(196 days)
The UniVy™ OsteoVy™ Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The UniVy™ OsteoVy™ Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The UniVy™ OsteoVy™ Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
The UniVy" OsteoVy™ Cervical IBF System is comprised of implant components. The implant component is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject UniVy™ OsteoVy™ Cervical IBF spacer is comprised of additively manufactured Titanium 6Al-4V ELI conforming to ASTM F3001-14.
This document is a 510(k) Premarket Notification from the FDA regarding the UniVy™ OsteoVy™ Cervical IBF System, an intervertebral body fusion device. The purpose of this notification is to determine if the device is substantially equivalent to a legally marketed predicate device.
Based on the provided text, the device in question is a physical medical implant, not an AI/ML-driven device or diagnostic tool. Therefore, the information requested about acceptance criteria, study data provenance, expert ground truthing, MRMC studies, standalone performance, training sets, and how ground truth for training was established is not applicable to this document. These criteria are specifically relevant for regulatory submissions of AI/ML software as a medical device (SaMD) or clinical decision support systems.
However, I can extract information related to the device's substantial equivalence and non-clinical testing, which serves a similar purpose in demonstrating safety and effectiveness for a physical device.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
For a physical device like an intervertebral body fusion system, the "acceptance criteria" are typically related to mechanical performance, material properties, and biocompatibility, often defined by adherence to recognized ASTM standards. The document states that the subject device (UniVy™ OsteoVy™ Cervical IBF System) leverages the test results of a predicate device (Reliance Cervical IBF System) because of their substantial equivalence.
| Acceptance Criterion (Implicitly based on predicate testing) | Reported Device Performance (Implied by equivalence) |
|---|---|
| Mechanical Performance (e.g., static and dynamic compression, expulsion resistance) in accordance with various ASTM standards (e.g., ASTM F2077, ASTM F2267) | Met standards; subject device has the same general design. |
| Material Biocompatibility (Titanium 6Al-4V ELI conforming to ASTM F3001-14) | Met standards; subject device uses the same material. |
| Sterilization Effectiveness | Met standards; subject device has the same sterilization method. |
2. Sample Size for Test Set and Data Provenance:
- Not Applicable. This device is not an AI/ML system, so there isn't a "test set" in the context of diagnostic performance evaluation. The "testing" refers to non-clinical bench testing.
- The document states: "The predicate Reliance Cervical IBF System (K202266) has undergone non-clinical testing using various ASTM standards at a third party facility." The specific sample sizes for these biomechanical tests are not provided in this document but would be detailed in the original predicate device's 510(k) submission and the test reports.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This concept of "ground truth" established by experts is relevant for diagnostic or AI/ML performance evaluation, not for the mechanical testing of a physical implant.
4. Adjudication Method:
- Not Applicable. This is relevant for expert consensus in diagnostic studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is specifically for evaluating the effectiveness of a diagnostic tool or AI assistance in a clinical reading environment. This device is a surgical implant.
6. Standalone Performance:
- Yes, in the sense of non-clinical bench testing. The "standalone performance" for this device refers to its mechanical and material properties tested in a lab setting, against established ASTM standards, independent of human interaction in a diagnostic context. The document implies that the UniVy™ OsteoVy™ Cervical IBF System's standalone performance is equivalent to its predicate through the "non-clinical testing" section.
7. Type of Ground Truth Used:
- Not Applicable for AI/ML "ground truth." For a physical medical device, the "ground truth" equivalent would be the objective measurements from laboratory testing against pre-defined engineering and material standards (e.g., ultimate tensile strength, fatigue life, biocompatibility markers, conformity to material specifications). These are derived from established scientific and engineering principles and standardized test methods, not expert consensus on clinical images or pathology.
8. Sample Size for the Training Set:
- Not Applicable. This device does not use a training set for an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable.
In summary, the provided document describes a 510(k) premarket notification for a physical spinal implant. The criteria for AI/ML device evaluation are not relevant here. The substantial equivalence of the UniVy™ OsteoVy™ Cervical IBF System is established by demonstrating that it has equivalent technological characteristics (material, design, function, intended use, etc.) to a legally marketed predicate device (Reliance Cervical IBF System, K202266), which has already undergone the necessary non-clinical bench testing to prove its safety and effectiveness.
§ 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.