(55 days)
MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient's knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKnee® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon's preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.
MyKnee R Pin Positioners are a line extension to the currently marketed MyKnee Cutting Blocks (K093806) and MyKnee PPS-Pin Positioners (K170106). The MyKnee R blocks are single use, patient-specific pin positioner blocks designed based on CT images of a patient's knee and the primary TKA implant in situ. They are intended to position the pins for placement of the standard instruments according to the surgeon's preoperative surgical planning. The MyKnee R Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices. They are available in left and right configuration with sizes 1-6 for the both the femurs and the tibia and, as the predicate devices, they can be provided in both non-sterile version.
The provided FDA 510(k) summary for Medacta International S.A.'s MyKnee R Pin Positioners does not describe the specific acceptance criteria and detailed study that proves the device meets those criteria in the way typically expected for an AI/CADe device.
The MyKnee R Pin Positioners are patient-specific surgical guides, not an AI or CADe device in the sense of image analysis or diagnostic assistance. The performance data section explicitly states "No clinical studies were conducted," and the non-clinical studies primarily focus on software validation and cadaver testing validating the intended use, functional characteristics, and features of the physical guides themselves.
Therefore, many of the requested items related to AI/CADe performance (e.g., AUC, sensitivity/specificity, MRMC studies, ground truth establishment for training and test sets, number of experts, adjudication methods) are not applicable to this submission.
However, based on the information provided, we can infer and present what is available, noting the limitations of this document regarding the specific questions.
Here's an attempt to address the request based on the provided document:
Device: MyKnee R Pin Positioners
Device Type: Patient-specific anatomical pin positioners (surgical guides) for revision total knee replacement. This is NOT an AI/CADe device for image analysis or diagnosis.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance values in the context of accuracy metrics (e.g., for an AI algorithm's diagnostic performance). Instead, the "performance data" section focuses on validation activities for the physical device's functionality and intended use.
| Acceptance Criteria Category (Inferred from document) | Assessed Performance / Study Outcome |
|---|---|
| Software Validation | Confirmed (details not provided) |
| Functional Characteristics & Features (Cadaver) | Validated (details not provided) |
| Intended Use (Cadaver) | Validated (details not provided) |
| Biocompatibility | Leveraged from predicate devices |
| Sterilization Efficacy | Leveraged from predicate devices |
| Manufacturing Process Consistency | Confirmed (identical to predicate) |
| Material Properties | Confirmed (identical to predicate) |
| Device Usage | Confirmed (identical to predicate) |
| Shelf Life | Confirmed (identical to predicate) |
| Packaging | Confirmed (identical to predicate) |
Note: The document states that "testing activities were conducted to written protocols" and that the "slight differences between the subject and predicate devices do not raise new questions of safety and effectiveness." This implies that the acceptance criteria for these functional aspects were met, but the specific numerical targets or results are not detailed in this public summary.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The "Cadaver testing" refers to testing the physical device's function. The number of cadavers or specific test cases is not provided.
- Data Provenance: The document does not specify the country of origin for any data related to the cadaver testing. It is implied that the software processes CT images, but the origin of these CT images (e.g., patient demographics, retrospective/prospective collection) is not detailed as this is not an image analysis AI device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable in the AI/CADe sense. This submission is for a physical surgical guide. Ground truth for the geometric accuracy or fit of the guides would likely be established through engineering measurements and potentially surgeon feedback during cadaver trials, rather than expert consensus on image interpretation. The document does not specify the number or qualifications of any experts involved in the cadaver testing or validation of the guide's fit.
4. Adjudication Method for the Test Set
- Not Applicable. As there's no clinical imaging data interpretation or diagnostic task, there is no need for an adjudication method for establishing ground truth from image readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. The document explicitly states "No clinical studies were conducted." The device is a surgical guide, not an AI assistance for human readers in diagnostic tasks.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No standalone algorithm performance study (in the AI sense) was done. The "software validation" performed is likely related to the accuracy of the software in converting CT images into the physical design of the pin positioners and ensuring the correct output for manufacturing, not for diagnostic performance.
7. Type of Ground Truth Used
- For the cadaver testing, the ground truth would inherently be physical measurements and functional assessment of the pin positioners in situ, confirming that they achieve their intended purpose of guiding pin placement accurately according to preoperative plans. No diagnostic "ground truth" (e.g., pathology, outcomes data, or expert consensus on image findings) is mentioned or relevant to the device's function.
