Search Results

When used with the bone screws, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one 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. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material.

When used with the SpinPlate, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. When used with the SpinPlate, the Integra Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The Integra Spine Vu aPOD Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate, is a stand alone device. If the Integra Spine Vu aPod Intervertebral Body Fusion Device is used only with the SpinPlate then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Vu aPOD Intervertebral Body Fusion Device consists of lumbar spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu aPOD spacers are manufactured from PEEK OPTIMA LT1 polymer per ASTM F2026 while the bone screws and SpinPlate are comprised of Titanium alloy (Ti-6AI-4V ELI) per ASTM F136. Radiographic markers present with the Vu aPOD spacers are comprised of tantalum per ASTM F560. The Vu aPOD Intervertebral Body Fusion Device is for lumbar spinal use at one or two contiguous levels from the L2-L3 to L5-S1 disc levels.

This document is a 510(k) summary for a medical device called the "Integra Vu aPOD Intervertebral Body Fusion Device." It describes the device, its intended use, material composition, and how it compares to a predicate device. Importantly, it includes information about performance standards but explicitly states that no clinical or animal testing was performed.

Therefore, based on the provided text, I cannot answer the requested questions about acceptance criteria, actual device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth for a study proving the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and similarity in design, materials, and other characteristics, rather than through performance in a clinical study.

Here's what I can extract and rephrase from the document regarding "acceptance criteria" and "performance" in the context of this 510(k) submission:

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

Explanation: The performance criteria here are the compliance with specific ASTM mechanical testing standards. The "reported device performance" is the conclusion that the device passed these tests to a degree that demonstrated substantial equivalence to the legally marketed predicate device (K101310). The 510(k) process relies on demonstrating equivalence rather than establishing new clinical safety and effectiveness through a full clinical trial.

For the remaining questions (2-9), the document explicitly states:

"Clinical Testing: There was no clinical or animal testing performed for this submission."

Therefore, I cannot provide answers for the following points as they relate to clinical or AI-based performance studies:

• 2. Sample size used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

This device falls under a category where mechanical testing for substantial equivalence to an existing device is typically sufficient for 510(k) clearance, rather than extensive clinical studies or AI performance evaluations.

Ask a specific question about this device

The Stainless Steel Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system (T1-S2/ilium), a posterior non-pedicle screw fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of alternative varieties of pedicle screws and surgical instruments to provide surgeons with further options for implant placement and deformity correction. The Stainless Steel Spinal System components can be rigidly locked together creating a construct for promoting fusion. The individual implant components are fabricated from medical grade stainless steel alloy 316 LVM described by such standards as ASTM F 138 and ISO 5832-1.

The provided text describes a medical device, the Stainless Steel Spinal System, and its substantial equivalence to a predicate device based on performance tests. However, it does not include information about AI or machine learning. Therefore, I cannot answer most of your detailed questions regarding acceptance criteria, study design, expert involvement, or ground truth establishment in the context of an AI device.

Here's what I can extract from the provided text regarding the device's performance based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not Available in the Provided Text for AI-related questions):

• Sample size used for the test set and the data provenance: Not applicable as this is a mechanical device, not an AI system using a test set of data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Explanation of the Provided Information:

The Stainless Steel Spinal System is a physical medical device. The "acceptance criteria" for this device are based on mechanical performance standards (ASTM F-1717 and ASTM F-1798) for spinal implant constructs. The study performed involved conducting these mechanical tests on the device. The reported performance is that the "construct performed as designed and met or exceeded all product specifications," which indicates successful fulfillment of the acceptance criteria based on these mechanical standards.

The document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device, primarily through material composition, design concept, indications for use, manufacturing, and performance testing for physical, non-AI devices. There is no mention of AI, machine learning, or software components that would require the kind of data-driven performance analysis you've asked about (e.g., test sets, ground truth, expert review).

Ask a specific question about this device

The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The purpose of this submission is the addition of the Malibu adjustable cross connector from SeaSpine Inc. to the Coral™ Spinal System. Cross connectors are used to connect the bi-lateral rods of a spinal construct to add torsional rigidity. The cross connectors are available in two styles, straight and contoured, the different styles offer the surgeon options intraoperatively. The straight cross connector offers the surgeon a low profile compared to the surrounding construct. The contoured cross connector offers surgeons an option that is slightly higher in profile but provides additional clearance between the cross connector and the spinal construct.

The information provided describes a medical device submission (K120047) for the Coral™ Spinal System and its expansion with the Malibu adjustable cross connector. It focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and mechanical testing, rather than presenting a study of device performance against specific clinical acceptance criteria.

Therefore, many of the requested categories for acceptance criteria and the study proving adherence cannot be directly addressed from the provided text, as they pertain to clinical or functional performance. The document primarily describes mechanical performance tests to establish substantial equivalence.

Here's the breakdown based on the provided text, with "N/A" for information not present in the document:

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

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

• Sample Size: Not specified for the mechanical tests.
• Data Provenance: N/A (mechanical tests, not clinical data)

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

• N/A (Ground truth is not relevant for mechanical performance testing establishing substantial equivalence.)

4. Adjudication method for the test set

• N/A (Adjudication is not relevant for mechanical performance testing establishing substantial equivalence.)

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: No.
• Effect Size: N/A (This device is a spinal fixation system, not an AI-assisted diagnostic tool.)

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

• No. (This device is a spinal fixation system, not an algorithm.)

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

• The "ground truth" for the device's performance is its ability to meet the mechanical standards outlined in ASTM F-1717. This is based on engineering and physical testing standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• N/A (This pertains to mechanical testing and substantial equivalence, not a machine learning model's training set.)

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

• N/A (Not applicable for this type of submission.)

Ask a specific question about this device