(33 days)
The Paramount® Anterior Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. Paramount® Anterior Cervical Cage System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.
The Paramount® Anterior Cervical Cage System consists of a selection of sterile, single use cervical interbody cages indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. The Paramount® Anterior Cervical Cage System cages are multi-component devices comprised of a cage body, anchor plate and graft containment plate. Spine Wave supplies the cage body and anchor plate as a paired combination, and the surgeon assembles the graft cap in situ. The Paramount® Anterior Cervical Cage system cages are offered in a variety of sizes and shapes to accommodate different patient anatomies and manufactured from titanium alloy (Ti-6Al-4V per ASTM F136), commercially pure titanium (ASTM F67) and PEEK-OPTIMA with 6% BaSO4. Using the Paramount® Anterior Cervical Cage Inserter, the surgeon places the cage body with undeployed anchor plate into the disc space. After placement, the surgeon uses the cage inserter to deploy the superior and inferior portions of the anchor plate into the adjacent vertebral bodies and pack the open end of the cage with autograft. Once grafting is complete, the surgeon snaps the graft cap into the open end of the cage.
The provided text describes a 510(k) premarket notification for a medical device called the "Paramount® Anterior Cervical Cage System." This submission is primarily to offer the implant as a sterile-packed option. There is no study described that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. The document focuses on demonstrating substantial equivalence to a predicate device and validating the sterilization process, biocompatibility, and shelf life of the sterile-packed product.
Therefore, many of the requested items regarding acceptance criteria and performance studies for diagnostic or clinical effectiveness cannot be answered from this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
No specific clinical acceptance criteria or reported clinical performance is described in this document. The "performance testing" section refers to validation of sterilization, biocompatibility, and shelf life, not clinical outcomes.
| Acceptance Criteria (Not Clinical) | Reported Device Performance (Non-Clinical Validation) |
|---|---|
| Sterilization Validation | Evaluated in accordance with ISO 11137 (Sterilization of health care products - Radiation). |
| Biocompatibility | Assessed per ISO 10993 (Biological evaluation of medical devices). |
| Shelf Life Validation | Validated in accordance with ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages). |
| Bacterial Endotoxin Testing | Evaluated in accordance with ANSI/AAMI ST-72:2011 (Bacterial endotoxins - Test methods, routine tests). |
| Material Strength/Performance | Proposed level of gamma sterilization does not change the strength and performance characteristics of materials. |
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. This document does not describe a clinical performance study with a test set of patients or data. The "testing" mentioned is for product characteristics (sterilization, biocompatibility, etc.).
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. No ground truth establishment for a test set is described as this is not a clinical performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described.
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 not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical intervertebral cage, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for clinical performance is mentioned.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. 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.