(65 days)
Intervertebral Body Fusion Device: The AccuLIF TL and PL Cage are indicated for intervertebral body fusion with autogenous bone graft material 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 or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. 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 autogenous bone graft.
The AccuLIF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6AI4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F 138-08, and Silicone Rubber (MED-4870). 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 arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands.
The AccuLIF TL and PL Cage comes in three sizes which are expandable from 6mm to 9mm, from 8mm to 12mm, and from 10mm to 16mm in 1mm increments. As well each size comes in two shapes, crescent and straight and each shape comes in two different footprints l 1mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape. Also the TL crescent shape comes in an 8 degree lordotic model as well as a 0 degree model for a total of 18 TL and PL models.
The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.
The AccuLIF TL and PL Cage system comprises a packaged sterile AccuLIF implant, an instrument tray, and a packaged sterile Unlock 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.
This document describes the Stryker Spine AccuLIF® TL and PL Cage, an expandable interbody fusion cage. The submission focuses on modifications to the AccuLIF Pressure Syringe, an accessory to the cage, rather than the cage itself. Therefore, the acceptance criteria and study details provided are specific to the performance of this accessory.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| AccuLIF Pressure Syringe Functionality: Maintain intended function after simulated cleaning, sterilization, and insertion/withdrawal impact. | Met. The AccuLIF Pressure Syringe was tested after 20 cycles of simulated cleaning, sterilization, and insertion/withdrawal impact. No adverse effects on intended function were observed. |
| Instrument and O-ring Integrity: Absence of damage to the instrument and o-rings after simulated use cycles. | Met. The instrument and o-rings were observed for damage after 20 simulated cleaning, sterilization, and use cycles. No signs of deterioration or malfunction were reported. |
| Pressure Delivery: Ensure appropriate pressure delivery to the AccuLIF TL or PL Cage. | Met. The pressure delivered by the instrument was examined and confirmed to ensure appropriate pressure continues to be delivered to the AccuLIF TL or PL Cage. |
| Overall Device Performance: Modified accessory does not adversely impact device performance compared to the predicate device. | Met. "The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicate device." "The modified accessory to the AccuLIF TL and PL Cage has identical indications, technological characteristics, and principles of operation as its predicate. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicate." |
2. Sample Size Used for the Test Set and Data Provenance
The study described is a non-clinical design verification test.
- Test Set Sample Size: The document mentions testing "after 20 cycles" of simulated cleaning, sterilization, and insertion/withdrawal impact. This implies a test regimen with 20 repetitions for each tested parameter, likely on one or a few sample units of the modified AccuLIF Pressure Syringe. The exact number of individual syringes tested is not explicitly stated beyond the "20 cycles" of evaluation.
- Data Provenance: The data is from non-clinical design verification testing, performed by the manufacturer, Stryker Spine. There is no mention of country of origin for the data (as it's laboratory/bench testing) or whether it's retrospective or prospective (as it's not a clinical study).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the study is a non-clinical design verification of an accessory (the syringe), not a clinical evaluation of the AccuLIF® TL and PL Cage. The ground truth for this type of test is established by engineering specifications and objective measurements, not expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Adjudication methods are typically associated with clinical studies where subjective assessments exist.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic or imaging devices where human readers interpret results. This submission pertains to a surgical implant accessory.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device (AccuLIF® TL and PL Cage and its pressure syringe) is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for this design verification study is based on engineering specifications and objective measurements. This includes:
- Observational assessment of damage to the instrument and o-rings.
- Measurement of pressure delivered by the instrument.
- Verification against design input requirements.
8. The Sample Size for the Training Set
This information is not applicable. There is no training set mentioned or implied as this is a device performance test, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.