance criteria, performance metrics (like sensitivity, specificity, AUC), study methodology, data provenance, ground truth establishment, or human reader studies.

The document is a regulatory submission demonstrating substantial equivalence to a previously cleared device, focusing on material, design, and intended use.

Here's a breakdown of what can be extracted and what is missing:

The core of the "Performance Data" section states: "Static and fatigue testing show the AcroMed pedicle screws (4.75 mm) to perform consistently with previously cleared components." This implies that the acceptance criteria for this device are met if its static and fatigue performance is consistent with a predicate device (cleared under K951116).

Here's the table based on the provided input, with many fields marked as "Not provided in the text" due to the nature of the document:

Summary of Missing Information and Why:

The provided document is a 510(k) summary for a physical medical device (pedicle screw). It primarily focuses on demonstrating "substantial equivalence" to a predicate device. For such devices, the performance data typically involves:

• Mechanical Testing: Static (e.g., yield strength, ultimate tensile strength) and fatigue (e.g., ability to withstand repeated loads without failure) tests.
• Biocompatibility Testing: Ensuring the material is safe for implantation.
• Sterilization Validation: Ensuring the device can be properly sterilized.

The questions you've asked (about sensitivity, specificity, AUC, expert consensus, MRMC studies, AI training sets, etc.) are highly relevant for diagnostic imaging devices or AI/CAD systems, which often involve interpreting medical images or data. They are not typically applicable to a device like a pedicle screw, where "performance" is measured in terms of mechanical integrity and biological compatibility.

To address your questions fully for this type of device, you would need to examine the full submission, which would include detailed test protocols, results, and standards referenced for the static and fatigue testing.

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