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The NextStep Arthropedix Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.

The NextStep Arthropedix Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.

The NextStep Arthropedix Total Knee System is designed for cemented use only.

The subject device submission includes a combination of devices based on previously cleared devices (K142649 and K150783) and devices with new designs. This submission will include several identical devices reviewed in K142649 and K150783, new devices not yet reviewed by FDA, and new cleaning, packaging, and sterilization validations for all implants. The subject device submission includes 2 system options for total knee replacement:

• Option 1 – Posterior Stabilized (PS), Cruciate Retaining (CR), and Ultra Congruent Cruciate Retaining (UC-CR) patellofemorotibial total knee replacement system that is based on the Progressive Orthopedic Total Knee System cleared in K142694 and K150783

  • Includes additional femoral component sizes, additional vitamin E UHMWPE material option for the symmetrical tibial inserts, and manufacturing patellar components from vitamin E UHMWPE only.

• Option 2 – Medial Pivot Total Knee System, including cruciate retaining (MP-CR) and cruciate substituting (MP-CS) tibiofemoral articulation

The provided FDA 510(k) clearance letter describes a medical device, the NextStep Arthropedix Total Knee System, but it is not a software device or an AI/ML device.

The document primarily focuses on the mechanical and material properties of a knee implant system, comparing it to predicate devices. There is no mention of "acceptance criteria" related to an algorithm's performance, nor is there a "study" involving data sets, expert ground truth, or statistical measures like sensitivity, specificity, or AUC, which are typical for AI/ML device evaluations.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The concepts of "test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," and "training set" are not applicable to the information provided in this 510(k) summary for a physical knee implant.

The "Non-Clinical and/or Clinical Tests Summary" section lists mechanical tests performed for the physical device, such as fatigue performance, interlock mechanism strength, and wear testing. These are physical tests, not evaluations of an AI algorithm's computational performance.

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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, traumator arthritis, theumatord arthritis.
• 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 tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

The GMK Sphere Revision is a Medacta GMK line extension to provide a larger product offering. The subject devices are designed for cemented use in total knee arthroplasty procedures. The GMK Sphere Revision system includes:

• Femoral components, left and right, sizes from 2 to 8, with or without TiNbN coating; ●
• . Tibial trays, left and right, sizes T3I4 and T4I3, with or without TiNbN coating;
• Distal wedges, 4 sizes (2, 3-4, 5-6, 7-8) with thicknesses 4, 8, 12, 16 and 20 mm; ●
• Posterior wedges, 6 sizes (2, 3-4, 5, 6, 7, 8) with thicknesses 4, 8 and 12 mm; ●
• Offset connectors from 2 to 5 mm. ●

The GMK Sphere Revision implants, both femoral components and tibial trays, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4 and they are available with or without Titanium Niobium Nitride (TiNbN) coating.

The GMK Sphere Revision wedges and offset connectors, are manufactured from Ti6A14V per ISO 5832-3.

The provided document describes a 510(k) premarket notification for a medical device, specifically a knee prosthesis called "GMK Sphere Revision." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through extensive clinical studies as one might find for novel AI/ML devices or high-risk devices.

Therefore, the information you've requested regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically associated with the development and validation of sophisticated medical software or AI/ML algorithms, is largely not present in this document. This document emphasizes non-clinical performance testing to show the new device (GMK Sphere Revision) is comparable to existing predicate devices, rather than an AI/ML system proving its diagnostic accuracy against human experts or a gold standard.

Here's how to interpret the available information concerning your request, and where the requested details are not applicable or not provided:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for clinical outcomes or diagnostic accuracy. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device's technical characteristics and performance in non-clinical tests are comparable to the predicate devices and meet relevant ISO and ASTM standards for biomechanical properties, wear, and material safety.
• Reported Device Performance: Instead of specific performance numbers against clinical metrics, the document lists the types of non-clinical tests performed. The implication is that the device passed these tests and exhibited performance comparable to the predicate.

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

• Test Set (for performance testing): For a medical device like a knee prosthesis, "test set" refers to the physical samples of the device components used for biomechanical and material testing. The document does not specify the number of samples used for each non-clinical test.
• Data Provenance: Not applicable in the context of clinical data for this type of submission. The tests are benchtop, in-vitro, or material characterization tests.

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

• Not Applicable. This document is for a traditional medical device (implantable prosthesis), not an AI/ML diagnostic system that requires expert ground truth labeling of patient data.

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

• Not Applicable. Adjudication methods are relevant for human reader studies or expert consensus for AI/ML ground truth, neither of which are 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. This is a 510(k) for a physical implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance comparisons are not relevant and were 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-based device.

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

• Not Applicable. For the non-clinical tests, the "ground truth" is defined by the accepted and validated methodologies of the ISO and ASTM standards themselves (e.g., how much force a component can withstand, how much wear occurs under specified conditions, etc.). There is no clinical "ground truth" such as pathology or outcomes data presented here.

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 above, no training set for an algorithm is involved.

In summary, the provided FDA 510(k) clearance letter and its summary are for a conventional orthopedic implant. The substantial equivalence pathway for such devices primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and comparable performance (through non-clinical bench testing) to a predicate device. It does not involve the types of studies, ground truth establishment, or expert-based evaluations typically associated with AI/ML-driven medical devices.

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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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