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The iTotal 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, traumatoid arthritis, rheumatoid arthritis or osteonecrosis of the knee
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity in which the ligamentous structurs 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 aligmment 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 bicompartmental prosthesis. The Indications for Use include:

• Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity.
• Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral 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® Knee Replacement Systems (hereafter referred to as the "iTotal KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar 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 manufactured from CoCrMo alloy and either single or dual-piece (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, a highly cross-linked Vitamin E infused polyethylene (iPoly XE) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE).
For user convenience, and similar to the predicate iTotal KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal KRS are provided to assist with implantation. The ancillary instruments may be provided sterile or non-sterile to be sterilized by the end-user and are for single-use only.
The purpose of this submission is to propose dimensional modifications to the iTotal KRS implants and changes to the ancillary instrumentation.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)'s K142161, K142404 and K152704.

The provided text describes a 510(k) submission for the ConforMIS iTotal Cruciate Retaining Knee Replacement System and ConforMIS iTotal Posterior Stabilized Knee Replacement System. This submission focuses on demonstrting substantial equivalence to predicate devices through non-clinical testing, rather than studies that generate new clinical performance data with acceptance criteria that would typically be reported for software products.

Therefore, the following information cannot be extracted from the provided text: acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, expert qualifications, adjudication method, MRMC study effect size, standalone algorithm performance, ground truth type for test set, sample size for training set, and how ground truth for the training set was established.

Here's the information that can be extracted regarding the comparison and testing performed:

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

No specific numerical acceptance criteria or device performance metrics in terms of clinical outcomes are reported in the provided document. The submission focuses on demonstrating substantial equivalence through non-clinical testing.

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

Not applicable. The reported tests are non-clinical laboratory tests, not tests on a clinical dataset with a "test set" in the context of AI/software performance.

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

Not applicable. Ground truth, in the context of expert review for clinical data, is not mentioned for these non-clinical tests.

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

Not applicable. Adjudication methods are typically used for establishing ground truth from expert reviews of clinical data, which is not described here.

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:

No. An MRMC comparative effectiveness study was not performed or referenced.

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

Not applicable. This is a knee replacement system, not an AI algorithm. The performance evaluation is based on the physical device's characteristics and its comparison to predicate devices, not algorithm-only performance.

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

Not applicable in the context of clinical ground truth. The evaluation is based on engineering principles and performance testing against established standards or predicate device characteristics.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML system that utilizes training sets.

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

Not applicable. See above.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described for this 510(k) submission):

The device, ConforMIS iTotal Cruciate Retaining Knee Replacement System and ConforMIS iTotal Posterior Stabilized Knee Replacement System, underwent non-clinical laboratory testing to demonstrate substantial equivalence to legally marketed predicate devices (ConforMIS iTotal CR Knee Replacement System K142161, K142404, K152704 and ConforMIS iTotal PS Knee Replacement System K142161, K142404, K152704).

The study involved the following non-clinical laboratory tests:

• Tibial Insert Spine-Femoral Cam Fatigue Testing: This test likely evaluates the durability and resistance to wear and tear of the tibial insert component under repeated stress, simulating physiological loading conditions.
• Range of Motion Analysis: This test would assess the range of movement permitted by the knee replacement system, ensuring it allows for an appropriate and functional range of motion for the patient.
• Cadaveric Evaluation: This type of evaluation uses cadaveric specimens to assess the device's fit, alignment, and potentially the surgical procedure in a simulated anatomical environment.

The conclusion drawn from these tests was that the present device is substantially equivalent to the predicate devices for their intended use. This implies that the performance in these non-clinical tests met the established performance characteristics or standards for the predicate devices, thereby demonstrating that the modified device is as safe and effective as the previously cleared devices. Clinical data was deemed not necessary to demonstrate substantial equivalence for this submission.

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