(108 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. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change.
The S128 ALIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. S128 ALIF System cages are standalone for devices
This document describes the FDA's decision regarding the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System and focuses on its substantial equivalence to previously cleared devices rather than a study about AI performance. Therefore, many of the requested categories are not applicable.
Here's the information extracted and interpreted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table with specific performance metrics for an AI device. Instead, it focuses on demonstrating substantial equivalence for a medical implant (ALIF System) by meeting established standards and performing tests relevant to its physical properties and function.
| Acceptance Criteria (Demonstrated Equivalence through) | Reported Device Performance (Successful Testing) |
|---|---|
| Functional Equivalence: Same Indications for Use | The modified cages (new lengths, widths, and lordosis) and packaging change have the same Indications for Use as the K140106 predicate cages. |
| Material Equivalence: Manufactured from same materials | The device is manufactured from the same materials as the predicate devices: Ti6Al4V (conforms to ASTM F136-13), PEEK (compliant with ASTM F2026-17), and Tantalum (compliant with ASTM F560-17). Instruments are stainless steel (compliant with ASTM A564/M564-13e1). |
| Process Equivalence: Same manufacturing processes | The device uses the same manufacturing processes as the predicate devices. Titanium cages are additively manufactured then machined. PEEK implants are manufactured using traditional methods. |
| Sterilization Equivalence: Same gamma sterilization | The device is gamma sterilized, the same as the K140106 predicate cages. Complies with AAMI/ANSI/ISO 11137-2:2013 and AAMI/ANSI/ISO 11137-1:2006/(R)2010. |
| Mechanical Performance: Dynamic Shear Compression strength | Successful Dynamic Shear Compression strength testing was performed per ASTM F2077-14. |
| Mechanical Performance: Expulsion testing | Successful Expulsion testing was performed. |
| Risk Management: Assessed for risk under Design Controls | All changes were assessed for risk and successfully tested under Design Controls. |
| Biocompatibility: Biological evaluation | Complies with AAMI/ANSI/ISO 10993-1:2009/(R)2013 Biological Evaluation Of Medical Devices. |
| Endotoxin Testing: AAMI/ANSI ST72 standard | Complies with AAMI/ANSI ST72:2011/(R)2016 Bacterial Endotoxins Test Methods. |
| Additional Standards Compliance: | Complies with ISO 17665-1 (Sterilization Of Health Care Products Moist Heat) and "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 2007." |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document describes the substantial equivalence of a physical medical implant (ALIF System) based on engineering tests, not a software device or AI algorithm evaluated on a data test set. The "tests" mentioned (Dynamic Shear Compression, Expulsion) refer to physical testing of the device itself.
- Data Provenance: Not applicable for an AI or software study. The data is generated from physical material and mechanical testing of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of device submission. The "ground truth" for the device's physical properties is established by adherence to ASTM standards and validated engineering test methods performed by qualified laboratories.
4. Adjudication method for the test set:
- Not applicable. There is no human expert adjudication of test results in the sense of consensus on medical images or diagnoses for this device. The physical tests are governed by standardized protocols.
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 submission is for a physical medical implant, not an AI or software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- The "ground truth" for this medical device's performance is based on established engineering standards and validated physical test methods. For example, ASTM F2077-14 for intervertebral body fusion devices sets the benchmark for acceptable mechanical performance. Material composition adherence to ASTM F136-13, F2026-17, F560-17, and A564/M564-13e1 provides the "ground truth" for material specifications. Sterilization validation using AAMI/ANSI/ISO standards establishes the "ground truth" for sterility.
8. The sample size for the training set:
- Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved for this type of device.
§ 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.