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Ask a specific question about this device

The Rialto™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The subject RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO Screws are made using Titanium Alloy and are 40mm- 60mm in length with a diameter of 12mm. This device may be implanted via a minimally invasive approach using fluoroscopy or navigated instruments compatible with Medtronic StealthStation® and IPC® POWEREASE®.

The provided FDA 510(k) clearance letter for the Rialto™ SI Fusion System does not contain information about the acceptance criteria and study proving a device meets those criteria in the context of an AI/Software as a Medical Device (SaMD).

The document describes a medical implant (Rialto™ SI Fusion System) and its mechanical and MRI safety performance, not an AI or software device. The studies mentioned (ASTM F2182-19e2, F2052-21, F2213-17, F2119-24, F2503-23) are for evaluating the safety and compatibility of passive implants in the Magnetic Resonance (MR) Environment, which are standard non-clinical tests for physical medical devices.

Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/SaMD, as the provided input does not pertain to such a device.

If you have a document describing the clearance of an AI/SaMD, I would be happy to analyze it for the requested information.

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The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textures, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

These implants may be implanted via a variety of open or minimally invasive anterior or oblique approaches.

The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation.

The Catalyft™ LS Expandable Interbody System is an expandable titanium alloy interbody device consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

The interbody devices incorporate Titan Surface Technologies™, where exterior surfaces include nanoLOCK™ surface treatments designed to improve bone fixation to adjacent bone. nanoLOCK™ surface technology provides a microscopic, roughened surface with nano-scale features. nanoLOCK surface technology is specifically engineered to have nano textured features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK surface technology demonstrates elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document.

The provided document is a 510(k) Premarket Notification for a medical device called the Catalyft™ LS Expandable Interbody System. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance data.

However, this document does not describe acceptance criteria for an AI/ML powered device, nor does it detail a study proving such a device meets acceptance criteria.

The device described, an intervertebral body fusion device, is a physical implant, not an AI/ML software device. The "Performance Data" section specifically lists mechanical tests (e.g., Static and Dynamic Compression, Subsidence, Expulsion, Wear Debris, Bone screw push out, MRI Safety Evaluation) that are relevant to the physical and biomechanical characteristics of an implantable device, not to the performance of an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving an AI/ML device meets them based on the provided input, as the input concerns a traditional medical implant.

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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, 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 the aforementioned 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. 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™ 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 (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD HorizonTM Spinal System rods may be connected to the VertexTM Reconstruction System with the VertexTM rod connector. Refer to the VertexTM Reconstruction System package insert for a list of the VertexTM indications of use.

Not Found

This document describes a spinal system, not an AI/ML powered device. Therefore, the requested information pertaining to AI/ML device performance, such as acceptance criteria for AI models, human expert adjudication, MRMC studies, standalone algorithm performance, and training/test set details are not applicable.

The provided text focuses on the substantial equivalence of the Medtronic CD Horizon™ Spinal System to predicate devices, supported by mechanical testing and rationales.

Here's an analysis of the provided text based on the request's categories, indicating where information is present and where it is not applicable for this type of device:

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

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

• Sample Size: Not explicitly stated in this summary. Mechanical testing usually involves a specific number of samples per test type (e.g., 5-10 samples per group).
• Data Provenance: Not applicable in the context of "data provenance" for patient data, as this is a mechanical device. The testing was conducted by Medtronic to demonstrate substantial equivalence to existing predicate devices.

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

• Not Applicable: This is a mechanical device, not an AI/ML diagnostic or therapeutic device that relies on expert interpretation for ground truth. Ground truth for mechanical performance is established through standardized testing protocols (ASTM standards) and engineering principles.

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

• Not Applicable: Adjudication methods are relevant for subjective interpretations, typically in clinical studies or AI model evaluations. For mechanical testing, the results are quantitative and directly measured against engineering specifications.

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

• Not Applicable: This is a mechanical device. MRMC studies are specific to evaluating diagnostic accuracy of imaging systems, often in the context of human reader performance with or without AI assistance.

