(29 days)
Dominator TM is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.
Dominator™ is a bioabsorbable device manufactured from a composite mixture of poly-L-lactic acid (PLLA) and calcium phosphate. It may be supplied with sutures with or without pre-attached needles.
The provided text is a 510(k) summary for a medical device (Dominator™ suture anchor) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device that existed before the current regulatory framework.
Here's a breakdown of why the requested information cannot be extracted from this document:
- Type of Device: The Dominator™ is a physical orthopedic implant (suture anchor), not a software algorithm or a diagnostic tool that would typically have performance metrics like those for AI.
- Regulatory Pathway: The 510(k) pathway for medical device clearance in the US primarily relies on demonstrating substantial equivalence, not conducting de novo clinical trials with predefined acceptance criteria and performance metrics in the way a new drug or novel AI diagnostic would.
- Content of Document: The document repeatedly states that "Dominator™ has the exact same intended use and indications as the predicate device" and that "Documentation provided demonstrates that the Dominator™ is substantially equivalent to the legally marketed predicate device and any differences do not raise concerns regarding safety and effectiveness." This doesn't involve setting new performance "acceptance criteria" for the Dominator™ to meet independently, but rather showing it's comparable to an already approved device.
- "Non Clinical Testing": While "Non Clinical Testing" is mentioned, the document only states that it "demonstrates that the Dominator™ is substantially equivalent to the predicate device." It does not provide details of specific tests, methodologies, or results that would allow for an "acceptance criteria" table or a description of a study with sample sizes, ground truth, or expert involvement.
Therefore, I cannot provide the requested information from the given text. The document's purpose is to show equivalence and not to detail a performance study against specific acceptance criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.