(133 days)
UNiD 3D printed interbody system device is indicated for intervertebral body fusion procedures 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. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
UNiD 3D printed interbody system device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The UNiD 3D printed cage is an intervertebral lumbar device, which consists of various implant sizes to adapt the implant to the patient anatomy. The implants are manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.
This document is a 510(k) premarket notification for the UNiD Patient Specific 3D printed cage. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and performance against those criteria as would be found for a novel device requiring extensive clinical trials.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance in a clinical sense. Instead, it describes mechanical tests performed following established ASTM standards to ensure the device's physical and mechanical properties are comparable to legally marketed predicate devices. The performance reported is that these tests were "conducted" and presumably met the requirements of these standards for substantial equivalence.
| Acceptance Criteria (Implied by ASTM Standards) | Reported Device Performance |
|---|---|
| Static Compression-shear | Tests were conducted. |
| Dynamic Compression | Tests were conducted. |
| Dynamic Compression-shear | Tests were conducted. |
| Subsidence (under Static Axial Compression) | Tests were conducted. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size for the non-clinical mechanical tests. Typically, these tests would involve a small number of device samples (e.g., 3-6 per test condition).
- Data Provenance: The tests were non-clinical (mechanical). There is no patient data or country of origin mentioned.
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 device is an intervertebral fusion cage, and the testing described is mechanical, not involving human interpretation or clinical ground truth establishment by medical experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set 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
Not applicable. This is not an AI/imaging device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical mechanical tests, the "ground truth" would be the established performance requirements and thresholds defined within the ASTM standards (F2077 and F2267). The device's performance is compared against these industry-accepted mechanical benchmarks.
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
§ 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.