(133 days)
The Renovis Tesera SC Stand-alone ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera SC Stand-alone ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.
The Renovis Tesera SC Stand-alone ACF System is a stand-alone system when used with the cover plate and screws provided, and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of three (3) screws and the cover plate assembly. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.
The Renovis Tesera C ACF System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one level from C2-T1. Renovis Tesera C ACF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.
The Renovis Tesera C ACF System is a non-stand-alone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability.
Tesera (or T3) describes Renovis' proprietary Tesera Trabecular Technology™ Porous Structure for the manufacture of the porous titanium on the superior and inferior surfaces of the implant.
The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System is a single, cervical implant System that includes two (2) "subsystems", the:
- Renovis Tesera C Anterior Cervical Fusion (ACF) System
- Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System .
The Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System cages are additively manufactured from Ti-6Al-4V and are available in a variety of sizes (widths, heights, and lordotic angles) to suit the individual pathology and anatomical conditions of the patient.
The Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System includes cages, and existing bone screws (self-drilling and self-tapping options) and anterior cover plate assembly. When used with the cover plate and screws, the Tesera SC ACF System cages require no supplementary fixation systems. The screws protrude through the interbody portion of the device into the adjacent vertebral bodies. The cages have windows in the side for visualization of the bone graft. When used without the cover plate and three screws the Renovis Tesera SC Stand-alone ACF cages require supplemental fixation.
The Renovis Tesera C Anterior Cervical Fusion (ACF) System is not stand alone and requires supplemental fixation.
The Renovis Tesera C/Tesera SC ACF System cages comply with ASTM F2924-14 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion.
The system also consists of reusable instrumentation. The instruments comply with ASTM A564/A64M-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes or ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
The provided text describes a 510(k) premarket notification for the Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System. This submission focuses on establishing substantial equivalence to a predicate device through mechanical testing and does not involve a study evaluating AI performance. Therefore, many of the requested sections related to AI acceptance criteria, ground truth, expert involvement, and reader studies are not applicable.
Here's an analysis of the provided information, focusing on what is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| ASTM F2077 (Static Compression, Dynamic Compression, Static Shear Compression, Dynamic Shear Compression, Static Torsion, Dynamic Torsion Testing) | Conducted and found to be acceptable |
| Expulsion testing | Conducted and found to be acceptable |
| Subsidence testing (with and without screws) per ASTM F2267 | Conducted and found to be acceptable |
| Sterilization Validation: | Completed |
| AAMI/ANSI/ISO 10993-1 (Biological Evaluation) | (Implied acceptable, no specific result mentioned) |
| AAMI/ANSI ST72 (Bacterial Endotoxins) | (Implied acceptable, no specific result mentioned) |
| AAMI/ANSI/ISO 11137-2 (Radiation Sterilization Dose) | (Implied acceptable, no specific result mentioned) |
| AAMI/ANSI/ISO 11737-1 (Microbiological Methods) | (Implied acceptable, no specific result mentioned) |
| ISO 11607-2 (Packaging for Sterilized Devices) | (Implied acceptable, no specific result mentioned) |
| ISO 17665-1 (Moist Heat Sterilization) | (Implied acceptable, no specific result mentioned) |
| Materials/Manufacturing: | |
| ASTM F2924-14 (Additive Manufacturing Titanium) | Complies |
| ASTM A564/A64M-13e1 (Stainless Steel for Instruments) | Complies |
| ASTM F136-13 (Titanium for Instruments) | Complies |
| Porous Structure: | |
| T3 porous shell evaluation | Successfully tested |
| Other Standards: | |
| ASTM F1854-15 (Stereological Evaluation of Porous Coatings) | (Implied acceptable, no specific result mentioned) |
| ASTM F1147-05 (Tension Testing of Coatings) | (Implied acceptable, no specific result mentioned) |
| ASTM F1044-05 (Shear Testing of Coatings) | (Implied acceptable, no specific result mentioned) |
| ASTM F1160-14 (Shear and Bending Fatigue) | (Implied acceptable, no specific result mentioned) |
| ASTM F1978-17 (Abrasion Resistance of Coatings) | (Implied acceptable, no specific result mentioned) |
| ISTA 2A:2011 (Packaged-products weighing 150 lbs.) | (Implied acceptable, no specific result mentioned) |
| ASTM D4169:2016 (Performance Testing of Shipping Containers) | (Implied acceptable, no specific result mentioned) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission describes a medical device, not an AI/software device that would typically use a "test set" of data in the common sense. The testing described is bench testing of the physical implant.
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)
This information is not applicable. Ground truth, expert consensus, and expert qualifications are relevant for studies evaluating human or AI performance on diagnostic tasks. This submission is for a physical implant, where ground truth is established through standardized engineering and biological tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations during diagnostic studies.
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
This information is not applicable. MRMC studies are used to evaluate the impact of an AI system on human reader performance. This submission is for a physical medical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. "Standalone" performance refers to an AI algorithm operating independently, which is not relevant to a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established through adherence to recognized ASTM, AAMI/ANSI, and ISO standards for mechanical properties, biocompatibility, and sterilization. For example, the mechanical strength of the implant components and assemblies is evaluated against the parameters outlined in ASTM F2077. The porous structure's characteristics were "successfully tested," implying adherence to relevant specifications.
8. The sample size for the training set
This information is not applicable. A "training set" is used for machine learning. This submission is for a physical implant.
9. How the ground truth for the training set was established
This information is not applicable. This is relevant for machine learning models.
§ 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.