(29 days)
The iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- · Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
- · Post traumatic loss of joint function.
- · Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
- · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
- · Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
The iTotal PS Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartments.
The Indications for Use include:
· Painful joint disease due to osteoarthritis, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.
· Post traumatic loss of joint function.
- · Moderate varus, valgus or flexion deformity.
· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
iTotal Identity® Cruciate Retaining (CR) Knee Replacement System (KRS) and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System (KRS) are patient specific tri-compartmental faceted knee replacements systems. The iTotal Identity CR KRS is a faceted posterior cruciate ligament retaining knee replacement system. It is a semi-constrained, cemented knee implant which consists of femoral, tibial, and patellar components. iTotal Identity® PS KRS is a semi-constrained, cemented knee implant consisting of femoral, tibial, patellar and articular tibial insert components.
Using patient imaging and a combination of proprietary and off-the-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray and tray keel stem extension manufactured from titanium (Ti6AL4V-ELI) alloy, a tibial tray keel cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts (Two piece is CR only). The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E stabilized UHMWPE). The patellar component is provided in either a round or oval dome shape and may be manufactured from either UHMWPE or iPoly® XE.
For user convenience, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal Identity® CR KRS or iTotal Identity® PS KRS are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
The provided document is a 510(k) summary for a medical device (Conformis iTotal Identity® Cruciate Retaining (CR) Knee Replacement System and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System). It describes a modification to an already cleared device, specifically changing the raw material for the patellar component and tibial inserts.
*Crucially, this document does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts in an AI/ML context.
Therefore, I cannot extract the information requested regarding:
- Acceptance criteria related to AI/ML device performance metrics (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets where AI performance is evaluated against ground truth.
- Number of experts for ground truth establishment or their qualifications.
- Adjudication methods for test sets.
- MRMC comparative effectiveness studies or effect sizes for human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data).
- Training set sample size or ground truth establishment for the training set.
What the document does describe regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" relates to the material equivalency of a knee implant component, not an AI system.
Here's a breakdown of what can be gleaned from the document regarding the device and its "proof":
1. Acceptance Criteria and Reported Device Performance (related to material equivalency):
The document states:
- "The difference between the subject raw material and the predicate raw material is that the subject raw material will not be mechanically annealed."
- Acceptance Criteria (implicit for material equivalency): The new raw material (iPoly® XE without mechanical annealing) must have "no statistically significant impact on the physical or chemical properties when compared to the predicate material" and "raises no new issues regarding safety or effectiveness."
- Reported Device Performance (for material equivalency): "Testing to compare the subject raw material to the predicate material was conducted." and "The absence of an annealing step in the processing of the raw material does not have a statistically significant impact on the physical or chemical properties when compared to the predicate material and supports that the materials are equivalent."
2. Sample Size and Data Provenance:
Not applicable in the context of AI/ML. The "data" refers to physical and chemical properties of materials. The document does not specify the number of material samples tested or their provenance in terms of country or retrospective/prospective collection, as this is a material science characterization, not a clinical data study for AI.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. Ground truth here is established by material science testing and characterization, not expert human review of medical images for diagnostic purposes.
4. Adjudication Method:
Not applicable. This is not a study requiring adjudication of expert opinions.
5. MRMC Comparative Effectiveness Study:
Not applicable. No AI component or human reader study described.
6. Standalone Performance:
Not applicable. This is not an AI algorithm.
7. Type of Ground Truth Used:
The "ground truth" here is the established physical and chemical properties of the predicate material, against which the new material is compared. This is based on material characterization standards and laboratory testing, not medical expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for Training Set:
Not applicable. There is no training set for an AI/ML model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. There is no training set.
In summary, the provided text is for a material modification to a knee implant, demonstrating substantial equivalence through material testing, not for an AI/ML medical device. Therefore, most of the requested information regarding AI/ML device acceptance criteria and study methodology is not present in this document.
§ 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.