(272 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 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
The Medussa-PL Cage is comprised of a variety of implant sizes and instrumentation to accommodate various patient anatomy and pathology. All implantable components are manufactured with an additive manufacturing technology from medical grade titanium alloy Ti6Al4V-ELI per ASTM F136 and ASTM 3001. The cages are intended to be implanted via a Posterior Lumbar Intervertebral (PLIF) approach. Implants are single use and the system is provided sterile.
The provided text describes a medical device, the "Medussa-PL Cage," and its 510(k) premarket notification to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel algorithm or AI.
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), training set specifics, and specific performance metrics for an AI/algorithm-based device cannot be extracted from this document.
This document outlines the regulatory approval process for an intervertebral body fusion device and its physical performance testing, not the performance of an AI application.
Here's an explanation of why the requested information is not available in the provided text:
- Type of Device: The "Medussa-PL Cage" is an intervertebral body fusion device, a physical implant used in spinal surgery. It is not an AI or algorithm-based software device.
- Regulatory Pathway: The document describes a 510(k) premarket notification, which is a pathway for devices that are "substantially equivalent" to legally marketed predicate devices. This process primarily involves demonstrating that the new device has the same intended use, indications for use, technological characteristics, and safety/effectiveness profiles as an already approved device. It does not typically involve defining and testing against specific acceptance criteria for an AI's diagnostic or predictive performance.
- Performance Data Provided: The "Performance Data" section details mechanical testing such as static and dynamic axial compression, compression shear, static torsion, subsidence, expulsion, and abrasion. These tests are relevant to the physical properties and structural integrity of an implant, not the accuracy or reliability of an AI algorithm.
- Ground Truth and Experts: The concepts of "ground truth," "experts," "adjudication," and "human-in-the-loop performance" are specific to the evaluation of AI/algorithm performance. They are not applicable to the physical testing of an implant.
Therefore, I cannot fulfill the request for a table of acceptance criteria and device performance as it pertains to AI, nor any of the other AI-specific study details, because the provided document is not about an AI device.
§ 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.