(293 days)
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:
| Acceptance Criteria (Test Method) | Reported Device Performance (Summary) |
|---|---|
| Static Compression Shear and Compression (ASTM F2077-14) | Mechanical testing performed to demonstrate equivalence (Details of specific pass/fail values not provided in this summary). |
| Dynamic Compression Shear and Compression (ASTM F2077-14) | Mechanical testing performed to demonstrate equivalence (Details of specific pass/fail values not provided in this summary). |
| Subsidence (ASTM F2267) | Mechanical testing performed to demonstrate equivalence (Details of specific pass/fail values not provided in this summary). |
| Expulsion (FDA Guidance) | Mechanical testing performed to demonstrate equivalence (Details of specific pass/fail values not provided in this summary). |
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.
§ 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.