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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.

The OLYMPIC Deformity Band System is a system designed to stabilize a vertebrae during the fusion process. The system is composed of sublaminar bad cerclages and band connectors. 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.

This is a medical device, not an AI/ML device. The provided text outlines the 510(k) summary for the OLYMPIC Deformity Band System, a temporary orthopedic implant, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML model.

Therefore, I cannot provide the requested information. The document focuses on mechanical and material testing for a physical implant, not on the performance metrics of an AI system.

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The HILINE™ Fixation System consists of temporary implants for use in orthopedic surgery. The 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, interspinous, 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 and older, adult scoliosis, and spondylolisthesis;

· Spinal degenerative surgery, as an adjunct to spinal fusions;

· Use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The HILINE™ Fixation System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.

The HILINE™ Fixation System is a sublaminar fixation system consisting of bands and clamps to mate with 3.5-6.5mm diameter rods, and associated manual surgical instruments. The bands have a titanium anchor attachment on one end that is detached after insertion and is not intended to be implanted. HILINE™ implants are manufactured from polyethylene terephthalate (PET), titanium alloy, commercially pure titanium, stainless steel, or cobalt chromium molybdenum alloy.

The provided text is a 510(k) summary for the HILINE™ Fixation System, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices based on mechanical testing and material characteristics. The summary explicitly states:

"Performance data demonstrate substantial equivalence to the predicate devices."

However, the provided text does not contain the detailed information required to fill out the table regarding acceptance criteria, specific device performance metrics, or study design details for clinical or AI-related performance evaluations. The "Performance Data" section solely mentions mechanical testing in accordance with ASTM F1798. There is no indication of a study involving human readers, ground truth establishment by experts, or any AI component.

Therefore, several sections of your request cannot be fulfilled based on the given information.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

The document states that mechanical testing (static and dynamic tension, band pull-through, rod push-through, and static component torsion) was conducted in accordance with ASTM F1798, and that the performance data demonstrated substantial equivalence to the predicate devices. However, it does not specify the numerical acceptance criteria or the specific numerical results of these tests.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical or human-involved test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is 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, an MRMC study was not done. The device description and performance data section do not mention any AI component or human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm study was not done. The device description and performance data section do not mention any AI component.

7. The type of ground truth used: Not applicable. No ground truth for an AI algorithm or diagnostic performance study is mentioned. The "ground truth" relevant here pertains to the physical properties and performance of the device under mechanical stress, which are assessed through standardized mechanical testing (ASTM F1798).

8. The sample size for the training set: Not applicable. No training set for an AI algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable. No training set for an AI algorithm is mentioned.

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The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and id in the repair of bone fractures. The indications for use are as follows:

· 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 and older, adults scoliosis and kyphosis;

· Spine degenerative surgery as an adjunct to spinal fusions.

· Intended for use with a posterior spinal instrumentation construct when ligamentation is needed.

The LigaPASS™ system may also be used in conjunction with other medical implants made of titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.

The purpose of this submission is to expand the indications of the LigaPASS™ system to include the use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The LigaPASS™ 2.0 Ligament Augmentation System provides surgeons the ability to mimic anatomical muscle and ligament functionality and stabilization between vertebrae that are collapsed during surgery before fusion. The LigaPASS™ 2.0 Ligament Augmentation System is designed to restore balance and stability as a complement to a posterior thoracolumbar fixation system. Ergonomic instrumentation provides smooth assembly with self-stabilizing tensioners and torque-limiting locking tools. The LigaPASS™ 2.0 Ligament Augmentation System consists of a polyester (PET) band and titanium alloy medial open connector with 2 set screws.

LigaPASS™ bands allow the surgeon to create a posterior vertebra anchorage without theuse of a pedicle screw or hook. Instead of a pedicle screw or hook, the LigaPASS™ bands are laced around the vertebra independently of the vertebra anatomy and then connected to a LigaPASSTM connector to make the rod-bone connection.

