(76 days)
Not Found
The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.
I apologize, but the provided text is a 510(k) summary for a medical device called the "Acumed Bone Grafting System." This document describes the device, its components, materials, sterilization information, and a comparison to a similar device on the market.
It does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth, expert opinions, or any of the other specific details regarding the evaluation of a device's performance that you have requested.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The information you are asking for typically comes from clinical trial reports, validation studies, or performance evaluation documents, which are not present in this 510(k) summary.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "ACUMED" in a bold, sans-serif font. The letters are black and have a slightly futuristic or technical appearance. There is a horizontal line underlining the word. To the right of the word, there is a superscript "TM" symbol, indicating a trademark.
Quality Orthopaedic Instruments and Implants
Enclosure D - 510(k) Summary MAY - 7 1996
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.93.
The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.
The Acumed Bone Graft System is manufactured from 17-4 ph stainless steel. The instruments are provided non-sterile. Data that validates a set of recommended steam sterilization process parameters which obtain a resulting SAL 0f 106 are maintained on file at Acumed. Information regarding implantation, packaging, and labeling have been provided.
The Acumed Bone Graft System is similar to Wright Medical Technology's Precision Bone Grafting System in form, function, composition, and indications and is expected to perform as well as similar devices.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.