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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 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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The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee repair Systems, in patients with:

• joint impairment due to osteoarthritis or traumatic arthritis of the knee .
• previous tibial condyle or plateau fracture, creating loss of function .
• . valgus or varus deformity of the knee

The ConforMIS metal backed tibial component is intended only for use with bone cement.

The ConforMIS Metal Backed Tibial Component is to be used with either the ConforMIS Unicondylar Knee Repair System or the BiCompartmental Knee Repair ConforMIS System to provide the surgeon with an alternative tibial component in the event that prefers to use a metal backed he/she component rather than an all polyethylene component. It consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. The X/Y dimensions of the device (i.e. the twodimensional shape or "footprint"). are designed to conform to the patient's anatomy as closely as possible based on images (MRI or CT scan) of the patient's knee. It is available with UHMEPE inserts with minimal thickness from 6 to 14 mm.

The provided text is a 510(k) summary for the ConforMIS Metal Backed Tibial Component ("mBT"). It describes a device intended for knee repair and seeks to establish substantial equivalence to predicate devices, rather than proving specific performance against acceptance criteria through a clinical study.

Therefore, many of the requested sections about acceptance criteria, study details, human reader performance, and ground truth establishment cannot be found in this document. This document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. This document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that "Testing completed as part of the design verification procedure for the ConforMIS Metal Backed Tibial Component found this device to be as safe and effective as the predicate devices," implying that it met internal design verification standards, but no specific metrics are given.

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

• Cannot be provided. The document states, "Non-clinical Performance and Conclusions: Testing completed as part of the design verification procedure for the ConforMIS Metal Backed Tibial Component found this device to be as safe and effective as the predicate devices. further confirming substantial equivalence." This refers to non-clinical (likely bench or mechanical) testing, not a clinical test set with patient data. No details on sample size or data provenance for any "test set" are present.
• The document explicitly states, "Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence."

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)

• Cannot be provided. No clinical test set or ground truth establishment by experts is mentioned, as the submission relies on non-clinical performance and equivalence to predicates.

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

• Cannot be provided. No clinical test set or adjudication method is mentioned.

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

• Cannot be provided. This document describes a medical device (a knee implant component), not an AI algorithm or a diagnostic tool that would typically involve human readers or MRMC studies.

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

• Cannot be provided. This document is for a medical device (implant component), not an algorithm.

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

• Cannot be provided. No clinical ground truth is mentioned, as the submission focuses on non-clinical performance and substantial equivalence.

8. The sample size for the training set

• Cannot be provided. This document is for a physical medical device. It does not mention any "training set" in the context of an algorithm. The device design is customized "based on images (MRI or CT scan) of the patient's knee," but this refers to patient-specific design, not an algorithmic training process.

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

• Cannot be provided. No training set or ground truth establishment is mentioned.

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The ConforMIS, Inc., 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 a 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 or . rheumatoid arthritis of the knee
• post traumatic loss of joint function .
• . failed osteotomies, hemiarhtoplasties and unicondylar implants.
  The BiCompartmental Knee Repair System may be utilized when the medial or lateral condyle and the patellofcmoral areas have been affected by one or more of these conditions.
  The ConforMIS, Inc., BiCompartmental Knee Repair System is intended only for use with bone cement.

The ConforMIS, Inc., BiCompartmental Knee Repair System is a femorotibial semi-constrained total knee implant. The design of the product 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 and effectively addressed using a device that treats only a single knee compartment (i.e. a unicondylar or patellofemoral prosthesis), when the medial or lateral condyle and the patellofemoral regions are affected. Using patient imaging (either CT or MRI scans), a patient specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. The device is manufactured from cobalt chromium molybdenum alloy (ASTM-F-1537) from data obtained from images of the patient's individual geometry obtained using either CT or MRI scans. The tibial and patellar components are manufactured from Ulta-High Molecular Weight Polyethylene ("UHMWP" ASTM-F-648) The ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface. Off the Shelf (OTS) software is utilized to produce the surface Subsequently, Solid Works OTS software is used to create the design. ConforMIS, Inc., Implant Engineering Drawing. The BiCompartmental Knee Repair System is intended for use in conjunction with the tibial components of the ConforMIS Unicondylar Knee Replacement System and the patellofemoral components of the ConforMIS Total Knee Repair System.

The provided text is a 510(k) Summary for the ConforMIS, Inc. BiCompartmental Knee Repair System. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study that establishes acceptance criteria and proves the device meets those criteria through performance metrics.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to performance testing against specific acceptance criteria, which is not the primary purpose of a 510(k) substantial equivalence submission for this type of device.

Here's a breakdown of what can and cannot be derived from the provided text:

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

• Cannot be provided. The document states that the device is "substantially equivalent to FDA-approved predicate devices with regard to indications for use and technological characteristics." It does not present specific acceptance criteria (e.g., in terms of biomechanical performance, wear rates, etc.) or report detailed performance data against such criteria. The "performance" assessment is based on comparison to predicate devices, not on a standalone performance study with defined acceptance metrics.

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

• Cannot be provided. This document does not describe a clinical or performance test set. It refers to patient imaging (CT or MRI scans) being used to design patient-specific implants, but this is part of the manufacturing process, not a test set for evaluating the device's overall performance against acceptance criteria.

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):

• Cannot be provided. There is no mention of a test set with ground truth established by experts.

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

• Cannot be provided. No test set or adjudication method 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 implant, not an AI diagnostic tool that assists human readers.

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

• Not applicable. This device is a knee implant. While "ConforMIS, Inc., Implant Software is used to remove surface defects to produce a working design image of a smooth surface," this software is part of the design and manufacturing process, not a standalone diagnostic algorithm whose performance would be assessed in this manner.

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

• Cannot be provided. There is no mention of ground truth as part of a performance study.

8. The sample size for the training set:

• Cannot be provided. The document refers to "patient imaging (either CT or MRI scans)" being used to design the implant, suggesting individual patient data for custom manufacturing, not a "training set" in the context of an AI/ML algorithm development.

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

• Cannot be provided. No training set or ground truth establishment is described.

Summary of what can be extracted related to the device:

The ConforMIS, Inc. BiCompartmental Knee Repair System is a Class II medical device (NPJ) intended for use in patients with severe knee joint pain and disability due to conditions like osteoarthritis, traumatic arthritis, or rheumatoid arthritis, where a single-compartment prosthesis is insufficient. It is a patient-specific implant designed using CT or MRI scans of the patient's knee. The device is manufactured from cobalt chromium molybdenum alloy, with tibial and patellar components from Ultra-High Molecular Weight Polyethylene and is intended for use with bone cement.

The 510(k) submission demonstrates substantial equivalence to predicate devices (listed in the table in section {1}) in terms of "indications for use and technological characteristics." The document states:

• "The technological characteristics of the ConforMIS, Inc., BiCompartmental Knee Repair System are substantially equivalent to those of the cited predicate orthonedic devices."
• "The image analysis is identical to that used for the Imaging Therapeutics Interpositional Device (iPD) and the ConforMIS Unicondylar Implant."
• "This device is equivalent in terms of design process, materials, production process, and equipment."

The regulatory path chosen for this device (510(k) substantial equivalence) means that the testing and validation focus on demonstrating that the device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo performance data against a set of newly defined acceptance criteria. The FDA's letter (Section {4} and {5}) confirms the substantial equivalence determination, allowing the device to be marketed.

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