The LigaPASS™ 2.0 bands are comprised of a PET braid and pure titanium (T40) malleable leads at the ends of the bands. The malleable tips help the surgeon to lace the band around the vertebra. They can be bent by the surgeon to make it pass under and through the vertebral body easier.

The LigaPASS™ connectors allow surgeons to attach a rod to a vertebral body without the use of the pedicle. Instead of a pedicle screw, the LigaPASS™ connector use a facet band to make the rod-bone connection. The connectors are comprised of a connector body, a rod set screw, a locking set screw for the band and a polyester band. The body of these connectors is manufactured from titanium allov (Ti-6Al-4V). The part is compatible with any rods made of titanium or cobalt chromium alloys between diameters 5.5 mm and 6.0 mm.

The provided text is a 510(k) premarket notification decision letter and summary for the LigaPASS™ 2.0 Ligament Augmentation System. It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria.

The document pertains to a physical medical device (ligament augmentation system) used in orthopedic surgery, not a diagnostic or AI-powered device. The "Performance Testing Summary" explicitly states:

"No additional bench or animal testing was completed for the purpose of this 510(k) submission. The non-clinical performance of the LigaPASS™ 2.0 Medial System has been validated through a series of 510(k) submissions (K172021, K173506). Clinical data published in the literature were provided to support the use of ligament augmentation with the LigaPASS™ system in adult spinal deformity surgery."

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from this document.

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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bory fusion and aid in the repart of bone fractures. The include the following applications:

-Spinal trauma, used in sublaminar, or facet wiring techniques

-Spinal reconstruction surgery, incorporated into construction 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 LigaPASS system may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The CD Horizon™ Spinal System with or without Sextant™ intended for posterior, non-cervical fixation as an adjunct o fusion for the following indications: degenerative disc disease (DDD - defined as back pain with degeneration of the disc confirmed by history and radios). spondylolisthesis, trauma (i.e. fracture or dislocation), soinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis). tumor, pseudarthrosis, and or failed previous fusion. Except for hooks, when used as an anterclateral 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, the CD Horizon™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted below.

When used for posterior non-cervical pediation in pediatric patients, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to freat progressive spinal deformities (i.e. scolosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, the CD Horizon™ Spinal System is intended to tred pediativ patients diagnosed with the following conditions: spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and or failed previous fision. These cevices are to be allograft. Pediatic 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 at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the (TI-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the ing supplemental fixation in the following conditions: DDD (as reviously defined), spondylolisthesis, trauma, and/or tumor.

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

The purpose of this submission is to expand use of the previously cleared LigaPASS® Spinal System with the previously cleared CD Horizon™ 5.5/6.0 Spinal System rods.

LigaPASS® Spinal System: The LigaPASS® MEDICREA® INTERNATIONAL S.A. spinal system is composed of four components: a connector, two set screws and a band. The LigaPASS® system is designed to stabilize a vertebra in the same manner as a hook around the vertebra during development of solid bony fusion. The LigaPASS® system must be implanted via a posterior approach to complete a thoraco-lumbar fixation system as the PASS LP® MEDICREA® INTERNATIONAL S.A. spinal system. The implants are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136, with the exception of the band which is manufactured in polyethylene terephtalate (PET) and titanium T40 conforming to ISO 5832-2 specifications and ASTM F67.

CD Horizon™ Spinal System: 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.

I am sorry, but there is no information about acceptance criteria or a study proving device performance in the provided text. The document is a 510(k) premarket notification clearance letter from the FDA for a spinal system, discussing its substantial equivalence to predicate devices and detailing its indications for use, product description, and a general statement about performance testing. It mentions mechanical testing in accordance with ASTM 1798 but does not provide specific acceptance criteria or study results.

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The Mariner Cap 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:

• 1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
• 2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
• 3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Mariner Cap System shall be used in conjunction with the SeaSpine Mariner Pedicle Screw System whenever "wiring" may help secure the attachment of other implants.