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

• Not Applicable: This is a mechanical device. "Standalone" performance refers to AI algorithm performance without human intervention.

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

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance is established by the specified mechanical properties (e.g., strength, durability, fatigue resistance) defined by relevant ASTM (American Society for Testing and Materials) standards (F1717, F1798, F2503). Compliance with these standards indicates the device performs as intended for its mechanical application.

8. The sample size for the training set

• Not Applicable: "Training set" refers to data used to train AI/ML models. This is a mechanical device, not an AI model.

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

• Not Applicable: As no AI training set exists, no ground truth establishment for it is relevant.

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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. 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.

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.

This document, K233951, is a 510(k) premarket notification for the CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw). It is a notification demonstrating substantial equivalence to previously cleared predicate devices, not a study for a new device with new acceptance criteria and a detailed clinical trial. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not applicable to this type of submission.

Here's a breakdown of the relevant information provided and why other requested details are absent:

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

   • Acceptance Criteria (General): The acceptance criteria for this type of submission are typically that the new device does not present a "new worst case" compared to the predicate devices and meets established ASTM standards for spinal implants. The document explicitly states: "For the tested subject devices, the pre-determined acceptance criteria was met for all tests."
   • Reported Device Performance: The performance data reported is primarily through engineering bench testing according to existing ASTM standards for spinal implants. The document indicates that for tested devices, acceptance criteria were met. For rationalized devices (those where new testing was deemed unnecessary because they do not present a new worst case), the existing predicate data applies.

   Acceptance Criteria (Type)	Reported Device Performance
   ASTM F1717: Static Compression, Static Torsion, Compression Fatigue (Relevant for spinal system components)	Met pre-determined acceptance criteria for all tested devices.
   ASTM F1798: Axial Grip, Axial Torsion, Flexion Extension Static, Flexion Extension Fatigue Screw Reduction to Failure Testing (Relevant for pedicle screw systems)	Met pre-determined acceptance criteria for all tested devices.
   ASTM F2503: MRI Compatibility Evaluation	Met pre-determined acceptance criteria for all tested devices.
   Device does not present a "new worst case" compared to predicate devices (for rationalized devices). This implies that the performance characteristics (mechanical strength, material compatibility, etc.) are equivalent to or better than the predicate devices, as demonstrated by the existing predicate data or engineering analysis. The subject devices have the same intended use, indications for use, materials, similar overall design, fundamental technology, sterilization, and surgical technique as the predicate devices. The subject and predicate implants have the same function and fundamental scientific technology.	Applicable (existing predicate data is applicable).

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

   • This document refers to bench testing (mechanical, material, MRI compatibility). The "sample size" for such testing is generally a number of physical specimens tested to meet statistical power for engineering analysis, not a patient-based test set as in clinical studies. The document does not specify the exact number of physical samples for each test (e.g., how many screws were tested for axial grip).
   • Data Provenance: This is engineering test data, not patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable.

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 is an engineering test of spinal implant components, not an AI or diagnostic device requiring expert interpretation of medical images or patient data to establish ground truth.

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

   • Not applicable. Adjudication methods are used in clinical studies or performance studies where multiple readers or experts assess outcomes. This is bench 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 is a spinal implant device, not an AI or diagnostic software. Therefore, an MRMC study or AI assistance is not relevant to this submission.

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

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

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

   • Not applicable in the clinical sense. For mechanical testing, the "ground truth" is defined by the physical limits and standards outlined in the ASTM protocols (e.g., a screw must withstand a certain load without failure, or a material must not show adverse reactions in an MRI environment).

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable. As above, no training set for an AI/ML model is involved.

Summary of the 510(k) Submission:

This 510(k) submission for the CD Horizon ModuLeX Spinal System focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The primary "study" involved is a series of bench tests (mechanical and MRI compatibility) conducted according to established ASTM standards (F1717, F1798, F2503) for spinal implants. The key "acceptance criterion" for these tests is simply meeting the pre-determined specifications of these standards, and the document states that these criteria were met for all tested devices. For components not subjected to new testing, the justification ("rationalization") relies on the fact that they do not present a "new worst case" compared to previously cleared predicate devices, implying their performance aligns with the existing, cleared data. This type of submission does not involve clinical studies or AI performance evaluations.

