(233 days)
The HammerLock™ is indicated for small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.
The HammerLock™ is an addition to the OSSPlate™ line and is designed for use as an intramedullary bone fixation device. The OSSPlate™ is situated on the bone with the prongs extending through the cortex and in its final configuration the prongs are deflected inward to create a clamping force. With the HammerLock™ the device is situated in the intramedullary space with the prongs extending into the cancellous bone and in the final configuration the prongs are deflected outward to create a compressive force. Two models of the HammerLock™ are provided for physician choice, the HammerLock™ X-Type and HammerLock™ Loop. Both exhibit similar test results to the predicate devices. The HammerLock™ models transformed to their final configuration by body heat alone.
The provided text is a 510(k) summary for the OSSplate™ HammerLock™ Product. This document is related to a medical device for bone fixation, not a software or AI-based device, and therefore does not contain information about acceptance criteria or studies in the context of device performance metrics like sensitivity, specificity, or reader studies.
The document focuses on demonstrating substantial equivalence to a predicate device (Memometal Technologies (MMI-USA) SmartToe™) to classify it as a Class II medical device. This type of regulatory submission primarily relies on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, rather than performance studies with defined acceptance criteria for diagnostics or AI.
Therefore, the requested information, which pertains to the performance evaluation of a diagnostic or AI device (e.g., acceptance criteria for metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth establishment), is not present in the provided text.
The document states: "Both exhibit similar test results to the predicate devices." This is the closest it comes to mentioning performance, but it doesn't provide specific data, acceptance criteria, or details regarding those "similar test results."
In summary, none of the requested information regarding acceptance criteria and performance studies for a diagnostic or AI device can be extracted from this document because it describes a physical medical implant device's 510(k) submission based on substantial equivalence.
§ 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.