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

The use of the cementless GMK femur is limited to cases in which the surgeon considers the bone quality to be sufficient for cementless applications.

The GMK 3D Metal Tibial Baseplate is indicated for cemented application 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
• Collagen disorders, and avascular necrosis of the 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 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.

It is not possible to implant tibial wedges and extension stems with the GMK 3D Metal Tibial Baseplate.

Limitations for use for GMK Sphere/GMK SpheriKA used with kinematic alignment

GMK Sphere and GMK SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Collagen disorders, and/or avascular necrosis of the femoral condyle
• Moderate valgus, varus, or flexion deformities.

The GMK Sphere & GMK SpheriKA Cementless is a line extension to the GMK Total Knee System and includes the following devices:

• GMK Sphere Cementless Femoral Components, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes);
• GMK SpheriKA Cementless Femoral Components. Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes);
• GMK SpheriKA ST Cementless Femoral Components, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes).

The subject devices are marketed as individually packaged femoral components, designed for cementless use in total knee arthroplasty procedures where the surgeon considers the bone quality to be sufficient for cementless applications.

The GMK Sphere & GMK SpheriKA Cementless implants 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 double-layer coating composed of Titanium plasma spray according to ISO 13179-1 Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants -- Part 1: General requirements and Hydroxyapatite according to ISO 13779-2 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite on the internal surface pockets.

This document refers to the review of a 510(k) premarket notification for the "GMK Sphere & GMK SpheriKA Cementless" knee prosthesis. Based on the provided text, there is no acceptance criteria and study that proves the device meets the acceptance criteria in the traditional sense of evaluating an algorithm's performance against predefined metrics (e.g., sensitivity, specificity for diagnostic devices).

This submission is for a medical device (knee prosthesis), not an AI/ML powered device, and the "performance data" provided refers to engineering and biocompatibility testing, not clinical performance metrics or studies involving human readers or ground truth as would be relevant for AI.

Here's a breakdown of why the requested information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes a comparison to predicate devices, not the setting of specific performance targets (like accuracy, precision, etc.) for an AI/ML algorithm. The "performance data" listed are non-clinical engineering tests (mechanical properties, microscopy, pyrogenicity, biocompatibility, shelf-life) which are not presented with acceptance criteria and results in the format requested.

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm's performance evaluation. The "tests" performed are on the physical device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to an independently verified correct answer for a given input. This concept is not relevant to the described premarket notification for a knee prosthesis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no adjudication process described as it pertains to medical image interpretation or similar tasks for an algorithm.

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 document explicitly states: "No clinical studies were conducted." The device is a physical knee implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" as an expert-derived annotation or definitive diagnosis is not relevant to the evaluation of a physical knee implant.

8. The sample size for the training set: Not applicable. There is no AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML algorithm or training set.

In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review for a physical orthopedic implant (a knee prosthesis), not an AI/ML-powered medical device. Therefore, the questions related to acceptance criteria and study design for AI/ML performance evaluation are not applicable to this document. The "Performance Data" section details non-clinical laboratory testing for material properties, sterility, and biocompatibility to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation from AI/ML performance studies.

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The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy failed joint replacement and a grossly rotator cuff deficient shoulder joint.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The purpose of this submission is to gain clearance for the new Medacta Shoulder System: Threaded Glenoid Baseplate (also referred to as Threaded Glenoid Baseplate) which is part of the Medacta Shoulder System: Reverse; a modular system intended to be used for Reverse Shoulder Arthroplasties (RSA). The Medacta Shoulder System: Threaded Glenoid Baseplate is an alternative option to the pegged glenoid baseplate that is part of reference device Medacta Shoulder System (K170452). The Medacta Shoulder System: Threaded Glenoid Baseplate is made of titanium alloy.

