(56 days)
The CONDUIT™ Instruments are intended to be used with the EIT Cellular Titanium® Cages: EIT Cellular Titanium® Cervical Cage, EIT Cellular Titanium® ALIF Cage, EIT Cellular Titanium® TLIF Cage, EIT Cellular Titanium® LLIF Cage, EIT Cellular Titanium® T/PLIF Cage.
The CONDUIT™ Instruments are non-sterile, reusable instruments that may be used during placement of various EIT Cellular Titanium® Interbody Cages during spinal surgery. The CONDUIT™ Instruments are made from materials commonly used in orthopedic and neurological procedures which meet available national standards specifications. The purpose of this submission is to introduce a new set of instruments to be used with the EIT Cellular Titanium® Cervical and Lumbar Cages and there are no changes to the implant devices.
The provided text is a 510(k) Premarket Notification summary for the CONDUIT™ Instruments, which are non-sterile, reusable instruments used in spinal surgery. This document primarily focuses on demonstrating substantial equivalence to a predicate device (EIT Cellular Titanium® Interbody Cages, K201605) based on intended use, technological characteristics, and performance.
Crucially, this document does not describe the acceptance criteria or a study that proves the device meets specific performance metrics for an AI/algorithm-based medical device aiming to achieve clinical performance goals (e.g., sensitivity, specificity, accuracy).
Instead, the document references "Non-clinical testing conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use." This type of testing typically involves:
- Mechanical/functional testing: Ensuring the instruments function as intended (e.g., proper grip, secure attachment to implants, durability).
- Biocompatibility: Confirmation that materials are safe for patient contact (though these are instruments, not implants, so direct patient contact for prolonged periods is less relevant, but sterilization and handling are).
- Sterilization validation: Ensuring the instruments can be effectively sterilized for reuse.
- Material verification: Confirmation that the materials meet specified ASTM standards.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance of an AI/algorithm for this specific device from the given text.
The closest I can get to a "study" is the statement in section H:
"Non-clinical testing was conducted in accordance with Design Controls and Risk Management to confirm device performance for its intended use. The results demonstrate that the device performs as well as the predicate devices for the compared design inputs."
This implies a comparison against a predicate, likely in terms of functional equivalence and safety, rather than a clinical performance study with specific AI metrics.
In summary, none of the requested information (acceptance criteria for AI, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, standalone AI performance, training set details) is present in the provided FDA 510(k) documentation for the CONDUIT™ Instruments because it is a submission for surgical instruments, not an AI/algorithm-driven 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.