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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 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.
• 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 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 in patients 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 ConforMIS iDuo Bicompartmental Knee Repair System is intended for use in patients with severe knee joint pain and disability whose conditions cannot be solely addressed 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 iDuo 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.

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 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 femoral components of the devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and polyethylene inserts manufactured from UHMWPE or an all polyethylene tibial component. The patellar components are manufactured from UHMWPE.

This 510(k) submission describes the addition of Ethylene Oxide (EO) sterilization as an alternative to the existing VHP Gas Plasma sterilization for the ConforMIS iTotal CR Knee Replacement System, ConforMIS iUni Unicondylar Knee Replacement System, and ConforMIS iDuo Bicompartmental Knee Repair System. Therefore, the acceptance criteria and supporting study focus on demonstrating the safety and effectiveness of this new sterilization method.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of an algorithm's performance on patient data. Instead, the testing pertains to the physical device and its sterilization process.

• Sample Size for Sterilization Validation, EO Residual, and Material Compatibility Testing: The exact number of samples (devices and packaging materials) used for each test (sterilization validation, EO residual, product/packaging compatibility) is not explicitly stated in the provided text.
• Data Provenance: The studies were non-clinical laboratory tests, likely conducted in a controlled lab environment. The country of origin is not specified, but the applicant (ConforMIS Inc.) is based in Bedford, MA, USA. The data is prospective in the sense that it was generated specifically for this submission to validate the new sterilization method.

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

Not applicable. This is not a study involving human interpretation of data for medical diagnosis or prognosis that would require expert-established ground truth. The "ground truth" here is objective scientific measurements related to sterilization efficacy and material properties.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving subjective assessments that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This submission concerns device sterilization and material compatibility, not the comparative effectiveness of an AI algorithm in a clinical setting.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This submission does not involve an algorithm or AI.

7. Type of Ground Truth Used

The ground truth used for this submission is based on:

• Objective scientific standards and methodologies: For sterility validation (e.g., demonstrating a SAL of 1x10⁻⁶), EO residual limits (based on established toxicological standards), and material compatibility (physical and chemical integrity of the device and packaging after sterilization).
• Regulatory requirements and consensus standards: As governed by the FDA and referenced in the submission (e.g., 21 CFR regulations).

8. Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm with a training set.

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

Not applicable.

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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 in patients 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 .
• o 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 iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni KRS is comprised of a set of implants designed from patient images. The implant system consists of: 1 Femoral Implant t . 1 Tibial Component (all-polyethylene or metal backed) The implants of the iUni KRS consists of individually packaged femoral and tibial components and are provided with ancillary instrumentation to assist in the implantation procedure. The patient-specific femoral implant is made of Cobalt Chrome Molybdenum alloy (CoCrMo) and is personalized to match a patient's anatomy. The all poly tibial component is made from UHMWPE. The metal backed tibial component consists of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences. The outline, the bone contacting surfaces, and the articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT scan. Disposable, patient-specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the software. Instead, it describes a process of "software verification and validation testing of proprietary software" to demonstrate substantial equivalence to a predicate device.

The "performance" reported is that the device, after software modifications, is substantially equivalent to the previous versions. This determination is based on the conducted non-clinical laboratory testing.

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

The document does not specify a sample size for a test set in the context of typical machine learning or algorithm validation. The testing described is "software verification and validation testing," which usually involves testing the software's functionality, compliance with requirements, and performance against defined specifications, rather than a clinical dataset.

The data provenance is not mentioned. Since this is a software update for a pre-existing medical device, the "data" being processed by the software would be patient imaging scans (MRI or CT) used to design the patient-specific implants. However, the origin and nature of any specific dataset used for the "verification and validation" of the software itself are not detailed.

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

Given that the study is a "software verification and validation testing" for substantial equivalence, and not a clinical efficacy or performance study involving human interpretation of imaging, there is no mention of experts being used to establish ground truth for a test set in the traditional sense of medical image analysis (e.g., radiologists marking lesions). The "ground truth" for software validation would typically relate to the accuracy of the software's output compared to its specified design or known correct outputs (e.g., if a measurement is supposed to be X, the software calculates X). The document does not detail this aspect.

4. Adjudication Method for the Test Set

As there is no mention of a test set requiring expert interpretation or labeling, there is no adjudication method described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was done or reported. The submission focuses on demonstrating substantial equivalence of the modified software to a predicate device through non-clinical software testing, not on comparing human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The testing performed was standalone software verification and validation of SegSurf v3.0, iUniWorks v4.0, and iUni FemJigs v2.0. These software modules are proprietary and are used for "analysis... of images obtained by MRI or CT scan" to design patient-specific implants. This constitutes standalone algorithm testing, as it doesn't involve human interpretation of the algorithm's output in a diagnostic setting, but rather the internal validation of the software's calculations and functionalities.

7. The Type of Ground Truth Used

The ground truth for the "software verification and validation testing" would be the expected and correct outputs/behaviors of the software modules based on their design specifications and computational requirements. This is typically established through:

• Design specifications: What the software is designed to calculate or segment.
• Reference data/models: Using known inputs with manually calculated or established correct outputs to compare against the software's results.
• Mathematical correctness: Ensuring algorithms perform calculations accurately.

The document does not elaborate on the specific type of ground truth beyond stating "software verification and validation testing."

8. The Sample Size for the Training Set

The document does not provide information on the sample size for a training set. The described software (SegSurf, iUniWorks, iUni FemJigs) is for custom implant design based on individual patient imaging data. While these systems are likely built on underlying algorithms that may have been developed and trained using various datasets, the submission focuses on the validation of an updated version of these proprietary software modules. The training details of the original or updated algorithms are not part of this 510(k) summary.

