(350 days)
The II-Type Intervertebral Spacer is intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of non-operative treatment prior to treatment with an intervertebral cage. The II-Type Intervertebral Spacer is to be implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
II-Type Intervertebral Spacer consists of PEEK cages of various widths and heights, which include Ta markers, 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 autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft.
The provided text is for a medical device called an "II-Type Intervertebral Spacer," which is a physical implant used in spinal fusion surgery. This type of device does not typically involve AI, thus the questions regarding AI performance, human-in-the-loop, and training sets are not applicable.
Here's an analysis of the provided information concerning acceptance criteria and the study proving the device meets them:
1. Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance testing for the "II-Type Intervertebral Spacer" to demonstrate its substantial equivalence to predicate devices. The acceptance criteria are implicitly defined by the chosen ASTM standards, and the reported performance indicates that the device met these standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Compliance with ASTM F2077-11 for static and dynamic axial compression, static torsion, and static compression-shear tests | "Paonan has submitted data from testing performed in compliance with ASTM F 2077-11 including static and dynamic axial compression test, static torsion test, static compression-shear test... demonstrate that the II-Type Intervertebral Spacer is substantially equivalent to legally marketed lumbar interbody fusion and is therefore appropriate for use in lumbar interbody fusion as described in the indication above." The implication is that the performance was within acceptable limits as defined by the standard and comparative data with predicate devices. |
| Compliance with ASTM F2267-04 for subsidence testing | "...and ASTM F 2267-04 subsidence test using samples each of a worst case construct demonstrate that the II-Type Intervertebral Spacer is substantially equivalent to legally marketed lumbar interbody fusion and is therefore appropriate for use in lumbar interbody fusion as described in the indication above." The implication is that the subsidence performance was within acceptable limits as defined by the standard and comparative data with predicate devices. |
| Biocompatibility | "The II-Type Intervertebral Spacer are entirely made of Poly Ether Ketone (PEEK), a biocompatible material..." This implicitly meets the acceptance criterion for biocompatibility. |
| Modulus characteristics similar to vertebral bone | "...a biocompatible material with modulus characteristics similar to vertebral bone." This implicitly meets the acceptance criterion for mechanical properties relevant to bone. |
| Radiolucency (allowing imaging follow-up) | "They are fully radiolucent, which enables optimum follow-up with diagnostic imaging, as the interbody fusion progresses." Implied acceptance. |
| Radiological confirmation of cage position post-operatively | "Two metal wires at the opposite ends of the cage allow radiological confirmation of the cage position post operatively." Implied acceptance. |
| Substantial Equivalence to predicate devices in technical characteristics, performance, and intended use | "The II-Type Intervertebral Spacer has been demonstrated to be substantially equivalent to predicate system with respect to technical characteristics, performance, and intended use." This is the overarching conclusion of the submission. |
2. Sample size used for the test set and the data provenance:
- Sample size: The document states that testing was performed "using samples each of a worst case construct." It does not specify the exact number of samples for each test (e.g., 5 samples for axial compression, 3 for torsion, etc.), but it refers to "samples" in plural.
- Data provenance: The data is based on non-clinical (in vitro/mechanical) testing performed by Paonan Biotech Co., Ltd. The country of origin for the testing itself isn't explicitly stated, but the company is located in Taiwan, R.O.C. This is a prospective test specifically conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the device is a physical intervertebral spacer being evaluated through mechanical and materials testing against engineering standards, not through clinical trials or expert assessment of diagnostic images that would require "ground truth" established by human experts.
4. Adjudication method for the test set:
This question is not applicable for the same reasons as #3. Mechanical testing results are objective measurements against specified standard limits, not subjective interpretations requiring adjudication.
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 question is not applicable. The device is a physical implant for spinal fusion and does not involve AI or diagnostic imaging interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable. There is no algorithm associated with this device.
7. The type of ground truth used:
The "ground truth" for this device's acceptance is based on:
- Engineering standards: Specifically, compliance with ASTM F2077-11 and ASTM F2267-04. These standards define the parameters and acceptable limits for mechanical performance.
- Material properties: The inherent biocompatibility and mechanical properties (e.g., modulus) of PEEK.
- Comparative data: Performance relative to "legally marketed lumbar interbody fusion" predicate devices to demonstrate substantial equivalence.
8. The sample size for the training set:
This question is not applicable as there is no AI algorithm involved that would require a training set.
9. How the ground truth for the training set was established:
This question is not applicable as there is no AI algorithm involved.
§ 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.