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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 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 finction and stability.
• Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants.
• Revision procedures provided that analy landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

This implant is 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 I rie 1 olar 1 5 Kince Replacement be solely addressed by the use of a prosthetic device that treats only one or two of the three compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. 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 and only landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

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 (stem) cap manufactured from polyethylene (UHMWPE) and either one or two polyethylene inserts (Two piece is available with the CR KRS only). The polyethylene inserts may be manufactured from either UHMWPE (iPoly®) 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.

This document describes the 510(k) clearance for the iTotal Identity® Cruciate Retaining (CR) Knee Replacement System and iTotal Identity® Posterior Stabilized (PS) Knee Replacement System. This clearance specifically focuses on adding an additional sterilization process (Vaporized Hydrogen Peroxide Low-Temperature Sterilant-Vacuum (VHP LTS-V)) to the existing approved methods. No device modifications were made.

Therefore, the acceptance criteria and study proving the device meets these criteria relate to the sterilization process and its impact on the safety and effectiveness of the device, rather than the device's functional performance as a knee replacement system itself.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify the exact sample sizes used for sterilization validation (e.g., number of devices or sterilization cycles). Sterilization validation typically involves a statistically determined number of units.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that this is a 510(k) submission for a medical device, the testing would be conducted post-development and pre-market, implying prospective testing specific to the sterilization method change.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this submission. The "ground truth" here is objective scientific measurement (e.g., microbial load reduction for SAL, chemical residue levels for VHP residuals, biological response for biocompatibility). These are established through standardized testing protocols, not through expert consensus on images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to a process where multiple human readers assess data (e.g., medical images) and their disagreements are resolved by an independent expert. This submission concerns engineering and material testing for sterilization, not human interpretation of clinical data.

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

This is not applicable. This submission is for enabling an additional sterilization process for an existing knee replacement system. It does not involve AI, human readers, or image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is not an algorithm or software submission; it's a submission for a physical medical device and its manufacturing/sterilization process.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this sterile medical device submission is based on scientific and engineering measurements from validated laboratory testing. This includes:

• Microbiological testing: To establish Sterility Assurance Level (SAL) (e.g., bioburden testing, overkill methods, half-cycle testing).
• Chemical analysis: To measure residual levels of the sterilant.
• Biological assays: For biocompatibility testing to ensure the sterilized material does not elicit an adverse biological response.

8. The sample size for the training set

This is not applicable. A "training set" refers to data used to train machine learning models. This submission is for a physical medical device and its sterilization process, not an AI/ML product.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

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