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Cure™ 2.0 Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis), Pseudarthrosis, and Failed previous fusions.

Cure™ 2.0 Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.

Cure™ 2.0 Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

I am sorry, but the provided text is a 510(k) summary for a medical device (Cure™ 2.0 Anterior Cervical Plate (ACP) System). This type of document focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing.

The information you requested, such as acceptance criteria, reported device performance (with specific metrics like sensitivity, specificity, or accuracy), details about test sets (sample size, data provenance), ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, standalone algorithm performance, and training set details, are typically found in studies for AI/ML-enabled devices or diagnostic software.

The Cure™ 2.0 Anterior Cervical Plate (ACP) System is a physical implant, and its clearance is based on mechanical testing (ASTM F1717) to ensure it performs equivalently to an existing device. Therefore, the requested information about AI/ML device performance metrics and study design elements is not applicable to this document.

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The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C Cervical Intervertebral Body Fusion Device or anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C Cervical Intervertebral Body Fusion and with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and or craft to faciliate fusion. Non-operative treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implemented via an open anterior approach approach.

Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.

Talos®-C(HA) Cervical Intervertebral Body Fusion Devices

The Talos®-C(HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fuss are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. Non-operative tratment pror to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) Veeks. Talos®-C(HA) Cervices are to be implemented via an open anterior approach approach.

Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperloriotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.

The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® C Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.

The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.

The provided document is a 510(k) premarket notification letter and summary for a medical device (Talos®-C Cervical Intervertebral Body Fusion System). It does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

The document details the device's indications for use, technological characteristics, and non-clinical testing (mechanical tests like compression, shear, torsion, and subsidence testing, as well as Finite Element Analysis) to demonstrate substantial equivalence to predicate devices for spinal fusion.

**Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML study.**

This submission is for a physical implantable device, not a software or AI-based diagnostic/treatment system. The "testing" mentioned refers to biomechanical performance of the implant, not performance metrics related to diagnostic accuracy or AI model output.

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The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The Cure™ Lumbar Plate (Cure™ OPEL-L (S)) is available in a range of sizes to coincide with the surgical approach. The Cure™ OPEL-L (S) is similar to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole, the inclusion of a central rib at the through hole location and convexity in the sagittal plane at the screw hole locations. All Cure™ Lumbar Plates continue to be manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

This document is a 510(k) premarket notification for a medical device called the "Cure™ Lumbar Plate System." It details the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, the device in question is a spinal implant (Cure™ Lumbar Plate System), not an AI-powered diagnostic or assistive tool. Therefore, the typical acceptance criteria and study designs associated with AI/ML medical devices (such as MRMC studies, standalone performance, training/test sets, expert adjudication of ground truth, etc.) are not applicable here.

The document primarily discusses mechanical testing and an engineering analysis to demonstrate equivalence to a previously cleared predicate device.

Here's how to address the request given the nature of the document:

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

The document describes non-clinical mechanical testing rather than performance in a clinical setting against specific acceptance criteria for diagnostic accuracy. The acceptance criteria relate to mechanical properties and equivalence to the predicate device.

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

• Sample Size: Not applicable in the context of clinical "test sets" for AI/ML performance. The "testing" here refers to mechanical engineering tests on device prototypes/samples. The document does not specify the number of individual devices tested for mechanical properties, but it's standard engineering practice to test a representative sample.
• Data Provenance: Not applicable. This involves lab-based mechanical testing, not patient data.

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. Ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and measurements, not expert clinical consensus.

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

• Not applicable. This is relevant for clinical interpretation or subjective assessment, not mechanical properties.

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 passive spinal implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study was performed.

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

• Not applicable. This is not an algorithm.

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

• Ground Truth: For mechanical testing, the "ground truth" is defined by the objective physical properties and performance measured against established engineering standards (e.g., ASTM F1717) and benchmarks from the predicate device.

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.

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The Cure™ OPEL-C System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.

The Cure™ OPEL-C (T) and Cure™ OPEL-C (S) are available in a range of lengths to coincide with the surgical approach and screws that are available in multiple lengths and diameters. The Cure™ OPEL-C Plate System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

This document is a 510(k) premarket notification for a spinal implant. It describes the device, its intended use, and its equivalence to a predicate device. The information provided heavily focuses on regulatory approval based on substantial equivalence through non-clinical mechanical testing, rather than a clinical study involving human performance or diagnostic accuracy.

