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The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw fixation at the vertebral bodies of the cervical spine (C2-C7). The Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain in discogenic origin of the disc confirmed by patient history and radiographic studies with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity (defined as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

The Qualgenix Blue Mountain Cervical Plate is a system that includes titanium alloy (ISO 5832-3) plates and screws that are intended to stabilize the spine during the interbody fusion process.

The provided text describes a 510(k) summary for the Qualgenix Blue Mountain Cervical Plate, a spinal fixation device. However, this document does not describe an AI medical device or a study involving AI performance. It details a traditional medical device submission, focusing on substantial equivalence to predicate devices through material and mechanical testing.

Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies cannot be extracted from this document, as it pertains to a different type of medical device evaluation.

Below is a partial response based on the information that is available, specifically for mechanical testing.

Acceptance Criteria and Study for Qualgenix Blue Mountain Cervical Plate

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing indicates the device is "substantially equivalent to predicate devices" and was performed "per ASTM F1717-10". This implies that the device's performance results met or exceeded the established benchmarks derived from the predicate devices under the specified ASTM standard.

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

This information is not provided in the document. For mechanical testing, sample sizes would refer to the number of physical devices or components tested. The document does not specify these numbers or the provenance of any data beyond indicating "testing performed on this device."

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

This is not applicable to this type of device and study. The study involves mechanical performance testing against an ASTM standard, not clinical data requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and study. Mechanical tests follow predefined protocols and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. This study concerns the mechanical equivalence of a spinal implant, not the diagnostic or interpretative performance of an AI system or human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the mechanical performance study, the "ground truth" or benchmark was established by testing per ASTM F1717-10 and demonstrating substantial equivalence to predicate devices. This means the performance of the predicate devices under this standard served as the reference.

8. The Sample Size for the Training Set

This is not applicable as this study does not involve an AI algorithm or a "training set" in the context of machine learning.

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

This is not applicable as this study does not involve an AI algorithm or a "training set."

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The Qualgenix Ayers Rock Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. These patients should have had 6 weeks of non-operative treatment. The Qualgenix Ayers Rock Cervical Cage implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The Qualgenix Ayers Rock Cervical Cage is to be used with supplemental fixation.

The Ayers Rock Cervical Cage consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Ayers Rock Cervical Cage is manufactured from PEEK OPTIMA LT1 polymer. The Ayers Rock Cervical Cage is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.

The provided text describes a medical device, the Qualgenix Ayers Rock Cervical Cage, and its clearance through the 510(k) pathway. This pathway focuses on demonstrating substantial equivalence to a predicate device rather than conducting clinical trials to establish new safety and effectiveness. Therefore, the information typically requested regarding acceptance criteria based on a study, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (like MRMC) is not applicable or not provided in this type of submission for this particular device.

Here's a breakdown of the available information in relation to your request:

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

The provided document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity) for device performance in a clinical study. Instead, the device's acceptance is based on demonstrating substantial equivalence to predicate devices through preclinical testing and comparison of indications, design, and function.

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

Not applicable. The clearance is based on preclinical testing and comparison to predicate devices, not a clinical study with a "test set" of patients or data provenance in the context of clinical outcomes.

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 clinical studies, refers to definitive diagnoses or outcomes. For medical devices cleared via 510(k), especially for implants, the "truth" is established through engineering and biomechanical testing demonstrating equivalence to established devices, not expert consensus on patient data.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication in the way it's done for diagnostic algorithms.

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 implantable cervical cage, not a diagnostic AI device that would involve human readers or AI assistance in reading medical images.

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

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

7. The type of ground truth used

The "ground truth" for the Ayers Rock Cervical Cage is established through preclinical testing results (biomechanical and mechanical testing) demonstrating that its performance characteristics (e.g., static compression, dynamic compression, subsidence, expulsion) are equivalent to those of the predicate devices. The equivalence in design, materials (PEEK OPTIMA LT1 polymer), and intended use also serves as a critical part of the "truth" in the 510(k) context.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device 510(k) submission, as it's not an AI/algorithm-based device.

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

Not applicable, as there is no training set.

