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Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine 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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Fenestrated Screw System: Fenestrated Screw System: When used in conjunction with the listed compatible bone cements the OLYMPIC Fenestrated spinal implants are intended to restore 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 fusion. The OLYMPIC Fenestrated Screws augmented with the listed compatible bone cements are limited to use in spinal levels where the structural integrity of the spine is not severely compromised. Compatible bone cements include G21 V-STEADY, G21 V-FAST, Teknimed F20, and Teknimed HIGH V+.

Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine 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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

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

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

Fenestrated Screw System: Fenestrated Screw System: When used in conjunction with the listed compatible bone cements the OLYMPIC Fenestrated spinal implants are intended to restore 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 fusion. The OLYMPIC Fenestrated Screws augmented with the listed compatible bone cements are limited to use in spinal levels where the structural integrity of the spine is not severely compromised. Compatible bone cements include G21 V-STEADY, G21 V-FAST, Teknimed F20, and Teknimed HIGH V+.

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system.

The MASADA Modular Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of modular polyaxial screws, and rods. The system is supported by a comprehensive set of instruments to install the implants within the system for percutaneous and minimally invasive access. All implant components are manufactured from the materials listed in the table below.

Materials: Ti-6Al-4V ELI (ASTM F136), CP Titanium Grade 4 (ASTM F67), CoCrMo Alloy (ASTM F1537), Elgiloy CoCrNi Alloy (ASTM F1058), Nitinol #1 (ASTM F2063)

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The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications for use.

The CD Horizon™ LigaMAS Head Assembly used with the LigaPASS™ Spinal System is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma, used in sublaminar, or facet wiring techniques
• Spinal reconstruction surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and kyphosis;
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5 to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. Components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD Horizon™ Spinal System in non-pediatric cases. These components include TSRH™ rods, hooks, screws, plates, Crosslink™ plates, connectors, staples, and washers, GDLH™ rods, hooks, connectors, and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws.

Note: certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ hooks are intended for posterior use only. CD Horizon™ staples and CD Horizon™ Eclipse™ rods and associated screws are intended for anterior use only. However, for patients of smaller stature and pediatric patients, CD Horizon™ 4.5mm rods and associated components may be used posteriorly.

CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobalt-chromium-molybdenum alloy, or medical grade PEEK Optima-LT1. Certain CD Horizon™ Spinal System components may be coated with hydroxyapatite. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. The CD Horizon™ Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column. To achieve best results, do not use CD Horizon™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

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Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine 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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• Spinal trauma surgery, used in sublaminar or facet wiring techniques.
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
• Spinal degenerative surgery, as an adjunct to spinal fusions.

The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

S2AI Screws: The OLYMPIC Posterior Spinal Fixation System S2AI Screw System is intended for sacroiliac joint fusion for the following conditions:

• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

When connected to OLYMPIC posterior rods the OLYMPIC S2AI Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine 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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

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

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

S2AI Screws: The MASADA Modular Spinal Fixation System S2AI Screw System is intended for sacroiliac joint fusion for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
• To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

When connected to MASADA posterior rods the MASADA S2AI Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
• Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal stenosis
• Deformities or curvatures (i.e., scoliosis, kypohosis, and/or lordosis)
• Spinal tumor
• Pseudarthrosis
• Failed previous fusion

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system.

The MASADA Modular Spinal Fixation System S2AI Screw System consist of an assortment of implants in various lengths and diameters, and associated instrument sets for both Open and minimally invasive (MIS) approaches. The S2AI bone screw implant component made from Titanium alloy (Ti-6Al-4V-ELI) as described by ASTM F136. It is intended to provide sacroiliac joint fusion in the sacral alar iliac (SAI) trajectory (when used with commercially available sacroiliac joint fusion promoting devices), and provide foundational stabilization when connected to pedicle screw fixation systems in both the SAI and the Iliac trajectories. Additionally, the MASADA S2AI Screw System can be placed into the S1 pedicle. It is designed for connection to the MASADA Pedicle Screw System 5.5mm or 6.0mm diameter titanium alloy or cobalt chrome alloy spinal fixation rods.

