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

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 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.

This document is a 510(k) summary for the Altus Spine Titanium Interbody Fusion System (K171329). It describes the device, its intended use, and its substantial equivalence to previously cleared devices.

Based on the provided text, the following information can be extracted regarding acceptance criteria and the "study" (engineering analysis) that supports the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Engineering analysis," not a clinical study involving human patients or a specific test set of data in the typical sense for AI/software devices. Therefore, the questions about sample size and data provenance are not applicable in the context of this device and submission. This is a medical device clearance for an implant, not an AI/diagnostic software.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the clearance is for a physical medical implant, not an AI or diagnostic device requiring expert interpretation of data to establish ground truth. The "ground truth" here is the engineering and material properties of the device itself.

4. Adjudication Method

This information is not applicable as there is no independent review of "cases" or interpretations in this type of submission.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data, and AI assistance is being evaluated. This submission is for a physical orthopedic implant.

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

No, a standalone algorithm performance study was not done. This submission is for a physical orthopedic implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering principles and analysis: Demonstrating that changes to the device (larger graft windows, additional implant footprint) do not negatively impact its performance, strength, or stability compared to the predicate.
• Material specifications: Conformance to ASTM F136 for the titanium alloy.
• Established predicate device performance: The predicate devices (K170512, K160976) have already been deemed safe and effective, and the current device is shown to be substantially equivalent.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this engineering analysis for a physical medical implant.

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

This is not applicable for the same reasons as #8.

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