(90 days)
In cemented or cementless hip arthroplasty, when a screw hole plug is thought to be advantageous
The Trident® Screw Hole Plugs are small, threaded circular plugs which are intended to occlude acetabular screw holes not occupied by bone screws or the Trident® Bone Spike (subject device). The Trident® Screw Hole Plugs are fabricated from commercially pure titanium (CP Titanium). The Trident® Screw Hole Plugs incorporate a recess to accept a TORX® head screwdriver to allow the surgeon to place the desired number of plugs into the Trident® shell intraoperatively. The Trident® Screw Hole Plugs are intended to be inserted from the inside of the Trident® shell.
The Trident® Screw Hole Plugs, by occluding the shell screw holes, will help prevent intrusion of bone cement into the shell (when used in the cemented mode) or fibrous tissue (when used in a cementless mode), and potential migration of debris through open screw holes into the acetabulum.
The Trident® Bone Spike is fabricated from titanium alloy (Titanium 6 Aluminum 4 Vanadium), and is available in two lengths: 7mm and 9mm. The Trident® Bone Spike has a threaded base that is assembled to the screw hole(s) of the appropriate Trident® shell at the time of surgery. The undersurface of the base incorporates a recess to accept a TORX® screwdriver. The superior portion of the device is a spike that is intended to provide purchase into the prepared bone of the acetabulum. The surgeon has the option of using the Trident® Bone Spike in place of the Osteonics® Cancellous Bone Screws to provide supplemental fixation of the Trident® shell.
The provided text is a 510(k) Premarket Notification for the Trident® Screw Hole Plug and Trident® Bone Spike. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive de novo clinical study data to define and prove acceptance criteria for novel performance claims.
Therefore, the document does not contain the detailed information typically found in a clinical study report that would establish specific acceptance criteria and then demonstrate a device's performance against those criteria in a comprehensive manner. Instead, the submission relies on the concept of substantial equivalence, meaning the new device is as safe and effective as a previously cleared device.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance: This information is not explicitly stated or quantified in terms of clinical outcomes or performance metrics.
- Sample size, data provenance for a test set, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for a test set: These are all elements of a clinical effectiveness study, which is not presented here. The submission refers to "Testing was presented to support a claim of substantial equivalence," but the details of this testing are not provided in the excerpts. This "testing" likely refers to bench testing (e.g., mechanical strength, material compatibility) rather than clinical performance studies.
- Sample size or ground truth establishment for a training set: Since no machine learning or AI component is mentioned, there would be no "training set."
What the document does provide is:
- Device Identification: Proprietary names, common names, classification, and product codes.
- Intended Use/Indications: Clearly describes the purpose and conditions under which the devices are to be used (e.g., occluding screw holes, supplemental fixation in hip arthroplasty).
- Contraindications: Specific conditions where the devices should not be used (e.g., obesity).
- Material and Design: Details about the materials (CP Titanium, Titanium 6 Aluminum 4 Vanadium) and design features (threaded plugs, TORX® recess, spike).
- Substantial Equivalence Claim: The core of the 510(k) submission, stating that the device is substantially equivalent to predicate devices. The FDA's letter (K022799) confirms this determination.
In summary, based only on the provided text, it is not possible to describe the acceptance criteria and study that proves the device meets them in the requested format. The document's purpose is to demonstrate substantial equivalence, not to present a de novo clinical study with quantifiable acceptance criteria for clinical performance.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.