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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

• · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity:
• · Revision procedures where other treatments or devices have failed;
  The porous coated femoral component may be used cemented (biological fixation).
  The porous coated tibial baseplate is to be used uncemented (biological fixation).
  All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
  The Apex Knee™ Modular Tibial Augments are intended to the Tibia baseplate and cemented to the prepared tibia.

The proposed devices are intended to be used for primary and revision total knee replacement.
The Pegged Tibial Baseplates offer additional torsional stability by adding pegs to the posterior end of the device. The material of the proposed Pegged Tibial Baseplates are Cobalt Chrome, CoCr (ASTM F75).
The ECiMa tibial inserts are machined from compression molded highly crosslinked polyethylene with Vitamin E (VE-XLPE) and attaches to the cobalt chrome tibial baseplate via dovetails and a retaining

The provided text describes a 510(k) premarket notification for the "Apex Knee™ System," a knee joint prosthesis. However, the document does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device.

The document is a submission for a physical medical device (a knee implant), not an AI device. Therefore, the questions related to AI device performance (e.g., number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical implant, primarily through material characterization, mechanical testing, and biocompatibility testing. The "acceptance criteria" discussed are mainly related to the performance standards for the implant materials and design, such as wear testing, strength testing, and sterility assurance levels.

Here's a breakdown of what is and is not in the provided text:

Information NOT Found (as it pertains to an AI device):

• 1. Table of acceptance criteria and reported device performance for an AI device: Not present. The acceptance criteria relate to mechanical and biological properties of the implant.
• 2. Sample size and data provenance for an AI test set: Not applicable. The "test set" refers to mechanical samples and animal models, not patient data for AI evaluation.
• 3. Number of experts and qualifications for AI ground truth: Not applicable. Ground truth for an AI device (e.g., image annotation) is not relevant here.
• 4. Adjudication method for an AI test set: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI: Not applicable.
• 6. Standalone (algorithm only) performance for AI: Not applicable.
• 7. Type of ground truth for an AI device: Not applicable. Ground truth here refers to engineering specifications and biological response, not diagnostic labels for AI.
• 8. Sample size for an AI training set: Not applicable.
• 9. How ground truth for an AI training set was established: Not applicable.

What the document does provide regarding the physical device's "studies":

The document broadly mentions "non-clinical testing" conducted to demonstrate the safety and effectiveness and substantial equivalence of the modified Apex Knee™ System. These tests are the "study" proving the device meets its acceptance criteria (though not presented in the AI-specific format requested).

• Testing for Pegged Tibial Baseplates:
  • FEA (Finite Element Analysis) simulation
  • Peg location templating study
• Testing for ECiMa Tibial Inserts & Patellae:
  • Material characterization
  • PS (Posterior Stabilized) post strength testing
  • Insert disassembly strength testing
  • Wear testing
• Biocompatibility Testing for ECiMa material:
  • Intramuscular implantation in animal models
  • Implant toxicity and subcutaneous implantation in animal models
• Sterility: Validated sterilization process using ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10-6. Endotoxin testing via Limulus amebocyte lysate (LAL) on a quarterly rotating basis for product groups.

Conclusion:

This document is a regulatory submission for a physical knee implant and does not contain the specific information requested regarding AI device acceptance criteria and study methodologies. The "studies" mentioned are engineering and biological tests demonstrating the physical device's performance and safety.

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The OMNI TiN Coated Apex Knee™ is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed;
  The Apex Knee™ Modular Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.

The change that is the subject of this 510(k) is to add a thin coating of Titanium Nitride (TiN) to all surfaces of all CoCrMo substrate metal components (Femoral(s), Tibial Baseplate(s), and Revision Tibia Augments) as listed in the above Predicates. The purpose of the TiN coating is to substantially reduce release of CoCrMo metal ions into body fluids, bone or soft tissues.
There is no change to the fundamental scientific technology of the referenced OMNI Predicate Knee Systems (5) with the modifications in this 510(k) submission. This includes no changes to the substrate materials, design, sterilization, packaging, or method(s) of manufacture.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The text is a 510(k) premarket notification for a medical device called the "OMNI TiN Coated Apex Knee™ System."

