(118 days)
No
The description focuses on patient-specific design based on imaging data and validated software tools, but there is no mention of AI or ML algorithms being used in the design or manufacturing process.
No
Explanation: The device is a cutting block used to assist in the positioning of knee replacement components and guide marking before cutting. It is an intraoperative tool and not a device that directly treats a medical condition.
No
The device is described as an anatomical cutting block used intraoperatively to assist in the positioning of total knee replacement components and guide bone marking. It does not perform any diagnostic function of identifying a disease or condition.
No
The device description explicitly states that the device is "designed and manufactured from patient imaging data" and refers to "cutting blocks," which are physical objects used intraoperatively. The performance studies also include testing on physical properties like biocompatibility, dimensional accuracy, mechanical testing, and cleanliness, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the positioning of total knee replacement components intraoperatively and guide bone marking before cutting. This is a surgical aid used during a procedure on the patient's body.
- Device Description: The device is a physical cutting block designed to match a patient's anatomy for surgical guidance.
- Lack of In Vitro Activity: IVD devices are intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on biological specimens.
The device is a surgical planning and guidance tool used directly on the patient during surgery, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
MyKnee Cutting Blocks are intended to be used as anatomical cutting blocks specific for a single patient anatomy to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of hone before cutting.
MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use.
MyKnee Cutting Blocks are intended for single use only.
Product codes
JWH, OOG
Device Description
MyKnee Cutting Blocks are designed and manufactured from patient imaging data so that the cutting blocks match the patient's anatomy. The MvKnee Cutting blocks for the patient are used with Medacta's existing GMK Total Knee System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient imaging data
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
MyKnee Cutting Blocks were tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing was conducted on the worst case component size and option/design.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing included biocompatibility testing to ISO 10993 applicable to external communicating devices with limited (
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K093806 (1/3)
Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of the word "Medacta" in a bold, sans-serif font, with two triangular shapes above the "M". Below the word "Medacta" is the word "International" in a smaller font. To the right of the word "International" is a plus sign.
APR - 8 2010
510(k) Summar
Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 (+41) 91 696 60 66 FAX
Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@njkconsulting.com
Date Prepared: April 7, 2010
DEVICE INFORMATION
Trade/Proprietary Name: MyKnee Cutting Blocks
Common Name: Total Joint Replacement /Classification Name: Knee Joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis
21 CFR 888.3560 Class II Device Product Code: JWH, OOG
- K082358 Smith & Nephew, Inc. Patient Matched Predicate Devices: Cutting Blocks K090988 GMK Total Knee System
MyKnee Cutting Blocks 510(k)
Section 5 - Page 2 of 4
1
Product Description:
MyKnee Cutting Blocks are designed and manufactured from patient imaging data so that the cutting blocks match the patient's anatomy. The MvKnee Cutting blocks for the patient are used with Medacta's existing GMK Total Knee System.
Intended Use and Indications for Use:
MyKnee Cutting Blocks are intended to be used as anatomical cutting blocks specific for a single patient anatomy to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting.
MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use.
MyKnee Cutting Blocks are intended for single use only.
Comparison to Predicate Devices
MyKnee Cutting Blocks have the same intended use as the Smith & Nephew's Patient Matched Cutting Blocks except for use with the Medacta GMK system instead of the Smith & Nephew's cleared total knee systems. Both are manufactured from the same material using the type of process where the cutting blocks are matched to the patient's anatomy using data from patient imaging files.
MyKnee Cutting Blocks are also substantially equivalent to the standard distal femoral and proximal tibial cutting blocks used in conjunction with the GMK Total Knee system cleared under K090988. MyKnee Cutting Blocks are used with the GMK Total Knee System for the indications for use for which the GMK Total Knee System is cleared.
Performance Testing
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the MyKnee Cutting Blocks was conducted in accordance with various international standards and FDA quidance documents.
Non-clinical testing included biocompatibility testing to ISO 10993 applicable to external communicating devices with limited (