(141 days)
PISCESTM-SA ALIF Spacers (Standalone Use. With Integrated Fixation)
The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
· PISCESTM-SA Used With Screws:
When used with three (3) screws, interbody devices with a lordotic angle 20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.
· PISCESTM_SA Used With Anchors
When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation.
PISCESTM ALIF Spacers (Without Integrated Fixation)
PISCESTM ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudatthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior supplemental fixation.
PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are standalone interbody fusion devices. When used with anchors or without screws, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES" -SA interbodies are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, anchors, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.
The provided text does not contain information about specific acceptance criteria, study details, or performance results from a clinical or analytical study. The document is primarily a 510(k) submission summary for a medical device (PISCES™-SA Standalone ALIF Interbody System), demonstrating substantial equivalence to predicate devices through non-clinical testing.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies. The text explicitly states "Substantial equivalence is supported by the results of mechanical testing," and "Substantial equivalence is also supported by performing cadaveric implantation and cadaveric Range of Motion (ROM) studies." This indicates that the safety and effectiveness determination for this device was based on non-clinical data rather than human clinical trials.
The information I can extract about the testing performed is:
Non-clinical Testing Performed:
- Static and dynamic compression per ASTM F2077
- Static and dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267
- Expulsion testing
- Cantilever anchor bending
- Anchor impaction testing
- Cadaveric implantation
- Cadaveric Range of Motion (ROM) studies
Since the request asks for details that are typically associated with clinical or analytical studies involving human data or expert review for AI/ML devices, and this document pertains to a spinal implant cleared through substantial equivalence based on non-clinical data, the majority of the requested fields cannot be filled.
§ 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.