(90 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 (TI6A14V 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.
This document is a 510(k) premarket notification for the Stryker AccuLIF® TL and PL Cage, specifically for modifications made to the AccuLIF Pressure Syringe. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a study proving the device meets performance acceptance criteria via clinical outcomes or algorithm performance.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies. These elements are typically found in clinical study reports or performance validation reports for devices that rely on diagnostic accuracy or AI performance, which this submission does not cover.
The document states that "Design verification testing was conducted to assess the device modification. The non-clinical test results demonstrate that the modified device is substantially equivalent to the predicate." This refers to engineering and bench testing to ensure the modified syringe still functions as intended and does not negatively impact the implant's performance, maintaining its substantial equivalence to the previously cleared predicate device.
Here's what I can extract from the provided text based on the nature of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no table of acceptance criteria or reported device performance in the sense of clinical outcomes, accuracy metrics, or algorithm performance. The submission focuses on demonstrating substantial equivalence of a modified accessory (the pressure syringe) to a predicate device based on non-clinical (design verification) testing.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (for the syringe modification): Not explicitly stated in terms of a "test set" for clinical evaluation. The document mentions "Design verification testing," which implies engineering tests to validate the syringe's function. The sample size for these engineering tests is not provided.
- Data Provenance: The nature of the submission (510(k) for an accessory modification) suggests that data would primarily be from internal engineering and lab testing conducted by Stryker Corporation. There is no mention of country of origin for clinical data, as no clinical study demonstrating device performance is presented. The testing is non-clinical.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. For a 510(k) submission concerning an accessory modification and relying on non-clinical design verification, expert consensus for ground truth on clinical outcomes or image interpretations is not typically required or mentioned.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods are relevant for clinical studies or studies involving expert review of data (e.g., image interpretation), which this document does not describe.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This document does not mention an MRMC study. MRMC studies are used to assess the impact of a diagnostic device or AI on human reader performance, which is not the subject of this 510(k).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
No. This device is an intervertebral body fusion cage and its accessory (a pressure syringe), not an algorithm or AI-based device. Hence, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used:
Not applicable in the context of clinical "ground truth" (e.g., pathology, outcomes data). The "truth" for this submission revolves around the functional equivalence of the modified pressure syringe to its predicate, established through engineering design verification tests.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.
§ 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.