(149 days)
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft.
Patients should be skeletally mature and have at least six months of non-operative treatment.
The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used.
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The Renovis S128 ALIF System contains both fixed and variable angle screw options. The fixed angle screw option provides a tight fit with the cage. The variable angle screw option provides a slight clearance between the cage and the screw which allows for a small amount of variable screw angulations.
The Renovis S128 ALIF System cages are intended to be used with autogenous bone graft. The accompanying cover plate is designed to prevent screw back-out and must be used when the screws are implanted. NOTE: The cover plate assembly and screw are part of the implant construct.
The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and coverplate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum. The Renovis Si28 ALIF System is used with trials and implant specific manual instruments, and includes other class I manual orthopedic instruments.
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral fusion device. The acceptance criteria for the device were based on various mechanical performance tests as outlined by ASTM standards and specific FDA guidance documents. The study demonstrating the device meets these criteria involved physical performance testing of the device's components and the full implant system.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test Standard) | Reported Device Performance |
|---|---|
| Static Compression per ASTM F2077 | Successfully undergone |
| Dynamic Compression per ASTM F2077 | Successfully undergone |
| Static Shear-Compression per ASTM F2077 | Successfully undergone |
| Dynamic Shear-Compression per ASTM F2077 | Successfully undergone |
| Expulsion Testing w/screws per ASTM Draft Standard F04.25.02.02 | Successfully undergone |
| Expulsion Testing w/o screws per ASTM Draft Standard F04.25.02.02 | Successfully undergone |
| Subsidence testing per ASTM F2267 | Successfully undergone |
| Shear testing of metallic coatings per ASTM F1044 | Sample coupons of Titanium porous structure successfully undergone testing |
| Tensile testing of metallic coatings per ASTM F1147 | Sample coupons of Titanium porous structure successfully undergone testing |
| Abrasion per ASTM F1978 | Sample coupons of Titanium porous structure successfully undergone testing |
| Porosity-and microstructure per ASTM F1854 | Sample coupons of Titanium porous structure successfully undergone testing |
| Compliance with FDA Guidance: "Intervertebral Body Fusion Device" | Complies |
| Compliance with FDA Guidance: "Spinal System 510(k)s" | Complies |
| ASTM F 983-86 (Reapproved 2009) Standard Practice for Marking | Complies |
| ASTM F 565-04 (Reapproved 2009)e1 Standard Practice for Care/Handling | Complies |
| ASTM F2026 Standard Specification for PEEK Polymers | Complies |
| ASTM F-136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI | Complies |
| ASTM F 560-08 Standard Specification for Unalloyed Tantalum | Complies |
| ASTM A564 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes | Complies |
| ASTM F138 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire | Complies |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "worst case constructs" of the Renovis S128 ALIF System implants were used for mechanical testing and "sample coupons" of the Titanium porous structure were tested. However, the exact numerical sample sizes for each test are not specified in the provided text. The data provenance is pre-market performance bench testing, indicating it is prospective data obtained specifically for regulatory submission, and not from clinical trials or retrospective patient data. The country of origin for the data generation (e.g., in which lab/country testing was conducted) is not specified, though Renovis Surgical Technologies is located in Redlands, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the evaluation of this medical device's performance is based on standardized mechanical testing against pre-defined engineering criteria (ASTM standards and FDA guidance) rather than subjective expert assessment of clinical data or images. "Ground truth" in this context refers to the verifiable performance against these objective mechanical benchmarks.
4. Adjudication Method for the Test Set:
This information is not applicable as the device's performance was assessed through objective mechanical testing against established standards, not through a process requiring expert adjudication of subjective outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the document describes a pre-market notification for an intervertebral fusion device, which is an implantable medical device, not an AI-powered diagnostic tool. Therefore, no MRMC study involving human readers with or without AI assistance was conducted or would be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for this device's evaluation is defined by established engineering and material standards and FDA guidance documents. Specifically, successful performance in physical and mechanical tests (e.g., static/dynamic compression, shear, expulsion, subsidence) as per ASTM F2077, ASTM F2267, ASTM F1044, ASTM F1147, ASTM F1978, ASTM F1854, and various material specifications (e.g., PEEK, Titanium, Tantalum). The device's substantial equivalence is based on its ability to meet these objective, measurable criteria, indicating it performs comparably to predicate devices in mechanical integrity and material properties.
8. The Sample Size for the Training Set:
This information is not applicable. The context provided is for a traditional medical device (spinal implant) undergoing a 510(k) submission, which relies on demonstrating substantial equivalence through engineering testing and material characterization, not machine learning or AI models that require training sets.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
§ 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.