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The VerteGlide Spinal Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome for the following subset of patients:

• · Patients who may require serial magnetic resonance imaging;
• · Patients with small stature:

· Patients with low body weight, compromised tissue coverage adjacent to spinal implants, or increased risk of implant associated wound healing adverse events;

• · Patients at risk for implant prominence following surgery;
• · Patients with hyperkykyphotic spinal deformities; OR.

· Patients at elevated risk of cardiac arrest/sudden death from anesthesia associated with additional spinal surgery.

The VerteGlide Spinal Growth Guidance System is intended to be removed after skeletal maturity.

The VerteGlide Navigation Compatible Instruments are intended to be used during the preparation and placement of the VerteGlide Spinal Growth Guidance System screws. The VerteGlide Navigation Compatible Instruments have the option to be used with or without Medtronic StealthStation® System. Use of VerteGlide Navigation Compatible Instruments with Medtronic StealthStation® System during spinal surgery can assist the surgeon in precisely locating anatomical structures in the VerteGlide Spinal Growth Guidance System procedures. The Medtronic StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The VerteGlide Spinal Growth Guidance System consists of longitudinal members (rods), anchors (screws), and interconnection components (cross connector and rod clamp) in a variety of sizes to accommodate differing anatomic requirements. The VerteGlide Spinal Growth Guidance System also include surgical instruments.

The VerteGlide Spinal Growth Guidance System offers a solution for early-onset scoliosis (EOS) patients with potential for additional spinal growth. Fusion screws are used at the apex of the curve to rigidly lock the rod in place, while sliding (non-fusion) screws are used above and below the apex to stabilize but allow for continued growth. A unique rod design is used to provide rigid fixation of the fusion screws and further promote sliding of the non-fusion screws. Fixation to the bone is provided using standard fusion and non-fusion pedicle screws. While the non-fusion pedicle screws are rigidly fixed to the bone, they also allow for sliding along the rod axis during normal growth without requiring separate rod lengthening procedures. The VerteGlide Spinal Growth Guidance System allows for deformity correction and minimizes repeat surgeries needed until skeletal maturity.

The components of the VerteGlide Spinal Growth Guidance System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.

The provided text describes the VerteGlide Spinal Growth Guidance System, a medical device. However, it does not detail a study that proves the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with performance metrics like sensitivity, specificity, or accuracy in a diagnostic context).

The document is an FDA 510(k) clearance letter and a 510(k) Summary for a spinal growth guidance system. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a diagnostic or AI-driven system.

The "Performance Data" section primarily addresses biocompatibility, MR compatibility, and mechanical performance of the physical implant components. It states these aspects meet relevant ASTM and ISO standards, which serve as acceptance criteria for the hardware itself.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device and submission.

Here's a breakdown of what can be extracted and what cannot:

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

2. Sample size used for the test set and the data provenance: Not applicable. This was a physical device testing, not an algorithmic performance evaluation on a patient dataset. The "test set" would refer to the physical samples tested for mechanical strength, biocompatibility, etc., the details of which are not provided in this summary.

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 would be derived from physical measurements and standard testing protocols, not expert clinical interpretation of data.

4. Adjudication method for the test set: Not applicable.

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 or diagnostic imaging tool. The VerteGlide Navigation Compatible Instruments can be used with a Medtronic StealthStation® System, which is a navigation system, but the submission does not describe an MRMC study comparing human performance with and without this navigation assistance, nor is it the primary focus of the VerteGlide system's clearance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-only device.

7. The type of ground truth used:
* Biocompatibility: Conformance to ISO 10993-1 standards (chemical/biological assays).
* MR Compatibility: Physical measurements according to ASTM standards for heating, displacement, torque, and artifact generation.
* Mechanical Performance: Physical measurements (e.g., force, displacement, wear) against specified limits and comparison to predicate device performance.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the Study type:
The study described is a benchtop (in vitro) and material-based performance evaluation to demonstrate that the physical components of the VerteGlide Spinal Growth Guidance System are safe and perform as intended, and are substantially equivalent to a predicate device. This includes:

• Biocompatibility testing: To ensure the materials are not harmful to the body.
• MR Compatibility testing: To determine if the device is safe for use in an MRI environment.
• Mechanical performance testing: To ensure the device components have adequate strength, durability, and functional characteristics (like sliding mechanism) under simulated physiological loads and conditions.

