(22 days)
The Medussa-PL Cage is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The Medussa-PL Cage is additively manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001 and is available in a range of sizes to accommodate different patient anatomies, and pathologies.
I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter for a medical device (Medussa-PL Cage) and does not contain details about:
- Acceptance criteria and reported device performance: The document mentions "engineering analysis and the performance testing result" but does not provide specific acceptance criteria or quantitative performance data.
- Study design details: There is no mention of sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
- Ground truth information: While it states the device is for Degenerative Disc Disease (DDD) confirmed by "patient history and radiographic studies," it doesn't elaborate on how ground truth was established for any assessment studies, nor does it specify training set details.
The document primarily focuses on establishing substantial equivalence to a predicate device based on general similarities in design, materials, function, and indications for use, rather than presenting a detailed clinical or performance study with quantified acceptance criteria.
§ 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.