(71 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 cleared under K131122. The SI28 ALIF implants (cages) are to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes; see below) 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 cover plate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum.
This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized S128 implants (PEEK cages; titanium cages, screws and cover plates).
This document is a 510(k) Special Premarket Notification for the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System, focusing on the addition of gamma sterilization for its implants. It primarily addresses the safety and effectiveness of the sterilization method and its impact on the device's materials, rather than a clinical study of the device's performance in patients.
Therefore, the requested information focusing on clinical performance metrics, sample sizes for test/training sets, expert ground truth, and comparative effectiveness with AI is not directly applicable to this specific regulatory submission. This is because the submission is about a manufacturing change (sterilization method) to an already cleared device (K131122), not a new device or a clinical outcome study.
However, I can extract the information relevant to the performance data for the sterilization process, which is the core of this submission.
Acceptance Criteria and Reported Device Performance (for Gamma Sterilization)
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterility Assurance | Sterilization validated to a sterility assurance level (SAL) of 10⁻⁶ by selecting and substantiating a 25 kGy dose using the VDmax 25 method, according to ISO 11137-1. | Implants are sterilized by ⁶⁰Gamma irradiation validated to a sterility assurance level (SAL) of 10⁻⁶ by selecting and substantiating a 25 kGy dose by the VDmax 25 method, according to ISO 11137-1. |
| Material Compatibility (Titanium) | Titanium alloy components are not negatively affected by gamma sterilization and/or aging. | Titanium alloy components are not affected by gamma sterilization and/or aging. |
| Material Compatibility (PEEK) | After an average dose of 200 kGy and accelerated aging (simulating 10+ years), PEEK components should not show any significant difference compared to untreated PEEK. | PEEK components were tested to an average dose of 200 kGy and underwent accelerated aging to simulate 10 or more years. After aging, the samples were tested, and the results did not show any significant difference between untreated PEEK and gamma treated and aged PEEK. |
| Packaging Sterility Maintenance | Packaging validated to maintain sterility for 3 years, complying with ISO 11607-2 (accelerated aging simulation per ASTM F1980-07 and real-time aging) and performance following distribution per ISTA 2A. | Packaging has been validated to maintain sterility for 3 years in compliance with ISO 11607-2, demonstrates compliance with accelerated aging simulation per ASTM F1980-07 and real-time aging; and performance following distribution per ISTA 2A. |
Regarding the other requested information:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not describe a clinical test set with human subjects. The "test set" here refers to material samples (Titanium and PEEK) and packaging subjected to sterilization and aging simulations. The sample sizes for these material tests are not explicitly stated but are part of standard validation protocols for ISO 11137-1 and internal Renovis testing.
- Data provenance is from internal testing and validation performed by Renovis Surgical Technologies, Inc. and its sterilization/packaging validation partners. No country of origin for clinical data is applicable.
-
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):
- Not applicable as this is not a clinical study involving human expert interpretation of medical images or outcomes. Ground truth for material testing is based on established materials science and engineering principles and validated sterilization/packaging standards by qualified engineers and scientists.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective assessments (like image interpretation) where there might be disagreement among experts. Material and sterilization testing follows objective, quantifiable methods against pre-defined specifications.
-
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 about a medical device (surgical implant) and a manufacturing process change (sterilization), not an AI-powered diagnostic tool or image analysis software.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable for the same reason as above.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on established international and national standards for medical device sterilization (ISO 11137-1, ANSI/AAMI/ISO 11137-2), packaging (ISO11607-2, ASTM F1980-07), and material specifications (ASTM F2026, ASTM F136, ASTM F 560-08). This is objective, measurable data comparing post-sterilization/aging material properties to baseline and specified requirements.
-
The sample size for the training set:
- Not applicable. There is no machine learning or AI training set described in this document.
-
How the ground truth for the training set was established:
- Not applicable.
§ 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.