Therefore, many of the requested criteria related to a clinical study (like stand-alone performance, MRMC studies, sample sizes for training/test sets, ground truth establishment for clinical data, expert qualifications, and adjudication methods for clinical data) are not applicable or not present in this type of submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

Since this is a mechanical device cleared based on substantial equivalence through non-clinical testing, the "acceptance criteria" revolve around demonstrating comparable or superior mechanical performance to the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria

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

   • Sample Size: Not applicable in the context of a clinical test set from human data for this type of submission. The "test set" here refers to mechanical test samples, not patient data. The document does not specify the number of mechanical samples tested, but it states that "An engineering analysis was performed."
   • Data Provenance: Not applicable for clinical data. The data provenance is from laboratory mechanical testing.

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

   • This is not applicable. The "ground truth" for a mechanical device is established through calibrated measurement instruments and adherence to standardized testing protocols (ASTM F1717) in an engineering laboratory. No human experts are involved in establishing a "ground truth" for mechanical function in the way they would for, say, image interpretation.

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

   • This is not applicable. Adjudication methods are relevant for subjective interpretations, especially in clinical image analysis or diagnosis. Mechanical testing results are objective measurements.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human interpretation is involved. This device is a mechanical implant.

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

   • No, a standalone (algorithm) performance study was not done. This is a mechanical device, not a software algorithm.

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

   • The "ground truth" for this device is based on objective mechanical properties and performance standards as defined by ASTM F1717 and compared to a predicate device. It's not based on expert consensus, pathology, or outcomes data in the clinical sense.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of machine learning or AI algorithms for this device.

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

   • Not applicable. There is no "training set."

Summary of Relevant Information from the Document:

• Device Type: Spinal implant (Cure™ OPEL-C Plate System).
• Regulatory Path: 510(k) Premarket Notification based on Substantial Equivalence.
• Key Evidence for Substantial Equivalence: Non-clinical Mechanical Testing (engineering analysis) performed according to ASTM F1717.
• Comparison: The device was shown to be "superior in mechanical function to the predicate device" (K160604, Cure™ Anterior Cervical Plate System) in static compression bending, static tension, and dynamic compression bending.
• Differences from Predicate: Exclusive to the posterior side for interface with interbodies, absence of graft windows, increased maximum screw angulation, and decreased axial radius. However, "fundamental technological characteristics" and central locking mechanism are identical.

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The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The Cure™ Lumbar Plates (Cure™ - LP IView and Cure™ - QMax ) are available in a range of sizes to coincide with the surgical approach. The Cure™ - LP IView is identical to the Cure™ Anterior Lumbar plate with the exceptions of replacing the graft window with a through hole and the inclusion of a central rib at the through hole location. The Cure™ - LP QMax is identical to the Cure™ Lateral Lumbar plate with the exceptions of plate width and number of screw holes allocations. All Cure™ Lumbar Plates are manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The provided text describes a 510(k) premarket notification for the "Cure™ Lumbar Plate System." This document is a regulatory submission to the FDA, asserting substantial equivalence to an existing predicate device. It does not contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the context of AI/ML performance.

Medical device approvals like this typically focus on demonstrating safety and effectiveness based on similarity to previously approved devices (predicates) and mechanical testing for physical properties. They do not involve the kind of performance studies with ground truth, expert readers, or AI/ML metrics that your questions refer to.

Therefore, I cannot answer most of your detailed questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

Here's what I can extract based on the document's content:

• Device Name: Cure™ Lumbar Plate System
• Predicate Device: K171538 (Cure™ Lumbar Plate System)
• Purpose of the Submission: To demonstrate substantial equivalence of the Cure™ Lumbar Plate System (specifically the Cure™ - LP IView and Cure™ - LP QMax models) to the predicate device.
• Basis for Equivalence: Identical intended use and consistency in fundamental scientific technology.