The Mariner Cap is composed of three components: the Mariner Cap SP Connector, the Mariner Cap SP Locking Base, and the Locking Insert. The cap is designed to mate with the Mariner Pedicle Screw System screws. The Mariner Cap is added to the proximal end of the Mariner Screw and provides for an alternate method to attach the JAZZ Band and JAZZ Passer Band to skeletal structures as compared to the current method using a JAZZ connector (K171881).

The provided FDA 510(k) summary (K201240) describes the Mariner Cap System, a device intended for temporary stabilization as a bone anchor. However, this document does not contain the detailed information required to describe the acceptance criteria and a study that proves the device meets those criteria in the context of device performance as typically understood for AI/ML devices.

The document is a regulatory submission for a medical device (a physical implant), not a software or AI/ML device. Therefore, the "acceptance criteria" and "study" mentioned primarily refer to non-clinical mechanical testing to demonstrate substantial equivalence to a predicate device, rather than performance metrics like sensitivity, specificity, or reader improvement, which are common for AI/ML studies.

Here's a breakdown based on the information available and why certain aspects of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" and "reported device performance" are related to mechanical testing for equivalence to a predicate device.

Note: This is a very different type of "performance" than what would be reported for an AI/ML device. There are no accuracy, sensitivity, or specificity metrics.

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

• Sample Size for Test Set: Not applicable in the context of mechanical testing. The testing would involve a certain number of manufactured devices for various mechanical tests, but this isn't a "test set" of patient data. The document does not specify the number of Mariner Cap Systems or components tested.
• Data Provenance: Not applicable. The "data" refers to the results of mechanical tests performed on the physical device components, not patient data from a specific country or collected retrospectively/prospectively.

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

• Number of Experts: Not applicable. Ground truth as typically understood for diagnostic AI/ML (e.g., radiologist reads) is not relevant for this type of mechanical device testing. The "ground truth" here would be the physical properties and mechanical behavior of the device under specific test conditions, as measured by standard engineering methods.
• Qualifications of Experts: Not applicable. Engineering and quality assurance personnel would perform and analyze these tests, following recognized standards (like ASTM 1717).

4. Adjudication Method

• Adjudication Method: Not applicable. This concept is relevant for disagreements among human readers or algorithm outputs in diagnostic studies. For mechanical testing, results are quantitative and compared against established benchmarks or predicate device performance.

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

• MRMC Study: No. This type of study is specifically for evaluating the impact of an AI algorithm on human reader performance. The Mariner Cap System is a physical implant, not an AI/ML diagnostic tool.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: No. The device is a physical implant, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the mechanical testing, the "ground truth" would be the physical and mechanical properties of the device and its components, determined through standardized engineering tests (e.g., measuring forces, displacements, structural integrity, material properties) and compared against a predicate device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no training set as the device is not an AI/ML algorithm.

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

• Ground Truth for Training Set Established: Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary, the provided document describes a regulatory clearance for a physical medical implant (the Mariner Cap System) based on non-clinical mechanical testing demonstrating substantial equivalence to a predicate device. The questions posed in your request are largely tailored towards evaluating AI/ML-based medical devices, and thus many are not applicable to the context of this 510(k) submission.

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The Gecko Spinal System is a temporary implant for use in orthopedic surgery. The 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:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;

2. 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 and older, adult scollosis, kyphosis and spondylolisthesis;

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The Gecko Spinal System may also be used in conjunction with other Ortho Development's spinal rod systems made of similar metals whenever "wiring" may help secure the attachment of the other implants.

The Gecko Spinal System is an implantable device intended to provide immobilization and stabilization of spinal segments. The device consists of an implantable polyethylene terephthalate (PET) braided band with a stiffened guiding section at one end and a metal leader at the other (both removed before final implantation), an implantable grade titanium alloy clamp that mates with 5.5mm diameter rods, and an implantable grade titanium alloy nut that secures the band, clamp, and connecting rod together. All implants are provided sterile for single use only; the implant should not be re-used or re-sterilized under any circumstances.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "The Gecko Spinal System." It is a regulatory approval document and does NOT contain information about a study proving the device meets acceptance criteria derived from AI/machine learning performance.

