(133 days)
The ALTERA™ Spacer is an interbody fusion device in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s).
The ALTERATM Spacer is to be tilled with autogenous bone graft material. The device is intended to be used with supplemental fixation.
The ALTERA™ Spacer is an expandable lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The ALTERA™ Spacer accommodates various surgical approaches to the lumbar spine (posterior or transforaminal [posterolateral]) and allows articulation upon insertion. The device is available in various height ranges, allowing continuous expansion within the range, to fit the anatomical needs of a wide variety of patients. This device is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
The ALTERA™ Spacer is made from titanium allov, as specified in ASTM F136. F1295, and F1472. Internal components are made from radiolucent PEEK polymer and cobalt chromium molybdenum alloy, as specified in ASTM F2026 and F1537.
This document describes the ALTERA™ Spacer, an intervertebral body fusion device. The provided text is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a standalone clinical study report for device performance against specific acceptance criteria.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not present in this document. This typically means that the detailed performance evaluation for this type of device relies on non-clinical (mechanical) testing and comparison to predicate devices, rather than clinical trials with human subjects and ground truth established by experts.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Static and dynamic compression, static and dynamic compression shear, and subsidence in accordance with: |
- "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device." June 12, 2007
- ASTM F2077
- ASTM F2267 | "Results demonstrate that the ALTERA™ Spacer performs equivalently to or better than the predicate CALIBER® Spacer." |
| Biocompatibility | (Not explicitly stated, but implied by material selection conforming to ASTM standards and substantial equivalence) | Device made from titanium alloy (ASTM F136, F1295, F1472), PEEK polymer (ASTM F2026), and cobalt chromium molybdenum alloy (ASTM F1537). These materials are generally recognized as biocompatible for implantable devices. |
| Materials | Conformance to specified ASTM standards for implantable medical devices. | Conforms to ASTM F136, F1295, F1472 (titanium alloy), ASTM F2026 (PEEK), and ASTM F1537 (cobalt chromium molybdenum alloy). |
| Design / Function | Similar to predicate systems in technical characteristics, performance, design, materials, and intended use. | "The ALTERA™ Spacer is similar to the predicate systems with respect to technical characteristics, performance, design, materials, and intended use." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance data section refers to mechanical testing, not a test set of human subjects or patient data. The "sample size" would refer to the number of devices or test specimens used in the mechanical tests. The provenance would refer to the lab where tests were conducted, which is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the document describes mechanical testing, not a study involving human subjects or expert assessment for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #3.
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
This information is not applicable. This device is a physical interbody fusion device, not an AI software or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through mechanical testing standards (ASTM F2077, ASTM F2267) and comparison to the mechanical performance of predicate devices. There is no clinical "ground truth" from pathology or outcomes data presented in this 510(k) summary for the device itself proving its safety and effectiveness in human subjects directly, beyond the substantial equivalence claim.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not a machine learning model that requires a training set. The "training" for such a device would refer to its design and manufacturing processes.
9. How the ground truth for the training set was established
This information 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.