(116 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new worst-case performance compared to the predicate device. | The engineering analysis demonstrated that the Altus Spine Titanium Interbody Fusion System does not present a new worst case in performance compared to the predicates. |
| Substantial equivalence to predicate devices (K170512 and K160976) in terms of function, strength, and stability. | The system is considered substantially equivalent to the predicate devices, and no new questions of safety or effectiveness are raised. This is based on the determination that the modifications (larger graft windows and an additional implant footprint) do not alter the system function, strength, and stability. |
| Conformance to ASTM F136 (for titanium alloy material). | The Altus Spine Titanium Interbody Fusion System implants are made of titanium alloy (Ti-6Al-4V) that conforms to ASTM F136. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.