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The iTotal 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 knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis: The Indications for Use include:

• Painful joint disease due to osteoarthritis, traumatoid arthritis, rheumatoid arthritis or osteonecrosis of the knee
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity in which the ligamentous structurs 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 aligmment and positioning of the implant are identifiable on patient imaging scans.
  This implant is intended for cemented use only.

The iTotal 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, traumatic arthritis, rheumatoid arthritis, 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® Knee Replacement Systems (hereafter referred to as the "iTotal KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar components.
Using patient imaging and a combination of proprietary and off the shelf software a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either single or dual-piece (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, a highly cross-linked Vitamin E infused polyethylene (iPoly XE) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE).
For user convenience, and similar to the predicate iTotal KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal KRS are provided to assist with implantation. The ancillary instruments may be provided sterile or non-sterile to be sterilized by the end-user and are for single-use only.
The purpose of this submission is to propose dimensional modifications to the iTotal KRS implants and changes to the ancillary instrumentation.
The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)'s K142161, K142404 and K152704.

The provided text describes a 510(k) submission for the ConforMIS iTotal Cruciate Retaining Knee Replacement System and ConforMIS iTotal Posterior Stabilized Knee Replacement System. This submission focuses on demonstrting substantial equivalence to predicate devices through non-clinical testing, rather than studies that generate new clinical performance data with acceptance criteria that would typically be reported for software products.

Therefore, the following information cannot be extracted from the provided text: acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, expert qualifications, adjudication method, MRMC study effect size, standalone algorithm performance, ground truth type for test set, sample size for training set, and how ground truth for the training set was established.

Here's the information that can be extracted regarding the comparison and testing performed:

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

No specific numerical acceptance criteria or device performance metrics in terms of clinical outcomes are reported in the provided document. The submission focuses on demonstrating substantial equivalence through non-clinical testing.

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

Not applicable. The reported tests are non-clinical laboratory tests, not tests on a clinical dataset with a "test set" in the context of AI/software performance.

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

Not applicable. Ground truth, in the context of expert review for clinical data, is not mentioned for these non-clinical tests.

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

Not applicable. Adjudication methods are typically used for establishing ground truth from expert reviews of clinical data, which is not described here.

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:

No. An MRMC comparative effectiveness study was not performed or referenced.

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

Not applicable. This is a knee replacement system, not an AI algorithm. The performance evaluation is based on the physical device's characteristics and its comparison to predicate devices, not algorithm-only performance.

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

Not applicable in the context of clinical ground truth. The evaluation is based on engineering principles and performance testing against established standards or predicate device characteristics.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML system that utilizes training sets.

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

Not applicable. See above.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described for this 510(k) submission):

The device, ConforMIS iTotal Cruciate Retaining Knee Replacement System and ConforMIS iTotal Posterior Stabilized Knee Replacement System, underwent non-clinical laboratory testing to demonstrate substantial equivalence to legally marketed predicate devices (ConforMIS iTotal CR Knee Replacement System K142161, K142404, K152704 and ConforMIS iTotal PS Knee Replacement System K142161, K142404, K152704).

The study involved the following non-clinical laboratory tests:

• Tibial Insert Spine-Femoral Cam Fatigue Testing: This test likely evaluates the durability and resistance to wear and tear of the tibial insert component under repeated stress, simulating physiological loading conditions.
• Range of Motion Analysis: This test would assess the range of movement permitted by the knee replacement system, ensuring it allows for an appropriate and functional range of motion for the patient.
• Cadaveric Evaluation: This type of evaluation uses cadaveric specimens to assess the device's fit, alignment, and potentially the surgical procedure in a simulated anatomical environment.

The conclusion drawn from these tests was that the present device is substantially equivalent to the predicate devices for their intended use. This implies that the performance in these non-clinical tests met the established performance characteristics or standards for the predicate devices, thereby demonstrating that the modified device is as safe and effective as the previously cleared devices. Clinical data was deemed not necessary to demonstrate substantial equivalence for this submission.

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The iTotal 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 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.
• 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 iTotal Posterior Stabilized Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained, fixed bearing, cemented knee implant which consists of a femoral, tibial and patellar component.

The system is intended to treat patients who are candidates for total knee arthroplasty where the collateral ligaments are intact. Use of the iTotal PS KRS is usually based on surgeon preference, but it may be also used when total knee replacement is indicated and the posterior cruciate ligament is compromised, absent, or surgically excised.

Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).

For user convenience, and similar to the predicate, ancillary orthopedic manual surqical instruments designed for use with the iTotal PS KRS are provided to assist with implantation. The ancillary instruments are made from biocompatible nylon, and similar to the implants, are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone.

The intended use and function of the patient specific ancillary instruments remain similar to those described in the predicate 510(k)s (K140833).

This document describes a 510(k) premarket notification for the ConforMIS iTotal Posterior Stabilized (PS) Knee Replacement System (KRS). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in the way a clinical trial or AI performance study would.

Therefore, many of the requested categories for AI/medical device performance evaluation are not applicable or cannot be extracted from this document, as it concerns a medical implant that has undergone non-clinical laboratory testing for substantial equivalence, not a diagnostic AI algorithm.

