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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, 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. The implant 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 patientspecific 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 of the cutting of bone.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ConforMIS iTotal CR Knee Replacement System:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria for the device's performance in a clinical or analytical study. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices.

The "acceptance criteria" here are implicitly that the modified device performs similarly to or no worse than the predicate devices across various characteristics. The "reported device performance" is a confirmation that these characteristics are maintained or improved.

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

• The submission does not mention a traditional "test set" in the context of clinical or analytical performance data from patient samples. The substantial equivalence is primarily based on device description, materials, design, and software verification/validation.
• Data Provenance: Not applicable in the sense of clinical patient data, as the study relies on software testing and device characteristic comparison.

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

• Not applicable. This submission focuses on validating software and demonstrating equivalent physical/design characteristics to a predicate device, rather than assessing a device's diagnostic or clinical performance against expert-established ground truth from patient data.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring expert adjudication is described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data is not necessary to demonstrate substantial equivalence."

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

• While not a standalone clinical performance study, the submission does refer to "Software verification and validation testing of proprietary software iTotalWorks" and "Software verification and validation testing of proprietary software iTotalTib." This testing confirms the functionality and accuracy of the algorithms as they relate to the design and manufacturing of the patient-specific implants and instruments. This can be considered a form of standalone software validation, demonstrating the algorithm's performance in its specific intended function (designing the implant and instrumentation based on patient imaging).

7. The Type of Ground Truth Used:

• For the software verification and validation, the ground truth would have been established through design specifications, requirements documents, and potentially comparison to known good outputs or established engineering principles and measurements. For example, the software would be validated to ensure it accurately translates imaging data into the geometric specifications for the patient-specific implants and instruments within specified tolerances.

8. The Sample Size for the Training Set:

• Not applicable. The document does not describe a machine learning model that would require a "training set" in the typical sense of AI/ML-based diagnostic devices. The proprietary software mentioned (iTotalWorks and iTotalTib) likely refers to CAD/CAM software used for design and manufacturing, which does not typically undergo "training" with patient data in the same way an AI diagnostic algorithm would.

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

• Not applicable. (See point 8).

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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 implant is intended for cemented use only.

The iTotal Cruciate Retaining 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 quiding 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, K112780, K120068, K113378 and K120316.

Here's an analysis of the provided text regarding the ConforMIS iTotal CR Knee Replacement System, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device (ConforMIS iTotal CR Knee Replacement System) seeking clearance from the FDA. In the context of a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving this is typically a set of non-clinical tests and comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are demonstrating that the new device shares similar indications for use, technological characteristics, and performance (safety and effectiveness) as the predicate device(s). The "reported device performance" is the evidence presented to support this similarity.

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

• Test Set Sample Size: The document does not specify a "test set" in the traditional sense of a clinical or analytical study with a defined number of patient cases. The primary testing method described is software verification and validation testing of proprietary software (iTotal iView). This usually involves testing the software against a set of predefined requirements, scenarios, and potentially a dataset of patient images, but the exact number of "samples" or cases used for this internal testing is not disclosed in this summary.
• Data Provenance: Not specified for the software V&V. It's likely internal data or simulated data used for engineering validation. Given the nature of patient-specific implants, the input for the software would be patient imaging (CT or MR scans), but the origin of these scans for testing purposes is not explicitly stated. The submission is focused on demonstrating equivalence to an existing product, not on new clinical claims.

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

• Number of Experts: Not applicable/not specified. The detailed software verification and validation would typically involve software engineers, developers, and potentially expert clinicians (e.g., orthopedic surgeons) in defining requirements and evaluating software output (e.g., implant designs generated by the software), but the document does not outline a formal ground truth adjudication process by external experts with specific qualifications for a test set. The ground truth for the software's performance would be its ability to accurately and precisely process patient imaging data to generate the patient-specific implant and instrumentation designs according to predefined specifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. Since there isn't a defined "test set" requiring human interpretation or classification against a ground truth, an adjudication method like 2+1 or 3+1 is not mentioned. Software verification and validation is typically internal and relies on internal quality control processes and predefined acceptance criteria for software functionality and output accuracy.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device (ConforMIS iTotal CR KRS) is a knee replacement system and its associated patient-specific software and instruments used for implantation. It's not an AI diagnostic or assistive tool for image interpretation by human readers. The software assists in designing the implant and instruments based on patient imaging.
• Effect Size: Not applicable.

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

• Standalone Performance: The core of the new technology described is the "proprietary software iTotal iView" which generates the patient-specific surgical plan and designs the implants/instrumentation. The document states "Software verification and validation testing of proprietary t software iTotal iView" was performed. This implies testing of the algorithm itself, without a human in the loop for the design generation process. However, the outcome (the physical implant and instruments) is intended for human surgical use, and a surgeon is in the loop for the final implantation. The document doesn't explicitly detail "standalone performance" in terms of how the algorithm's output compares to a physician's manual planning, but rather focuses on verifying the software's functionality and accuracy in generating designs.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the software verification and validation, the ground truth would likely be established through:
  • Engineering specifications and design requirements: The software's output (implant dimensions, bone cut guides) would be compared against the target design parameters derived from the patient's anatomy as interpreted by design engineers and surgeons, often using CAD models or reference anatomical data.
  • Clinical expertise and anatomical models: The accuracy of the software's interpretation of patient imaging (CT/MR scans) and its subsequent design generation would be assessed against established anatomical principles and clinical requirements for knee replacement.
  • Comparison to predicate device's design principles: Since this is a 510(k) for a modified device, the "ground truth" also heavily relies on demonstrating that the software-generated designs maintain the established safety and effectiveness characteristics of the predicate devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not specified. The document describes "proprietary software" for designing the patient-specific implant and instruments. It does not explicitly state that this software utilizes machine learning or AI models that require a "training set" in the conventional sense. If it's a rule-based or conventional algorithmic software (common for CAD/CAM in medical devices at the time of this filing), a distinct "training set" might not exist. If it incorporates machine learning (which is not explicitly stated but possible even in 2012 for aspects like image segmentation or anatomical landmark identification), the training data details are not provided.

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

• Ground Truth Establishment for Training Set: Not applicable/not specified, as a "training set" and its ground truth are not mentioned for this device's software. If machine learning were involved, the ground truth for training data would typically be established by expert annotation of medical images (e.g., outlining anatomical structures) or precise measurements performed by qualified personnel.

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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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