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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 iDuo Bicompartmental Knee Repair System (iDuo KRS) 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 including restoring joint function and relief of pain due to:

• painful joint disease due to osteoarthritis, traumatic arthritis or rheumatoid arthritis of the knee.
• post traumatic loss of joint function
• failed osteotomies, hemiarthroplasties and unicondylar implants
  The iDuo KRS may be utilized when the medial or lateral condyle and the patellofemoral areas have been affected by one or more of these conditions. The iDuo KRS is intended for cemented use only.

The iDuo KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component (patellar component packaged separately). The product design incorporates a bone preserving approach with minimal bone resection for the treatment of severe pain and/or disability of a knee damaged by osteoarthritis or trauma. It is intended for use in those patients whose condition cannot be appropriately or effectively addressed using a device that treats only a single knee compartment (i.e. a unicompartmental or patellofemoral prosthesis) when the medial or lateral condyle and the patellofemoral regions are affected. 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. Two tibial components are offered: a single-piece all polyethylene tibial component manufactured from ultra-high molecular weight polyethylene ("UHMWPE") or a two-piece metal-backed tibial component which includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert manufactured from UHMWPE. The patellar component is manufactured from UHMWPE.

The provided text describes a 510(k) summary for a medical device, the ConforMIS® iDuo® Bicompartmental Knee Repair System (iDuo® KRS). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for meeting specific acceptance criteria through device performance.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document.

Here's a breakdown of the information that can be extracted and what is missing:

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

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

• Sample Size for Test Set: Not applicable. No clinical or standalone performance test set is described. The submission focuses on non-clinical laboratory testing for substantial equivalence.
• Data Provenance: Not applicable. The "nonclinical laboratory testing" details are not 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 applicable. No clinical test set with human-established ground truth is described.

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

• Not applicable. No clinical test set is 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 applicable. This device is a knee repair system (implant), not an AI diagnostic tool. No MRMC study or AI component is mentioned.

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

• Not applicable. This is an implantable medical device, not a standalone algorithm. The submission mentions "patient imaging (either CT or MR scans)" being used to design the patient-specific implant, but this is part of the manufacturing process, not an algorithm's standalone performance evaluation in the context of diagnostic accuracy.

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

• Not applicable. No ground truth for device performance in a clinical or diagnostic context is detailed in this 510(k) summary. The basis for substantial equivalence was "a detailed device description" and "nonclinical laboratory testing."

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" in the context of machine learning or AI for this device. The device itself is patient-specific, designed using patient imaging, but this is a design input, not a "training set" for an algorithm being evaluated.

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

• Not applicable. As above, no training set is described in the context of this device's submission.

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