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The OsteoCool™ 2.0 RF Ablation System is indicated for:
• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
• Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
• Ablation of benign bone tumors such as osteoid osteoma.

The subject OsteoCool™ 2.0 RF Ablation System includes the following hardware components:

1. OsteoCool™ 2.0 Radiofrequency Generator
2. OsteoCool™ 2.0 Peristaltic Pump & Pump Cable
3. OsteoCool™ 2.0 Connector Hub
4. OsteoCool™ 2.0 Cart
   The OsteoCool™ 2.0 RF Ablation System line extension includes the following commercially available sterile disposables that remain unchanged from the OsteoCool™ RF Ablation System K182497 (S.E. 12/17/2018):
5. OsteoCool™ RF Ablation Probe with Tube Kit
6. OsteoCool™ Independent Thermocouple with Introducer Kit:
   The OsteoCool™ 2.0 RF Ablation System delivers controlled radiofrequency (RF) energy in a bipolar manner with a cooling mechanism to facilitate RF lesions in target tissue. The OsteoCool™ 2.0 Radiofrequency (RF) Generator operates together with the OsteoCool™ RF Ablation Probe to deliver the RF energy to the target ablation site(s). The OsteoCool™ Tube Kit is used with the OsteoCool™ 2.0 Peristaltic Pump to circulate water internally through the OsteoCool™ RF Ablation Probe(s) during RF energy delivery. The OsteoCool™ 2.0 Pump Cable connects the OsteoCool™ 2.0 Peristaltic Pump to the OsteoCool™ 2.0 RF Generator, which controls the pump flowrate.
   The OsteoCool™ 2.0 Connector Hub connects the OsteoCool RF Ablation Probe(s) and OsteoCool™ Thermocouple (s) to the OsteoCool™ 2.0 RF Generator. The OsteoCool™ Thermocouple Monitor is used with the OsteoCool™ Thermocouple Introducer and enables temperature monitoring around the thermal ablation zones during procedures.

This document describes the OsteoCool™ 2.0 RF Ablation System and its substantial equivalence to a predicate device (OsteoCool™ RF Ablation System, K182497 S.E. 12/17/2018). The information provided focuses on the device's characteristics and the testing performed, rather than a study proving the device meets acceptance criteria in the context of an AI/ML model for medical imaging, as might be implied by the prompt's structured questions.

However, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence for a medical device and "device performance" as the data presented to support this claim, I will attempt to answer the questions based on the provided text.

The provided text does NOT describe an AI/ML device or a study involving human readers and AI assistance for an imaging application. Therefore, many of the questions regarding AI/ML specific criteria, ground truth establishment, expert adjudication, MRMC studies, and training/test set details are not applicable (N/A) to this document.

The document details the physical device's technical specifications and bench-top testing to demonstrate substantial equivalence to a prior version.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, the "acceptance criteria" are implied by the substantial equivalence demonstration, which relies on showing that the new device has "the same fundamental scientific technology, including principles of operation and mechanism of action" and performs comparably to the predicate device through various tests.

The product being reviewed is an RF ablation system, a physical medical device, not a software/AI system for diagnostics from imaging data. Therefore, the following AI/ML-specific questions are largely not applicable.

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

• Sample Size for Test Set: The document mentions "ex-vivo tissue" and "cadaveric bone" were used for bench-top validation testing. It does not specify the number of samples (e.g., number of tissue blocks, cadaveric segments) used.
• Data Provenance: The testing was "bench-top testing" performed by the manufacturer (Medtronic Sofamor Danek USA Inc.). It is laboratory testing; thus, it is not "country of origin of the data" in the sense of patient data, nor is it retrospective or prospective in the clinical study sense. It is laboratory product validation.

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

• N/A. This is a physical device being tested for its functional performance (e.g., lesion creation, electrical safety), not an AI/ML system requiring expert-annotated ground truth from medical images.

