(147 days)
The Atlas Spine Pivoting System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.
The Atlas Spine Pivoting System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The Atlas Spine Pivoting System consists of an implant manufactured from PEEK-Optima and insertion tools. The PEEK-Optima implant is crescent-shaped and radiolucent. The implant design includes three (3) radiopaque, tantalum markers, which allow postoperative radiographic confirmation of the device position and orientation. The design also includes two (2) titanium alloy pins which secure the implant to an insertion tool for placement and deployment. The Atlas Spine Pivoting System is provided in various configurations and heights; containing hollow core to receive bone autograft.
The provided text describes the Atlas Spine Pivoting System, an intervertebral body fusion device. The document primarily focuses on its substantial equivalence to predicate devices for 510(k) clearance, rather than a detailed performance study with acceptance criteria and results.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it mentions that "Pre-clinical, mechanical testing was performed… in accordance with ASTM F-2077 and ASTM F-2267." The conclusion states that "Provided documentation demonstrates that the Atlas Spine Pivoting System is substantially equivalent to the aforementioned predicate devices. This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." This implies that the device met performance standards rather than specific, pre-defined acceptance criteria with quantified results within this document.
If we were to infer the "acceptance criteria" from the statement about substantial equivalence, it would be that the mechanical performance (static axial compression, expulsion, subsidence, dynamic axial compression) of the Atlas Spine Pivoting System is comparable to that of legally marketed predicate devices, as assessed by complying with ASTM F-2077 and ASTM F-2267. However, the specific numerical targets and results are not provided in this summary.
| Acceptance Criteria (Inferred) | Reported Device Performance (Implied) |
|---|---|
| Mechanical performance, including static axial compression, expulsion, subsidence, and dynamic axial compression, must meet standards equivalent to legally marketed predicate devices. | "Pre-clinical, mechanical testing was performed on the Atlas Spine Pivoting System. Testing consisted of static testing in a load to failure mode in axial compression; static testing in expulsion; static testing in subsidence; and dynamic axial compression testing to estimate the maximum run out load. Testing was performed in accordance with ASTM F-2077 and ASTM F-2267. Data have been submitted to characterize the performance of the Atlas Spine Pivoting System." |
| Design, materials, and functional characteristics must be substantially similar to legally marketed predicate devices. | "The intended use, design, materials and functional characteristics of the Atlas Spine Pivoting System and the predicate devices are substantially the same. The height, width, length and lordotic angles of the Atlas Spine Pivoting implant are within the ranges available for the predicate devices." |
| Indication for Use must be substantially similar to legally marketed predicate devices. | "This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." (Referencing comparison to Novel® Spinal Spacer System, Atlas Spine Spacer, Pivotec Lumbar Interbody Fusion Device). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the mechanical testing. The document states "Testing consisted of static testing..." and "dynamic axial compression testing," implying multiple tests were run, but the number of devices or test iterations is not provided.
- Data Provenance: The testing was "Pre-clinical, mechanical testing" performed by the manufacturer, Atlas Spine, Inc. The location of the test facility is not specified beyond the manufacturer's address in Jupiter, FL, USA. This is retrospective data collected for the purpose of a 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the pre-clinical mechanical testing described. The "ground truth" here is compliance with engineering standards (ASTM F-2077 and ASTM F-2267), not expert consensus on medical images or patient outcomes.
4. Adjudication method for the test set:
Not applicable. This was mechanical testing against engineering standards.
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 is a medical device (intervertebral body fusion device), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not an AI algorithm.
7. The type of ground truth used:
- For Mechanical Testing: Compliance with established engineering standards (ASTM F-2077 and ASTM F-2267) regarding mechanical properties and performance (e.g., load to failure, expulsion resistance, subsidence resistance, run-out load). The "ground truth" is adherence to these validated test methods and achieving results comparable to predicate devices.
- For Substantial Equivalence: Comparison to the design, materials, indications for use, and mechanical function of previously cleared predicate devices (Novel® Spinal Spacer System, Atlas Spine Spacer, Pivotec Lumbar Interbody Fusion Device).
8. The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model. There is no concept of a "training set" for the type of testing described here.
9. How the ground truth for the training set was established:
Not applicable. There is no training set mentioned or implied.
§ 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.