Regarding "Non-clinical Testing" (Section G):
The document mentions "An engineering analysis was performed on the previously cleared Cure™ Lumbar Plate System" which "included static compression bending, static torsion, and dynamic compression bending." It concludes that the new plates are "superior in mechanical function and properties to the predicate device."

This section describes mechanical testing of the physical implant, not performance of an AI/ML algorithm. These tests are typically defined by ASTM standards and have their own internal acceptance criteria (e.g., minimum load-bearing capacity, fatigue life) but these are for the hardware and are not related to algorithm performance metrics like sensitivity, specificity, or reader improvement.

In summary, the provided document does not support answering the questions related to AI/ML device performance studies.

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The Cure™ Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vesses in the treatment of lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.

The Cure™ Lumbar Plate System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters. Cure™ Lumbar Plate System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The provided text describes a medical device, the Cure™ Lumbar Plate System, and its 510(k) premarket notification to the FDA. The information focuses on regulatory approval and equivalence to a predicate device, rather than the performance of a software or AI-driven diagnostic device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/software device performance, is not present in the provided text.

The document states that the Cure™ Lumbar Plate System is substantially equivalent to a predicate device (K022791 Synthes Anterior Tension Band System) based on technological characteristics and non-clinical testing.

Here's a breakdown of the available information based on your request, highlighting what is not applicable or not found:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as the document describes non-clinical mechanical and biological compatibility testing, not a clinical study on human subjects or an AI diagnostic test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as there is no mention of a "test set" in the context of expert ground truth for a diagnostic device. The evaluation was based on engineering and biological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. This describes a physical implantable device, not an AI-assisted diagnostic tool.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable in the context of diagnostic accuracy. For the non-clinical testing, the "ground truth" would be established engineering standards (ASTM F1717) and biological standards (ANSI/AAMI ST-72:2011).

8. The sample size for the training set:
This information is not applicable as there is no AI component or training set described.

9. How the ground truth for the training set was established:
This information is not applicable.

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The Talos® Lumbar (HA) PEEK IBF device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos® Lumbar (HA) PEEK IBF devices are intended to be used with autograft and/ or allograft comprised of cancellous and/or corticocancellous bone graft.

The Talos® Lumbar (HA) PEEK IBF Device is to be used in patients who have had six months of non- operative treatment.

Talos® Lumbar (HA) PEEK IBF devices are to be implanted via a direct posterior, transforaminal, laterior or anteriolateral approach in the lumbosacral spine. The Talos®-P WB (HA), Talos®-TL (HA), Talos®-T (HA), Talos®-L (HA), and Talos®-A (HA) are intended to be used with supplemental fixation.

Additionally, the use of Hyperlordotic Talos®-A (HA) devices (lordotic angle greater than 20°) are intended to be used exclusively with anterior supplemental fixation.

The Talos® Lumbar (HA) PEEK IBF Devices are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The Talos® Lumbar (HA) PEEK IBF Device is available in six configurations: Talos®-P (HA), Talos®-P WB (HA), Talos®-T (HA), Talos®-TL (HA), Talos®-L (HA), and Talos®-A (HA). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-P (HA), Talos®-P WB (HA), Talos® –TL (HA) and Talos® –L are rectangular devices. The Talos® –T (HA) and Talos® – A (HA) have curved lateral walls and rounded edges. The implants are available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient anatomy. In addition, tantalum or titanium markers at the opposite ends are offered which allow radiological confirmation for proper IBF positioning.

The provided text describes the regulatory clearance for a medical device, the Talos® Lumbar (HA) PEEK IBF Devices, and demonstrates its substantial equivalence to a predicate device. However, this document does not contain information about an AI/ML-based medical device. Therefore, a study proving the device meets acceptance criteria for an AI/ML device is not applicable and cannot be derived from this text.

The acceptance criteria and study details requested in the prompt (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth establishment) are specific to the validation of AI/ML algorithms, particularly in image analysis. The Talos® Lumbar (HA) PEEK IBF Devices are physical implants used in spinal fusion surgery.