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Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:

• Sternotomy indications including the "rewiring" of osteomized sternums;
• Repair of long bone fractures due to trauma or reconstruction.

Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries for internal fixation of discontinued bone structures. The product are not to be used in conjunction with other bone fixation implants, like plates. The surgical sutures and tapes are made of UHMWPE (ultra-high molecular weight polyethylene), the needles are made in AISI300 steel series, according to the standard ASTM F899 and cerclage is assembled on an ABS loader, additional instruments may be used as well. Those materials are identical to those used in other cleared GMReis devices like the reference device cleared under K223114. It is provided in sterile condition sterilized by Ethylene Oxide.

Based on the provided FDA 510(k) clearance letter for the Stitch Cerclage - Suture System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is an FDA 510(k) clearance letter, which means the device has already been cleared. This letter summarizes the regulatory decision and mentions that studies were performed, but it does not contain the detailed study protocols, results, or data itself. Therefore, I will extract all available information and explicitly state when information is not present in this document.

Acceptance Criteria and Device Performance Study Summary

The acceptance criteria for this device are largely implied through the comparison to a predicate device and the successful completion of specified mechanical tests. The performance study focused on demonstrating substantial equivalence to the predicate device, particularly in mechanical properties relevant to its intended use as a bone fixation cerclage.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens, number of cycles for fatigue) used for the mechanical testing. It mentions "chemical composition, creep test, tension static and fatigue tests."
• Data Provenance: The studies were conducted by the manufacturer, GM Dos Reis Industria e Comercio Ltda, which is based in Campinas, Brazil. The data is based on mechanical testing, not clinical data, and therefore is not characterized as retrospective or prospective in the usual clinical sense. It's laboratory-based performance data.

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

• For this type of mechanical device clearance, "ground truth" is established through engineering standards, validated test methodologies, and comparison to the known performance of predicate devices.
• The document does not mention the use of human experts (like radiologists) for "ground truth" establishment as would be common for AI/imaging device clearances. The "experts" involved would be engineering and quality control personnel at the manufacturer and potentially external testing laboratories, ensuring compliance with test methodologies.

4. Adjudication Method for the Test Set

• Since this is a mechanical device performance study, no explicit "adjudication method" in the sense of clinician consensus on medical images is applicable or mentioned. The "adjudication" is inherent in the adherence to established mechanical testing protocols and statistical analysis of the results to demonstrate equivalence to the predicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This type of study is specifically relevant for imaging devices or AI algorithms where human readers' performance is being evaluated or augmented. The Stitch Cerclage Suture System is a physical medical device, not an imaging or AI diagnosis system.
• The document explicitly states: "No clinical data were included in this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. This concept pertains to AI algorithms. The Stitch Cerclage Suture System is a physical product and does not have an "algorithm-only" performance component.

7. Type of Ground Truth Used

• The "ground truth" for this device type is established through objective, quantifiable mechanical properties and material composition, compared against established industry standards (where available) or the performance of a legally marketed predicate device.
• Specifically, the study compared "chemical composition, creep test, tension static and fatigue tests" to information from a published article ("Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022)) and to the predicate device.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal validation and verification activities, but this is distinct from training an AI model.

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

• Not applicable. As there is no AI "training set," there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is derived from engineering principles, relevant material standards (e.g., ASTM F899 for steel), and performance expectations set by the predicate device.

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The Humeral Plating System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The Cerclage Button is intended for use with the humeral plating system and FiberTape® cerclage suture, to augment fracture stabilization with humeral plates in long bone fixation. The cerclage button is designed for use with the humeral plating system and may not be used alone.

The Arthrex Humeral Plating and Cerclage Button consist of straight humeral plates and a 3.5 threaded cerclage button for use in the repair of proximal humerus fractures. The devices are provided sterile (gamma) and non-sterile, for single use. The proposed plates range in length from 90.5 - 309 mm and include suture holes for soft tissue refixation. The proposed devices are manufactured from titanium alloy conforming to ASTM F136. The proposed devices are compatible with Arthrex 3.5 mm screws (K241592 and K203294) and Arthrex 4.0 mm screws (K150456, K143614, and K103705).

