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The Evolis/GMK knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis.
• Avascular necrosis of femoral condyle.
• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate.

In case a semi-constrained liner is used, an extension stem must be implanted both on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

GMK Sphere/Spherika can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis, rheumatoid arthritis.

• · Collagen disorders, and/or avascular necrosis of the femoral condyle.
• · Moderate valgus, varus, or flexion deformities.

The purpose of this submission is to notify the FDA of the GMK SPHERE range Extension, that includes GMK Spherika Femurs and GMK Fixed Tibial Trays Plus.

Subject devices are sterile implantable devices designed for tricompartment of the natural knee joint.

The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures.

GMK Spherika femoral component is an implantable device intended to be used in case of total knee arthroplasty to replace the femoral articular surfaces of the knee joint. GMK Spherika femoral component can be used in Kinematic Alignment surgical technique. The Kinematic Alignment surgical technique was already cleared in K173890.

GMK Tibial Trays Plus are a range extension of the GMK Tibial trays already cleared, in details they are fixed intermediate sizes of the tibia trays.

The subject devices are a line extension to Medacta previously cleared implants: GMK Sphere (K121416), GMK Sphere Extension (K140826), GMK Knee Prosthesis- GMK Sphere Tibial Insert Flex (K162035), GMK Sphere - Kinematic Alignment ( K173890), GMK Sphere CR Tibial Inserts (K181635), GMK Sphere E-Cross (K202022), GMK Total Knee System-TiNbN Coating (K202684), Medacta International SA, GMK Total Knee System (K090988), GMK Line Extension (K120790), GMK Narrow K122232, MK Extension (K142069) and

The subject devices are manufactured with the same materials of the previous cleared femurs and tibial trays.

The submission includes the following implants:

• . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4)
• . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated
• . GMK Spherika Femoral Component Anatomical, Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4)
• GMK Spherika Femoral Component Anatomical, Left and Right, Sizes from 1 to 7 and . from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated
• Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes ● made in Co-Cr-Mo (ISO 5832-4)
• Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated

The subject devices, both Femoral Components and Tibial Trays, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Allov.

In regards to the Femurs and Tibial Trays TiNbN Coating, they are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Niobium Nitride (TiNbN) coating.

Like the predicate tibial trays devices, the tibial trays plus subject of this submission have a Fixed Tibial Tray Plug that is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.

The subject device also includes the utilization of the GMK Sphere E-cross tibial insert FLEX, already cleared (K202022) in case of retention of an efficient posterior cruciate ligament in the Kinematic Alignment configuration.

The Kinematic Alignment surgical technique was already cleared in K173890.

In this case there are no new implants or instruments, GMK Sphere E-cross tibial insert FLEX, already cleared (K202022).

The provided text describes mechanical performance tests for knee implants, not a study evaluating an AI/ML powered device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or human-in-the-loop performance for an AI/ML device.

The document is a 510(k) summary for a submission by Medacta International SA for a knee prosthesis, the "GMK-SPHERE Spherika Femurs and Tibial Trays plus". It focuses on demonstrating substantial equivalence to already cleared predicate devices through design comparisons and non-clinical mechanical testing, which is typical for traditional (non-AI/ML) medical devices.

No information about an AI/ML device, its acceptance criteria, or a study proving those criteria are met is present in this regulatory document.

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The GMK Knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Avascular necrosis of femoral condyle
• Post traumatic loss of joint configuration
• Primary implantation failure

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semiconstrained liner is used, an extension stem must be implanted both on the fibial and on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

The GMK Sphere CR Tibial Inserts are a line extension to the GMK Sphere Total Knee System and are comprised of the following products:

• Tibial insert fixed CR: Left and Right, Sizes 1-6, Thicknesses 10-11-12-13-14 mm, UHMWPE (ISO 5834-2) Type 1.

The purpose of this submission is to introduce a new GMK Sphere insert design that does not require Posterior Cruciate Ligament (PCL) release. The introduction of the subject items does not require additional instrumentation needed during the surgical procedure (with exception of the specific CR trial tibial inserts) and does not alter the intended use or outcomes.