The document primarily focuses on non-clinical testing to establish substantial equivalence with a predicate device, as required for 510(k) clearance by the FDA. This typically involves:

• Mechanical Testing: As mentioned, "Testing per ASTM F2077 (Static Compression, Static Compression Shear, Dynamic Compression, Dynamic Compression Shear) and ASTM F2267 (Subsidence) was performed." These are standard tests for the mechanical integrity and performance of spinal implants.
• Biocompatibility Testing: "Bacterial endotoxin testing (BET) has been performed." This is relevant for patient safety regarding the material.
• Material Comparison: The key difference highlighted is the material composition (HA PEEK vs. PEEK) and the study aims to prove equivalent performance despite this material difference.

In summary, the provided document relates to a traditional medical device (an implant) and its regulatory clearance based on non-clinical performance data, not an AI/ML device requiring a clinical performance study with human readers or AI algorithm performance metrics.

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Cure™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Defined as kyphosis, lordosis, or scoliosis), Pseudarthrosis, and Failed previous fusions.

Cure™ Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.

Cure™ Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The provided text describes the 510(k) premarket notification for the CURE™ Anterior Cervical Plate (ACP) System. This kind of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against defined acceptance criteria (as might be found for a novel device or AI/software product).

However, I can extract the information relevant to non-clinical testing which serves a similar purpose in this context: to show the device meets certain performance standards and is equivalent to the predicate.

Here's an analysis based on the provided text, framed as closely as possible to your request, acknowledging the limitations for an AI/software product's type of study:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (Anterior Cervical Plate System), the "acceptance criteria" are implied by the ASTM standards and the "performance" is demonstrated through equivalency.

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

• Sample Size: The document does not specify the exact number of plates, screws, or test repetitions used for the mechanical testing. It states "Testing... was performed."
• Data Provenance: The data comes from non-clinical (mechanical) testing performed by Meditech Spine, LLC, to establish equivalency to the predicate device. It is not patient or human data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the human data sense.

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

This is not applicable to this type of device and study. The "ground truth" for mechanical testing is defined by the objective measurements according to the ASTM standards and the performance of the predicate device. Expert consensus or qualifications for reading images/data are not relevant here.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing results are objective measurements and do not typically involve adjudication in the way clinical studies with human assessors would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for AI/software devices (especially in imaging) where human readers evaluate cases with and without AI assistance. This document is for a physical spinal implant device, and the evaluation is based on mechanical performance.

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

This is not applicable. This is not an algorithm or software device. The "standalone performance" refers to the device's mechanical integrity and performance according to engineering standards.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing is based on:

• Established ASTM (American Society for Testing and Materials) Standards: F1717 and F543. These standards define the methodologies and expected performance ranges for such devices.
• Performance of the Predicate Device: The CURE™ ACP System's performance was compared to a legally marketed predicate device (K072650 IST Anterior Cervical Plate and K926453 Synthes CSLP) to establish substantial equivalence. The predicate device's known mechanical performance serves as the benchmark.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or software algorithm that uses a "training set" of data.

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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Talos® Intervertebral Body Fusion Devices:

The Talos® IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos® IBF Devices are intended to be used with autograft comprised of cancellous and/or corticocancellous bone graft.

The Talos® IBF Device is to be used in patients who have had six months of non-operative treatment. Talos® IBF devices are to be implanted via a direct posterior, transforaminal, lateral, or anterior approach in the lumbosacral spine. The Talos®-A, Talos®-L, Talos®-T are intended to be used with supplemental fixation.

Talos®-C Cervical Intervertebral Body Fusion Devices:

The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in sketally mature patients with Degenerative Disc (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.

Talos®-C (HA) Cervical Intervertebral Body Fusion Devices:

Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Non-operative treatment prior to treatment with Talos@-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.

Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.

The Talos® IBF Device is made of polymer, polyetheretherketone (PEEK). The Talos® IBF Device is available in four configurations: Talos®-P, Talos®-L, and Talos®-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® –P and Talos® –L are rectangular devices and the Talos® – A have curved lateral walls and rounded edges. The implants are available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allow the Talos® IBF radiological confirmation for proper positioning.

The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.

The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.

This document is a 510(k) premarket notification for Meditech Spine, LLC's Talos® Intervertebral Body Fusion Devices. It focuses on changes to previously cleared devices, specifically the addition of allograft bone options and a change in marker material for cervical devices.

