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The ConforMiS Unicondylar Knee Replacement System (iUni) is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface with evidence of adequate healthy bone sufficient for support of the implanted components. Candidates for unicondylar knee replacement include those with: · Joint impairment due to osteoarthritis or traumatic arthritis of the knee · Previous femoral condyle or tibial plateau fracture, creating loss of function · Valgus or varus deformity of the knee · 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 ConforMlS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solelyaddressed by the use of a prosthetic device that treats only a single knee compartment, such as unicondylar or patellofemoral prosthesis. The indications for use include restoring joint function and relief of pain due to: · Painful joint disease due to osteoarthritis · Traumatic arthritis of the knee Post traumatic loss of joint function · Failed osteotomies, hemiarthroplasties and unicondylar implants The Duo Bicompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of the above noted conditions. The iDuo implant is intended for cemented use only.

The iTotal Posterior Stabilized {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, 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 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 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, theumatoid 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.

ConforMIS knee replacement systems are patient-specific semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis ortrauma. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral components of the devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo and polyethylene inserts manufactured from UHMWPE or an all polyethylene tibial component. The patellar components are manufactured from UHMWPE.

This document is a 510(k) premarket notification for knee replacement systems. It does not present a study or acceptance criteria for a device that relies on an algorithm or AI. Instead, it describes a non-clinical performance evaluation for sterilization validation of existing knee replacement systems.

Therefore, most of the requested information regarding acceptance criteria and studies for an AI/algorithm-based device simply do not apply to this document.

However, I can extract the information relevant to the non-clinical performance evaluation described:

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

   Acceptance Criteria	Reported Device Performance
   Sterilization Validation to establish a SAL of 1x10^-6 for Vaporized Hydrogen Peroxide (VHP) sterilization.	Device components are effectively sterilized using Vaporized Hydrogen Peroxide, achieving a SAL of 1x10^-6.
   VHP residual testing	(Implicitly met, as effective sterilization was confirmed)
   Product and packaging compatibility with VHP sterilization	(Implicitly met, as effective sterilization was confirmed)

2. Sample size used for the test set and the data provenance: Not applicable. This is a non-clinical sterilization validation, not a study involving patient data or a test set in the context of an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a non-clinical sterilization validation, not an analysis requiring expert ground truth for an algorithm.

4. Adjudication method for the test set: Not applicable.

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: Not applicable. This document does not describe an AI device or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe an algorithm or AI device.

7. The type of ground truth used: For the sterilization validation, the "ground truth" would be the scientifically established standard for sterility (SAL of 1x10^-6) as defined by regulatory bodies and testing protocols.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning model.

9. How the ground truth for the training set was established: Not applicable.

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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, patello-femoral or bi-compartmental 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants.
  The iTotal CR KRS is intended for cemented use only.

The iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma.
Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant and related instrumentation are designed, that best meet 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 one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.
For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The function and general design features of the patient specific ancillary instruments remain similar to those described in the predicate 510k i.e. K094050, K103117 and K112780.

The provided text describes the KonforMIS iTotal CR Knee Replacement System, but it is a Knee Replacement System, not an AI/ML powered medical device. As such, the standard acceptance criteria and study methodologies for AI/ML devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment methods) are not applicable.

The document pertains to a 510(k) premarket notification for a traditional medical device, specifically a modified version of an existing knee replacement system. The focus of the submission and the FDA's review is on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing performance against specific AI/ML metrics.

Therefore, many of the requested fields cannot be filled as they are not relevant to this type of device and submission.

Here's a breakdown of the available information regarding its 'acceptance criteria' (which in this context means demonstrating substantial equivalence) and the 'study' (which is non-clinical testing):

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implicitly about demonstrating that the modified device is as safe and effective as the predicate device(s) through a comparison of physical and functional characteristics, and specifically for the new software component, through verification and validation.

2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device, not an AI/ML model for diagnostic or prognostic purposes with a 'test set' of patient data in the conventional sense. The "test set" refers to the proprietary software verification and validation, which would involve software testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth established by experts is mentioned for this type of device. The determination of substantial equivalence relies on device comparison and non-clinical testing data.

4. Adjudication method for the test set
Not applicable. Not an AI/ML device with a human-adjudicated test set.

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
Not applicable. This is not an AI-assisted diagnostic or prognostic device, and no human reader study was conducted for this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The proprietary software is part of the instrumentation for the surgeon as a human-in-the-loop tool, it is not a standalone algorithm performing a diagnostic task. The software itself underwent "software verification and validation testing," which is a standalone assessment of the software's functionality and correctness, but not in the context of diagnostic performance metrics.

7. The type of ground truth used
Not applicable. The "ground truth" concept as applied to AI/ML to validate diagnostic accuracy is not relevant here. The device's safety and effectiveness are established through comparison to a predicate device and engineering testing.

8. The sample size for the training set
Not applicable. The software described is for patient-specific implant and instrumentation design, not an AI/ML model that is 'trained' on a dataset in the typical sense.

9. How the ground truth for the training set was established
Not applicable, as there's no 'training set' for an AI/ML model as described in the conventional sense.

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The iTotal® CR Knee Replacement System 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, patello-femoral or bi-compartmental 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, hemiarthoplasties, and unicondylar, patello-femoral or bi-compartmental implants. The iTotal® CR Knee Replacement System is intended for cemented use only.

The proposed iTotal CR Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tri- compartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system.. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component. The product design incorporates a bone preserving approach with minimal bone resection of the tibia and femur for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. Using patient imaging (either CT or MR scans), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The device is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.

The ConforMIS iTotal® Cruciate Retaining (CR) Knee Replacement System received 510(k) clearance based on demonstrating substantial equivalence to predicate devices through non-clinical laboratory testing. No clinical studies or human-in-the-loop performance studies were performed to establish acceptance criteria or device performance in a clinical setting.

Here's a breakdown of the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, there isn't a direct "acceptance criteria" table with specific performance metrics and reported values in the way one might see for an AI algorithm or a diagnostic device. Instead, the acceptance was based on the device meeting the performance objectives of a series of bench tests, indicating it performed as safely and effectively as legally marketed predicate devices. The document states: "Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate devices for the proposed intended use." and "Results of the bench testing conducted demonstrate that the iTotal KRS is substantially equivalent to the Predicate Knee Systems."

The types of testing performed, which serve as the implicit "acceptance criteria" by demonstrating equivalence, include:

2. Sample Size Used for the Test Set and Data Provenance

This submission is for a medical device (knee replacement system) and relies on non-clinical bench testing, not a test set of patient data/images. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context. The "samples" would refer to the physical devices or components subjected to laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no "ground truth" expert review of a test set as this was a physical device, not a diagnostic or AI-driven system.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication in the context of this device submission.

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

Not applicable. This is not an AI-assisted diagnostic device, nor was an MRMC study conducted.

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

Not applicable. This is a physical knee replacement device, not an algorithm.

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

Not applicable in the typical sense for a diagnostic device. The "ground truth" for this device's safety and performance was established through engineering principles, material science, and mechanical testing standards relevant to orthopedic implants. The performance was compared to established predicate devices using these physical and mechanical tests.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and does not have a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set for an AI algorithm.

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