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria, as typically found in submissions for AI/ML-based medical devices. The document describes a traditional 510(k) premarket notification for a Class II metallic bone fixation appliance (Arthrex Humeral Plating System and Cerclage Button).

The "Performance Data" section mentions mechanical testing (4-point bend, MRI compatibility) and bacterial endotoxin testing, which are standard for orthopedic implants to demonstrate engineering performance and biocompatibility compared to predicate devices. However, this is not a study proving an AI/ML device meets clinical acceptance criteria.

Therefore, I cannot extract the information required to populate the fields you listed, such as sample size, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device described in this document.

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Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
• · Sternotomy indications including the "rewiring" of osteomized sternums
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
• · Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
• · Repair of long bone fractures due to trauma or reconstruction
• · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
• · Spinal applications including sublaminar and intrafacet wiring of the spinal column

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only.

The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex FiberTape and TigerTape Cerclage Sutures and Arthrex Radiopaque FiberTape Cerclage Sutures:

Device: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

The provided document is a 510(k) Premarket Notification summary, indicating a submission to expand and align the indications for the Arthrex Radiopaque FiberTape Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage Sutures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the available text, the study presented focuses on demonstrating mechanical equivalence and biocompatibility, not clinical performance with human-in-the-loop for diagnostic accuracy. Therefore, several of the requested sections (e.g., MRMC studies, expert qualifications, adjudication methods, training set details) are not applicable or cannot be extracted from this document, as they pertain to AI/diagnostic device performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and biocompatibility testing, not a clinical study on patient data.

• Mechanical Testing: The sample size for dynamic tensile fatigue testing is not explicitly stated in terms of the number of sutures tested, only the duration/cycles (5 million cycles). The provenance of the "test set" (i.e., the sutures themselves) would be from the manufacturer (Arthrex Inc.).
• Biocompatibility (Bacterial Endotoxin): The sample size for this testing is also not explicitly stated (e.g., how many units were tested), only the method.

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

Not applicable. This device is a surgical suture, not a diagnostic device requiring expert interpretation of results to establish ground truth from a test set. The validation relies on engineering and biological testing standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of diagnostic interpretation 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 device is a surgical suture, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance: The "ground truth" is defined by established engineering standards for suture performance (e.g., ability to withstand 5 million fatigue cycles) and substantial equivalence to predicate devices with a known safety and effectiveness profile. This is typically determined by physical measurements and adherence to pre-defined mechanical property specifications.
• Biocompatibility/Pyrogenicity: The ground truth is defined by established biological safety standards (e.g., EP 2.6.14/USP <85> pyrogen limits) to ensure the device does not cause adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, no AI model or training set is applicable here.

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Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine 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, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

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

Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which 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 a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.

Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The MASADA Modular Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion. The system is composed of modular polyaxial screws, monoaxial screws, rods, cross connectors, rod connectors, sublaminar band cerclages, band connectors, and hooks. The system is supported by a comprehensive set of instruments to install the implants within the system. All implant components are manufactured from the materials listed in the table below.

The provided text is an FDA 510(k) clearance letter for a medical device called the "MASADA Modular Spinal Fixation System." This document is a regulatory approval, not a scientific study report describing the performance of an AI/ML device. Therefore, it does not contain the information requested regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML system.

The "Non-clinical Test Summary" explicitly states: "An engineering analysis determined that no new worst case conditions have been introduced since the previously cleared submission (K231694)." and the "Clinical Test Summary" explicitly states: "No clinical studies were performed."

This means the clearance was based on substantial equivalence to predicate devices through design, materials, and engineering analysis, rather than new performance data from a clinical or AI/ML-specific study.

Therefore, I cannot provide the requested table and details about acceptance criteria and study findings for an AI/ML device based on the given input.