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

• N/A. Not applicable to physical device bench 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:

• N/A. This is a physical RF ablation device, not an AI/ML software for image interpretation or diagnosis.

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

• N/A. This is a physical device designed for human use in a medical procedure. It is not an algorithm that functions in a "standalone" capacity.

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

• The "ground truth" for this device's performance would be the physical measurements of the lesions created (length, width, temperature isotherm), electrical parameters, and material biocompatibility, as determined by standard laboratory techniques and instruments, not expert consensus on medical images or pathology from human subjects.

8. The sample size for the training set:

• N/A. This device is not an AI/ML model that undergoes "training." Its performance is based on its engineered design and physical properties.

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

• N/A. Not applicable as there is no "training set" for this physical device.

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CD Horizon™ Fenestrated Screw Set
When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are 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, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), pseudarthrosis, and/or failed previous fusion.
Additionally. CD Horizon™ Fenestrated Screws may be used for immobilization when used for trauma (e.g., fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion.
When used in conjunction with Kyphon™ HV-R™ Bone Cement or Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Kyphon™ HV-R™ Bone Cement or Medtronic HV-R™Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

CD Horizon™ Spinal System
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), 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.
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) 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. 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 spondvlolisthesis 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.

CD Horizon™ Fenestrated Screw Set
The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) bone cement (Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion. These implants may also serve as traditional pedicle screws when used without bone cement in patients.
CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert for information regarding those implants. Care should be taken so the correct components are used in the spinal construct.
CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobalt-chromium-molybdenum alloy. Never use stainless steel and titanium implant components in the same construct.
Do not use CD Horizon™ Fenestrated Screw implants with components from any system other than the CD Horizon™ Spinal System.

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.
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.

The provided text does not describe a study involving an AI/ML device or its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for a Class II medical device (Thoracolumbosacral Pedicle Screw System), specifically the Medtronic CD Horizon™ ModuLeX™ FNS Screw Set and CD Horizon™ ModuLeX™ Spinal System.

The document discusses:

• Device Description: Spinal screws, rods, and associated components used for spinal fixation.
• Indications for Use: Various spinal conditions like degenerative disc disease, spondylolisthesis, trauma, etc., for which the device can be used as an adjunct to fusion, or to restore spinal column integrity for a limited time in tumor patients when augmented with bone cement.
• Predicate Devices: The new devices are compared to previously cleared Medtronic spinal systems (K201362 and K221244) to establish substantial equivalence.
• Performance Data: The performance data primarily consists of mechanical/bench testing conducted according to ASTM standards (ASTM F1798 and ASTM F1717) to demonstrate that the new device has similar design features and does not present a new worst-case compared to the predicate devices. A risk analysis was also performed.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, expert review, or ground truth for an AI/ML device, as this information is not present in the provided document. The document focuses on demonstrating the mechanical equivalence of a physical implantable medical device to existing predicate devices, not the performance of an AI/ML algorithm.

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The ZEVO™ Anterior Cervical Plate System is interior interbody screw fixation from C2 to T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) turnors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions

The ZEVO™ Anterior Cervical Plate System consists of temporary implants (plates and bone screws) intended for anterior screw fixation of the cervical spine during the development of a cervical spinal fusion. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The device is intended for the anterior screw fixation from C2- T1 in the cervical spine.

The ZEVO™ Anterior Cervical Plate System implants are available in a broad range of size offerings, and are supplied in both sterile and non-sterile form.

The implant components are made from titanium alloy, with plates having subcomponents manufacturing from nitinol (NiTi).

The purpose of this submission is to establish MR Conditional labeling for this implant system.

This submission (K231090) describes the ZEVO™ Anterior Cervical Plate System. However, this document does not contain information regarding an AI/ML device.

The purpose of this submission is to establish MR Conditional labeling for this implant system. The document focuses on demonstrating the magnetic resonance (MR) safety of the ZEVO™ Anterior Cervical Plate System through non-clinical testing.

Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or adjudication methods related to an AI/ML device, as this document does not pertain to such a device.

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