(147 days)
The PLIF STS, TLIF STS and OLIF STS (Spine Truss System) are indicated for use 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. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
The 4WEB PLIF STS, TLIF STS and OLIF STS (Spine Truss System) consists of a series of titanium implants that are designed to provide mechanical support to the spine while biologic fusion occurs. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy. The device is available in multiple sizes to accommodate varied patient's anatomy.
This document is focused on the regulatory clearance of a medical device, specifically a Spine Truss System, based on substantial equivalence to predicate devices, rather than an AI/ML powered medical device. Therefore, the requested information on acceptance criteria and studies proving an AI device meets those criteria, as well as details like sample sizes for test/training sets, expert qualifications, adjudication methods, and MRMC studies, are not applicable and cannot be extracted from the provided text.
The document discusses preclinical testing for mechanical performance of the spine truss system, which is different from validating an AI algorithm's performance.
Here's what can be extracted related to the device and its assessment, framed as closely as possible to your request, but highlighting the difference in context:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Standards) | Reported Device Performance (Summary of Preclinical Testing) |
|---|---|
| Meet requirements of static axial compression per ASTM F2077 | Performed as intended, demonstrating substantial equivalence to predicate devices. |
| Meet requirements of static compression shear per ASTM F2077 | Performed as intended, demonstrating substantial equivalence to predicate devices. |
| Meet requirements of dynamic axial compression per ASTM F2077 | Performed as intended, demonstrating substantial equivalence to predicate devices. |
| Meet requirements of dynamic compressive shear per ASTM F2077 | Performed as intended, demonstrating substantial equivalence to predicate devices. |
| Meet subsidence requirements per ASTM F2267-04 | Performed as intended, demonstrating substantial equivalence to predicate devices. |
| Meet expulsion testing requirements | Performed as intended, demonstrating substantial equivalence to predicate devices. |
Important Note: These are mechanical performance criteria for an implantable device, not performance metrics for an AI algorithm. The reporting states the devices "performed as intended, demonstrating substantial equivalence," which is the regulatory standard for this type of device, implying the test results fell within acceptable ranges defined by the ASTM standards for equivalence. Specific numerical performance values are not provided 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):
- Sample Size for Test Set: Not applicable in the context of an AI device. For the mechanical testing of the Spine Truss System, the sample size (number of devices tested) for each specific test (static axial compression, dynamic axial compression, etc.) is not explicitly stated in this summary.
- Data Provenance: Not applicable in the context of an AI device. The tests are preclinical mechanical tests performed on physical devices, not clinical data sets from patients of a specific 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):
- This is not applicable as the device is a spinal implant, not an AI diagnostic tool. Ground truth in this context refers to the defined parameters of the ASTM mechanical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI diagnostic study requiring expert 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:
- Not applicable. This device is a physical medical implant, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the preclinical mechanical testing, the "ground truth" is defined by the objective quantitative measurements and pass/fail criteria established by the ASTM standards (e.g., ASTM F2077, ASTM F2267-04) for intervertebral body fusion devices.
8. The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
§ 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.