Based on the provided text, the device itself (hardware) has not undergone changes, but the submission is for modifications to the indications for use concerning bone graft material and material change for radiopaque markers. Therefore, the acceptance criteria and study information relate to demonstrating that these proposed changes do not introduce new safety or effectiveness concerns, and that the device remains substantially equivalent to its predicate devices.

Here's the breakdown of the requested information based solely on the provided text:

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

The document does not explicitly state "acceptance criteria" in a quantitative table format for device performance (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly that the modified indications and marker material do not increase risk and maintain substantial equivalence to the predicate devices. The "reported device performance" is framed in terms of clinical outcomes from published literature for similar devices.

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

• Test Set Sample Size: Not explicitly stated as a specific number of patients or cases. The document refers to "Published retrospective clinical data" rather than a newly conducted study by the submitter.
• Data Provenance: "Published retrospective clinical data for lumbar and cervical intervertebral body fusion devices similar to the Talos® Intervertebral Body Fusion Devices..." No specific country of origin is mentioned.

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

This information is not provided in the document. As the clinical data referenced is "published retrospective clinical data," details about expert review for ground truth within those studies would not typically be part of this 510(k) summary.

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

This information is not provided in the document, as it refers to existing published literature rather than a new study with a specific adjudication protocol.

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

• MRMC study done? No. This document is for intervertebral body fusion devices, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.
• Effect size of human reader improvement with AI? Not applicable.

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

• Standalone study done? No. This document is for intervertebral body fusion devices, not a standalone AI algorithm.

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

The document references "published clinical outcomes" for similar devices. This implies that the "ground truth" for the effectiveness of allograft in fusion procedures would be based on clinical outcomes data (e.g., fusion rates, patient reported outcomes, absence of complications) from those retrospective studies.

8. The sample size for the training set

The concept of a "training set" is not applicable here as this is not an AI/ML device being developed or validated. The document refers to existing published clinical literature.

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

Not applicable, as this is not an AI/ML device, and no "training set" in that context is referenced. The "ground truth" in the context of the referenced clinical literature would have been established through standard clinical follow-up and evaluation methods of the respective studies.

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Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion.

Non-operative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.

Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.

The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.

The provided document is a 510(k) summary for a medical device called Talos®-C (HA) Cervical Intervertebral Body Fusion Devices. This type of regulatory filing demonstrates substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed results for sensitivity, specificity, and other performance metrics typically associated with AI/software devices.

Therefore, the requested information elements related to AI device performance are not applicable and cannot be extracted from this document. This document focuses on the mechanical and material equivalence to a predicate device, as well as the indications for use.

Here's an analysis based on the information available:

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

The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or AUC as one would expect for an AI device. Instead, the acceptance criteria for this 510(k) submission are implied to be the successful demonstration of substantial equivalence to the predicate device, particularly in terms of mechanical function and properties.

The reported device performance is that the Talos®-C (HA) Cervical IBF Devices are equal in mechanical function and properties to the predicate device, thereby establishing equivalency in safety and effectiveness.

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 describes non-clinical mechanical testing of physical devices (implants), not a study involving patient data. Therefore, the concept of "sample size for the test set" in the context of patient data, data provenance, retrospective/prospective study, or country of origin is not applicable. The "test set" here refers to the physical devices manufactured and tested. The document does not specify the number of individual implants tested in each mechanical test, but it refers to standard ASTM methods, which typically involve a specified number of samples for statistical validity.

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

This is not applicable. The ground truth for mechanical testing is established by the physical measurements and standards defined in the ASTM test methods, not by expert human interpretation of data like in medical imaging.

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

This is not applicable as it pertains to human interpretation of data, which is not what this document describes.

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

This is not applicable. This submission is for mechanical spinal implants, not an AI device or software that assists human readers.

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

This is not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this device's performance is based on established engineering standards and physical measurements from mechanical testing (e.g., force, displacement, cycles to failure) as defined by ASTM 2077 and ASTM 2267.

8. The sample size for the training set

This is not applicable. The device is not an AI or machine learning model that requires a training set.

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

This is not applicable. The device is not an AI or machine learning model.

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