(178 days)
When used as an intervertebral body fusion device, the ROI Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
When used as a vertebral body replacement device, The ROI System of implants is indicated for use to replace a vertebral body that has been resected or excised due to turnor of trauma/fracture: The device is intended for use as a partial vertebral body: replacement in the thoracolumbar spine (from 74 to 15) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bane.
The ROI-A implants are intended to be implanted singularly while the ROF-T implantsmay be implanted singularly or in pairs.
The proposed ROI: Interbody Fusion System will be offered in two: (2) configurations of various sizes. The configurations are designed based on surgical approach, and consist of: 1) ROI-T, transforaminal approach and-2) ROI-A, antentor approach.
The provided text describes the LDR Spine ROI Interbody Fusion System, its indications for use, and a 510(k) summary, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical or performance study with defined metrics.
Here's a breakdown of what is and isn't in the document, based on your requested information:
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A table of acceptance criteria and the reported device performance:
- Not provided. The document states: "Mechanical test results demonstrate that the proposed ROI Interbody Fusion System is substantially equivalent to the predicate device." This indicates that mechanical testing was performed, but no specific acceptance criteria (e.g., minimum compression strength, fatigue life) or quantitative performance results are listed or compared in a table. The core assertion is "substantial equivalence," not meeting defined performance thresholds.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "Mechanical test results," which are typically laboratory-based engineering tests, not involving human subjects or data provenance in the clinical sense. No sample sizes for these tests are mentioned.
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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/Not provided. This type of information is relevant for studies involving the interpretation of medical images or clinical judgment to establish ground truth, often for AI/ML device evaluations. This document concerns a physical implant and mechanical testing, where "ground truth" would be engineering specifications and measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication methods are used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, particularly for establishing ground truth from multiple readers. This is not mentioned as part of the mechanical test summary.
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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:
- No MRMC study was done. This device is an interbody fusion system (a physical implant), not an AI/ML-driven diagnostic tool that would typically involve a multi-reader multi-case study to assess AI assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in the context of "ground truth" as you've defined it. For mechanical testing, the "ground truth" would be established engineering standards and physical measurements of mechanical properties (e.g., strength, stiffness, fatigue life) of the device and its predicate.
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The sample size for the training set:
- Not applicable/Not provided. This is relevant for AI/ML models. For mechanical testing, there's no "training set."
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How the ground truth for the training set was established:
- Not applicable/Not provided. Same as above, there's no training set mentioned.
In summary, the provided document is a regulatory submission for a physical medical device (an implant) and details its indications for use and a claim of substantial equivalence based on mechanical testing. It does not include the detailed performance study information with acceptance criteria, sample sizes, expert ground truth establishment, or AI-related metrics that you've requested. These types of details are typically found in more extensive study reports or clinical trial summaries, which are not part of this 510(k) summary.
§ 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.