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The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).

The Altus Spine Interbody Fusion is to be combined with cleared supplemental fixation systems.

The Altus Spine Titanium Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Titanium Interbody Fusion System implants are made of PEEK with Tatalum conforming to ASTM F2026 and ASTM F560 and Titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

The Altus Spine Titanium Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

The provided document is a 510(k) premarket notification letter from the FDA for the "Altus Spine Interbody Fusion System." This letter and the accompanying 510(k) summary pertain to a medical device (an intervertebral body fusion device) and not an AI or software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

1. Indications for Use: The system is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at specific spinal levels (L2-S1), requiring six months of non-operative treatment, and may include patients with previous non-fusion surgery or Grade 1 spondylolisthesis. It must be combined with cleared supplemental fixation systems.
2. Technological Characteristics: The purpose of this submission is to include PEEK and Titanium alloy intervertebral body fusion devices into the existing Altus Spine Interbody Fusion System family. The core design and fundamental technology remain the same as the predicate devices, with only minor dimensional changes.
3. Non-Clinical Tests: Engineering analysis was presented to demonstrate that the revised system does not present a new worst-case performance and is substantially equivalent to the predicates. This typically involves mechanical testing (e.g., static and dynamic compression, torsion) to show the device meets established performance standards for interbody fusion devices, but specific details of these tests or their acceptance criteria are not provided in this summary.

In summary, as this is a medical device clearance based on substantial equivalence, the type of information requested (AI/SaMD-specific details) is not present in this document.

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The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis at the involved level(s).

The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

The Altus Spine Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Interbody Fusion System implants are made of Polyetheretherketone (PEEK) that conforms to ASTM F2026 (Invibio PEEK-Optima® LT1 or Solvay Specialty Polymers Zeniva™ ZA-500 PEEK), and titanium alloy conforming to ASTM F136 or tantalum conforming to ASTM F560. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Tantalum wire markers are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and poster-operatively.

The Altus Spine Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

This document is a 510(k) premarket notification for the "Altus Spine Interbody Fusion System." It describes a medical device, its intended use, and claims substantial equivalence to previously cleared devices.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device.

The document describes a physical medical device (an intervertebral body fusion device) made of PEEK and titanium/tantalum. The performance evaluation mentioned is mechanical testing in accordance with ASTM F2077 and ASTM F2267 for static and dynamic compression, shear compression, subsidence, and expulsion. This is a standard evaluation for implantable orthopedic devices, not an AI/ML clinical performance study.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance as it relates to AI/ML.

Here's why the provided text isn't relevant to your request:

• Device Type: This is a physical intervertebral fusion device, not an AI/ML-powered diagnostic or therapeutic tool.
• Performance Evaluation: The "non-clinical tests" mentioned are mechanical tests for the structural integrity and stability of the implant, not clinical performance metrics typical for AI/ML algorithms (like sensitivity, specificity, AUC, recall, etc.).
• No AI/ML Components: The document does not mention any artificial intelligence, machine learning, software, or algorithms as part of the "Altus Spine Interbody Fusion System."

If you have a different document related to an AI/ML device, please provide it.

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The Altus Spine Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Altus Spine Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

The Altus Spine Interbody Fusion System implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Altus Spine Interbody Fusion System implants are made of Polyetheretherketone (PEEK) that conforms to ASTM F2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. Tantalum wire markers are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and poster-operatively.

The Altus Spine Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device.

This document describes the Altus Spine Interbody Fusion System and its substantial equivalence to predicate devices, rather than a study evaluating the performance of a device against specific acceptance criteria in a clinical or AI context.

Therefore, the requested information elements related to AI/algorithm performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to this document. This document focuses on the mechanical testing of a medical implant and its equivalence to previously approved devices.

However, I can extract the information related to the device's characteristics and the non-clinical tests performed:

1. Table of Acceptance Criteria and Reported Device Performance:

Further details on the requested information are not available in the provided text, as this document is a 510(k) summary for a medical device rather than a performance study of an AI or diagnostic tool.

Here's why the other points are not applicable:

• 2. Sample size used for the test set and the data provenance: This relates to human or image data for an algorithm. The document describes mechanical tests on physical devices.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic task or human ground truth required for mechanical testing of an interbody fusion system.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical device 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, as this is not an AI diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for mechanical device testing; the "ground truth" here is adherence to mechanical performance standards.
• 8. The sample size for the training set: Not applicable, as no algorithm training is involved.
• 9. How the ground truth for the training set was established: Not applicable, as no algorithm training is involved.

In summary, this document is a regulatory submission for a physical medical device, not a performance study of a diagnostic algorithm.

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