The provided text is a 510(k) summary for a medical device (GMK Sphere CR Tibial Inserts). It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, or training set information. This document pertains to the regulatory clearance of a physical medical implant (a knee replacement component) through a substantial equivalence pathway, not the evaluation of an AI-powered diagnostic or predictive tool.

The "Performance Data" section mentions mechanical data, constraint measurements, contact pressures, dynamic physiological loads, and range of motion, but these are related to the physical properties and biomechanical function of the implant, not the performance of an algorithm.

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MyKnee® PPS-Pin Positioners are intended to be used as anatomical pin positioners specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding of bone before cutting. MyKnee® PPS-Pin Positioners are intended for use with the GMK Total Knee System and its cleared indications for use. MyKnee® PPS-Pin Positioners are intended for single use only.

The MyKnee® PPS-Pin Positioners are single use femoral and tibial pin positioning patientspecific blocks. The MyKnee® PPS-Pin Positioners are designed and manufactured from patient MRI imaging data so the positioners match the patient's anatomy. The MyKnee® PPS-Pin Positioners are used with Medacta International SA's existing GMK Total Knee System. GMK Primary, GMK Sphere and GMK-Primary Narrow. The pin positioners are developed only for placement of the standard metal instruments (distal/tibial cut guide and 4-in-1 femoral cut guide) following the positions planned by the surgeon.

The MRI images are provided by the hospitals to Medacta International SA prepared according to a specific protocol for an individual patient. Medacta International SA uses these images in combination with Mimics (Materialise) and Solidworks (Dassault Systemes) to import DICOM images from a patient's MRI scans and these scans are then processed into accurate 3D models.

The MyKnee® PPS-Pin Positioners are manufactured from medical grade nylon for sintering which is identical to the predicate devices. MyKnee® PPS-Pin Positioners blocks are available in sizes 1-7 for the femur and sizes 1-6 for the tibia. The pin positioners will be provided in both non-sterile and sterile versions.

Here's a breakdown of the acceptance criteria and the study information for the MyKnee® PPS-Pin Positioners, based on the provided document:

This device is not an AI/ML device, therefore, please note that some of the requested information, such as sample size for the test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details, are not applicable or not explicitly detailed in the context of a traditional medical device submission for a physical pin positioner. The provided document focuses on demonstrating substantial equivalence to a predicate device through non-clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the document as this is not an AI/ML device that would typically have a separate "test set" in that context. The "test" here refers to non-clinical evaluations of physical device properties.
• Data Provenance: The studies were non-clinical, involving design comparisons, breakage evaluations, manufacturing process evaluations, functional/fitting evaluations, and sterilization impact studies of the physical device. This data would be generated in a lab or workshop setting by Medacta International SA.

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

This information is not applicable and not provided. The "ground truth" for a physical device like a pin positioner is its physical properties and functionality, which are assessed through engineering and performance testing, not by expert interpretation of data in the same way as an AI/ML diagnostic device.

4. Adjudication Method for the Test Set

Not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in interpreting medical images or clinical data, which is not relevant for the testing of this physical device.

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. The document explicitly states "no clinical studies were conducted." MRMC studies are generally used to evaluate the diagnostic performance of AI/ML systems with or without human-in-the-loop.

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

Not applicable. The MyKnee® PPS-Pin Positioners are physical, patient-specific surgical guides, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on engineering and performance specifications, design requirements, and established material properties. This is verified through:

• Measurement against design specifications (dimensional/geometrical comparison).
• Physical testing for durability (breakage evaluation).
• Assessment of manufacturing consistency (manufacturing process evaluation).
• Evaluation of intended function (functional and fitting evaluation), likely in cadaver workshops.
• Compliance with biocompatibility standards (by demonstrating equivalence to predicate materials).
• Compliance with sterilization requirements.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth established for training.