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

Since no information is provided about a training set, the method for establishing its ground truth is also not mentioned.

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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 in patients 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.

ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni is comprised of a set of implants designed from patient images. The implant system consist of:

• 1 Femoral Implant
• 1 Tibial Component (all-polyethylene or metal backed)

The implants of the iUni KRS will be composed of individually packaged femoral and tibial components and will be provided with ancillary instrumentation to assist in the implantation procedure.

The patient-specific femoral implant will be made of Cobalt Chrome Molybdenum alloy (CoCrMo) and will be personalized to match a patient's anatomy.

The all poly tibial component is made from UHMWPE. The metal backed tibial component will consist of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences.

The outline bone contacting and articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT scan.

Disposable, patient-specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System.

The provided text describes a 510(k) submission for the ConforMIS iUni Unicondylar Knee Replacement System. This submission is for clarifying the indications for use statement and does not involve any changes to the device itself. Therefore, a study to prove device performance relative to acceptance criteria as if it were a new AI/software device is not relevant in this context.

The document explicitly states:

• "Non-clinical laboratory testing was not performed as there is no change to the device."
• "Clinical data is not necessary to demonstrate substantial equivalence."
• "The determination of substantial equivalence for this device was based on the indications for use statements and the device design. The design of the iUni KRS was previously determined to be substantially equivalent to predicate devices. A comparison of the designs and the indications for use statements confirmed that the modification to the indications for use does not affect device performance and is, therefore, also substantially equivalent."

This 510(k) is essentially an administrative update to align the indications for use with previous clearances and FDA guidance. There are no performance metrics or detailed studies presented for this particular submission. The "device performance" in question here is the device's substantial equivalence to existing predicate devices based on its design and intended use, not on specific quantitative performance metrics tested in a study for this submission.

Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document, as such studies were not part of this specific 510(k) submission.

However, I can provide information based on the premise of the submission, which is about substantial equivalence, not new performance data.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable for this submission. No new test set data was generated or analyzed as there was no change to the device. The evaluation was based on a comparison of device descriptions and indications for use statements against existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this submission. No new ground truth was established as there was no study for device performance.

4. Adjudication method for the test set
Not applicable for this 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 for this submission. This device is a physical knee replacement system, not an AI/software device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for this submission. This device is a physical knee replacement system, not an algorithm.

7. The type of ground truth used
Not applicable for this submission. The "ground truth" for this 510(k) was the existing regulatory clearances and indication statements of the predicate devices.

8. The sample size for the training set
Not applicable for this submission.

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

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The ConforMIS Unicondylar Knee Replacement System (iUni KRS) with curved tibial insert is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components.

Candidates for unicondylar knee repair 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 and
• valgus or varus deformity of the knee.

This implant is intended for cemented use only.

The ConforMIS iUni Implant System is comprised of a set of implants designed from patient images. The implants consist of

• 1 Femoral Implant .
• 1 Tibial Trav o
• 2 or 3 Tibial Inserts 0

The implants of the iUni Implant System will be composed of individually packaged femoral and tibial components.

The femoral implant will be made of Cobalt Chrome Molydenum (CoCrMo) and will be personalized to match a patient's anatomy, thus becoming patient specific.

The tibial implants will consist of a CoCrMo tibial tray and two or three Ultra High Molecular Weight Polyethylene (UHMWPE) tibial inserts of varying thicknesses.

The outline bone contacting and articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT Scan.

Disposable, patient- specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System

The provided text describes a 510(k) summary for the ConforMIS® iUni Unicondylar Knee Replacement System. This submission is for a medical device (knee implant), not an AI/ML-driven device or study assessing algorithm performance. Therefore, many of the requested fields are not applicable.

Here's the information that can be extracted from the provided text, along with indications where the requested information is not available or relevant to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable for a non-clinical device submission. The "test set" here refers to components used in non-clinical lab testing. Specific numbers for units tested are not detailed in the summary.
• Data Provenance: Not applicable in the context of clinical data for this type of submission. The tests performed are described as "Femoral Fatigue," "Femoral Implant fixation," "Cadaveric testing," and "Software validation testing." These are laboratory-based tests, not human data.

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

• Number of Experts: Not applicable. Ground truth, in the context of AI/ML, refers to human-labeled data. This submission describes physical device testing and software validation, not interpretation of data by experts to establish a "ground truth."
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations of data, which is not relevant to the non-clinical lab tests 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which this is not.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical knee implant. While it uses proprietary software for design based on patient images, "standalone performance" in the context of an algorithm refers to its diagnostic or predictive capability without human intervention. The software here is a design tool, not a diagnostic algorithm. Software validation testing was performed to support changes, but this is validation of the software's ability to correctly design implants, not a "standalone performance" as in AI/ML.

7. The type of ground truth used

• Type of Ground Truth: For the non-clinical tests (femoral fatigue, fixation, cadaveric), the "ground truth" would be engineering specifications, biomechanical expectations, and potentially anatomical landmarks from cadaveric studies. For software validation, the "ground truth" would be the expected output or design parameters based on input images. This is not "expert consensus, pathology, or outcomes data" as typically understood in AI/ML.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This device is a physical implant designed using proprietary software, not an AI/ML model trained on a dataset. The software is used to design personalized implants from patient images, implying it's an image processing and design tool, not a learning algorithm that undergoes a training phase in the AI sense.

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

• How Ground Truth Established: Not applicable, as there is no "training set" in the AI/ML sense. The software's accuracy in generating designs from patient images would typically be validated against known anatomical models or expert-reviewed designs, but this is part of software validation, not AI/ML training ground truth.

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