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The ACTIFY™ Unicondylar Knee System is indicated for unicompartmental knee replacement due to the following conditions:

1. Moderately disabling joint disease of the knee resulting from painful osteo- and/or post-traumatic arthritis, or avascular necrosis.
2. Revision of previous unsuccessful unicompartmental knee replacement or other procedure.
3. Alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
4. Previous tibial condyle or plateau fractures with loss of anatomy or function.
5. Varus or valgus deformities.
   These devices are indicated for cemented use only.

The ACTIFY™ Unicondylar Knee System implants consist of femoral and tibial implants that are used as part of a unicompartmental knee system for partial knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. ACTIFY Unicondylar femoral implants are manufactured from cobalt chrome alloy, tibial inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) with and without Vitamin E, and tibia trays are manufactured from titanium alloy.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (ACTIFY™ Unicondylar Knee System) and does not contain information about acceptance criteria, device performance, sample size, ground truth establishment, or expert qualifications for a study proving the device meets acceptance criteria.

The document discusses:

• The FDA's decision of substantial equivalence to predicate devices.
• The indications for use of the device.
• The materials and components of the device.
• A list of performance tests conducted (fatigue, wear, interlocking strength, etc.) according to various ASTM and ISO standards.
• A general statement that "Performance data demonstrate substantial equivalence to the predicate devices."

It does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any clinical or large-scale performance study.
3. Information on experts, adjudication methods, or ground truth for a test set.
4. Details on MRMC studies or AI assistance.
5. Information about standalone algorithm performance.
6. Sample sizes or ground truth establishment for a training set.

Therefore, I cannot fulfill your request based on the provided text.

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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 STRIDE Unicondylar Knee devices are indicated for patients with:

• Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
• Previous tibial condyle or plateau fractures with loss of anatomy or function.
• Varus or valgus deformities.
• Revision of previous arthroplasty procedures.
  These devices are indicated for cemented use only.

The STRIDE Unicondylar Knee device is a unicompartmental prosthetic implant that resurfaces one femoral condyle, and one side of the tibial plateau. The femoral component is made of cobalt chrome and the tibial component is. made of titanium with a UHMWPE insert that snaps into place. The device is nonconstrained; the articulating surface of the UHMWPE insert is flat and joint stability is maintained by ligaments and other soft tissue surrounding the knee.

The provided text describes the 510(k) summary for the STRIDE Unicondylar Knee, a unicompartmental prosthetic implant. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and non-clinical bench testing. It does not include information about clinical studies with human subjects or AI/algorithm-based performance.

Here's a breakdown of the requested information based on the provided text:

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

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

This information is not applicable as the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study on a test set of data.

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)

This information is not applicable as the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study requiring expert ground truth.

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

This information is not applicable as the submission describes engineering analysis and non-clinical (bench) testing, not a clinical study requiring adjudication.

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

This information is not applicable. The device is a physical knee implant, not an AI or imaging diagnostic tool, and therefore no MRMC study, human readers, or AI assistance is relevant.

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

This information is not applicable as the device is a physical knee implant, not an algorithm.

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

This information is not applicable as the device is a physical knee implant and the testing focused on engineering and material performance rather than diagnostic accuracy against a ground truth. The "ground truth" here is implied to be engineering specifications and predicate device performance.

8. The sample size for the training set

This information is not applicable as the submission pertains to a physical medical device and its engineering analysis, not a machine learning model requiring a training set.

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

This information is not applicable as the submission pertains to a physical medical device and its engineering analysis, not a machine learning model requiring a training set and its associated ground truth.

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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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The EVOLUTION™ Unicondylar Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. correction of functional deformity;
3. revision procedures where other treatments or devices have failed: and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION™ Unicondylar Knee System is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
   The EVOLUTION™ Unicondylar Knee System is for cemented use only.