Summary of the Study Proving Acceptance Criteria:

The document describes a series of non-clinical studies to demonstrate substantial equivalence of the MyKnee® PPS-Pin Positioners to the predicate device (MyKnee® Cutting Blocks, K093806). These studies focused on:

• Design Comparison (Dimensional/Geometrical): This compared the subject device to the predicate, noting the key difference as the removal of integrated cut slots. The evaluation concluded this difference did not raise new safety or effectiveness concerns.
• Breakage Evaluation: Assessed the structural integrity and durability of the device.
• Manufacturing Process Evaluation: Verified the consistency and control of the manufacturing process.
• Functional and Fitting Evaluation: Conducted according to written protocols, likely in cadaver workshops, to ensure the pin positioners function as intended in guiding surgical instruments.
• Biocompatibility: Noted that the material (medical grade nylon for sintering) and manufacturing process are identical to the predicate device, for which biocompatibility testing (to ISO 10993-1, -5, -10 for short-term contact) had already been conducted and deemed sufficient.
• Sterilization Studies: Included a "sterilization dimensional and functional impact study" and a "gamma sterilization criticality assessment" to ensure the sterilization process does not compromise the device's integrity or function, and that both non-sterile and gamma-sterilized versions are acceptable.

The conclusion is that these non-clinical studies and comparisons support that the MyKnee® PPS-Pin Positioners are as safe and effective as the predicate devices, and the minor design differences do not raise any new questions of safety or effectiveness, thus proving substantial equivalence for device acceptance. No clinical studies were performed.

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The 3DMetal Tibial Cones are indicated for use with the GMK Hinge knee systems, as well as the GMK tibial extension stems and offsets.

Specific indications are as follows:

• · Severely painful and/or disabled joint as a result of arthritis, theumatoid arthritis or polyarthritis.
• · Post traumatic loss of joint configuration.
• · Considerable loss of function of the knee joint.
• · High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
• · Primary implantation failure.
• · Former revision arthroplasty.

The 3DMetal Tibial Cones are implantable devices to be used as fillers in cases of severe bone deficiency. The subject devices are to be cemented to the GMK Revision and GMK Hinge systems' tibial trays. The subject devices have a full-density layer that prevents cement occluding the pores of the external layer.

The purpose of this submission is to gain clearance for the tibial cones available in centred and eccentric versions. The tibial cones are available in sizes XS, S, M, and L with heights of 20 mm and 25 mm.

The subject devices are intended to be used with the cleared indications for use and the tibial trays of Medacta's GMK Revision (K102437) and GMK Hinge (K130299) systems.

The 3DMetal Tibial Cones are manufactured with titanium alloy substrate, which is identical to predicate devices Regenerex Porous Titanium Sleeve Augments (K072336). However the subject devices' material is processed using electron beam melting (EBM) similar to the material of referenced device Delta TT Acetabular System (K141395).

This document is a 510(k) premarket notification for a medical device called "3DMetal Tibial Cones." The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval application (PMA).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with specific numerical targets and reported device performance. Instead, it states that "testing was conducted to written protocols with acceptance criteria that were based on standards and FDA guidance documents." The performance data is described qualitatively, referencing compliance with various ASTM standards.

However, based on the performance data section, we can infer the types of tests conducted and their implied acceptance criteria (compliance with standards).

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

The document does not specify the sample size for any of the non-clinical mechanical or pyrogenicity tests. It simply states that "testing was conducted to written protocols."

The data provenance is from non-clinical laboratory testing performed by the manufacturer, Medacta International SA. There is no mention of country of origin for the data beyond the manufacturer's location (Switzerland), and the studies are inherently prospective as they were conducted to support this submission.

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

Not applicable. This submission focuses on the substantial equivalence of a physical medical device (tibial cones) for knee replacement, based on mechanical testing and material properties, not on diagnostic performance or interpretation by experts. Therefore, there is no "ground truth" in the traditional sense established by experts for a test set.

4. Adjudication Method for the Test Set:

Not applicable. As there is no ground truth requiring expert consensus or interpretation, no adjudication method was used.

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 submission is for an implantable medical device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant and was not performed.

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

Not applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the established scientific and engineering standards and principles demonstrated through laboratory testing. The device is evaluated against:

• Mechanical performance standards: ASTM F1800-12, ASTM F1044-05, ASTM F1160-14, ASTM F1147-05, ASTM F1854-09.
• Biocompatibility standards: Implied by comparison to predicate devices and general standards for implantable materials.
• Material composition standards: ISO 5832-3:1996, ASTM F2924-12a.
• Pyrogenicity standards: European Pharmacopoeia §2.6.14, USP chapter .

