(56 days)
The Ascential IBD PEEKc Spacers are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Ascential IBD PEEKc Spacers are to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach.
The Ascential IBD PEEKc Spacer is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
The Ascential IBD PEEKC Spacer is a hollow, ring-shaped PEEK Optima® LT1 implant with three Tantalum marker pins. The spacers are offered in a variety of lengths, heights, and lordotic angles to adapt to varying patient anatomies. The hollow, ring-shaped implants have serrations on the top and bottom surfaces of the spacer. The hollow space of the implant is intended to hold bone graft material. The IBD PEEKC spacer is to be used as an interbody fusion device (IBD) for the cervical spine (from C2-C3 to C7-T1).
The Ascential IBD PEEKC Spacers to be used for cervical IBD applications are available in a variety of sizes, from 4 mm to 12 mm in height (in 1 mm increments), two depths: 12 mm and 14 mm and two widths: 14 mm and 16 mm. There are also 0° and 4° wedge shaped options that allow the surgeon to choose the size better suited to the patient's anatomy and pathology.
Class I instruments are provided for successfully performing anterior cervical interbody fusion procedures.
The Ascential IBD PEEKC Spacer is a sterile version (gamma sterilized) of the AVS® AS PEEK Spacer
The provided text is a 510(k) Premarket Notification for the Ascential IBD PEEK(c) Spacer, an intervertebral body fusion device. The document primarily focuses on establishing substantial equivalence to a predicate device, the AVS® AS PEEK Spacer (K142251), particularly regarding the impact of terminal sterilization (gamma sterilization) on the device's material properties and performance.
The "study" or justification provided in this document is a comparison of material properties after sterilization and reliance on previous testing of the predicate device. It is not a clinical study or a comparative effectiveness study involving human readers or AI.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance (Table)
This document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or clinical outcomes that would typically be associated with AI or diagnostic device studies. Instead, the acceptance criteria are implicitly related to maintaining the mechanical properties and sterility of the device after gamma sterilization, and being "substantially equivalent" to an existing predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Mechanical properties of sterilized material equivalent to non-sterilized material. | The sterilized material of IBD PEEK(c) has mechanically equivalent material properties to the non-sterile AVS AS implants. Supporting documentation from Invibio shows that gamma sterilization (up to 75 kGy) of PEEK-OPTIMA® material does not impact mechanical performance. |
| Pyrogenicity within limits. | Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 is used for pyrogenicity testing to achieve the Endotoxin limit of |
§ 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.