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The Mont Blanc Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

The Mont Blanc Pedicle Screw System is comprised of a variety of monoaxial and polyaxial pedicle screws and rods. The rods are provided straight and intended to interface with the screws, which are traditional saddle design. This device is intended to be used with bone graft to provide immobilization and stabilization of a spinal segment as an adjunct to fusion. The Mont Blanc Pedicle Screw System is fabricated from wrought Ti-6Al-4V (ISO 5832-3).

The provided text is a 510(k) summary for a medical device called the "Mont Blanc Pedicle Screw System." It describes the device, its intended use, and the basis for its substantial equivalence to previously cleared devices.

However, the questions you've asked are about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of device performance, sample sizes for test and training sets, expert review, and ground truth establishment.

Based on the provided document, the device described is a pedicle screw system, which is an orthopedic implant. For this type of device, "performance testing" typically refers to mechanical testing to ensure the device's structural integrity and durability, rather than a clinical study evaluating diagnostic accuracy or algorithmic performance as would be the case for an AI/ML device.

Therefore, the information you are requesting about

1. Acceptance criteria and reported device performance (in terms of sensitivity, specificity, etc.)
2. Sample sizes for test set and data provenance
3. Number of experts and qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study
6. Standalone algorithm performance
7. Type of ground truth (pathology, outcomes data, etc.)
8. Sample size for training set
9. How training set ground truth was established

is not present in the provided 510(k) summary.

The document states:

• Performance Testing: "Testing performed indicates the Mont Blanc Pedicle Screw System is substantially equivalent to predicate devices. Testing included mechanical testing per ASTM F1717, including static and dynamic compression bending and static torsion." This refers to laboratory-based mechanical tests, not clinical studies.
• Acceptance Criteria: These would be defined by the ASTM F1717 standard for pedicle screw systems (e.g., minimum loads for static and dynamic failure, or deformation limits) but are not explicitly detailed in the summary.
• Device Performance: The documented performance is that it met the requirements of ASTM F1717, showing it is "substantially equivalent" to predicate devices. Specific numerical results from these tests (e.g., actual breaking strength values) are not provided in this summary.

In summary, this document does not contain the type of information you are asking for, which is typically found in submissions for AI/ML-driven diagnostic devices or devices that rely on complex data analysis and expert interpretation. It describes a traditional, passive mechanical implant.

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The Qualgenix Twin Peaks Lumbar Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The Qualgenix Twin Peaks Lumbar Cage is to be used with supplemental fixation.

The Qualgenix Twin Peaks Lumbar Cage consists of lumbar spinal interbody fusion devices in 20mm and 25mm footprints as well as instrumentation designed specifically for the implantation of these devices. The cage is manufactured from PEEK OPTIMA LT1 polymer. Bone graft is intended to be placed in the middle of the device.

The provided text describes a medical device, the Qualgenix Twin Peaks Lumbar Cage, and its 510(k) summary for FDA clearance. However, the document does not contain information related to software performance, AI algorithms, or clinical studies involving human readers or ground truth establishment for diagnostic purposes, which are typically found in submissions for AI/ML-enabled devices.

Instead, this document focuses on the mechanical and material performance of a medical implant and its substantial equivalence to predicate devices. Therefore, I cannot provide a response that includes acceptance criteria and study details relevant to an AI-powered diagnostic device based on the given text.

The information provided pertains to:

• Device Trade Name: Twin Peaks Lumbar Cage
• Manufacturer: Qualgenix
• Indications For Use: Intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.
• Device Description: Lumbar spinal interbody fusion devices made of PEEK OPTIMA LT1 polymer, with 20mm and 25mm footprints.
• Predicate Devices: DePuy Spine Lumbar Cages (K081917), SpineArt Juliet Cage (K101710), and Scient'X Tribeca Cage (K080588).
• Performance Standards/Testing: Preclinical testing per ASTM F2077 (static compression, static torsion, dynamic compression), expulsion testing, and ASTM F2267 (subsidence testing). These standards evaluate the physical and mechanical properties of the implant.

Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance (in the context of AI/ML), sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types related to an AI device.

The document states that performance standards were met through preclinical testing to demonstrate substantial equivalence, not through clinical or diagnostic performance studies typical for AI/ML products.

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