(62 days)
Intended Use
CORIOGRAPH Pre-Op Planning and Modeling Service is intended to provide pre-operative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Indications for Use
The CORIOGRAPH Pre-op Planning and Modeling Service is indicated for use for the following procedures:
- unicondylar knee replacement (UKR)
- . total knee arthroplasty (TKA)
The subject CORIOGRAPH Knee Pre-Op Plan is a medical function module within the CORIOGRAPH Pre-Op Planning and Modeling Service. This service is an additional offering being introduced by Smith & Nephew to allow for preoperative planning for surgical procedures based on patient imaging for total knee arthroplasty (TKA) and unicondylar knee replacement (UKR). The CORIOGRAPH Knee Pre-Op Plans will be generated for specific patients and anatomy by Smith and Nephew personnel using the CORIOGRAPH Knee Pre-Op Plan Software System V1.0, which is the subject of this submission. The CORIOGRAPH Knee Pre-Op Plans will output bone models of the patient anatomy and will generate patient-specific pre-operative plans which may be used on the REAL INTELLIGENCE CORI Surgical System.
The provided text is a 510(k) summary for the CORIOGRAPH Knee Pre-Op Plan. It discusses the device's substantial equivalence to a predicate device and details non-clinical testing. However, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving those criteria are met.
Here's a breakdown of what can be answered and what information is missing:
1. A table of acceptance criteria and the reported device performance
The document states, "Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System. Summative usability testing demonstrated that participating surgeons were able use the subject device safely and effectively in a simulated use environment. Smith and Nephew, Inc. has concluded that all design inputs have been met and that the verification and validation testing performed did not raise any new questions of safety or effectiveness."
This is a general statement of compliance, not a detailed table of specific acceptance criteria (e.g., accuracy metrics, specific tolerances) and their corresponding reported performance values. Therefore, a table cannot be fully constructed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. The document refers to "verification and validation testing" and "summative usability testing" but does not specify the sample size for these tests or the origin/nature of the data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the text. The document mentions "participating surgeons" in the usability testing, but their number or specific qualifications (beyond being surgeons) are not detailed. It does not mention experts establishing ground truth for a test set in the context of performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is a "Knee Pre-Op Plan" which suggests it aids in surgical planning, not necessarily in interpretation tasks typically associated with MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states, "Verification and validation testing demonstrated the safety and effectiveness of the software applications used in the CORIOGRAPH Knee Pre-Op Plan and demonstrated the safety and effectiveness of the generated CORIOGRAPH Knee Pre-Op Plan when used as an input to the CORI Surgical System." This implies standalone testing of the software's output, as well as its interaction as an input to another system. However, specific metrics of "algorithm-only" performance are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly provided in the text. Given the device provides "pre-operative planning for surgical procedures based on patient imaging," the ground truth for evaluating its accuracy would likely be related to the accuracy of anatomical landmark identification, implant positioning, or surgical outcomes, but this is not specified.
8. The sample size for the training set
This information is not provided in the text. The document discusses "software applications" and "planning tools and processes" but does not detail any machine learning models or training sets.
9. How the ground truth for the training set was established
This information is not provided in the text, as no training set details are given.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.