(319 days)
AnyPlus® PEEK Lumbar Fusion Cage device is intended for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The AnyPlus PEEK Lumbar Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine.
The GS Medical AnyPlus PEEK Lumbar Cage device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether-ketone (PEEK OPTIMA LTI) (Manufacturer - INVIBIO) body (PEEK conforming to ASTM F2026) with the x-ray markers made of Tantulum (conforming to ASTM F560). This submission includes the addition of sizes to the model PLIF devices, a revision of the shapes of the ALIF, PLIF and TLIF model and the addition of the TPLIF model based on the PLIF design to accommodate surgeons using a Transforaminal Posterior Lateral Interbody Fusion (TPLIF) surgical approach.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ASTM F2077 and ASTM F2267) | Reported Device Performance |
|---|---|
| Static Axial Compression | Equivalent to or higher than legally marketed predicate device |
| Dynamic Axial Compression | Equivalent to or higher than legally marketed predicate device |
| Static Compression-Shear Testing | Equivalent to or higher than legally marketed predicate device |
| Dynamic Compression-Shear Testing | Equivalent to or higher than legally marketed predicate device |
| Static Torsion Testing | Equivalent to or higher than legally marketed predicate device |
| Dynamic Torsion Testing | Equivalent to or higher than legally marketed predicate device |
| Expulsion Testing | Equivalent to or higher than legally marketed predicate device |
| Static Subsidence Testing under Axial Compression | Equivalent to or higher than legally marketed predicate device |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in the document. The testing was non-clinical (mechanical bench testing), so it would involve a certain number of devices tested for each parameter. The document indicates "All performance test results" suggests that a sufficient number was tested to make a comparative claim, but the exact count isn't provided.
- Data Provenance: Non-clinical (bench testing) performed by the manufacturer, GS Medical Co., Ltd. The country of origin for the device manufacturing is Korea.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. This was non-clinical mechanical testing, not a study involving human experts establishing ground truth for diagnostic or clinical outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. As non-clinical mechanical testing, there is no "adjudication method" in the traditional sense. The performance was measured directly against established standards (ASTM F2077, ASTM F2267) and compared to a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No. The document explicitly states: "No clinical testing was performed."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was a standalone study done? This is a medical device (implantable cage) and not an AI algorithm. Therefore, the concept of a "standalone algorithm" study does not apply. The performance evaluated was the standalone mechanical integrity of the device itself.
7. Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" for this non-clinical testing was defined by the performance specifications outlined in the ASTM standards (ASTM F2077, ASTM F2267) and the measured performance of a legally marketed predicate device. The device was deemed "substantially equivalent" if its performance met or exceeded these established benchmarks.
8. Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This refers to the training of an AI algorithm. This device is a physical medical implant, not a software algorithm, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Was Established: Not applicable, as this is not an AI algorithm.
§ 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.