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The Altus Spine Cervical 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 C3-C7. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks 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 I spondylolisthesis at the involved level(s).

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

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

The Altus Spine Cervical 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) Summary for the Altus Spine Cervical Interbody Fusion System (K172253). It describes the device, its indications for use, and a summary of non-clinical tests conducted to establish substantial equivalence to predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not explicitly state numerical acceptance criteria for performance metrics. Instead, it relies on comparative testing to a predicate device. The general acceptance criterion is "substantially equivalent" to the predicate device.

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

• Sample Size: The document does not specify the sample size for each of the 8 different non-clinical tests performed. It only states that "8 different tests were conducted."
• Data Provenance: The tests are "non-clinical tests," meaning they were conducted in a lab setting (e.g., mechanical testing) rather than on human or animal subjects. The country of origin is not specified, but the submission is to the U.S. FDA. The data is prospective for the device under review, as these are tests performed on the actual device to support the 510(k).

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

This is not applicable to this type of submission. The "ground truth" here is established by standardized testing protocols (ASTM standards) and engineering principles, not by expert medical consensus on individual cases.

4. Adjudication method for the test set:

Not applicable. This is not a study involving human readers or interpretation of medical images. The evaluation is based on objective measurements from mechanical tests.

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 interbody fusion system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness study was performed or is relevant to this submission.

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

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

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

The "ground truth" for the non-clinical tests is defined by the requirements and test methods specified in the ASTM standards (F2077-14 and F2267-04), which are recognized industry standards for spinal implant testing. The performance of the test device is compared against the performance of the predicate device under these standardized conditions.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

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The Alamo C is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment prior to treatment with an intervertebral cage. The device system must be used with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.

The Alamo C is designed for use as a cervical intervertebral body fusion device. The device is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560 for radiographic visualization.

The device footprint has a hollow centre to accommodate bone graft to facilitate bone integration and fusion between the end plates from an anterior (ACIF) surgical approach. The device is available in various axial footprints and heights to accommodate variability among patients and the inferior and superior surfaces are designed with ridges to improve fixation and stability and prevent back out and migration.

Here's an analysis of the provided text regarding the Alamo C device, focusing on the requested information:

Summary of Acceptance Criteria and Study Details for Alamo C

The provided text describes a 510(k) submission for the "Alamo C" intervertebral body fusion device. Crucially, this submission is for minor modifications (additional axial footprints) to an already cleared device. Therefore, the "study" described is a mechanical performance study to demonstrate that these modifications do not negatively impact the device's safety and effectiveness compared to the predicate device. This is not a clinical study involving human subjects or AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document only mentions "Performance testing" and "mechanical testing." For mechanical testing, this typically refers to a set number of physical samples of the modified device.
• Data Provenance: The data is generated from mechanical testing of the device itself (likely in a lab setting). It is not clinical data from human subjects and thus doesn't have a "country of origin" or "retrospective/prospective" designation in the typical sense for clinical studies.

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

• This question is not applicable as this is a mechanical performance study, not a clinical study that requires expert judgment for ground truth.

4. Adjudication Method for the Test Set

• This question is not applicable for a mechanical performance study.

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

• No, an MRMC comparative effectiveness study was not done. This device is an intervertebral body fusion device, not an imaging or diagnostic AI tool that would typically undergo such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, this question is not applicable. The Alamo C is a physical medical device (an implant), not an algorithm or AI.

7. The Type of Ground Truth Used

• The "ground truth" for this study is the established performance standards and criteria defined by ASTM F2077 for intervertebral body fusion devices. The device's performance is compared against these pre-defined mechanical requirements.

8. The Sample Size for the Training Set

• This question is not applicable. There is no "training set" as this is a mechanical test of a physical device, not an AI model.

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

• This question is not applicable. There is no ground truth for a training set in this context.

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The C-Thru™ Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used as a vertebral body replacement device, the C.Thru™ Spacers are indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The C-Thru™ Spacers are also indicated to reartial vertebral body replacement for the treatment of fractures of the thoracic and luced to purch The C-Thru™ Spacers are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged proiod,

When used as a cervical intervertebral fusion device, the C-Thru Anterior Spinal System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radia graphic studies. These patients should have had six months of non-operative treatment. The C-Thru Spacers are intended for use with supplemental fixation and autogenous bone graft to facilitate the fusion.

The C-Thru™ Anterior Spinal System consists of a spacer constructed of medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.

This document, K092336, is a 510(k) premarket notification for a medical device called the C-Thru™ Anterior Spinal System, a type of intervertebral fusion device. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to prove effectiveness or meet novel acceptance criteria.

Therefore, the provided text does not contain information regarding traditional acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or comparative effectiveness studies in the context of AI or advanced diagnostic devices.

The document focuses on establishing substantial equivalence based on:

• Technological characteristics: Material, design, and sizing being similar to predicate devices.
• Intended use and indications: Being the same as or similar to predicate devices.
• Mechanical testing: To demonstrate that the device is substantially equivalent for its intended use to other spacers on the market.

Based on the provided text, I cannot complete the requested tables and descriptions because the document does not present a study with acceptance criteria and reported device performance in the way a diagnostic AI device or a new therapeutic device with novel claims would.

Here's why and what information is available:

Regarding Acceptance Criteria and Device Performance:

• No explicit acceptance criteria for device performance are listed. The "acceptance criteria" for a 510(k) submission are typically related to demonstrating substantial equivalence, e.g., showing mechanical properties are comparable to predicates, and that the device doesn't raise new questions of safety or effectiveness.
• No "reported device performance" in terms of clinical outcomes, sensitivity, specificity, or other diagnostic metrics are provided. The document states that "Based upon the mechanical testing, C-Thru™ Anterior Spinal System is substantially equivalent for its intended use to other spacers currently on the market," but it does not provide specific performance metrics from this testing.

Regarding Sample Sizes, Experts, and Ground Truth:

• No information is provided for sample sizes of test or training sets, data provenance, number or qualifications of experts, adjudication methods, or types of ground truth for clinical performance evaluation. This information is typical for diagnostic or AI device studies, not for a 510(k) for a spinal implant based on substantial equivalence to existing technology.
• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This is a physical implant, not an AI diagnostic assistant.
• No standalone (algorithm only) performance study was done. This is not an algorithm.

In summary, the K092336 document is about a specific type of medical device (spinal implant) and its regulatory pathway (510(k) substantial equivalence), which does not involve the kind of performance studies you are asking about, often seen with AI/diagnostic devices.

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