The design features of the EVOLUTION™ Unicondylar Knee System are summarized below:

• Femoral components manufactured from Cobalt Chrome Alloy
• Femoral component sizes 1 5, Resurfacing- or Resection-based .
• Tibial inserts manufactured from UHMWPE
• Tibial insert: Universal, sizes 1 - 5
• Tibial insert: Conforming, sizes 1 5, left and right .
• Tibial component thickness: 8, 9, 10, 11, 12mm
• Tibial bases manufactured from Titanium Alloy
• Tibial base sizes 1 – 5, left and right
• All-poly tibial components manufactured from UHMWPE
• All-poly Universal: sizes 1 - 5, left and right
• All-poly Conforming: sizes 1 - 5, left and right
• All-poly tibial component thickness: 7, 8, 9, 10, 11, 12mm
  The EVOLUTION™ Unicondylar Knee System was evaluated via mechanical testing and engineering analyses; including static stability, contact area, lock detail, femoral component strength, range of motion, and wear testing. A review of these results indicates that the EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

The provided text describes a 510(k) premarket notification for the "EVOLUTION™ Unicondylar Knee System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through a new clinical effectiveness study.

Therefore, the document does not contain information about explicit acceptance criteria and a study designed to prove the device meets those criteria in the way envisioned by the posed questions (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance).

Instead, the "study" demonstrating the device's acceptability is based on showing equivalence to existing devices through mechanical testing and engineering analyses, along with a comparison of design features and materials.

Here's a breakdown based on the provided text, addressing the questions where applicable and explaining why certain information is not present:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria (Implied)	Reported Device Performance
   Functional equivalence to predicate devices.	"The EVOLUTION™ Unicondylar Knee System components are equivalent to predicate devices"
   Capability of withstanding expected in vivo loading without failure.	"capable of withstanding expected in vivo loading without failure"
   Safety and effectiveness supported by substantial equivalence.	"The safety and effectiveness of the EVOLUTION™ Unicondylar Knee System are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."
   Indications for use identical to previously cleared predicate devices.	"The indications for use of the EVOLUTION™ Unicondylar Knee System are identical to the previously cleared predicate devices."
   Design features and materials substantially equivalent to predicate devices.	"The design features and materials of the subject devices are substantially equivalent to those of the predicate devices."
   Fundamental scientific technology unchanged relative to predicate devices.	"The fundamental scientific technology of the modified devices has not changed relative to the predicate devices."

   Note: The "acceptance criteria" here are implied by the 510(k) process, which is about demonstrating substantial equivalence, not setting and meeting novel performance thresholds. The "reported device performance" directly addresses these equivalence claims.

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

   • This information is not applicable/not provided because the submission relies on mechanical testing, engineering analyses, and comparison to predicate devices, not a clinical "test set" of patients with discrete performance metrics.
   • The "study" here is primarily a comparison document and technical report, not a clinical trial.

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):

   • This information is not applicable/not provided. Ground truth in the context of a clinical test set is not relevant for this type of submission. The "ground truth" for demonstrating equivalence largely lies in technical specifications, material properties, and mechanical test results, assessed by engineers and regulatory bodies.

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

   • This information is not applicable/not provided. There was no clinical "test set" requiring adjudication.

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:

   • This information is not applicable/not provided. This is a medical device (knee implant) submission, not an AI or imaging diagnostic device.

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

   • This information is not applicable/not provided. Not an AI or software device. Performance is assessed through mechanical testing and equivalence, not an algorithm.

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

   • The "ground truth" in this context is the established safety and effectiveness of the predicate devices, as well as accepted engineering principles, material science standards, and mechanical testing results. The submission argues that because the new device's design, materials, and mechanical performance are equivalent to these established devices, it also shares their safety and effectiveness profile.

8. The sample size for the training set:

   • This information is not applicable/not provided. There is no "training set" in the context of an implantable medical device submission based on substantial equivalence.

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

   • This information is not applicable/not provided. See point 8.

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The ConforMIS Unicondylar Knee Repair 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 ConforMlS Unicondvlar Knee Repair System (iUni KRS) with curved tibial insert is composed of individually packaged femoral and tibial components. The femoral component is manufactured of cobalt chromium molybdenum (CoCrMo) alloy. The tibial implant is offered in two configurations; an all polymer (UHMWPE) configuration and metal-backed configuration. The Metal-backed Tibial implant consists of two components: a CoCrMo tibial tray and an ultra-high molecular weight polyethylene (UHMWPE) tibial trav insert.

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. In this manner, the implant is personalized on its bone contact and articular surfaces to match a patient's anatomy, thus becoming patient specific.