While it discusses the device's indications for use, its description, predicate devices, and non-clinical testing performed on the Titanium Nitride (TiN) coating, it explicitly states:

"7. Clinical Testing: No clinical studies were performed."

This immediately indicates that there will be no information regarding:

• A table of acceptance criteria and reported device performance (as this would typically come from clinical or comprehensive performance studies).
• Sample sizes for test sets, data provenance, or details about training sets (as these are relevant to studies, especially those involving AI/ML or extensive clinical trials).
• Numbers of experts, their qualifications, or adjudication methods for ground truth (again, these are related to studies, particularly those involving human interpretation or AI model validation).
• MRMC studies, effect sizes for human readers, or standalone AI performance.
• Types of ground truth established.

The document focuses on demonstrating substantial equivalence to predicate devices through

• Indications for Use,
• Material changes (addition of TiN coating), and
• Non-clinical testing of the coating properties (Chemical Composition, Thickness, Hardness, Adhesion Strength, Surface Roughness, and Wear Resistance).

Therefore, I cannot fulfill your request based on the provided text, as the necessary information for describing acceptance criteria and a study proving device performance is not present.

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The Apex All Poly Tibia is intended for use as part of a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed.

The Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

The Apex All Poly Tibia is used as part of a primary or revision cemented total knee implant using established total knee arthroplasty procedures. The All Poly Tibia is intended for use with bone cement, single use implantation and for use only with the Apex Knee™ System Femoral and Patella components.

The device is machined from compression molded Ultra High Molecular Weight Polyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblock tibia and designed for posterior cruciate substitution.

The provided text describes a 510(k) premarket notification for the "Apex All Poly Tibia" device, which is part of the "Apex Knee™ System." The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The information focuses on non-clinical testing for the device.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "All samples tested met the acceptance criteria." however, it does not specify the sample sizes used for any of the non-clinical tests (FEA Contact Stress Testing, Peg Stiffness Analysis, Cement Mantle Stress Analysis, FEA Abrasive Wear, or Insert Contact Pressure and Contact Area Testing).

The data provenance is not explicitly stated beyond being non-clinical tests typically conducted in a lab environment. There is no mention of country of origin of the data, or if it's retrospective or prospective.

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

Since these are non-clinical engineering tests (FEA, stiffness, wear, contact pressure), the concept of "ground truth" established by human experts in the typical clinical sense (like radiologists reading images) does not apply. The "ground truth" for such tests would be based on established engineering principles, material properties, and test standards (e.g., ASTM F2083-08). The document does not mention any human experts establishing ground truth for these specific non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. As these are non-clinical engineering tests with objective measurements against defined acceptance criteria (implicitly derived from engineering standards or predicate device performance), there is no mention of an adjudication method involving human interpretation.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to this submission. The device is a physical knee implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Engineering principles and simulations: For FEA Contact Stress, Peg Stiffness, Cement Mantle Stress, and FEA Abrasive Wear.
• Standardized test methods: Specifically, ASTM F2083-08 for Insert Contact Pressure and Contact Area Testing.
• Comparison to predicate device specifications/performance: While not explicitly detailed as "ground truth," the overall goal of the 510(k) is to demonstrate substantial equivalence to predicate devices, implying that the performance of the new device should be within acceptable limits relative to the predicates.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

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The Apex Knee System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis:
• Rheumatoid arthritis: .
• Correction of functional deformity: .
• Revision procedures where other treatments or devices have failed. .
  The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.

The Apex Knee System Porous Coated Tibial Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome tibial components have a plasma sprayed CP titanium porous coating (ASTM F1580) with a plasma sprayed overcoat of hydroxyapatite (ASTM F1185), and are intended for use without bone cement. Fixation of the porous coated tibial component is achieved by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System includes a tibial component option with two holes for supplemental fixation using cancellous bone screws, and the same porous coating. The Apex Knee System consists of a range of sizes of femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a size-for-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.

