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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 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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