Search Results

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, 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 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.

Using patient imaging and a combination of proprietary and offthe-shelf software, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The femoral implant 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. The polyethylene inserts may be manufactured from either UHMWPE or iPoly® XE (a highly cross-linked vitamin E infused polyethylene) The patellar component may also be manufactured from either UHMWPE or iPoly® XE.

For user convenience, and similar to the predicate iTotal CR KRS, single-use, patient-specific ancillary orthopedic manual surgical instruments designed for use with the proposed iTotal CR 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 function and general design features of the patient-specific implants and ancillary instruments remain similar to those described in the predicate 510(k), K161366.

This document does not contain the detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML device.

The provided text is a 510(k) summary for the Conformis iTotal Cruciate Retaining (CR) Knee Replacement System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161366) rather than establishing new performance metrics.

Here's a breakdown based on your requested information, highlighting what is and is not present in the provided text:

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

• Not present in this document. This document does not establish specific performance acceptance criteria (e.g., accuracy, precision) for a medical image analysis algorithm or AI component in the typical sense. Instead, it focuses on demonstrating that the updated software produces results comparable to the predicate software and that the overall device design and materials remain unchanged.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not present in this document. There is no mention of a test set sample size or data provenance as this 510(k) is not presenting a clinical performance study. The "test set" in this context refers to the software verification and validation testing, but no details on the data used are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not present in this document. Ground truth for clinical performance is not discussed as there is no clinical performance study being presented. For software verification, ground truth would likely be based on engineering specifications or comparisons to output from the previous software version.

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

• Not present in this document. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. This is not applicable to the type of submission described.

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 present in this document. This device is a knee replacement system, and the software components are for patient-specific implant design and surgical planning. It is not an AI-assisted diagnostic tool for human readers, so an MRMC study is not relevant here.

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

• The document states "Software verification and validation testing of proprietary software" was performed. This implies standalone testing of the algorithm (software modules) to ensure they function as intended and produce expected outputs for implant design and surgical planning. However, no specific details of this testing are provided. The software's output (implant design and surgical plan) is ultimately used by human surgeons during the procedure.

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

• For the "Software verification and validation testing," the ground truth would likely be based on:
  • Engineering specifications: The software should produce designs that meet predefined geometric and functional requirements.
  • Comparison to predicate software outputs: The updated software (iTotalWorks 6.0, iTotalFem CR 1.0, iTotalTib CR 5.0, iTotal CR iView 4.0) should produce designs and plans that are equivalent or demonstrate appropriate improvements compared to the predicate software (iTotalWorks 5.1, iTotal FemJigs 3.0, iTotalTib CR 4.3, iTotal CR iView 3.0). The purpose of the changes is to improve manufacturing efficiencies through automation, implying the output should remain consistent with the validated predicate.
• No clinical "ground truth" (pathology, outcomes data) is mentioned as it's not a diagnostic device.

8. The sample size for the training set

• Not applicable/Not present. This document discusses a change in software versions (i.e., v5.1 to v6.0 for iTotalWorks, etc.) for a workflow that custom designs existing implants. It is not describing a machine learning model that was specifically "trained" on a dataset in the way an AI diagnostic algorithm would be. The "proprietary and off-the-shelf software" uses patient imaging to design a patient-specific implant based on pre-defined algorithms and rules, not necessarily a training phase with a distinct training set.

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

• Not applicable/Not present. As there's no explicitly defined "training set" in the context of an AI/ML model for this device, there's no discussion of how ground truth for such a set was established.

In summary:

This 510(k) pertains to a knee replacement system where the software is used for patient-specific implant design and surgical planning. The submission is a modification to an already cleared device and focuses on demonstrating that changes to the software modules for CAD manufacturing processes do not alter the substantial equivalence of the device to its predicate. The "study" mentioned is "Software verification and validation testing of proprietary software," which ensures the new software performs as intended and produces results consistent with the previously cleared versions. This is a technical (engineering) validation rather than a clinical performance study with human readers or AI diagnostic capabilities.

Ask a specific question about this device

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 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 one or two polyethylene inserts manufactured from UHMWPE of identical configuration. The patellar component is manufactured from UHMWPE.

Here's a summary of the acceptance criteria and study information for the ConforMIS iTotal® CR Knee Replacement System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not specified. The document states "Nonclinical Testing: The determination of substantial equivalence for this device was based on a detailed device description. The following non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the intended use: Detailed software description and software verification and validation testing of proprietary software". This implies the "test set" primarily refers to the software itself rather than a patient cohort.
   • Data Provenance: Not specified. The tests were "non-clinical laboratory testing" and focused on software and device characteristics.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The determination of substantial equivalence was based on software verification and validation and a detailed device description, not on expert-adjudicated patient data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there was no expert adjudication of patient data for this submission.

4. 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 submission concerns a physical knee replacement system and its associated software for patient-specific design, not an AI-assisted diagnostic or interpretative tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, in essence, a standalone evaluation of the algorithm (software) was performed through "Software verification and validation testing of proprietary software." The software (SegSurf(T) version 2.0) is described as using "patient imaging (either CT or MR scans) 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." This indicates the software operates independently to design the implant.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the software's performance would internally be defined by the accuracy and precision of its design functions against predetermined anatomical and mechanical specifications, likely derived from engineering principles and clinical requirements for knee implants. No external ground truth from patient pathology or outcomes data is mentioned for this specific submission's verification and validation process.

7. The sample size for the training set: Not specified. The document refers to "proprietary and off the shelf software" for designing patient-specific implants using imaging data, but does not detail the training set used for any machine learning components within this software.

8. How the ground truth for the training set was established: Not specified.

Ask a specific question about this device

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 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 is designed for bone preservation, 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. The joint restoring design provides for more natural kinematics by maintaining the patient specific femoral sagittal curves, preserving the patient specific femoral offset, preserving the medial and lateral joint lines and having a patient specific fit.

The provided text describes a medical device, the ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, and its clearance process. However, it does not contain information related to a study that establishes acceptance criteria for performance metrics of a device, nor does it describe a study involving an algorithm's performance in a diagnostic or image analysis context.

This document is a 510(k) summary for a knee replacement system, which focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and software validation for surgical planning assistance, rather than clinical performance metrics in terms of diagnostic accuracy or reader improvement.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device meets them, as it is not present in the provided text.

Here's why and what information is available:

• Type of Device: This is for a physical medical implant (knee replacement system), not an AI/algorithm-driven diagnostic or image analysis device that would have performance metrics like sensitivity, specificity, or reader improvement.
• Focus of the Document: The document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to already marketed devices. This typically involves:
  • Descriptions of the device and its intended use.
  • Comparison to predicate devices.
  • Non-clinical testing (e.g., mechanical, software validation) to show safety and effectiveness are comparable.
  • Crucially, it explicitly states: "Clinical data is not necessary to demonstrate substantial equivalence." This means no patient outcome or diagnostic performance study was provided or required for this clearance.

The document does mention:

• Software validation testing: "Software validation testing of proprietary software" was performed. This implies the software used for designing the patient-specific implant was validated, but details of this validation (e.g., specific metrics, acceptance criteria, sample size, ground truth) are not provided. This validation would likely pertain to aspects like geometric accuracy, consistency, etc., not diagnostic performance.
• Other testing: Patello femoral lateral subluxation testing, Femoral fatigue testing, and Cadaveric testing were performed to establish substantial equivalence. These are mechanical and functional tests for the physical implant components.

Ask a specific question about this device