(230 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. 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 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. This device is offered in both titanium alloy and PEEK (POLYETHERETHERKETONE) versions. This interbody device is provided in both sterile and non-sterile forms. Refer to the package label for sterility information. The subject PERIMETER® Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height and between 19mm and 28mm in width. The device is designed with teeth across both superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion resistance.
The provided text is a 510(k) summary for the PERIMETER® Interbody Fusion Device. It focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing and literature review. It does not contain information about clinical studies with human participants, AI algorithms, or detailed performance metrics that would typically be found in an acceptance criteria and study section for a medical device with an AI component.
Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
Here's what I can infer from the document and how it relates to the requested information:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices. This is demonstrated through mechanical testing results and published literature, which would compare the PERIMETER® device's mechanical properties (e.g., strength, stiffness, resistance to expulsion) to those of the predicate devices. The document does not explicitly state numerical acceptance criteria, but rather implies they would be "comparable" or "equivalent" to the predicate devices.
- Reported Device Performance: The document states "Documentation, including mechanical test results and published literature, was provided which demonstrated that the subject PERIMETER® Interbody Fusion Device is substantially equivalent to several recently down classified interbody cages..." This indicates that performance was evaluated mechanically, but the specific numerical results or metrics are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document refers to mechanical test results, not clinical test sets with human data. Therefore, there is no information on human sample sizes, data provenance, or retrospective/prospective study design in this submission. Mechanical testing typically involves a set number of devices tested under specific conditions.
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 submission is based on mechanical testing and comparison to predicate devices, not human-read interpretations or ground truth established by medical experts for a diagnostic or AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as this is related to human interpretation of data, which is not the focus of this 510(k) summary.
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:
- No, this document does not mention any MRMC study, AI, or human-in-the-loop performance. It pre-dates widespread AI integration in medical devices and focuses on the physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, there is no mention of any algorithm or standalone performance being evaluated.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" here would be the mechanical properties and performance specifications of the predicate devices, against which the PERIMETER® device was compared. The exact tests and their respective "ground truth" values (e.g., maximum load at failure, subsidence measurements) are not detailed but are implied to be part of the documentation submitted to the FDA.
8. The sample size for the training set:
- Not applicable. This is not an AI-based device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
In summary, this 510(k) summary for the PERIMETER® Interbody Fusion Device pertains to a physical medical implant and demonstrates substantial equivalence through mechanical testing and literature review, not through clinical trials or studies involving AI algorithms. Therefore, most of the requested information regarding AI device performance metrics, human reader studies, and ground truth establishment for diagnostic purposes is not present in the provided text.
§ 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.