Essentially, the ground truth is the device's ability to consistently meet these recognized safety and performance benchmarks.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The device's design and manufacturing processes are based on established engineering principles and material science.

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

Not applicable. As there is no training set for an AI/machine learning model, this question is not relevant.

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The GMK® knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, theumatoid arthritis or polyarthritis
• · Avascular necrosis of femoral condyle.
• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

The GMK Sphere Tibial Insert Flex is a line extension to the GMK Sphere Total Knee System and is comprised of the following products:

• Tibial Insert Fixed Flex: Left and Right, Sizes 1-6, 10-20mm (including intermediate ● sizes 11mm and 13mm) UHMWPE (ISO 5834-2)Type 1, Fixation Screw: Ti6Al5V (ISO 5232-3)

The purpose of this submission is to modify the surgical technique provided to surgeons to show that the GMK Sphere Tibial Insert Flex titanium screws' use as optional, instead of required. This technique modification does not alter the intended use or outcomes.

This document describes a 510(k) premarket notification for the GMK® Sphere Tibial Insert Flex. The purpose of this submission is to modify the surgical technique for the device, making the use of titanium screws optional instead of required, and to introduce additional thickness sizes.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and the lack of new safety and effectiveness questions arising from the proposed changes. The performance is assessed through various tests and analyses.

   Acceptance Criterion (Implied)	Reported Device Performance
   Biocompatibility	"Biocompatibility testing conducted on the predicate devices for the same material supports the biological safety of the GMK Sphere Tibial Insert Flex. Additional testing was deemed unnecessary."
   Mechanical Performance (with optional screw use)	"Based on the risk analysis, static analysis combined with previous static and dynamic/fatigue test on the clipping system, the GMK Sphere Tibial Insert Flex remains safe and consistent for the intended use though the fixation screw is not used."
   Sterilization Validation	One of the analyses conducted or leveraged was "Sterilization Validation". No specific performance outcome is detailed, but the inclusion implies it met established standards.
   Shelf Life	One of the analyses conducted or leveraged was "Shelf Life". No specific performance outcome is detailed, but the inclusion implies it met established standards. The shelf life is stated as 5 years in the comparison table (Page 5).
   Pyrogenicity (for applicable components, if claimed non-pyrogenic)	"Limulus Amebocyte Lysate (LAL) testing was evaluated to establish the device meets pyrogen limit specifications." (Medacta does not intend to claim "non-pyrogenic" for Femoral Distal Augmentations, implying pyrogenicity was evaluated where relevant but not necessarily claimed as part of the primary device's properties).
   Safety and Effectiveness (overall, for modified features)	"The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the subject device is adequately supported by the substantial equivalence information, materials information, and analysis data provided..."

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

   The document describes engineering and laboratory tests rather than clinical studies with human subjects or a "test set" of patient data in the typical sense for an AI/diagnostic device. The tests mentioned include:

   • Static and Dynamic/Fatigue Test on Clipping System (K090988): This test was leveraged from a previous submission (K090988). The sample size (e.g., number of components tested) for this mechanical testing is not specified in this document. The provenance is internal laboratory testing.
   • Sterilization Validation, Shelf Life, LAL testing: These are standard laboratory tests conducted on device materials or products. The sample sizes for these tests are not specified, but would typically involve a statistically appropriate number of units as per relevant international standards (e.g., ISO, ASTM). The provenance is internal laboratory testing.

   There is no mention of country of origin of data or whether it was retrospective or prospective, as it pertains to device testing, not patient data analysis.

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

   This information is not applicable to this submission. This document pertains to a medical device modification and its mechanical and material properties, not an AI/diagnostic device that requires expert-established ground truth from a test set of patient data. The "ground truth" here is established through engineering principles, material science, and regulatory standards.

4. Adjudication Method for the Test Set:

   This is not applicable as there is no "test set" of patient cases requiring adjudication by experts. The determination of device safety and effectiveness is based on engineering analyses and adherence to material and manufacturing standards.

