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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 Sigma High Performance Unity Knee Resurfacing System is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

The Sigma High Performance Unity Knee Resurfacing System is indicated for single or multicompartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All Sigma High Performance Unity Knee Resurfacing System components are intended for CEMENTED USE ONLY.

The Sigma High Performance Unity Knee Resurfacing System is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create: a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee; two unicompartmental femorotibial replacements for both the medial and lateral sides of the knee; a patellofemoral replacement; a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee; or a tricompartmental patellofemorotibial replacement for the medial and lateral sides of the knee.

This submission adds metal-backed unicompartmental tibial components to the previously cleared GCK System. The Sigma High Performance Unity Knee Resurfacing System metalbacked unicompartmental tibial components consist of wrought forged Co-Cr-Mo unicompartmental tibial trays and XLK cross-linked UHMWPE unicompartmental tibial inserts. The trays and inserts are available in 6 sizes and in left medial / right lateral and right medial / left lateral configurations. Each tibial insert is available in 5 thicknesses. The Sigma High Performance Unity Knee Resurfacing System metal-backed unicompartmental tibial components are intended for use with the previously cleared GCK unicompartmental femoral components.

The document provided describes a 510(k) premarket notification for a medical device, the Sigma High Performance Unity Knee Resurfacing System metal-backed unicompartmental tibial components. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval).

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a performance study with well-defined metrics, thresholds, and clinical outcomes, is not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence through:

• Comparison to predicate devices: Showing the new device has the same intended use, similar design, and materials as previously cleared devices.
• Non-clinical testing: Engineering analysis, wear simulator testing, and mechanical testing to support the substantial equivalence claim.

Here's an analysis based on the provided text, addressing your points where information is available or indicating its absence due to the nature of a 510(k) submission:

Analysis of Device Acceptance and Supporting Studies

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

• Acceptance Criteria: No explicit "acceptance criteria" are provided in the document in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or specific clinical outcomes). For a 510(k) for an orthopedic implant, acceptance is typically based on demonstrating substantial equivalence to a predicate device in terms of design, materials, indications for use, and performance under non-clinical testing (mechanical, wear).
• Reported Device Performance: The document states that "Engineering analysis, wear simulator testing and mechanical testing were performed to demonstrate the substantial equivalence of the Sigma High Performance Unity Knee Resurfacing System mctal-backed unicompartmental tibial components to the predicate devices." However, specific performance data (e.g., precise wear rates, fatigue strength results, or other mechanical test values) and the acceptance thresholds for these tests are not detailed in this 510(k) summary. The conclusion is that these tests demonstrated substantial equivalence, implying they met unstated internal or recognized standard-based criteria.

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/provided as no clinical test set (i.e., human subject data) was used. The testing described is non-clinical (engineering, wear simulation, mechanical). Therefore, there is no provenance or sample size related to human 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/provided. No clinical test set requiring expert ground truth establishment was conducted. The "truth" in this context is based on engineering principles and established material and mechanical testing standards.

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

• This information is not applicable/provided. No clinical test set requiring adjudication was conducted.

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/provided. This device is a knee prosthesis, not an imaging analysis AI or a diagnostic tool that involves "human readers" or "AI assistance." Therefore, an MRMC study is irrelevant to this device.

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

• This information is not applicable/provided. This device is an orthopedic implant, not an algorithm.

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

• The "ground truth" for demonstrating substantial equivalence for this device would be based on engineering standards, material specifications, and biomechanical principles. For example, wear simulator testing would follow specific ISO or ASTM standards, with "ground truth" being the established scientific understanding of material wear in the physiological environment, and the results compared against predicate device performance or accepted thresholds.

8. The sample size for the training set

• This information is not applicable/provided. There is no "training set" in the context of an orthopedic implant 510(k) submission.

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

• This information is not applicable/provided. There is no "training set" or associated ground truth establishment for this type of device submission.

In summary, the provided text describes a 510(k) premarket notification for an orthopedic implant. This submission pathway relies on demonstrating substantial equivalence to a legally marketed predicate device primarily through non-clinical testing (engineering, mechanical, wear simulation). It explicitly states, "Clinical testing was not necessary to determine substantial equivalence between the subject Sigma High Performance Unity Knee Resurfacing System Tibial Components and the predicate devices." Therefore, many of the typical clinical study parameters (sample size, ground truth experts, MRMC, etc.) are not relevant or provided in this document.

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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 ConforMIS BiCompartmental Knee Repair System to provide the surgeon with an alternative tibial component in the event that he/she prefers to use a metal backed 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.

This 510(k) summary (K063432) for the ConforMIS Metal Backed Tibial Component (mBT) does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for performance evaluations of novel devices. Instead, it relies on substantial equivalence to predicate devices and prior testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the Metal Backed Tibial Component itself as it is a modification of an existing system. The "performance" described is about its substantial equivalence.

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

The document does not provide information on a specific "test set" for the Metal Backed Tibial Component. The testing mentioned refers to "design verification procedures for the ConforMIS Unicondylar Knee System." No details on sample size or data provenance (country, retrospective/prospective) for those verification procedures are included in this summary.

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

This information is not provided in the document. The submission focuses on engineering and material equivalence, not clinical decision-making validated by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This submission is for a knee implant component, and such studies are typically associated with imaging devices or diagnostic algorithms.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical knee implant component, not an algorithm or software. Its performance is inherent in its physical properties and design when implanted, not standalone algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on engineering and performance characteristics deemed acceptable for existing, legally marketed predicate devices. The substantial equivalence argument relies on the new device having similar design, materials, and function such that its performance is expected to be equivalent to devices already proven safe and effective. It explicitly states: "Clinical data and conclusions are not necessary to demonstrate substantial equivalence."

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this traditional medical device submission. "Training sets" are relevant for AI/ML algorithms, not for the design and testing of a knee implant component.

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

This question is not applicable as there is no "training set" in the context of this device submission.

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