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510(k) Data Aggregation
(329 days)
Image Guided Surgical Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a long bone can be identified relative to a CT based model or fluoroscopic image of the anatomy or by an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to, acetabular cup placement as part of a partial or total hip arthroplasty (primary or revision).
Subject of this Premarket Notification are the Smith & Nephew Image Guided Surgical Instruments for Hip Applications for use on the BrainLAB VectorVision? Hip Navigation System. Along with the associated hip software, the image guided surgical instruments for hip applications can be recognized and tracked in real time in the surgical field. Smith & Nephew has previously received clearance for Image-Guided Instruments and Software for Hip Applications under K021798 for use on the Medironic Surgical Navigation Technologies SteathStation® Platform Systems. The Smith & Nephew Image Guided Surgical Instruments for Hip Applications have been developed in order to utilize the intra-operative image-guided technology to track the immediate location and position of the surgical instruments during surgical hip procedures using the BrainLAB VectorVision2 Hip Navigation System.
The provided text does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance, nor does it describe a study with the specific elements requested.
This 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices for Smith & Nephew Image-Guided Surgical Instruments for Hip Applications. It lists predicate devices and reiterates the indications for use, but it does not present new performance data or acceptance criteria for this specific submission.
Therefore, I cannot provide the requested table and study details based on the input document. The document essentially states that the device uses the same fundamental scientific technology as the listed predicate devices and that the indications for use have not changed. This implies that the performance expectations would be similar to those of the predicate devices.
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(157 days)
The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement. (Does not include an indication for High Tibial Osteotomy (HTO) module).
Orthopilot® 2 Navigation Platform uses transmitters that are mounted to the patients bones, or are flexible to palpate landmarks and a camera to monitor the spatial location of those transmitters in relation to each other and the medical instruments. These locations are used to locate the centers of rotation of the femur head, ankle, knee. These measurements allow for greater accuracy than mechanical methods of ascertaining implantation sites and positions.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) premarket notification for the Orthopilot 2 Navigation Platform. It focuses on regulatory compliance, device description, indications for use, and substantial equivalence to previously cleared devices.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily states that the Orthopilot 2 Navigation Platform complies with general safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, CAN/CSA-C22.2 No. 601.1-M90), but these are performance standards for electrical and medical equipment safety, not clinical performance acceptance criteria for the navigation system's accuracy or efficacy in positioning endoprostheses. The FDA's letter also indicates that no applicable performance standards have been promulgated under Section 514 specifically for this device system.
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