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

   This is not applicable. This document describes a traditional medical device (knee prosthesis) modification and does not involve AI assistance or human reader performance.

6. Standalone (Algorithm Only) Performance:

   This is not applicable. The device is a physical knee prosthesis, not an algorithm.

7. Type of Ground Truth Used:

   The "ground truth" in this context is established by:

   • Engineering principles and performance standards: For static and dynamic/fatigue testing, the "ground truth" is that the device must withstand certain forces and cycles without failure, as determined by established engineering specifications and benchmarks for similar devices.
   • Material properties and biocompatibility standards: For materials, sterilization, and LAL testing, the "ground truth" is adherence to ISO standards (e.g., ISO 5834-2 for UHMWPE, ISO 5832-3/4 for metals) and regulatory limits for pyrogens, ensuring biological safety.
   • Substantial equivalence: The ultimate "ground truth" for this 510(k) submission is that the modified device is "as safe and effective as the predicate devices" based on the provided data and analyses.

8. Sample Size for the Training Set:

   This is not applicable. There is no "training set" in the context of this traditional medical device submission. The device's design is based on established engineering principles and prior device designs, not machine learning training.

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

   This is not applicable as there is no training set.

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The GMK knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis. · Avascular necrosis of femoral condyle. · Post traumatic loss of joint configuration. · Primary implantation failure. Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.

The GMK Sphere Total Knee System allows for medial-pivot rotation of the knee joint and is comprised of the following components: - Femoral Component Left and Right, Sizes 1-7 Co-Cr-Mo (ISO 5832-4) - Tibial tray fixed cemented Left and Right, 4 intermediate sizes . Co-Cr-Mo (ISO 5832-4) - Tibial Insert Fixed Flex and Congruent, Left and Right, Sizes 1-6, 10mm-20mm . UHMWPE (ISO 5834 -2) Type 1, Ti6Al4V (ISO 5232-3)

The provided text does not contain detailed information about specific acceptance criteria with numerical thresholds, nor does it describe a study where a medical device's performance is measured against such criteria.

Instead, the document is a 510(k) summary for the GMK Sphere Total Knee System, which focuses on demonstrating substantial equivalence to predicate devices. This type of submission relies on showing that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness.

Here's a breakdown of what the document does provide in relation to performance and equivalence:

1. Acceptance Criteria and Reported Device Performance (as inferred from the substantial equivalence claim):

The document states that "A review of the mechanical data indicates that the GMK Sphere is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure." This implies that the acceptance criteria are essentially equivalence to predicate devices in terms of mechanical performance and the ability to withstand physiological loads without failure.

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

• Sample Size: Not specified. The document mentions "mechanical data" but does not detail the number of samples or specific tests performed, or the number of simulated uses, etc..
• Data Provenance: Not specified. It's likely laboratory testing.

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

This information is not applicable and not provided. The testing described is mechanical, not involving human interpretation of data for ground truth establishment.

4. Adjudication method for the test set:

Not applicable, as it's mechanical testing.

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

No, an MRMC study was not done. This type of study is typically for evaluating diagnostic devices where reader performance is a key factor. This document is for a Class II knee prosthesis.

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

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

7. The type of ground truth used:

For mechanical testing of implants, the "ground truth" is typically defined by engineering standards (e.g., ASTM standards for range of motion, fatigue life, strength) and the performance characteristics of predicate devices that have been deemed safe and effective.

8. The sample size for the training set:

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable.

In summary:

The provided text describes a 510(k) submission for a knee prosthesis, which focuses on demonstrating substantial equivalence to previously cleared devices through mechanical performance testing. It does not describe a study that uses acceptance criteria with specific numerical thresholds met by the device's performance in a way that would be typical for, for example, an AI/ML-driven diagnostic device. The "acceptance criteria" here are implicitly linked to the performance of the legally marketed predicate devices, and the "study" is the mechanical testing conducted and reviewed to support the equivalence claim.

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MyKnee Cutting Blocks are intended to be used as anatomical cutting blocks specific for a single patient anatomy to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of hone before cutting.

MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use.

MyKnee Cutting Blocks are intended for single use only.

