(98 days)
The Renovis S141 Lumbar Interbody Cage 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). Renovis S141 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 S141 System must be used with supplemental fixation cleared by FDA for use in the lumbar spine.
The Renovis S141 Lumbar Interbody Cage System consist of 3 designs and each design is available in either PEEK or titanium alloy. The PLIF implants are available as a lordotic form, while the OLIF implants are provided with no lordosis. The implants are available in various heights and lengths to accommodate patients' anatomy. The implants are provided sterile, and a set of instrument for implantation is provided to facilitate implantation. Two radiographic markers made of tantalum per ASTM F650 are included in the PLIF and OLIF PEEK implants, and three radiographic markers made of tantalum per ASTM F560 are included in the TLIF PEEK implant to allow radiographic visualization.
This document is a 510(k) summary for the Renovis S141 Lumbar Interbody Cage System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, materials, dimensions, function, and mechanical testing. It is not a study that proves a device meets acceptance criteria in the sense of a clinical trial or an AI/software performance study.
Therefore, many of the requested items related to AI/software performance, ground truth, expert adjudication, and clinical study details are not applicable or cannot be extracted from this type of regulatory submission. This document describes mechanical performance testing against established standards, not a clinical study with human subjects, AI algorithms, or expert readers.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Testing Standards: | The Renovis S141 Lumbar Interbody Cage System was tested according to: |
| ASTM F2077 | - Static and dynamic axial compression |
| ASTM F2267 | - Subsidence |
| - Expulsion | |
| Outcome: | Test results demonstrate that the Renovis S141 Lumbar Interbody Cage System is substantially equivalent to the predicate devices. |
Note: The document states the device was tested to these standards and found substantially equivalent, but it does not provide specific numerical acceptance criteria or performance metrics for each test (e.g., "subsidence must be less than X mm, and observed subsidence was Y mm"). It only states the overall conclusion of substantial equivalence.
Regarding the other requested information:
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document describes mechanical testing of physical devices, not a study involving human patient data or software/AI. The "test set" here refers to the physical samples of the interbody cage system tested mechanically. The sample size for these mechanical tests is not specified, nor is data provenance in the context of clinical/patient data.
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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)
- Not Applicable. Ground truth in the context of expert review applies to diagnostic devices or AI, not mechanical orthopedic implants. The "ground truth" for mechanical testing is defined by the physical properties and performance characteristics measured against engineering standards.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is relevant for expert review or clinical event assessment, not for mechanical testing of physical devices.
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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 mechanical device, not an AI or diagnostic imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device (lumbar interbody cage system), not an algorithm or software. No standalone algorithm performance was assessed.
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7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. For mechanical testing, the "ground truth" is defined by the established engineering standards (ASTM F2077 and ASTM F2267) and the measured physical performance (axial compression, subsidence, expulsion).
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8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning algorithm, so there is no "training set."
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9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.
§ 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.