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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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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.

The provided text is a 510(k) premarket notification decision letter from the FDA for the Altus Spine Titanium Interbody Fusion System. It states that the device is substantially equivalent to legally marketed predicate devices.

The document discusses the mechanical properties and design equivalency, but it does not describe any clinical study or provide acceptance criteria related to device performance in a clinical setting (such as accuracy, sensitivity, specificity, etc.) for an AI/ML device.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving device performance in the context of an AI/ML device, as this document pertains to a medical device for spinal fusion that does not appear to involve AI/ML.

Here's why some of the requested points are not applicable to the provided document:

• A table of acceptance criteria and the reported device performance: This document focuses on demonstrating substantial equivalence based on material and design, not clinical performance metrics for an AI/ML system.
• Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: 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: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document states that "Engineering analysis was presented to demonstrate that the Altus Spine Titanium Interbody Fusion System does not present a new worst case in performance and is substantially equivalent to the predicates." This refers to mechanical integrity and design equivalence, not AI/ML performance.

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