8. Sample Size for the Training Set
- Not Applicable. This is not an AI/ML model that requires a training set for learning. The device's design is based on established principles of patient-specific instrumentation derived from CT images, not on training a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. Since there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the device's development lies in anatomical principles, engineering specifications, and the accuracy of the CT data used for individual patient planning.
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May 4, 2022
Medacta International S.A. % Chris Lussier Senior Director, Ouality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K220705
Trade/Device Name: MyKnee R Pin Positioners Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 9, 2022 Received: March 10, 2022
Dear Chris Lussier:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name MyKnee R Pin Positioners
Indications for Use (Describe)
MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient's knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKne® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon's preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: March 9, 2022 Date Revised: May 3, 2022
II. Device
| Device Proprietary Name: | MyKnee R Pin Positioners |
|---|---|
| Common or Usual Name: | Total Joint Replacement |
| Classification Name: | Knee joint patellofemorotibial polymer/metal//polymersemiconstrained cemented prosthesis |
| Primary Product Code: | JWH |
| Regulation Number: | 21 CFR 888.3560 |
| Device Classification: | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
-
MyKnee PPS-Pin Positioners, K170106, Medacta Interational SA A
In addition, the following reference device is cited within the submission: -
A My Knee Cutting Blocks, K093806, Medacta International SA
IV. Device Description
MyKnee R Pin Positioners are a line extension to the currently marketed MyKnee Cutting Blocks (K093806) and MyKnee PPS-Pin Positioners (K170106).
The MyKnee R blocks are single use, patient-specific pin positioner blocks designed based on CT images of a patient's knee and the primary TKA implant in situ.
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K220705 page 2 of 3
They are intended to position the pins for placement of the standard instruments according to the surgeon's preoperative surgical planning.
The MyKnee R Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices.
They are available in left and right configuration with sizes 1-6 for the both the femurs and the tibia and, as the predicate devices, they can be provided in both non-sterile version.
V. Indications for Use
MyKnee® R Pin Positioners are intended for use as anatomical pin positioners specific for a single patient anatomy in case of revision total knee replacement. They are designed based on CT images of a patient's knee and the primary TKA implant in situ to assist in positioning the total knee replacement components intraoperatively and in guiding the marking of bone prior to cutting. MyKnee® R Pin Positioners are intended for single use only. Resections are performed through the standard or revision cutting guides. These are positioned on the pins placed in the holes drilled through the MyKnee® R Pin Positioner blocks after removal of the primary total knee implant components and according to the surgeon's preoperative planning. MyKnee® R Pin Positioners are intended for use with GMK® Primary, GMK® Sphere, GMK® SpheriKA, GMK® Revision, GMK® Hinge and their cleared indications for use.
VI. Comparison of Technological Characteristics
The subject MyKnee R Pin Positioners and the predicate MyKnee PPS Pin Positioners (K170106) are substantially equivalent with regards to the following characteristics:
- guide design; ●
- checking features; ●
- manufacturing process; ●
- material;
- biocompatibility;
- device usage;
- sterility;
- shelf life; and
- packaging.
The MyKnee R Pin Positioners differs from the predicate device, MyKnee PPS Pin Positioners (K170106), with regards to the following characteristics:
- anchoring points; .
- sizes range; ●
- instruments compatibility; and ●
- applicable image file. ●
Discussion
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K220705 page 3 of 3
The slight differences between the subject and predicate devices do not raise new questions of safety and effectiveness. Medacta International SA has not made any changes to the manufacturing process, material, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices with respect to the predicate devices.
The comparison of technological characteristics and performance data provided within this submission, supports the substantial equivalence of the subject devices with respect to the predicate devices.
VII. Performance Data
Based on the risk analysis, testing activities were conducted to written protocols. The following validation and tests are provided in support of the substantial equivalence determination:
Non-Clinical Studies
- · Software validation;
- · Cadaver testing validating subject devices' intended use, functional characteristics and features.
Biocompatibility data and sterilization studies submitted in support of the predicate devices were leveraged.
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
The information provided above supports that the MyKnee R Pin Positioner are substantially equivalent to the predicate devices.
§ 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.