The content focuses on:

• Regulatory approval: 510(k) clearance, substantial equivalence to predicate devices.
• Device description: Components, materials, intended use, indications for use.
• Performance data (non-clinical): Sterilization (gamma radiation), shelf life (packaging), biocompatibility, and mechanical testing (static and dynamic band tension, axial grip, torsional grip, axial compression). These are standard engineering and material science tests for implantable medical devices, not performance metrics for an AI/ML algorithm.
• Absence of clinical testing: "None provided for basis of substantial equivalence." This explicitly states that no clinical trials were conducted or submitted for this specific 510(k) clearance.

Therefore, I cannot extract the requested information regarding acceptance criteria for an AI-powered device, study details for AI performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment for AI. This information is simply not present in the provided text.

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The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The 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 and older, adult scoliosis, and spondylolisthesis;
• · Spinal degenerative surgery, as an adjunct to spinal fusions;
• · The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.

The RESPONSE BandLoc Spinal Fixation implant consists of a titanium alloy tulip head clamp attached to a polyester band and includes a set screw for affixing the clamp to a rod used for spinal fusion. The polyester band is available in two configurations-single and double (DUO) band. Both band configurations include a tip portion with an internal titanium insert enclosed in the band to enable the user to more easily pass the tip through the spinal anatomy. The final implanted devices are identical. Combinations of 5.5 and 6.0 diameter rods offered in titanium alloy, and/or cobalt chromium alloy can be utilized.

All implants are made from implantable grade materials and provided sterile and are single use only; the implants should not be re-used or re-sterilized under any circumstances.

This submission adds an additional implant configuration to the system, describes a modification to a system-specific (Class II) instrument, and adds MR conditions to the labeling.

The system is implanted using general (Class I, 510(k) exempt) and system-specific (Class II) instruments.

The provided text describes a 510(k) premarket notification for the OrthoPediatrics Response BandLoc Spinal Fixation device. It highlights the device's indications for use, comparison to a predicate device, and performance data from mechanical testing, electromagnetic compatibility, and biocompatibility. However, it does not include information about specific acceptance criteria or an analytical study comparing the device's performance against those criteria in a format applicable to AI/ML devices, or detailed clinical study information with human readers, sample sizes for test/training sets, or methods for establishing ground truth as requested in the prompt.

The information provided pertains to a traditional orthopedic implant, not an AI/ML device. Therefore, many of the requested fields are not applicable to the content of this document.

Here's an attempt to answer the questions based only on the provided text, while noting the limitations due to the nature of the device:

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

   Acceptance Criteria	Reported Device Performance
   Withstand anticipated loads during sublaminar passage	The BandLoc DUO assembly passed an internal tensile strength test. "The subject device met the pre-determined acceptance criteria for all tests."
   Mechanical performance of fusion construct	Mechanical testing data from predicate K161267 leveraged to support static and dynamic compression testing of a spine construct (ASTM F1717). No specific performance results for the current device are provided, but leverage implies equivalence.
   Corrosion susceptibility	Mechanical testing data from predicate K161267 leveraged to support corrosion susceptibility (ASTM F2129) of the tulip head. No specific performance results for the current device are provided, but leverage implies equivalence.
   BandLoc Tensioner modification	"The modified instrument met pre-determined acceptance criteria" following life cycle testing to simulate worst-case use.
   MR-Conditional Status	Determined to be MR-Conditional in accordance with ASTM F2052 (Magnetic Induction Displacement), ASTM F2213 (Magnetically Induced Torque), ASTM F2182 (RF Induced Heating), and ASTM F2119 (MR Image Artifacts). This implies meeting the requirements of these standards for "MR-Conditional" labeling.
   Biocompatibility	Supported by leveraging information from predicate K161267 per ISO 10993-1. Implies the device is biocompatible based on similar materials and manufacturing.

