(81 days)
The Renovis S180 Lateral Lumbar Interbody Fusion 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 at the involved level(s). Patients should be skeletally mature and have at least six months of non-operative treatment with the devices.
The Renovis S180 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine. Renovis S180 System implants are to be used with autogenous bone graft.
The Renovis S180 Lateral Lumbar Interbody System is an additional offering to the Renovis system of interbody fusion devices. This application describes changes in lengths, widths, heights and lordosis configurations; material standard; packaging; and additive manufacturing device. The S180 LLIF 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 a lateral surgical approach for insertion. The S180 LLIF System cages are manufactured from Ti6A14V compliant with ASTM F2924 Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion. The system also includes instruments which are manufactured from Stainless steel and Ti-6Al-4V.
This document describes the Renovis S180 Lateral Lumbar Interbody Fusion System, which is a medical device for spinal fusion. The information provided is from a 510(k) premarket notification. As such, the "study" referred to is primarily bench testing to demonstrate the device's mechanical and functional equivalence to predicate devices, rather than a clinical trial involving human subjects. Therefore, many of the typical acceptance criteria and study details discussed for AI/software devices (like sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth for training) are not applicable in this context.
Here's the information parsed from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Dynamic axial compression testing in accordance with ASTM F2077 | Successful |
| Expulsion, static push-out testing | Successful |
| Mechanical Tensile Testing per ASTM E8/E8M-15a methods | Successful |
| Sterilization validation | Conducted and acceptable |
| Compliance with various ISO, ISTA, ASTM standards and FDA Guidances (listed in point I of the document) | Compliant |
| Biocompatibility (cytotoxicity) per AAMI/ANSI/ISO 10993-5 | Conducted and acceptable |
| Determination of population of microorganisms on product per AAMI/ANSI/ISO 11737-1 | Conducted and acceptable |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. The document mentions "new worst-case S180 LLIF cages" were tested, implying physical units of the device were subjected to mechanical and functional tests. The specific number of units tested for each benchmark is not detailed.
- Data Provenance: Not applicable. This refers to bench testing of the physical device, not a study involving human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth as typically defined for clinical effectiveness or diagnostic accuracy studies is not relevant here. The "ground truth" for this device's performance is adherence to established engineering standards and successful completion of specified mechanical and sterilization tests, which are objective measurements.
4. Adjudication method for the test set
- Not applicable. As this is bench testing against established standards, adjudication in the sense of expert consensus on clinical outcomes or diagnoses is not performed. Test outcomes are determined by instrumental measurements against predefined pass/fail criteria per the relevant ASTM/ISO standards.
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 a physical intervertebral fusion device, not an AI or diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
- For the bench testing, the "ground truth" is defined by established engineering and medical device standards (e.g., ASTM F2077 for dynamic axial compression, ASTM E8/E8M-15a for tensile testing, ISO 11607-2 for packaging, AAMI/ANSI/ISO 10993-1/5 for biocompatibility). The device's performance is compared against the requirements and specifications within these standards.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning 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.