(106 days)
Vusion® OS is indicated for use as an intervertebral body fusion device at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Vusion® OS is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment.
Vusion® OS consists of implants with various widths, lengths, and degrees of lordosis. The implant is provided in widths from 9mm to 11mm, lengths from 20mm to 35mm, and heights ranging from 7mm to 16mm.The implants are made from Polyetheretherketone (PEEK Optima LT1, ASTM F2026) and contain tantalum markers (tantalum per ASTM F560), which allow radiographic confirmation of proper positioning. The implants have ridged teeth that resist rotation and migration, and holes to accommodate bone graft. The implant geometry includes a bulleted nose, fixation teeth on the superior and inferior surfaces, side windows, a graft window passing between the superior and inferior surfaces, and an insertion hole and rails for implant placement control. The implant is sold non-sterile.Vusion® OS is implanted using a standard or oblique PLIF (Posterior Lumbar Interbody Fusion) approach and is intended to be used singly or in pairs with supplemental fixation.
Here's a breakdown of the acceptance criteria and the study information for the Vusion® OS device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance |
|---|---|
| Static compression testing per ASTM F2077 | Mechanical test results demonstrate substantial equivalence to predicate devices. |
| Dynamic compression testing per ASTM F2077 | Mechanical test results demonstrate substantial equivalence to predicate devices. |
| Static torsion testing per ASTM F2077 | Mechanical test results demonstrate substantial equivalence to predicate devices. |
| Subsidence testing per ASTM F2267 | Mechanical test results demonstrate substantial equivalence to predicate devices. |
| Expulsion testing per ASTM Draft Standard F-04.25.02.02 | Mechanical test results demonstrate substantial equivalence to predicate devices. |
2. Sample Size for the Test Set and Data Provenance:
The provided document describes non-clinical mechanical testing and does not refer to a "test set" in the context of patient data or clinical images. Therefore, information regarding human data sample size or provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" consists of mechanical prototypes of the device.
3. Number of Experts and Qualifications for Ground Truth Establishment:
This information is not applicable as the study described is non-clinical mechanical testing, not a study involving expert interpretation of medical data or images.
4. Adjudication Method for the Test Set:
This information is not applicable as the study described is non-clinical mechanical testing. Adjudication methods are typically used in studies involving human interpretation of data for ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not reported. The study focused on the mechanical properties of the device compared to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This information is not applicable. The device is an intervertebral body fusion implant, a physical medical device, not an AI algorithm. Therefore, "algorithm-only" performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" for this device's evaluation was based on established engineering standards and measurements as defined by the ASTM testing protocols (e.g., F2077, F2267, F-04.25.02.02). The performance of the Vusion® OS was compared to the performance of predicate devices based on these objective mechanical measurements.
8. Sample Size for the Training Set:
This information is not applicable. The device is a physical implant, not an AI algorithm that requires a training set. The study involves mechanical testing of device prototypes.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of this device. The mechanical properties of the Vusion® OS and its predicate devices, as measured against ASTM standards, served as the basis for comparison and demonstration of substantial equivalence.
§ 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.