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

   • Mechanical Testing (tensile strength): The document states "an internal method." No sample size is specified.
   • Mechanical Testing (fusion construct, corrosion): Leveraged from predicate K161267. No sample sizes specified in this document for the predicate's tests.
   • Electromagnetic Compatibility: No specific "test set" sample size for patients/cases is applicable since these are device-specific engineering tests. The tests were performed on the device itself.
   • Biocompatibility: Leveraged from predicate K161267. This typically involves material testing, not patient data in the context described.
   • Provenance: "internal method" suggests in-house testing.

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 to this type of device and testing. The ground truth for mechanical, EMC, and biocompatibility tests is established by published test standards and engineering principles, not expert medical opinion on images or clinical data.

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

   • Not applicable to this type of device and testing.

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

   • Not applicable. This device is an orthopedic implant, not an AI/ML medical device designed to assist human readers.

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

   • Not applicable. This device is an orthopedic implant, not an AI/ML algorithm. The performance tests (mechanical, EMC, biocompatibility) are standalone for the device itself against established standards.

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

   • Mechanical Testing: Engineering test standards (ASTM F1717, ASTM F2129), internal test methods, and pre-determined acceptance criteria based on mechanical properties and expected loads.
   • Electromagnetic Compatibility: Published ASTM standards (F2052, F2213, F2182, F2119) for determining MR-Conditional status.
   • Biocompatibility: ISO 10993-1, which provides guidelines for biological evaluation of medical devices.

8. The sample size for the training set

   • Not applicable. This device is an orthopedic implant, not an AI/ML device that requires a training set.

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

   • Not applicable. This device is an orthopedic implant, not an AI/ML device that requires a training set or associated ground truth.

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The JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are 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:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
2. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The JAZZ Systems may also be used in conjunction with other medical implants made of titanium alloy or Cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.

JAZZ PF enables the passing of a JAZZ braid around or through the upper spinous process. The main difference with the JAZZ regular connector is that in the subject device the braid is locked horizontally, that is, along the spine axis, instead of vertically. On each side of the instrumented levels, a JAZZ PF connector is implanted on the union rod below the upper pedicle screw. A JAZZ braid is passed and locked through a 1st connector, above or through the spinous process and back through the second connector on the other side. The slack that can exist in the band is removed using the JAZZ PF Band Reducer (Enrouleur Instrument) without applying any tension in the band and the 2nd connector is locked. By doing so, flexion is controlled which helps in the primary stabilization of the levels where fusion has to be achieved.

The provided text describes a medical device, JAZZ PF, and its substantial equivalence determination by the FDA. However, it does not include detailed information regarding "acceptance criteria" for a study in the context of device performance, nor does it present a study that rigorously proves the device meets specific acceptance criteria in a quantitative sense as might be expected for an AI/CADe device.

Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices. This means the device is considered safe and effective because its technological characteristics and intended use are similar to those of devices already legally marketed. The performance data mentioned is for mechanical durability testing, not for diagnostic or analytical performance against ground truth.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be provided based on the text:

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

Based on the provided text, the primary "acceptance criterion" for this type of device (spinal implant) in a 510(k) submission is typically demonstrating mechanical durability and safety comparable to predicate devices. The study mentioned is a mechanical test.

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

• Sample Size for Test Set: Not explicitly stated as "test set" in the context of an analytical or diagnostic study. For the dynamic compression testing, the number of devices or constructs tested is not specified, only that "JAZZ PF constructs passed."
• Data Provenance: Not applicable in the context of clinical data for AI/CADe. The performance data is from mechanical testing of the device itself.

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 the context of a diagnostic or analytical AI study (e.g., expert consensus on medical images) is not relevant for this device's mechanical performance testing.

4. Adjudication method for the test set

Not applicable. There's no adjudication process mentioned for a mechanical test.

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 spinal implant, not an AI/CADe device that assists human readers.

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

No. This is a spinal implant, not an algorithm.