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The Mbrace Cable is designed as a cerclage system for long bones and to reattach the greater trochanter in case of fractures or osteotomies. The device is intended for long-term implantation inside the human body for single use only. The Mbrace Cable is not intended for use as a suture cable in soft tissue approximation and/or ligation.

The Mbrace cable is an implantable flexible braided cable made of UHMWPE and designed as a cerclage bone system. The Mbrace cable is provided individually packed, sterile and single-use.

Here's a breakdown of the acceptance criteria and study information based on the provided text, categorized as requested. It's important to note that the document primarily describes the non-clinical performance testing conducted to demonstrate substantial equivalence, rather than a clinical effectiveness study with human subjects.

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

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes performance tests conducted and the general outcomes. The acceptance criteria can be inferred from the stated goals of the tests.

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 for Test Set: The document does not specify the exact number of devices or test samples used for the quasi-static load, dynamic resistance, pyrogenicity, or biocompatibility tests. It only mentions that the tests were conducted. For the Design Validation, it states "sawbone workshop," implying physical models were used, but the quantity of models or devices tested within the workshop is not detailed.
• Data Provenance: Not explicitly stated. The manufacturer, Medacta International SA, is located in Switzerland, but the location where the tests were performed or the origin of any raw data used in validation is not mentioned. Given these are non-clinical hardware tests, "retrospective or prospective" doesn't directly apply in the same way it would to clinical patient data. The tests are prospective in the sense that they were planned and executed to support 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)

Not applicable. This device is a bone fixation cable, and the performance data presented is from non-clinical mechanical, material, and sterilization tests. The "ground truth" for these types of tests is established by industry standards, engineering principles, and validated test methods, rather than expert consensus on medical images or patient outcomes. The "sawbone workshop" likely involved surgical or biomechanical experts, but their number and specific qualifications are not detailed.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where multiple human readers interpret data to establish a ground truth or resolve discrepancies. These methods are not relevant for the non-clinical hardware validation tests described.

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 is a medical device (bone fixation cable), not an AI/CAD system. Therefore, an MRMC study or AI assistance evaluation is not relevant or applicable.

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

Not applicable. This is a medical device, not a software algorithm.

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

For the non-clinical tests described:

• Mechanical Performance: Ground truth derived from established engineering and biomechanical principles, material science, and relevant ISO/ASTM standards (implied, though not explicitly cited beyond "written protocols"). The predicate device's performance often serves as a benchmark for comparison.
• Biocompatibility: Ground truth from established biocompatibility standards (e.g., ISO 10993 series, though not explicitly cited).
• Pyrogenicity/Sterilization: Ground truth from pharmacopoeial standards (European Pharmacopoeia §2.6.14, USP <85>, USP <151>).

8. The sample size for the training set

Not applicable. This is a medical device for which non-clinical performance data is provided, not an AI or machine learning model 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 this type of device.

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DALL-MILES Cable System
The DALL-Miles System is indicated for reattachment of the trochanter in any hip procedure using the trochanteric osteotomy (total or partial) approach.
The DALL-MILES Mini Cleat is indicated for vertical reattachment or reinforcement of the trochanter in any situation where the surgeon feels that the trochanter is at risk for detachment. The Mini Cleat is intended for use with the DALL-MILES System for trochanteric reattachment only.
The DALL-MILES Cables and Cable Sleeves are indicated for trochanteric reattachment and trauma surgery of the hip; to stabilize bone graft material; and for supplementary cerclage fixation with plates and screws for fracture fixation.
The DALL-MILES Trochanteric Grips and Grip Plates are indicated for use in the fixation of the greater trochanter due to trochanteric fracture or osteotomy with intramedullary fixation as the primary device.
The DALL-MILES Trochanteric Grip Plate is additionally indicated for use in the fixation of the greater trochanter due to extended trochanteric osteotomies.

Femoral Heads
The indications for use for total hip and hemi hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Femoral Mesh
The indications for use for total hip and hemi hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   Surgical Mesh. Surgical Mesh is intended to be used to reinforce bone or tissue in any situation where additional strengthening and support is required due to poor bone/tissue quality.