Here's an attempt to address your request based on the provided text, noting where information is not applicable:

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

The document does not present explicit "acceptance criteria" in terms of clinical performance metrics with target values. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device through non-clinical laboratory testing. The "performance" reported are the results of these tests, which support the claim of substantial equivalence.

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

• Sample size for test set: Not applicable in the context of human data or a "test set" for an AI algorithm. The "test set" here refers to the physical devices and materials used in the non-clinical laboratory tests. The document does not specify the number of components or constructs tested for each non-clinical test (e.g., how many femoral components were fatigued).
• Data provenance: Not applicable. The "data" comes from physical laboratory testing of the device components, not from patient data (retrospective or prospective).

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

Not applicable. There is no human "ground truth" establishment in this context, as it's mechanical and functional testing of an implant rather than diagnostic assessment.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among experts for ground truth in diagnostic cases. This document describes non-clinical laboratory tests, which would follow established testing protocols and standards, not expert 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

Not applicable. This is not an AI-assisted diagnostic device, and therefore no MRMC study with human readers was conducted or is relevant.

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

Not applicable. This is not an algorithm, but a physical knee implant.

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

Not applicable. For the non-clinical tests, the "ground truth" would be established engineering standards, material properties, and biomechanical principles against which the device's performance is measured or compared to the predicate's known performance.

8. The sample size for the training set

Not applicable. This device is a physical knee implant, not an AI model requiring a training set. The design of the implant is patient-specific based on imaging, but this is a manufacturing process, not a machine learning training process.

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

Not applicable for the same reason as above.

Ask a specific question about this device

The iTotal 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 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 iTotal 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 compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.

The Indications for Use include:

• Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
• Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity.
• 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 iTotal® Knee Replacement Systems (hereafter referred to as the "iTotal® KRS") are patient specific tricompartmental faceted knee replacement systems. The iTotal® KRS are semi-constrained, cemented knee implants which consist of femoral, tibial, and patellar components.

Using patient imaging and a combination of proprietary and off the shelf software a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two (CR only) polyethylene inserts. The polyethylene inserts may be manufactured from either UHMWPE, or for iTotal CR KRS, a highly cross-linked Vitamin E infused polyethylene (iPoly XETM) The patellar component is also manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XETM).

For user convenience, and similar to the predicate iTotal KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal® KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone.

The function and general design features of the patient specific implants and ancillary instruments remain similar to those described in the predicate 510(k)'s K140423 and K140833.

The provided text describes a 510(k) premarket notification for the ConforMIS iTotal Cruciate Retaining Knee Replacement System (iTotal CR KRS) and ConforMIS iTotal Posterior Stabilized Knee Replacement System (iTotal PS KRS). It is a submission to establish "substantial equivalence" to legally marketed predicate devices, rather than a study demonstrating a novel device's performance against specific acceptance criteria.

Therefore, many of the requested elements about acceptance criteria, device performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods are not applicable or explicitly stated in this type of regulatory document. The focus here is on demonstrating that the modified device is as safe and effective as a previously cleared device, rather than proving performance against new, quantitative acceptance criteria.

However, I can extract information related to the changes made and the testing performed to demonstrate substantial equivalence.

Here's a breakdown of the information available in the document, framed to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in the sense of quantitative performance metrics for the device itself (e.g., accuracy, sensitivity, specificity). Instead, it aims to demonstrate "substantial equivalence" to a predicate device. The "performance" being evaluated is that the modified device, particularly its manufacturing software, retains the same functionality and characteristics as the predicate.

2. Sample Size for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. This submission focuses on demonstrating substantial equivalence through non-clinical testing, particularly software verification and validation, rather than a clinical test set of patients or anatomical data. The "test set" here refers to the software's internal testing of its CAD manufacturing process. No specific numbers of "cases" or "patients" are mentioned for this software testing.
• Data Provenance: Not applicable in the context of patient data. The "data" being evaluated is the software's output and internal workings.

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

• Number of Experts: Not applicable. This document is about software updates for a medical device's manufacturing process, not expert review of medical images or patient outcomes.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As there are no human readers or diagnostic interpretations being evaluated, there is no need for an adjudication method.

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

• MRMC Study Done: No. This is a 510(k) submission for a knee replacement system, specifically focusing on updates to its proprietary software for manufacturing. MRMC studies are typically used for evaluating diagnostic imaging systems or AI-assisted diagnostic tools by comparing human reader performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Standalone Study Done: Yes, in a sense, as the software's performance is evaluated independently of a human operator during the manufacturing process. The "non-clinical testing" involves "Software verification and validation testing of proprietary software" (SegSurf, iTotal FemJigs, iTotalTib, iTotal TibJigs, iTotal iView). This evaluates the algorithm's functional output (e.g., consistency of design generation) for its intended purpose in manufacturing. However, this is not a "standalone performance" in the context of, for example, an AI algorithm diagnosing disease from images.

