(84 days)
The PERIMETER® Interbody Fusion Device is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. 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 six months of non-operative treatment. Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and oblique. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
The PERIMETER® Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The PERIMETER® Interbody Device is to be used with supplemental instrumentation.
The device is offered in Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI ) or PEEK Optima LT1 (Polyetheretherketone). This interbody device is provided in sterile forms. Refer to the package label for specific implant sterility information.
The PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 21mm to 28mm in length and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4 degrees to 15 degrees of angulation. Both the PEEK Optima LT1 and Titanium Alloy devices are designed with teeth across both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance. Additionally, the Titanium Alloy version of this device offers lateral windows for visibility of the Autogenous bone graft.
This 510(k) summary describes a medical device, not an AI/ML powered device, therefore, many of the typical acceptance criteria for AI/ML performance metrics are not applicable. The device is the PERIMETER® Interbody Fusion Device, an implant used for interbody fusion in the spine. The "study" mentioned refers to non-clinical tests conducted to prove substantial equivalence to a predicate device.
Here's the information based on the provided text, recognizing the difference in device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test/FDA Guidance | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Dynamic Axial Compression Bending | ASTM 2077-03 "Test Methods for Intervertebral Body Fusion Devices" | Meet all acceptance criteria specified in ASTM 2077-03. | The subject device successfully met all acceptance criteria for these tests. |
| Static Compression Bending | An Finite Element Analysis in line with ASTM 2077-03 | Substantially equivalent to the predicate PERIMETER® Interbody Fusion Device. | Additional documentation was provided which demonstrated the subject intervertebral devices to be substantially equivalent to the predicate PERIMETER® Interbody Fusion Device. |
| Static Compression Shear | An Finite Element Analysis in line with ASTM 2077-03 | Substantially equivalent to the predicate PERIMETER® Interbody Fusion Device. | Additional documentation was provided which demonstrated the subject intervertebral devices to be substantially equivalent to the predicate PERIMETER® Interbody Fusion Device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" in the context of clinical trials or data analysis. The performance evaluation was based on non-clinical mechanical testing. For the mechanical tests, the sample size would refer to the number of physical devices tested or the specifications of the finite element analysis model. This information is not provided in the summary.
- Data Provenance: Not applicable as this refers to non-clinical, in-vitro/computational testing, not patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. For mechanical testing, the "ground truth" is defined by the physical laws and engineering standards (e.g., ASTM 2077-03). Expert interpretation would be involved in designing the test and analyzing results, but not in establishing a "ground truth" in the sense of clinical diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies among expert readers. This document details mechanical testing, not clinical reader studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No. This is a mechanical device, not an AI/ML system that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to an implantable medical device, not an algorithm. The performance described is the device's inherent mechanical properties.
7. The type of ground truth used
- The "ground truth" for the mechanical performance tests is established by engineering standards and physical principles as outlined in ASTM 2077-03 and finite element analysis (FEA) methodology. The goal was to demonstrate performance equivalent to a predicate device.
8. The Sample Size for the Training Set
- Not applicable. This document describes a medical device, not an AI/ML system. There is no concept of a "training set" in this context. The device's design and properties are based on engineering principles and materials science.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth to be established for it. The device's design is based on established engineering and biomechanical principles for intervertebral fusion devices, not on data training.
§ 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.