The conclusion states that the data supports the differences between the subject and predicate devices and that the VerteGlide Spinal Growth Guidance System is substantially equivalent. A Post Market Surveillance Study (522 Order) will be issued to address potential safety concerns related to wear debris, indicating that some long-term clinical data will be collected after market entry.

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MARVEL™ Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth 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, as part of a growing rod construct.

MARVEL™ Growing Rods are posterior stabilization rods that can be surgically lengthened by manual mechanical actuation on a periodic basis as the patient grows. These rods are used as part of a growing rod construct consisting of MARVEL™ rods and screws, and are limited to a posterior approach. The rods include a tapered distal tip for a minimally invasive surgical approach. MARVEL ™ Growing Rods are manufactured from titanium alloy and PEEK.

The provided text describes a medical device submission (K213196) for MARVEL™ Growing Rods. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format you requested for an AI/algorithm-based device.

Therefore, the information required to answer your specific questions about acceptance criteria, study data, ground truth, and expert involvement for an AI medical device cannot be found in this document.

This document describes a physical medical device (growing rods for spinal deformities) and primarily relies on mechanical performance testing and material biocompatibility to demonstrate substantial equivalence, not the performance of an AI algorithm.

To explicitly answer your points:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical performance tests (static and dynamic compression bending, static component torsion) in accordance with ASTM F1717 and ASTM F543, and bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011. It states "Performance data demonstrate substantial equivalence to the predicate devices" but does not provide specific numerical acceptance criteria or reported performance values for these tests.
2. Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical rods, not a test set for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are not relevant for the mechanical testing of a physical device.
4. Adjudication method: Not applicable.
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 not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Daytona® Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth 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 extended axial connectors may be used with any cleared Daytona® Small Stature Spinal System rod construct. The Daytona® Small Stature Growth Rod Conversion Set is not intended to be used in coniunction with staples.

The Daytona® Small Stature Growth Rod Conversion Set is a non-cervical spinal device intended to convert a traditional fusion construct into a non-fusion, growth- enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The system consists of single-use extended axial connectors designed to interact with constructs consisting of hooks, screws, connectors, and rods. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

This appears to be a 510(k) summary for a medical device (Daytona® Small Stature Growth Rod Conversion Set). Based on the provided text, the submission does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria based on performance data.

Instead, the submission relies on a demonstration of substantial equivalence to an already legally marketed predicate device (Xia® Growth Rod Conversion Set, K142114) through non-clinical mechanical testing.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is explicitly stated as "Not applicable" for clinical testing in the provided document.

Here's a breakdown of why based on the text:

• "Non-Clinical Testing: The Daytona® Small Stature Growth Rod Conversion Set demonstrated similar mechanical performance to the predicate system based on mechanical testing per ASTM F1798." This indicates that the device's performance was compared to the predicate through mechanical tests, not clinical efficacy or diagnostic accuracy.
• "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." This explicitly states that clinical performance data (which would typically involve patient outcomes, diagnostic accuracy, or human-in-the-loop studies related to AI/algorithm performance) was not used for this submission.

The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are highly relevant for AI/Machine Learning device submissions where performance is assessed against clinical ground truth. This document pertains to a mechanical implant device where substantial equivalence is demonstrated through engineering and mechanical testing standards.

Therefore, many of your specific points for requested information (1-9) are not applicable to the content provided.

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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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In-Line Connector Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth 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, as part of a growing rod construct.

CREO® Stabilization System: In-Line Connector Growing Rods consist of rod-to-rod connectors which can be surgically lengthened on a periodic basis as the patient grows. These connectors may be used as part of a growing rod construct consisting of rods, screws, hooks, offset connectors, and cross-connectors, and are limited to a posterior approach. When used as part of a growing rod system, In-Line Connector Growing Rods are intended for use only with CREO® Stabilization System fusion constructs cleared for pediatric use. In-Line Connector Growing Rods are manufactured from titanium alloy.

REVERE® Stabilization System: In-Line Connector Growing Rods consist of rod-to-rod connectors which can be surgically lengthened on a periodic basis as the patient grows. These connectors may be used as part of a growing rod construct consisting of rods, screws, hooks, offset connectors, and cross-connectors, and are limited to a posterior approach. When used as part of a growing rod system, In-Line Connector Growing Rods are intended for use only with REVERE® Stabilization System fusion constructs cleared for pediatric use. In-Line Connector Growing Rods are manufactured from titanium alloy.

