(147 days)
The Signature Orthopaedics Arlington PLIF/TLIF system is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLIF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.
The Signature Orthopaedics Arlington PLIF/TLIF cages are manufactured from PEEK OPTIMA LT1 per ASTM-F2026.
The Arlington PLIF/TLIF cage is intended for implantation by a posterior or transforminal approach. The device consists of a rectangular cage geometry with a bulleted tip to ease insertion and serrated teeth on the inferior and superior surfaces to resist expulsion from the disc space. The center of the cage is hollow to allow loading of bone graft.
This document is a 510(k) premarket notification for a medical device called the Arlington PLIF/TLIF Cage, an intervertebral body fusion device. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your request, highlighting what information is available and what is not available within this document:
1. A table of acceptance criteria and the reported device performance
The document provides the following:
| Acceptance Criteria (Standard) | Reported Device Performance (Testing Conducted) |
|---|---|
| ASTM-F2077 Test Method for Intervertebral Body Fusion Devices | Static and dynamic axial compression and compression shear testing |
| ASTM-F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression | Subsidence testing |
Detailed reported performance (e.g., specific load values, deflection, or subsidence measurements) is NOT provided in this document. The document only states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Arlington PLIF/TLIF is adequate for anticipated in-vivo use" and "Non-clinical testing results support the substantial equivalence decision." This implies that the device met the requirements of the standards, but the specific numerical outcomes are absent.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document states "non-clinical testing and engineering evaluations" were conducted, but does not mention how many test samples (e.g., cages) were used for each test.
- Data provenance: Not explicitly stated as retrospective or prospective given this is non-clinical performance testing. The manufacturer is Signature Orthopaedics Pty Ltd from Australia, implying the testing was conducted either in Australia or at an accredited testing facility that may be in another country.
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)
Not applicable. This document describes non-clinical, mechanical performance testing of an implantable device, not a diagnostic or AI-driven device that requires human expert review for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this is mechanical testing, not a study involving human adjudication of clinical data.
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 notice is for a physical implant (intervertebral cage), not an AI diagnostic or assistance tool. Therefore, no MRMC study or AI-related effectiveness is mentioned or relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For mechanical testing, the "ground truth" refers to the established standards and specifications (ASTM-F2077 and ASTM-F2267) and the physical properties and behavior of the materials and device under controlled testing conditions. There is no biological or expert consensus "ground truth" as would be for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
Summary of available information:
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on material composition, intended use, indications for use, and a statement that non-clinical mechanical performance testing (static/dynamic axial compression, compression shear, and subsidence testing) against specific ASTM standards (F2077, F2267) was conducted and supported equivalence. However, it does not provide the detailed quantitative results of these performance tests, nor does it address evaluation criteria relevant to AI/diagnostic devices.
§ 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.