MyKnee Cutting Blocks are designed and manufactured from patient imaging data so that the cutting blocks match the patient's anatomy. The MvKnee Cutting blocks for the patient are used with Medacta's existing GMK Total Knee System.

This 510(k) summary for the MyKnee Cutting Blocks describes performance testing; however, it does not provide detailed acceptance criteria or a specific study designed to "prove" the device meets acceptance criteria in the way one might expect for a software or AI/ML device.

Instead, the documentation focuses on demonstrating substantial equivalence to predicate devices through a combination of non-clinical testing and design validation. Given the nature of the device (patient-matched cutting blocks for total knee replacement), the "acceptance criteria" discussed are largely related to manufacturing quality, material properties, and dimensional accuracy, rather than clinical efficacy as might be assessed with AI.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "MyKnee Cutting Blocks were tested as part of design verification to written protocols with pre-defined acceptance criteria. The testing met all acceptance criteria..." However, the specific acceptance criteria and their corresponding reported performance values are not detailed in this summary.

Based on the text, the following types of performance were evaluated, implying associated acceptance criteria existed:

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

The document mentions "a cadaver laboratory" for design validation. This implies the use of human cadavers as a test set. However:

• Sample Size: The exact number of cadavers used is not specified.
• Data Provenance: This would be from cadaveric studies, likely performed in a laboratory setting. It is retrospective in the sense that the cadavers were not living patients undergoing surgery, but rather preserved specimens. The country of origin is not specified but would typically be the country where the manufacturing or validation studies were performed (likely Switzerland where Medacta is based, or potentially the US if outsourced).

3. Number of Experts and Qualifications

This information is not provided in the summary. While the study involved surgical tools, there is no mention of experts establishing a ground truth for a test set in the context of diagnostic performance.

4. Adjudication Method

This information is not provided in the summary. This type of adjudication is typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), which doesn't appear to be the primary focus of the performance testing described here.

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

No, an MRMC comparative effectiveness study was not done with human readers and AI assistance. This device is a physical cutting block, not an AI diagnostic or assistive tool in that traditional sense. The "patient-matched" aspect refers to the manufacturing process creating a custom physical tool from patient imaging data, not an AI providing clinical interpretations.

6. Standalone (Algorithm Only) Performance

The closest analog to "standalone performance" for this device would be the accuracy and precision of the MyKnee Cutting Blocks themselves in matching the patient's anatomy and guiding cuts. This was part of the "dimensional accuracy and precision" testing, and "software tools used to manufacture the MyKnee Cutting Blocks were validated for their intended use." However, it's not an algorithm only in the sense of a standalone AI model; it's the accuracy of the manufactured physical product derived from digital data. No specific performance metrics are given.

7. Type of Ground Truth Used

For the cadaver laboratory design validation, the ground truth would likely involve:

• Physical measurements: Direct measurements of the bone cuts and component positioning on the cadaveric knees after using the MyKnee Cutting Blocks, compared against surgical plans derived from the patient imaging data.
• Expert surgical assessment: Evaluation by surgeons to confirm if the blocks facilitate accurate and appropriate resections as intended.

8. Sample Size for the Training Set

The phrase "training set" is typically used for machine learning models. For this device, the "training" for the manufacturing process comes from the engineering design, material science, and manufacturing protocols. There isn't a "training set" of data in the AI/ML sense. The "patient imaging data" for each individual patient is used to design their specific cutting blocks, not to train a general model.

9. How Ground Truth for Training Set Was Established

Given that there is no "training set" in the AI/ML sense, this question is not applicable to the MyKnee Cutting Blocks device as described. The "ground truth" for the overall design and manufacturing process would be established through engineering specifications, material properties testing, and verification of the manufacturing process (as implied by process reproducibility and software validation).

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The iMNS Medacta Navigation System is intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, instrument and implant positioning during joint replacement.

The iMNS Medacta Navigation System provides computer assistance to the surgeon based on anatomical landmarks and other specific data obtained intra-operatively that are used to place surgical instruments.