Intramedullary Plug, Centralizer
The indications for use of total hip replacement prostheses include:
· noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
· rheumatoid arthritis;
· correction of functional deformity;
· revision procedures where other treatments or devices have failed; and,
· treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The EXETER Centralizer is intended to be used to centralize the femoral stem within the intramedullary canal and is intended to be used with bone cement.
The EXETER 2.5mm Intramedullary Bone Plug is intended to be used to restrict the migration of bone cement down the femoral canal and permit cement pressurization during total hip arthroplasty and is intended to be used with bone cement.

Exeter X3 RimFit Cups
The indications for use for total hip arthroplasty include:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.
   The Exeter X3 RimFit Cup is intended for cemented use only.

Femoral Stems
The indications for use for total hip and hemi hip arthroplasty include:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   The Exeter V40 Femoral Stem is intended for use in total or hemi hip replacement. It is intended for cemented use only.

The devices covered by this bundled submission are Stryker Total Hip Systems which include Dall-Miles cable system components, femoral heads, femoral mesh, Intramedullary Plug, Centralizer, acetabular cups, and femoral stems. All devices are commercially available and have been cleared in prior 510(k) submissions.

This FDA 510(k) letter and summary (K240418) is for a "Stryker Orthopaedics Hip Systems Labeling Update." This submission is not for a new medical device or an AI/software device that requires performance evaluation. Instead, it is a "Change Being Effected" bundled submission to add a contraindication to the labeling of existing, already cleared Stryker Orthopaedics Hip Systems.

Therefore, the provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It explicitly states under "Non-Clinical Testing" and "Clinical Testing" that these were not required as a basis for substantial equivalence because the technological characteristics of the subject devices are identical to those of the predicate devices.

In summary, the request for information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not applicable to this document, as it pertains to a labeling update for previously cleared devices, not a new device or a device requiring new performance data.

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The Smith & Nephew ACCORD Cable System is indicated for use in general orthopaedic repair procedures including general cerclage of the femur, trochanteric reattachment, fixation of fractures in conjunction with intramedullary prosthesis (i.e., femoral stem) and screw fixation techniques.

The ACCORD Cable System includes cables (with or without clamps), trochanteric grips, and plates. (K223762).
The Smith & Nephew ACCORD Cable System consists of Cobalt Chrome cables (without clamps) to be used with the ACCORD Titanium trochanteric grips or ACCORD Titanium plates and also Stainless Steel and Cobalt Chrome cables with clamps to be used alone. These materials are identical to the material that has been previously cleared in K223762, K031162, and K993106.
The implants within this system are single-use and are Gamma sterilized.

The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the Smith & Nephew ACCORD Cable System. It does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Instead, this submission is for labeling updates to an existing, previously cleared medical device (ACCORD Cable System). The core assertion is that there are no significant changes in design, technological characteristics, function, sterilization, or packaging as a result of these labeling updates. Therefore, no performance testing (bench, animal, clinical) was required for this specific 510(k) submission (K233949).

Consequently, I cannot extract the information required to answer your prompt, as the prompt is designed for a study demonstrating the performance of a new or significantly modified device, particularly one involving AI/ML and associated acceptance criteria. The document explicitly states:

• "There is no significant change in design, technological characteristics, function, sterilization or packaging of the devices as a result of this submission."
• "The subject Smith & Nephew ACCORD Cable System devices are identical in function, design features, materials, packaging, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared (K223762, K031162). These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled."
• "Therefore, since there are no changes to the design features, or manufacturing methods of the subject ACCORD Cable System devices, no performance testing (bench, animal, clinical) was required."

This 510(k) relies on the substantial equivalence to its predicate devices (K223762, K031162, K993106), which would have had their own studies to demonstrate safety and effectiveness at the time of their clearance. However, those studies are not detailed in this document.

Therefore, I cannot provide the requested information based on the provided text. The document describes a regulatory filing for a non-AI/ML device that did not require new performance studies due to the nature of the submission (labeling updates only).

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