Acceptance Criteria and Study Details for Apex Knee System Porous Coated Tibial Components

The provided document describes a 510(k) premarket notification for the Apex Knee System Porous Coated Tibial Components. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics against those criteria. Therefore, the device "meets the acceptance criteria" by demonstrating substantial equivalence to the predicate device through a comparison of intended use, design, and materials, supported by material and design testing.

This document does not outline specific acceptance criteria in terms of clinical performance metrics (e.g., patient outcomes, reduction in pain scores, mobility improvements) and a study explicitly proving the device meets those criteria. Instead, the "acceptance criteria" are the FDA's requirements for demonstrating substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily focused on demonstrating similarities and justifying differences from legally marketed predicate devices. The "reported device performance" is the demonstration of these similarities and the safety/effectiveness of the new features through material and design testing, rather than clinical performance outcomes.

• Porous coating characterization: Adhesion strength, porosity, pore size, chemical composition (HA content).
• Biocompatibility testing: To ensure the new materials (HA overcoat system) are safe for implantation.
• Mechanical testing: To demonstrate the structural integrity of the porous coated components, especially for the screw holes if present, and to ensure the coating does not compromise mechanical performance.
• It is stated that the "porous coating is identical to... K043123," implying that the safety and effectiveness of this specific coating for biological fixation has already been established and accepted by the FDA. |

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

Given this is a 510(k) submission based on substantial equivalence, there is no "test set" in the context of clinical data with human subjects as typically understood for a novel device. The "test set" would refer to bench testing samples (e.g., specific numbers of components subjected to mechanical tests, material analysis samples). This information is not provided in the summary.

Data Provenance: The primary "data provenance" for demonstrating substantial equivalence is the prior FDA clearance of the predicate devices:

• Apex Knee System (K060192 and K073602)
• Apex Modular™ HA Hip Stem (K043123)

The data used to support these previous clearances would have included a range of non-clinical (bench) and potentially limited clinical data (for K043123 regarding biological fixation), but this document doesn't detail their original provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This type of premarket notification does not involve establishing ground truth from experts on clinical data. The "expertise" involved is that of the FDA reviewers who assess the substantial equivalence claim based on engineering, material, and regulatory principles.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set with human data requiring an adjudication method is described.

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

No. An MRMC study is typically used for diagnostic or imaging devices to assess reader performance. This is a submission for an implantable orthopedic device, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical prosthetic device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) determination is the established safety and effectiveness of the legally marketed predicate devices, specifically:

• The overall design and intended use of the Apex Knee System (K060192 and K073602).
• The specific plasma-sprayed CP titanium with HA overcoat for biological fixation, as proven safe and effective in the Apex Modular™ HA Hip Stem (K043123).

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of machine learning or AI algorithms for this device. The development of the device relied on engineering design principles, biomaterials science, and regulatory compliance, drawing from established knowledge and testing of the predicate devices.

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

Not applicable. As there is no training set for an algorithm, this question is not relevant. The basis for the acceptability of the design and materials is the extensive regulatory and scientific background supporting the predicate devices.

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The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation, with the option of using a porous coated femoral component for uncemented or cemented fixation. This prosthesis may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; .
• . Rheumatoid arthritis;
• Correction of functional deformity; .
• Congenital dislocation; ●
• Revision procedures where other treatments or devices have failed. .

The Apex Knee System Porous Coated Femoral Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome femoral components have a sintered porous coating (ASTM F1377). Fixation of the femoral component is achieved using either PMMA bone cement or by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System consists of a range of sizes of femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a sizefor-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.

The provided text describes a 510(k) premarket notification for the Apex Knee System Porous Coated Femoral Components. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove performance against specific acceptance criteria. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details will not be explicitly found in this document.

However, I can extract the relevant information from the document that addresses the comparison to predicate devices, which is the basis for this 510(k) clearance.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is the claim of equivalence.