7. The type of ground truth used

Not applicable in the context of an AI/CADe device. The "ground truth" for the mechanical test is adherence to engineering specifications for load and cycles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of Device and Study from Text:

The JAZZ PF is a temporary spinal implant for stabilization during fusion and fracture repair. Its approval (K191217) was based on demonstrating substantial equivalence to existing predicate devices (NuVasive VersaTie System - K173117 and JAZZ System - K182771). The key performance data provided in the submission was a dynamic compression test where JAZZ PF constructs "passed 5 million cycles at a load of 600N," indicating its mechanical durability. The submission also addressed sterilization, cleaning, and biocompatibility by providing rationales that the device did not constitute a new worst-case compared to predicates. The document does not describe a study involving human readers, AI algorithms, or clinical performance against a diagnostic ground truth.

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The Karma® Fixation System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternom following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.

The Karma® Fixation System is a temporary implant to be used in orthopedic surgery. The Karma® implant is a bony anchor designed to provide temporary stabilization of the spine for bony fusion or consolidation of a fracture. The Karma® Fixation System is designed for a posterior approach. The include the following applications:

1. Spinal trauma surgery: Karma® implants can be used in sublaminar wiring techniques;

2. Spinal degenerative surgery: Karma® implants may be used as an adjunct to spinal fusions with bone graft (autograft or allograft) at level(s) of use.

The Karma® Fixation System consists of a strap manufactured from PEEK conforming to ASTM F2026 compounded with 7.5% barium sulphate for radiopacity and Tantalum conforming to ASTM F560. The leading tip of the device is comprised of a spherical feature followed by a tapered neck to allow for an instrument to assist in advancing the strap through or around the bony structures to be secured. Both the spherical tip and the head of the device contain a tantalum pin for visualization when fluoroscopic imaging is used. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop created by feeding the strap through the latch to be made consecutively shorter or taught by continuing to pull the strap through the latch. Prior to creating the loop, the spherical tip of the device is cut off and discarded to allow for the strap to pass through the latch. The latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.

This document is an FDA 510(k) summary for a medical device called the Karma® Fixation System. It explicitly states: "No additional testing was performed in support for this 510(k) Premarket Notification. An engineering rationale was provided to demonstrate substantial equivalence when compared to the predicate device."

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in this document. The device's clearance is based on substantial equivalence to a predicate device (K180728) through an engineering rationale, rather than new performance testing.

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The VersaTie System is a temporary implant for use in orthopaedic surgery. The 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:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques.

2. 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 and older, adult scoliosis, kyphosis and spondylolisthesis.

3. Spinal degenerative surgery, as an adjunct to spinal fusions.

The VersaTie System may also be used in conjunction with other medical implants made of titanium alloy or cobalt chromium alloy whenever "wiring" may help secure the attachment of the other implants.

The VersaTie System is part of a spinal posterior fixation system designed to provide an interface between spinal anatomy and a rod used in spinal surgery. The device is secured around posterior vertebral structures such as the lamina, facet, and transverse processes from T1-L5. The system is comprised of braided bands, clamps and set screws designed to attach to titanium alloy or cobalt-chromium alloy rods. The purpose of this submission is to introduce design modifications to previously cleared components and add new sterilization method for the clamp component to previously cleared VersaTie System.

This document is a 510(k) Premarket Notification from the FDA regarding the NuVasive® VersaTie® System. This device is a bone fixation cerclage system, which is a temporary implant used in orthopedic surgery for spinal stabilization and fracture repair.

The document describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information about a study proving the device meets specific acceptance criteria related to AI/software performance, nor does it discuss ground truth establishment, expert adjudication, or MRMC studies.

The section "Performance Data" states:
"Gamma sterilization validation, sterile packaging validation, integrity of the sterile barrier over time validation are performed to qualify new packaging and sterilization method for the VersaTie System. The results demonstrate that the subject NuVasive VersaTie System is substantially equivalent to the predicate."

This clearly indicates that the "performance data" refers to physical properties and sterilization aspects of the medical device, not the performance of an AI or software component.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a traditional medical device submission, not one for an AI/ML-enabled device.

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