(118 days)
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.
The SeaSpine Beachside System is an intervertebral fusion device with large central graft windows, which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers are manufactured from polyetheretherketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 and titanium alloy per F136 for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile packed. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in trays for storage, protection, and organization prior to and during the steam sterilization process.
The provided text is a 510(k) summary for the SeaSpine Beachside System. It describes the device, its intended use, and its similarities to predicate devices. However, this document does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria, particularly in the context of AI/ML performance.
The "Non-Clinical Testing" section mentions mechanical performance tests (compression, compression-shear, subsidence, wear evaluation, and expulsion testing) and bacterial endotoxin testing. While these are acceptance criteria for the device's mechanical and biological properties, they are not related to an AI/ML algorithm's performance.
The "Clinical Testing" section explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This further confirms that no clinical study (which would typically involve human subjects and outcome measures) was performed or required for this 510(k) clearance.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and a study to prove they are met, as the provided document does not pertain to an AI/ML device in the way your prompt describes.
If you have a document describing an AI/ML device, please provide that text, and I will do my best to extract the requested information.
§ 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.