The provided documents are a 510(k) summary and FDA clearance letters for the CREO® Stabilization System and REVERE® Stabilization System. These documents pertain to medical devices, specifically stabilization systems for spinal deformities, not AI/ML-driven diagnostic or prognostic tools. Therefore, much of the requested information about acceptance criteria, study design for AI performance, expert adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment, which are typical for AI/ML device evaluations, is not applicable to this submission.

The FDA clearance is based on the substantial equivalence of the devices to legally marketed predicate devices, not on a study proving the device meets specific acceptance criteria in the context of AI/ML performance metrics (like sensitivity, specificity, AUC).

Here's a breakdown of the applicable information:

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

Since this is a substantial equivalence submission for medical devices (spinal stabilization systems) and not an AI/ML diagnostic tool, traditional performance metrics like sensitivity, specificity, or AUC with predefined acceptance criteria are not provided. The "performance" is demonstrated by showing that the technological characteristics and intended use are substantially equivalent to existing, legally marketed predicate devices.

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

Not applicable. This submission is for substantial equivalence of a physical medical device. It does not involve a "test set" in the context of evaluating an AI/ML algorithm's performance on a dataset. The "data" provenance mentioned is a "clinical literature review."

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

Not applicable. There was no "ground truth" to establish for a test set in the context of AI/ML performance. The review of clinical literature would have been performed by the manufacturer's regulatory and clinical affairs team to support their claims of safety and equivalence.

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

Not applicable. There was no "test set" requiring adjudication for AI/ML performance.

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-assisted device.

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

Not applicable. This is not an AI algorithm.

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

Not applicable in the context of AI/ML. The "ground truth" for this medical device submission is the established safety and effectiveness of the predicate devices and the scientific and engineering principles demonstrating the equivalence of the new device. The submission mentions a "clinical literature review" which would draw from published studies, which in turn might report on pathology, outcomes data, or expert clinical observations for the predicate and similar devices.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set for which a ground truth needs to be established.

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The Polaris Spinal Growth System is indicated in patients with potential growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome.

The Polaris Spinal Growth System may be used with any cleared traditional Polaris Spinal System construct, including any cleared Polaris Spinal System compatibilities.

The Polaris Spinal Growth System is a non-cervical spinal fixation device made from titanium alloy (Ti-6Al-4V) per ASTM F136 and Cobalt Chrome Alloy (Co-28Cr-6Mo) per ASTM F1537. The system is comprised of Growth Connectors which are intended to be used with the Polaris Spinal System implants and instruments. The design and size offerings of the Polaris Spinal Growth System connectors are identical to those currently available in the Polaris Spinal System but are indicated for growth rod constructs. These growth rod constructs typically require repeated plannedlengthening procedures until a determination is made that the patient is ready for a final fusion procedure. After the spine is fused, these devices serve no functional purpose and may be removed.

The provided text describes a 510(k) submission for a medical device called the "Polaris Spinal Growth System." This submission is a declaration of substantial equivalence to a predicate device, as opposed to a new device requiring extensive clinical trials and complex acceptance criteria for AI/Software-as-a-Medical-Device (SaMD) performance.

The document primarily focuses on mechanical testing to demonstrate that the Polaris Spinal Growth System performs as intended and is substantially equivalent to existing, legally marketed devices. It does not contain information relevant to AI/SaMD performance, such as:

• Acceptance criteria for an algorithm's diagnostic or therapeutic performance. The device is a physical implant, not a software algorithm.
• Study design for evaluating algorithm performance (test sets, ground truth, expert review, MRMC studies).
• Sample sizes for training sets for machine learning models.
• Effect size for human reader improvement with AI assistance.

Therefore, I cannot extract the information required to answer your prompt in detail. The available information relates to the acceptance criteria for the mechanical performance of a physical implant, not the performance of an AI/SaMD.

Here's what I can provide based on the document, focusing on the mechanical performance. Please note that this is not related to AI/SaMD and will not fill all requested fields:

Acceptance Criteria and Device Performance (for Mechanical Properties):

Study Details (for Mechanical Testing):

• Sample size used for the test set and data provenance: The document states "mechanical testing of the Polaris Spinal Growth System constructs were assessed and tested." It does not specify the exact number of constructs tested (sample size) or where these tests were physically performed (data provenance in terms of country of origin). It is not a clinical study with retrospective/prospective human data.
• Number of experts used to establish ground truth: Not applicable. Ground truth for mechanical testing is based on engineered specifications and standardized test methods (ASTM F1717, ASTM F1798).
• Adjudication method: Not applicable. Mechanical tests have objective, measurable outcomes.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not a study assessing human readers or AI assistance.
• Standalone (algorithm only) performance: Not applicable. This device is a physical implant.
• Type of ground truth used: Engineering standards (ASTM F1717, ASTM F1798) for mechanical properties.
• Sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance for a traditional medical device (spinal implant) based on mechanical testing and substantial equivalence, not an AI/SaMD. As such, it does not contain the information requested in your prompt regarding AI/SaMD performance evaluation.