Examples of some surgical procedures include but are not limited to: Total Knee Replacement Minimally Invasive Total Knee Replacement

The iMNS Medacta Navigation System is a device for computer aided navigation of surgical instruments used in total knee replacement surgery. The system works on the common principle of stereotaxic technology in which passive markers are securely mounted on the patient's bones and an infrared camera is used to monitor the spatial location of those markers. This information is used to locate the anatomical landmarks such as centers of rotation of the femur head, knee and ankle intraoperatively. These measurements are displayed on a computer screen in real time. The instruments are then outfitted with the passive markers to improve the positioning of the cutting guides. The information from the system with the "navigated" instruments assists the surgeon in conducting the bone resections and positioning of the orthopedic surgical implants. The surgeon maintains control of the surgery and makes any decisions required with regard to bone resections and implant positioning but the iMNS Medacta Navigation System provides real time support and information throughout the surgery.

The iMNS Medacta Navigation System consists of the following kev components:

• · An acquisition system composed of two infrared cameras equipped . with infrared light emitting diodes (LED) to track the position of the passive markers.
• . A computer running the proprietary Medacta software and a monitor,
• . Interface devices of a keyboard, foot pedal and optional mouse to control the system, and
• Manual reusable surgical instruments. .

The software application called GMK v4.2.2 is designed to work with Medacta's GMK Total Knee System, cleared under K090988. The manual reusable surgical instruments include instruments specifically designed for navigated surgery and other standard surgical instruments needed to conduct total knee replacement.

The Medacta iMNS Navigation System (GMK v4.2.2) is a computer-aided navigation system for total knee replacement surgery. The device was tested through a series of "design verification and validation" protocols with predefined acceptance criteria. These tests were conducted as part of the Special 510(k) submission (K100314) to demonstrate substantial equivalence to its predicate device (iMNS Medacta Navigation System v4.0, K083872).

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

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

The document states that "The iMNS Medacta Navigation System was tested as part of design verification and validation to written protocols with pre-defined acceptance criteria. The testing met all acceptance criteria." However, specific numerical acceptance criteria (e.g., accuracy thresholds) and their corresponding reported device performance values are not detailed in the provided text. The tables list the Protocol IDs, Report IDs, and Titles of the verification and validation activities.

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

The document primarily describes internal design verification and validation activities. It mentions "Design validation was conducted on the iMNS Medacta Navigation System in a simulated user setting by a surgeon". It does not specify a sample size for a test set (e.g., number of patients or cases), nor does it provide information on data provenance (country of origin, retrospective/prospective). The testing appears to be conducted in a simulated environment rather than on patient 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)

The design validation was conducted "by a surgeon". The specific number of surgeons, their qualifications, or how they established "ground truth" (e.g., in a simulated environment for measurement accuracy) is not detailed beyond the mention of "a surgeon."

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

The document does not describe any adjudication method for the test set results. The validation was conducted by "a surgeon," implying a single expert evaluation for the simulated user setting.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. The device is a surgical navigation system, not an AI diagnostic tool for human readers. It assists the surgeon directly in instrument positioning.

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

The document implies that "standalone" testing (algorithm only performance) was inherently part of the design verification and validation activities, particularly for functionalities related to "res resection planning," "single point acquisition," and "mechanical axis and sagittal plane reconstruction." These would evaluate the accuracy and functionality of the software's calculations and measurements independent of the surgeon's real-time input, though the text does not explicitly use the term "standalone performance." The "simulated user setting" test with a surgeon would combine both algorithm and human-in-the-loop.

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

Given the nature of the device (surgical navigation), the "ground truth" for the verification and validation activities likely involved predefined geometric or anatomical targets and measurements within the simulated environment. For example, for "resection planning," the system's output for bone cuts would be compared against the ideal planned cuts. For "mechanical axis and sagittal plane reconstruction," the system's computed axes would be compared against known or calculated true axes. The document does not explicitly state the type of ground truth in terms such as "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of 510(k) submission generally focuses on design verification and validation of a defined software version, not on the developmental process involving a training set for machine learning. The system's core principle is "stereotaxic technology," implying pre-programmed algorithms rather than machine learning models requiring training data.

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

Since a training set is not mentioned, there is no information on how its ground truth would have been established.

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