• Apex Knee System (K060192) for cemented components
• Sigma Cruciate-Retaining Porocoat® Femoral Components (K062654) for porous coated components |
  | Identical Intended Use | Indications for Use are identical to the predicate Apex Knee System, with the added option of uncemented fixation for the porous coated femoral component. |
  | Similar Design Features | Similar design (asymmetric femur, anatomic patella groove, metal-backed UHMWPE tibial component, patella design) to predicate devices. The key difference is the addition of a porous coating. |
  | Similar Materials | Femoral component: Cobalt chrome.
  Porous coating: Sintered cobalt chrome (same as DePuy predicate and Sponsor's K031110) |
  | Same Manufacturing, Packaging, Sterilization Methods | Identical to the predicate Apex Knee System (K060192). |

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

• Not applicable. This submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to existing predicate devices rather than new clinical testing against a specific test set. No new clinical study data or patient samples are presented for this purpose in the document. The 'test set' in this context would be the comparison against specifications and characteristics of the predicate devices.

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

• Not applicable. As this is a 510(k) based on substantial equivalence, there is no "test set" in the sense of clinical data requiring expert review for ground truth. The evaluation is against the features and performance of predicate devices as described in their own 510(k)s or regulatory clearances.

4. Adjudication method for the test set:

• Not applicable. No clinical data test set requiring adjudication is presented.

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 total knee replacement prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this submission.

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

• Not applicable. This device is a total knee replacement prosthesis and does not involve an algorithm or AI component.

7. The type of ground truth used:

• Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) hinges on the established characteristics, performance, and regulatory clearances of the legally marketed predicate devices. The "truth" is that the new device is functionally and materially similar enough to the predicates to warrant substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device is a physical medical implant, not an AI model requiring a training set.

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

• Not applicable. See point 8.

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The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and . avascular necrosis;
• Rheumatoid arthritis; .
• Correction of functional deformity; .
• Revision procedures where other treatments or devices have failed. .

The Apex Knee System is a primary or revision total knee replacement. This knee replacement is intended for use with bone cement and single use implantation. This knee system consists of a range of sizes of cobalt chrome femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a size-for-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.

This document focuses on the Apex Knee System, a total knee replacement device. The provided text is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study evaluating acceptance criteria of a novel device. Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission.

However, I can extract information related to the device's characteristics and its comparison to existing devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify "acceptance criteria" in the sense of performance metrics for a novel device, nor does it present "reported device performance" from a study. Instead, it demonstrates substantial equivalence to predicate devices. The table below summarizes the design and material characteristics of the Apex Knee system and compares them to two predicate devices. This comparison serves as the basis for claiming substantial equivalence, implying that if the predicate devices are "accepted," then a device with similar characteristics also meets the necessary safety and effectiveness profile.

Note: The "Acceptance Criteria" column above is an interpretation of the characteristics present in the predicate devices that the Apex Knee System is demonstrating equivalence to. The direct performance metrics for "acceptance" are not explicitly stated as they would be in a clinical trial or performance study report.

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

• Test Set Sample Size: Not applicable. This is a 510(k) submission, which relies on demonstrating substantial equivalence to legally marketed predicate devices, not on a separate "test set" of patients or data for a novel performance study. The "data" here refers to the design specifications and material properties of the Apex Knee System being compared.
• Data Provenance: Not applicable in the context of human data. The "data" consists of the design and material specifications of the Apex Knee System and the predicate devices. This information is typically generated through engineering design, material testing, and manufacturing processes. The document does not mention human data from trials or registries.

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

Not applicable. Ground truth for a clinical test set is not established in a 510(k) submission that relies on predicate device comparison. The "ground truth" for this submission is implicitly the established safety and effectiveness of the existing predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" in the context of clinical data for adjudication here. The comparison is against predicate device specifications, which is a regulatory review process.

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

Not applicable. This device is a knee prosthesis, not an imaging diagnostic device that would typically involve human readers for interpretation. Therefore, an MRMC study is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device (total knee replacement), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth," in the context of a 510(k) for a physical device, is effectively the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the Apex Knee System is substantially equivalent in its design, materials, and intended use to these predicates, it shares the same safety and effectiveness profile.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of developing this physical medical device. Device design and material selection are based on engineering principles, biomechanical testing, and historical clinical performance of similar devices, not machine learning training data.

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

Not applicable, as there is no training set in the machine learning sense.

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