(137 days)
The MONUMENT™ Spacer is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The MONUMENT™ Spacer is to be filled with autogenous bone graft material, and is to be used with four titanium alloy screws that accompany the implant. The device is intended to be used with supplemental fixation (i.e. pedicle screws, facet fixation).
The MONUMENT™ Spacer is an anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectorny. The MONUMENT™ Spacer is intended to aid in reduction of a Grade 1 spondylolisthesis. The spacer is available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bonv fixation. The spacer is to be filled with autogenous bone graft material. The MONUMENT™ Spacer is made from radiolucent PEEK polymer and titanium alloy, as specified in ASTM F136, F1295, and F2026. The mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295, and are available with hydroxyapatite (HA) coating, as specified in ASTM F1185.
This looks like a 510(k) summary for a medical device called the MONUMENT™ Spacer, an intervertebral body fusion device. The summary describes the device, its indications for use, and a brief mention of performance data and substantial equivalence to predicate devices.
However, the provided text does not contain the specific information needed to fulfill your request for acceptance criteria and a study proving those criteria are met.
Here's why and what's missing:
- Acceptance Criteria Table: The summary states that mechanical testing was conducted "in accordance with the 'Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Fusion Device,' June 12, 2007, ASTM F2077, and ASTM 2267." While these documents outline standards for testing, they do not explicitly state the specific numerical acceptance criteria used by Globus Medical for the MONUMENT™ Spacer. For example, it doesn't say "compressive strength must be greater than X N" or "subsidence must be less than Y mm."
- Reported Device Performance: The summary broadly states, "Performance and comparative analysis data demonstrate that the different technological features do not affect the safety and effectiveness of the device and support substantial equivalence to the predicate devices." This is a conclusion, not a presentation of the specific performance results (e.g., actual measured ultimate compressive strength, fatigue life cycles, etc.) against specific criteria.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document refers to "Mechanical testing" but provides no details about study design, sample sizes, data acquisition methods, or any human reader involvement. This type of device (intervertebral body fusion device) typically relies on mechanical bench testing rather than studies involving expert readers, human performance, or image analysis. Therefore, most of the questions related to these aspects are not applicable or cannot be answered from the provided text.
In summary, this document indicates what types of tests were performed (mechanical), but not the specific acceptance criteria or the detailed results from those tests.
To answer your questions, I would need a different type of document, such as the full test report from the mechanical testing, which would outline the specific criteria and the measured performance data.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The prompt requests "A table of acceptance criteria and the reported device performance," which is not available in the given document.
§ 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.