(327 days)
IMPIX 3D Print cages are 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 or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
IMPIX 3D Print cages are to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
The IMPIX 3D Print PLIF, IMPIX 3D Print TLIF, and IMPIX 3D Print TLIF-S are intervertebral lumbar devices, which consists of a variety of shapes and sizes. The implants are manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications) from additive manufacturing process.
MATERIALS: Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001.
Function: The 3D printed Lumbar cage was developed as an implant:
- · To provide immobilization and stabilization of anterior spinal segments
- · to augment the development of a solid spinal fusion
- · to provide stability to ease fusion
- · to be mechanically resistant to allow the fusion of the operated level
The provided text is a 510(k) summary for the IMPIX 3D Print Cages, an intervertebral body fusion device. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving performance against defined acceptance criteria in the context of an AI/software device.
Therefore, many of the requested elements regarding acceptance criteria and a study proving device performance (especially for AI/software) are not applicable or cannot be extracted from this document, as it describes a physical medical device.
However, I can extract information related to the device's characteristics and the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of numerical acceptance criteria for a specific performance metric, as might be seen for a software device. Instead, it references adherence to ASTM standards for mechanical testing.
| Acceptance Criterion Type | Specific Criteria (from ASTM standards) / Goal | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Adherence to ASTM F2077 "Standard Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267 "Standard Test Methods Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression". | Testing was performed following the protocols outlined in ASTM F2077 and ASTM F2267. Specific tests conducted include: Static Compression, Static Compression-shear, Dynamic Compression, Dynamic Compression-shear, Subsidence test, and Expulsion test. | The document states that testing was "performed... following the protocols," which implies the device met the requirements of these standards for the specified tests. However, it does not provide specific numerical outcomes or thresholds met for each test, only that the tests were conducted. The goal is to demonstrate "mechanical safety and performances" and that the device is "mechanically resistant to allow the fusion of the operated level." |
| Material Conformance | Titanium Alloy (Ti-6Al-4V) conforming to ASTM F3001 specifications. | Manufactured in titanium alloy (Ti-6Al-4V ELI conforming to ASTM F3001 specifications). | The device meets the specified material standard. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for each mechanical test. The ASTM standards would define the number of samples required for each test.
- Data Provenance: The tests are non-clinical (mechanical bench testing) performed on the physical device. The country of origin for the data (where the tests were conducted) is not specified in the document, but the manufacturer is based in France. The data is prospective in the sense that these tests were conducted as part of the 510(k) submission for this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This is a physical device undergoing mechanical testing, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. This is mechanical testing against defined ASTM standards, not a diagnostic test requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is a physical medical device, not an AI/software diagnostic tool. No MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This is a physical medical device.
7. Type of Ground Truth Used:
- For the mechanical tests, the "ground truth" is defined by the protocols and acceptance criteria within the ASTM standards (F2077 and F2267). This involves precise measurements of load, displacement, and material properties, rather than an "expert consensus" or "pathology" as would be seen for diagnostic imaging.
8. Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set was used.
§ 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.