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The NuVasive Growth Rod Conversion Set is indicated in 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 growth rod conversion implants may be used with Armada, Reline 4.5-5.0 rod constructs ranging in diameter from 4.5mm to 6.35mm. The NuVasive Growth Rod Conversion Set is not intended to be used in conjunction with staples.

The NuVasive Growth Rod Conversion Set consists of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. Implant components are available in a variety sizes and can be rigidly locked into a variety of different rod diameters. The devices are manufactured from biocompatible medical grade titanium alloy.

The provided text is a 510(k) summary for a medical device (NuVasive® Growth Rod Conversion Set). It details the device's intended use, technological characteristics, and a comparison to predicate devices, but does not contain information regarding
acceptance criteria, specific performance claims (e.g., accuracy, sensitivity, specificity), or the details of a clinical study with human readers, ground truth establishment, or statistical analysis.

The document states:

• "No additional testing was provided to support usage for the non-fusion indication." (Page 5, Section G. Performance Data)
• "Testing previously performed for Reline System (K143684) and Reline 4.5-5.0 System (K170126) to support fusion applications included subject devices. Comparison to predicate devices indicated for growth rod conversion was performed." (Page 5, Section G. Performance Data)

This indicates that the submission relied on existing testing data for other devices (Reline System and Reline 4.5-5.0 System) that included components similar to the subject device, and a comparison to predicate devices. It does not describe a specific study conducted to prove the current device meets acceptance criteria in the way one might expect for a diagnostic or AI-powered device (e.g., performance metrics, clinical reader studies).

Therefore, it is not possible to provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, or MRMC studies based on the provided text. The device's substantial equivalence relies on demonstrating similar technological characteristics and intended use to existing predicate devices, rather than a new clinical performance study for this specific device clearance.

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The K2M Growing Spine System implants are indicated in 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 Growth Guidance implants may be used with any cleared K2M rod construct ranging in diameter 4.5mm to 6.35mm. The Growth Rod Conversion implants may be used with 4.5mm and 5.5mm rod constructs. The K2M Growing Spine System is not intended to be used in conjunction with staples.

The K2M Growing Spine System consists of screw and connector components. The purpose of this 510(k) is to enable these system components to be used as part of a growing rod construct.

Function: When used as part of a growing rod construct, the system implants are designed to accommodate growth in patients under 10 years of age.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study proving it, or the other requested details such as sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification letter from the FDA regarding the K2M Growing Spine System, indicating its substantial equivalence to predicate devices and detailing its intended use. It does not include specific performance metrics, studies, or clinical trial data in the format you've requested.

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The CD HORIZON® Growth Rod Conversion Set is indicated in 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 CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods, SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

The CD HORIZON® Growth Rod Conversion Set consists of a variety of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct which can be surgically lengthened on a periodic basis as the patient grows. The CD HORIZON® Growth Rod Conversion Set components are manufactured from stainless steel or titanium alloy and are designed to interact with rod-based pedicle screw/hook constructs in which the rods range in diameter from 3.5mm to 5.5mm. The CD HORIZON® Growth Rod Conversion Set is specifically to be used with any traditional CD HORIZON® Spinal System (3.5mm) fusion construct cleared for pediatric usage. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods, SPIRE® Spinous Process Plates and/or Shape Memory Alloy (SMA) Staples. The CD HORIZON® Growth Rod Conversion Set is limited to a posterior approach. The CD HORIZON® Growth Rod Conversion Set connectors are provided in both sterile and non-sterile form. The sterile implants are sterilized via gamma irradiation.

This device is a CD HORIZON® Growth Rod Conversion Set and the 510(k) summary (K150200) describes a submission to add sterile connectors and set screws to the existing device, utilizing gamma irradiation and sterile packaging. This submission is about a modification to an existing medical device, specifically regarding its packaging and sterilization process, rather than a new device with performance metrics related to diagnostic accuracy or clinical outcomes. Therefore, the standard elements for performance criteria and a study proving those criteria (as might be expected for an AI/ML device or a device with clinical efficacy claims) are not applicable in the usual sense.

