Search Results
Found 1 results
510(k) Data Aggregation
(154 days)
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System
The Innovasis HAcancellous PEEK-C Porous HA PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
This device is to be used in patients who have had six weeks of non-operative weatment. The HAcancellous PEEK-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAcancellous PEEK-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
The HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System is for Anterior Cervical Discectomy and Fusion (ACDF). The implant is available in multiple size options to match vertebral anatomy and is intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain.
The HAcancellous PEEK-C Implants are made from Invibio® PEEK-OPTIMA® HA Enhanced1 and include Pore Matrix™M Technology2. Hydroxyapatite (HA) is fully integrated throughout the implant, including the porous layers. The HAcancellous PEEK-C Implant is made from PEEK which has a modulus of elasticity similar to human vertebral bone. The Porous Layers on the endplate contact surfaces and along the vertical walls of the graft window utilize Pore Matrix Technology, a geometry that unlike smooth PEEK, is designed to mimic anatomical cancellous bone, with interconnected spherical pores. The surface porosity is designed to promote cell signaling, on-growth, in-growth, and fusion. The HAcancellous PEEK-C Implant may provide an increased opportunity for bone ingrowth and for achieving early integration3. In vitro performance or animal studies may not be representative of clinical performance. The HAcancellous PEEK-C lmplant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and is radiolucent allowing assessment of the fusion process, while three tantalum spheres enable implant visualization during the surgical procedure. The implants come in 7 heights, 6-12mm in 1mm increments and 8 Footprints with an 8° lordotic angle. Reusable instruments to support ACDF surgeries are provided with the implants in sterilization sets. Innovasis implants are designed and validated for use with these instruments described in the Surgical Technique Guide. Usage of any instrumentation outside of the validated design intent is considered off-label use.
The provided text describes the regulatory clearance for the "HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System," an intervertebral body fusion device.
It's important to note that this document is a 510(k) summary for a medical device (an implantable hardware device), not an Artificial Intelligence (AI) or machine learning (ML) enabled diagnostic or interpretive device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML evaluation (like MRMC studies, ground truth establishment by experts, training/test set provenance, etc.) are not applicable to this type of device.
The "study" referenced in this document concerns the mechanical and material performance of the implant, not its diagnostic accuracy or the performance of an AI algorithm.
However, I can extract information related to the device's performance and how it was shown to meet regulatory requirements for its intended use, framed within the context of a non-AI medical device.
Here's an attempt to answer your request based on the provided text, while explicitly stating where AI/ML-specific criteria cannot be met:
Acceptance Criteria and Device Performance for HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System
This device is a physical, implantable medical device, not an AI/ML system. Therefore, the "acceptance criteria" and "study" are related to its mechanical performance, material properties, and biocompatibility, rather than diagnostic accuracy or human-AI reader performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for physical device) | Specific Standard / Test | Reported Device Performance |
|---|---|---|
| Mechanical Performance & Functional Equivalence | ASTM F2077: "Test Methods for Intervertebral Body Fusion Devices" (Static and dynamic strength, fatigue endurance in compression, compression-shear, torsional loading) | "The Innovasis HAcancellous PEEK-C cervical interbody fusion device exhibited substantially equivalent characteristics to previously cleared predicate devices and FDA published data for strength, stiffness, and cyclic endurance in all planes of spinal loading." |
| Load-Induced Subsidence (Endplate Interaction) | ASTM F2267: "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices under Static Axial Compression" | (Covered under general mechanical performance statement - "substantially equivalent characteristics to previously cleared predicate devices and FDA published data for strength, stiffness, and cyclic endurance") |
| Expulsion and Simulated Insertion Performance | Device-specific tests (implied) | "The device was also evaluated in expulsion and simulated insertion." (No specific quantitative performance metric provided, but implied satisfactory performance given clearance). |
| Material Biocompatibility & Composition (HA PEEK) | ASTM F560 (for Tantalum markers); General biocompatibility evaluation for Invibio® PEEK-OPTIMA® HA Enhanced | "The HAcancellous PEEK-C implants are manufactured from Invibio® PEEK-OPTIMA® HA Enhanced polyetheretherketone with hydroxyapatite. HA is a naturally occurring mineral in bone and is widely used in the orthopedic field. The radiographic markers meet ASTM F560 for unalloyed Tantalum." "Materials (biocompatibility profile) are substantially equivalent [to predicate devices]." |
| Instrument/Accessory Material Composition | ASTM F899 (for Surgical Stainless Steel); ASTM D6394 SP031 (for RADEL) | "The HAcancellous PEEK-C instruments/accessories are machined from Surgical Stainless Steel per ASTM F899. The HAcancellous PEEK-C rasps are coated with Titanium Nitride. The HAcancellous PEEK-C sterilization sets are comprised of Anodized 5052 Aluminum and have components made of Nylon, Silicone, Stainless Steel, and RADEL per ASTM D6394 SP031." (Implies meeting these standards is acceptance criteria for materials). |
| Equivalence to Predicate Devices (Overall assessment) | Comparison of technological characteristics, design, mechanical strength, indications for use, materials | "The HAcancellous PEEK-C Porous HA PEEK Cervical IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate devices, K181115, Innovasis CxHA® PEEK Cervical IBF System and K173030, Nuvasive Cohere Cervical IBF. -Technology is substantially equivalent. -Design and implant sizes are substantially equivalent. -Mechanical strength is substantially equivalent. -Indications for use are substantially equivalent. -Materials (biocompatibility profile) are substantially equivalent." |
Regarding AI/ML Specific Criteria:
As this is a physical implantable device, the following points are not applicable and therefore, no information is provided in the document for them:
2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices for mechanical testing, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI sense is established by experts for physical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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-assisted reading device.
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.): Not applicable in the AI/ML sense. The "ground truth" for a physical device is its adherence to mechanical performance standards and material specifications.
8. The sample size for the training set: Not applicable. This device does not use a "training set."
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical implant based on its substantial equivalence to previously cleared predicate devices, primarily demonstrating safety and effectiveness through mechanical testing, material characterization, and comparison to established standards for intervertebral body fusion devices. It does not involve AI or machine learning technology.
Ask a specific question about this device
Page 1 of 1