(174 days)
The 4CIS® PEEK PLIF IBF Device is an intervertebral body device intended for use skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic pack pain with degeneration of the disk confirmed by history and radiographic studies. 4CIS Peek PLIF IBF devices are intended to be used with autologous bone graft to facilitate fusion. The device is to be used in patients who have had six months of non-operative treatment. The 4CIS PEEK PLIF IBF devices are to be implanted via a direct posterior approach. The device is implanted singly or in pairs, with supplemental fixation.
The subject device, 4CIS® PEEK PLIF Cage System is made of devices for fixation of spine. This system allows maximum preservation of bony endplate and vertical square teeth ensure enough contact surfaces with bony endplate, which prevents "sinking-in" of cage into the vertebral body, while vertical teeth increase the anchoring and prevent slipping. It has two tantalum markers for ease of visualization on radiographs. The components are manufactured from PEEK-OPTMA LT1 (Polyetheretherketone, ASTM F2026) material.
The provided text describes a 510(k) summary for the "4CIS® PEEK PLIF Cage System", an intervertebral body fusion device. This document focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies and acceptance criteria typically associated with AI/ML-driven diagnostic devices.
Therefore, many of the requested categories for a study proving device performance (such as sample sizes, expert qualifications, ground truth methods, and MRMC studies) are not applicable or cannot be extracted from this specific 510(k) summary. The summary primarily discusses mechanical testing and the device's indications for use.
Here's a breakdown of the information that can be extracted and a clear indication of what cannot.
1. A table of acceptance criteria and the reported device performance
The provided document describes a medical device (spinal implant) and not a diagnostic AI/ML system. Therefore, the concept of "acceptance criteria" and "reported device performance" in the context of sensitivity, specificity, or other diagnostic metrics is not applicable here. The performance mentioned is mechanical testing.
Acceptance Criteria & Device Performance (for mechanical properties):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet ASTM F2077 mechanical testing standards for intervertebral body fusion devices. | Mechanical testing as listed in APPENDIX 10 (details not provided in this summary). |
| Biocompatibility of PEEK-OPTIMA LT1 | Implied by use of ASTM F2026 material and regulatory approval. |
| Radiographic visualization (for tantalum markers) | Has two tantalum markers for ease of visualization on radiographs. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document refers to mechanical testing of a physical device, not an algorithm tested on a dataset.
- Data Provenance: Not applicable for the reasons above.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no diagnostic "ground truth" establishment in the context of mechanical testing. Expertise would be in materials science and biomechanics for evaluating the testing.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring adjudication of expert opinions on a test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML diagnostic device, and therefore, no MRMC study or AI-assisted human reader performance analysis was performed or described.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- Ground Truth (for mechanical testing): Material specifications (e.g., ASTM F2026 for PEEK), biomechanical principles, and established international standards for intervertebral body fusion devices (such as those referenced in ASTM F2077, though not explicitly detailed in the provided excerpt). The "ground truth" here is the objective physical performance and material properties.
8. The sample size for the training set
- Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML algorithm that requires a training set.
Summary of what is present in the document:
The provided 510(k) summary focuses on demonstrating substantial equivalence of the 4CIS® PEEK PLIF Cage System to legally marketed predicate devices. This typically involves:
- Device Description: What the device is made of and how it functions.
- Intended Use/Indications for Use: The specific medical conditions and patient population for which the device is designed.
- Performance Data (Mechanical Testing): Mention of mechanical testing (in APPENDIX 10, not included here) to ensure the device meets established safety and performance standards for spinal implants (e.g., strength, fatigue, subsidence resistance). This is the key "study" mentioned for this type of device.
- Material Biocompatibility: Ensured by using a well-established and approved material (PEEK-OPTIMA LT1, ASTM F2026).
- Substantial Equivalence Argument: Comparing the device's features, materials, and intended use to existing, legally marketed devices.
The document does not contain information about clinical trials, AI/ML performance, expert reviews of diagnostic images, or any of the elements pertinent to evaluating a software-as-a-medical-device (SaMD) or AI-driven diagnostic tool.
§ 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.