7. Type of Ground Truth Used

• Type of Ground Truth: For the software verification and validation, the "ground truth" would be the expected and validated outputs of the software based on engineering specifications and existing design principles for knee replacement systems. This is an internal engineering "ground truth" rather than a clinical ground truth like pathology or patient outcomes. The software is expected to accurately translate patient imaging data into a patient-specific implant design that meets established anatomical and design requirements.

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated, nor is the concept of a "training set" directly applicable in the same way it would be for an AI algorithm that learns from data. The software mentioned (SegSurf, iTotal FemJigs, etc.) appears to be rule-based or algorithmic software for CAD manufacturing, rather than a machine learning model that undergoes "training" on a dataset.

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

• Ground Truth for Training Set: Not applicable in the context of an AI training set. If the software involves any machine learning components (which is not explicitly stated but implied by "proprietary software modules" being updated for "increasing automation"), the "ground truth" for its development would be based on expertly defined anatomical landmarks, surgical principles, and biomechanical requirements of knee replacement design. This would be established by engineers, orthopedic surgeons, and domain experts during the software's initial development and refinement.

Ask a specific question about this device

The iTotal 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, traumatic arthritis, . rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
• . Post traumatic loss of joint function.
• Moderate varus, valgus or flexion deformity.
• 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 iTotal Posterior Stabilized Retaining Knee Replacement System (hereafter referred to as the "iTotal PS KRS") is a patient specific tricompartmental faceted, cruciate sacrificing knee replacement system. The iTotal PS KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component.

The system is intended to treat patients who are candidates for total knee arthroplasty where the collateral ligaments are intact. Use of the iTotal PS KRS is usually based on surgeon preference, but it may be also used when total knee replacement is indicated and the posterior cruciate ligament is compromised, absent, or surgically excised.

Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific implant is designed, that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and a polyethylene insert that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The patellar component is manufactured from either UHMWPE or from a highly cross-linked Vitamin E infused polyethylene (iPoly XE™).

For user convenience, and similar to the predicate (iTotal CR KRS), ancillary orthopedic manual surgical instruments designed for use with the iTotal PS KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone.

The intended use and function of the patient specific ancillary instruments remain similar to those described in the predicate 510ks i.e. K131467 & K131019. There are only a few differences such as the addition of jigs to guide the bone cutting for the femoral box, the introduction of a full thickness flexion spacer to help assess joint space, and the insert trials that are made to match the tibial insert with the spine feature.

The provided text describes the 510(k) summary for the ConforMIS iTotal Posterior Stabilized Knee Replacement System (iTotal PS KRS). It details the device, its intended use, and the studies conducted to establish its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the iTotal PS KRS were not explicitly provided as numerical targets. Instead, the study's goal was to demonstrate substantial equivalence to predicate devices through functional testing. The "reported device performance" is the conclusion that the device's performance in these non-clinical tests was comparable to the predicate devices, thereby meeting the implicit acceptance criteria of being "safe and substantially equivalent."

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

The document details non-clinical laboratory tests, meaning physical and mechanical tests performed on the device components, not on human patients. Therefore, terms like "test set," "country of origin," and "retrospective or prospective" do not directly apply in the typical medical device AI/software context.

• Sample Size for Test Set: Not explicitly stated as a number of "samples" in a clinical sense. The tests involve multiple specimens of the device components (e.g., femoral components, tibial trays, inserts) subjected to various mechanical loads and conditions. The specific number of specimens per test is not provided in this summary.
• Data Provenance: N/A, as these are non-clinical, laboratory-based tests of physical components, not patient data.

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

N/A. This information is relevant for studies involving human assessment or interpretation (e.g., image review by radiologists). For the mechanical and functional testing described, "experts" in establishing ground truth would refer to engineers and technicians conducting the tests and interpreting the results according to established engineering and regulatory standards, not clinical experts.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers (e.g., radiologists) when establishing ground truth from patient data. This is not applicable to the non-clinical laboratory testing described.

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

No. An MRMC comparative effectiveness study involves human readers assessing cases with and without AI assistance to measure the AI's impact on human performance. The studies mentioned here are entirely non-clinical laboratory tests to determine physical and mechanical equivalence, not human-in-the-loop performance studies.

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

The device is a physical knee replacement system and patient-specific surgical instruments, not an AI algorithm. Therefore, "standalone algorithm performance" (without human-in-the-loop) is not applicable.

The closest analogy to "standalone performance" in this context would be the "Software verification and validation testing" mentioned, which assesses the performance of the software used to design the patient-specific implants. However, no details are provided about the outcome or methodology of this software testing other than its inclusion in the list of non-clinical tests.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would be the established engineering and biomechanical properties, performance characteristics, and material specifications required by the FDA guidance document and by existing predicate devices.

• Type of Ground Truth: Engineering and biomechanical standards, material specifications, and performance characteristics (e.g., fatigue life, contact stress, constraint) of predicate devices as set forth in "The FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003."

8. The Sample Size for the Training Set

N/A. This concept is for machine learning models. The device is a physical implant system, not an AI model trained on data. The software used to design the patient-specific implants would likely be developed and validated rather than "trained" in the machine learning sense. The summary provides no information on the development or validation of this software, or any "training set."

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

N/A, for the reasons mentioned in point 8.

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