(199 days)
The AnyPlus® Cervical PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. AnyPlus® Cervical PEEK cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. AnyPlus® Cervical PEEK cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
The AnyPlus® Cervical PEEK Cage System is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether-ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® Cervical PEEK Cage System are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® Cervical PEEK Cage System is supplied non-sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage System is designed for interbody stabilization of the cervical spine.
The provided text describes the 510(k) summary for the "AnyPlus® Cervical PEEK Cage System," which is a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.
However, I can extract the relevant information from the provided text as if the non-clinical testing served as the "study" for this type of medical device's performance acceptance.
Here's the breakdown based on your request, interpreting "acceptance criteria" as meeting performance standards and "study" as the non-clinical testing performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| ASTM 2077-11: Static Axial Compression | All performance test results were equivalent to or higher than a legally marketed predicate device. |
| ASTM 2077-11: Dynamic Axial Compression | All performance test results were equivalent to or higher than a legally marketed predicate device. |
| ASTM 2077-11: Static Compression-Shear | All performance test results were equivalent to or higher than a legally marketed predicate device. |
| ASTM 2077-11: Dynamic Compression-Shear | All performance test results were equivalent to or higher than a legally marketed predicate device. |
| ASTM 2077-11: Static Torsion | All performance test results were equivalent to or higher than a legally marketed predicate device. |
| ASTM 2077-11: Dynamic Torsion | All performance test results were equivalent to or higher than a legally marketed predicate device. |
| ASTM 2077-11: Expulsion Testing | All performance test results were equivalent to or higher than a legally marketed predicate device. |
| ASTM F2267-04: Static Subsidence (Axial Compression) | All performance test results were equivalent to or higher than a legally marketed predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in terms of patient data or clinical cases for a test set. This is a non-clinical study. The "test set" refers to the physical devices tested according to the ASTM standards. The specific number of devices tested for each standard is not provided in this summary.
- Data Provenance: The testing was non-clinical, involving physical devices in a laboratory setting. Therefore, there's no country of origin for "data" in the sense of patient data, nor is it retrospective or prospective. It's a laboratory-based evaluation of device mechanics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For non-clinical, mechanical testing of a medical implant, "ground truth" is established by the specified ASTM test method and engineering principles, not by expert consensus on clinical findings. The results are objective measurements of physical properties.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "test set" involves objective mechanical testing against engineering standards, not subjective interpretations requiring adjudication.
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 document pertains to a physical medical implant (a cervical PEEK cage system), not an AI/ML device for diagnostic imaging or similar applications where human readers' performance would be evaluated. No such study was conducted or is relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is derived from the established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. These standards define the mechanical performance requirements and test methodologies. The device's performance measured against these objective, standardized tests serves as the ground truth for its mechanical properties.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical submission for a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #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.