The provided text is a 510(k) summary for the ConforMIS® Unicondylar Knee Repair System (iUni® KRS). This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing specific performance acceptance criteria and proving them through a new study with a statistical design. Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test and training sets, expert qualifications, and detailed study types) is not present in this regulatory document.

However, I can extract information related to the device and its regulatory submission.

Device Description and Purpose:

The ConforMIS Unicondylar Knee Repair System (iUni KRS) with a curved tibial insert is designed to replace damaged articular surfaces in one compartment of an osteoarthritic knee. The device is personalized to the patient's anatomy using proprietary software analysis of MRI or CT scan images. It comprises femoral and tibial components. The femoral component is CoCrMo alloy. The tibial implant comes in two configurations: all UHMWPE or metal-backed (CoCrMo tray with UHMWPE insert).

Substantial Equivalence Claims:

The submission asserts substantial equivalence to existing, legally marketed iUni Unicondylar Knee Repair Systems (reference K043570, K063432, K072368, and K072586).

I. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain a table of explicit acceptance criteria with numerical targets or specific performance metrics derived from a new study designed to prove these criteria. Instead, it relies on a determination of substantial equivalence to predicate devices. The "performance" mentioned is in the context of safety.

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

The document states: "Non-clinical laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate device for the proposed intended use."

• Sample Size for Test Set: Not specified. As this is a 510(k) summary for substantial equivalence, it likely refers to various materials, mechanical, and perhaps wear testing, rather than a clinical "test set" in the sense of patient data.
• Data Provenance: Not specified, but "non-clinical laboratory testing" generally implies in-vitro or bench testing, not human subject data.

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

Not applicable. The submission is based on non-clinical laboratory testing and comparison to predicate devices, not on a study requiring expert-established ground truth on a test set (e.g., for diagnostic accuracy).

IV. Adjudication Method for the Test Set:

Not applicable. No clinical test set with adjudicated ground truth is described.

V. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study is not mentioned. This device is a surgical implant, not an imaging AI diagnostic tool, so an MRMC study would be out of scope for this type of submission.

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

Not applicable in the context of a medical device implant. The "proprietary software" is used to design the implant, which is then surgically implanted by a human. There is no "algorithm only" performance metric in this context.

VII. The type of ground truth used:

For the non-clinical testing, the "ground truth" would be established engineering standards, material properties, biomechanical test methods, and potentially wear simulation protocols that are considered acceptable for demonstrating the safety and performance of orthopedic implants.

VIII. The sample size for the training set:

Not applicable. This is not a machine learning submission in the sense of training a diagnostic algorithm on a dataset. The "proprietary software" analyzes individual patient images to design personalized implants, but there's no mention of a "training set" for the software in the context of this 510(k). The clinical data comes from predicate devices.

IX. How the ground truth for the training set was established:

Not applicable for the reasons stated above.

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MAKO Surgical Corp. Unicondylar Knee Implant System III components are for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteo- or post-traumatic arthritis
• Revision of previous unsuccessful unicompartmental knee replacement
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis

These components are single use only and are intended for implantation with bone cement.

This device consists of a CoCMo femoral condyle component, a titanium alloy baseplate, and ultra-high molecular weight polyethylene tibial onlay and inlay components have been designed to fit the medial and lateral compartments and are intended for cemented, one-time use only. The femoral condyle component features a polished articular surface, a cement pocket, and 2 fixation pegs. The design of the femoral condyle component allows for up to 155° flexion. The tibial components consist of a tibial onlay (tibial baseplate and tibial onlay insert) and a tibial inlay. The tibial onlay components snap together with an interlocking mechanism. The tibial inlay contains a dovetail channel on the bottom side and a peripheral cement channel to enhance fixation when cemented in the tibia.

The MAKO Surgical Corp. Unicondylar Knee Implant System III is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

There is no information in the provided text regarding acceptance criteria for a device, nor any study that proves a device meets acceptance criteria. The text describes the MAKO Surgical Corp. Unicondylar Knee Implant System III, its components, materials, sterilization, and indications for use, and confirms its substantial equivalence to predicate devices, but lacks details on performance studies or acceptance criteria.

Therefore, I cannot fulfill your request for the specific information points you've outlined.

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