(213 days)
ORIO Cervical Intervertebral Body Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. ORIO Cervical Intervertebral Body Fusion Cages used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. ORIO Cervical Intervertebral Body Fusion Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The ORIO Lumbar Intervertebral Body Fusion Cage 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. Degeneralive 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). ORIO lumbar intervertebral body fusion cage implants are to be used with autogenous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral or lateral approach. The ORIO Lumbar Intervertebral Body Fusion Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The ORIO Intervertebral Body Fusion Cages were developed as implants for the stabilization of the lumbar spinal column and anterior cervical spondylodesis. The ORIO implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.
Here's a breakdown of the acceptance criteria and study information for the ORIO Intervertebral Body Fusion Cages, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Mechanical Strength | Meets required mechanical strengths as per ASTM F2077/F2267 standards. | The ORIO Intervertebral Body Fusion Cages meet required mechanical strengths. | Non-clinical Tests |
| Material Compatibility | Uses PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications). | The device is made of PEEK-OPTIMA LT1 polymer (ASTM F2026). | Material Specification |
| Indications for Use (Cervical) | Skeletally mature patients with DDD of the cervical spine with accompanying radicular symptoms at one disc level (C3-C7), defined by discogenic pain and radiographic studies, for anterior approach with autograft bone and supplemental fixation; at least 6 weeks of non-operative treatment prior. | The device's indications match this criterion. | Review of Indications |
| Indications for Use (Lumbar) | Skeletally mature patients with DDD of the lumbar spine at one or two contiguous levels from L2-S1, defined by discogenic back pain and radiographic studies; may have up to Grade 1 spondylolisthesis or retrolisthesis; used with autogenous bone graft and implanted via transforaminal, open posterior, anterior/anterolateral, or lateral approach, with supplemental fixation; at least 6 months of non-operative treatment prior. | The device's indications match this criterion. | Review of Indications |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not describe human clinical trials or a specific "test set" in the context of typical medical device performance evaluation (e.g., diagnostic accuracy, clinical outcomes). The evaluation primarily focuses on non-clinical mechanical testing and comparison to predicate devices.
- Test Set Sample Size: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of devices tested, which is not specified in the document beyond a general statement that "tests indicate the... cages meet required mechanical strengths."
- Data Provenance: Not applicable for human data. The non-clinical tests are presumed to be conducted in a laboratory setting. There is no mention of country of origin or whether the data is retrospective or prospective for any human studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. The evaluation relies on standardized mechanical testing against ASTM standards and a comparison of design and materials to previously cleared devices. Expert consensus for "ground truth" as typically understood in AI or clinical studies is not relevant here.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable given the nature of the evaluation (non-clinical mechanical testing and comparison to predicate devices).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document does not mention any MRMC comparative effectiveness study. This type of study would typically assess the impact of AI on human reader performance, which is not relevant for an intervertebral body fusion cage.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not applicable. The device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this submission.
7. The Type of Ground Truth Used:
The "ground truth" for this device's acceptance is based on:
- Standardized Mechanical Testing: Adherence to established ASTM standards (F2077/F2267) for mechanical strength. The standards themselves define the "ground truth" for acceptable performance.
- Material Specifications: Adherence to ASTM F2026 for the PEEK material.
- Predicate Device Equivalence: The primary basis for clearance is demonstrating "substantial equivalence" to previously cleared devices by having "the same indications and material, and similar designs." The "ground truth" for this is the historical clearance of those predicate devices.
8. The Sample Size for the Training Set:
This information is not applicable. The device is an implanted medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set for this 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.