(76 days)
The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
The AccuLIF TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). As with the predicate expandable AccuLIF TL and PL Cage devices, the device is inserted in unexpanded state with a delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangements using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device automatically locks at 1mm increments as it expands. The AccuLIF TL and PL Cage come in a variety of sizes, shapes, and lordotic angles to accommodate patient anatomy.
The AccuLIF TL and PL Cage system comprises a packaged sterile AccuLIF implant, an instrument tray, and a packaged sterile Tubing Assembly. Within the TL or PL instrument trays are an inserter, pressure syringe, slap hammer, graft insertion cannula, graft insertion pusher, bone graft block, and TL or PL distractor trials. Additional instruments supplement the instrument trays.
The provided text is a 510(k) summary for the Stryker AccuLIF® TL and PL Cage, an intervertebral body fusion device. This type of regulatory document focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for studies of the device itself.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
Instead, the document highlights that:
- The device is substantially equivalent to predicate devices (Stryker Spine, ACCULIF® TL and PL Cage K143163, and Medtronic, Capstone Spinal System, K123027) based on material, design, mechanical performance, and indications.
- The primary change in this submission is the expansion of indications to include degenerative scoliosis.
- Published clinical data for lumbar interbody fusion devices similar to the Stryker Spine AccuLIF TL and PL devices was provided in support of this application. This is the closest the document comes to mentioning performance data. It states that "The published clinical outcomes demonstrated that the use of the lumbar interbody fusion procedures to treat patients diagnosed with degenerative scoliosis above does not adversely affect performance of the system and does not represent a new worst case scenario."
- No changes were made to the existing devices, and therefore no additional implant testing was required or performed for this specific 510(k) submission.
In summary, the provided text describes a regulatory submission establishing substantial equivalence, not a study designed to prove the device meets specific acceptance criteria with detailed performance metrics.
§ 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.