However, I can extract the relevant information regarding the "acceptance criteria" and the "study" that proves the device meets them, reinterpreting these terms in the context of this specific 510(k) submission.

Acceptance Criteria and Device Performance (in the context of sterilization and packaging):

Study Information (reinterpreted for sterilization and packaging validation):

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

   • Test Set Sample Size: The document does not specify a "sample size" for a clinical or performance test set in the traditional sense, as this submission is focused on sterilization and packaging validation. Instead, the "testing" involved adherence to established standards and protocols for manufacturing, sterilization, and packaging. These standards (e.g., ISO, ASTM) would have their own sample size requirements for their validation methods, but these are not enumerated here.
   • Data Provenance: The data is based on adherence to international and US standards for medical device manufacturing, materials, sterilization, and packaging. This is generally laboratory-based testing conducted by the manufacturer or contracted labs, rather than data from specific countries or retrospective/prospective studies on patient populations.

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

   • Not applicable in the context of this specific submission. The "ground truth" here is adherence to established engineering, materials science, and sterilization standards, validated by standard test methods rather than expert consensus on clinical data. The FDA reviewers are experts in regulatory compliance and relevant scientific fields.

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

   • Not applicable. This is not a study requiring adjudication of expert interpretations.

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

   • Not applicable. This is a spinal implant component, not an AI/ML device.

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

   • Not applicable. This is not an algorithm.

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

   • The "ground truth" is adherence to validated engineering standards and material specifications (ASTM F136, ASTM F138, ISO 11137, ASTM D4169, ASTM F88, ASTM F1929) for material composition, sterilization efficacy, and packaging integrity. The primary "ground truth" for the overall submission is demonstrating substantial equivalence to a previously cleared predicate device (K133904) based on these technical considerations.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device and does not involve a training set.

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

   • Not applicable.

Summary of the study/evidence presented:

The "study" in this context refers to the engineering and validation documentation provided by Medtronic Sofamor Danek USA, Incorporated to demonstrate that the changes (sterile connectors with pre-loaded set screws and gamma irradiation sterilization) to the CD HORIZON® Growth Rod Conversion Set do not alter its fundamental scientific technology or safety and effectiveness compared to the predicate device.

The evidence relies on:

• Material Equivalence: Stating that the materials (stainless steel per ASTM F138 or titanium alloy per ASTM F136) are identical to those in the predicate device and have a long history of safe clinical use.
• Design Equivalence: Confirming that no design changes were made to the implants themselves.
• Sterilization Validation: Referring to compliance with ISO 11137-1 and ISO 11137-2 for gamma irradiation.
• Packaging Validation: Referring to compliance with ASTM F88/F88M, ASTM D4169, and ASTM F1929 for seal strength, shipping, and leak detection.
• Risk Analysis: Performed to support the claim that the modified device does not represent a new worst case.

The conclusion is that, based on this documentation and adherence to standards, the modified device is substantially equivalent to the predicate device due to identical design, materials, method of implantation, and intended use, with only the sterilization and packaging method being updated.

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The Xia® Growth Rod Conversion Set is indicated in 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 Xia® Growth Rod Conversion Set may be used with any cleared Xia® 4.5 Spinal System rod construct. The Xia® Growth Rod Conversion Set is not intended for use in conjunction with staples.

The Xia® Growth Rod Conversion Set consists of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The Xia® Growth Rod Conversion Set components are manufactured from titanium alloy and are designed to interact with constructs consisting of hooks, screws, connectors, and 4.5mm diameter rods. The Xia® Growth Rod Conversion Set is intended for use only with Xia® 4.5 Spinal System fusion constructs cleared for pediatric use.

The provided text describes the Xia® Growth Rod Conversion Set, a medical device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity for an AI-powered device).

This document is a 510(k) premarket notification for a medical device (Xia® Growth Rod Conversion Set), which primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the "Summary of the Performance Data" section (Page 4, Table "510(k) Summary") states:
"Engineering analysis demonstrated that introduction of the Growth Rod Conversion Set does not adversely affect performance of the Xia® 4.5 Spinal System and does not represent a new, worst case scenario. No additional performance data was provided."

This indicates that the "study" conducted was an engineering analysis to ensure the new component does not negatively impact the performance of an existing, cleared system, rather than a clinical study evaluating diagnostic accuracy or a specific set of performance metrics against acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text. The document is about a different type of medical device review process (510(k) for a physical implantable device) that relies on substantial equivalence and engineering analysis, not diagnostic performance metrics or human reader studies.

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