The Threaded Glenoid Baseplate is intended to replace only the glenoid side of the glenohumeral joint. The Threaded Glenoid Baseplate is intended to be used in the reverse configuration only. The Threaded Glenoid Baseplate is designed to be fixed on the glenoid bone by means of a central threaded post and the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with a Glenoid Baseplate by means of a taper Morse connection and secured by a central securing screw. The Threaded Glenoid Baseplate directly couples with the Glenoid Polyaxial Locking Screws and Glenoidsphere as part of the Medacta Shoulder System (K170452).

The provided text describes a 510(k) premarket notification for a medical device (Medacta Shoulder System: Threaded Glenoid Baseplate), not an AI/ML powered device. Therefore, the information requested in the prompt, such as acceptance criteria for AI performance metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and non-clinical performance testing for a physical implant. The relevant "acceptance criteria" in this context refer to the successful completion and passing of these mechanical and material tests based on established standards.

Here's the information that can be extracted or inferred from the provided text, framed within the spirit of the request as much as possible for a non-AI device:

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

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

• Sample size: Not specified as individual units. For mechanical testing, samples are typically tested until the standard's criteria are met or failure modes are understood. The text states "testing was conducted."
• Data provenance: The tests were non-clinical (laboratory/mechanical testing). The device manufacturer is Medacta International SA, located in Switzerland. The testing was conducted in support of an FDA 510(k) submission in the USA.

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)

• Not applicable. This device is a physical implant, not an AI model that requires expert-established ground truth from medical images or data. The "ground truth" here is the physical and mechanical performance of the device against engineering standards.

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

• Not applicable. This is not an AI/ML clinical study. Adjudication methods are relevant for resolving discrepancies in human expert evaluations, which is not pertinent to mechanical testing.

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. The document explicitly states: "No clinical studies were conducted." This relates to a physical implant, not an AI device, so MRMC studies examining reader performance with or without AI assistance are not relevant.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

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

• The "ground truth" for this device's performance is defined by established engineering and material science standards (e.g., ASTM F1378-12, ASTM F2028-14, European Pharmacopoeia, USP chapters). Compliance with these standards demonstrates the physical and mechanical integrity and biocompatibility of the implant.

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. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System.

The Evolis Total Knee System 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.

The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System. The Medacta Bone Screws have a thread diameter of 6.5 mm. The Medacta Bone Screws come in six lengths from 20 mm to 45 mm in increments of 5 mm. The Medacta Bone Screws are made of titanium alloy (Ti6-Al4-V) according to ISO5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy.

The provided K091069 510(k) summary describes a traditional 510(k) submission for the Medacta Bone Screws. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through material, design, and performance testing against recognized standards, rather than a clinical study evaluating diagnostic performance using AI.

Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Performance testing," which was conducted in accordance with ASTM F543-07 and FDA guidance documents. This testing demonstrated conformance to these standards.

Information on AI-Related Aspects (Not Applicable to this 510(k)):

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This was not an AI-based diagnostic device. The "test set" would refer to the physical bone screws tested per ASTM F543-07, not a dataset.
• 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): Not applicable. There was no "ground truth" in the clinical sense for this type of device submission. Performance was based on mechanical testing.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for bone screws is their mechanical properties meeting established engineering standards.
• The sample size for the training set: Not applicable. This was not an AI device, so there was no training set.
• How the ground truth for the training set was established: Not applicable.

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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 marker and and 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 optimally 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 key 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 Evolis Global Femur First is designed to work with Medacta's Evolis Total Knee System, cleared under K081023. The manual reusable surgical instruments include instruments specifically designed for navigated surgery and other standard surgical instruments needed to conduct total knee replacement.

The provided text describes performance testing for the iMNS Medacta Navigation System. However, it does not contain specific acceptance criteria, reported device performance metrics, or details about the study design that would allow for a comprehensive answer to all parts of your request.

Here's what can be extracted and what information is missing:

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

Missing Information: Specific quantitative or qualitative acceptance criteria were not provided in the document. Therefore, actual reported performance metrics cannot be listed. The document only states that "all acceptance criteria" were met.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document refers to "simulated user setting" and "a surgeon," but no details on the number of cases or the nature of the data (retrospective/prospective, country of origin) are given.

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

• Number of Experts: "a surgeon" – implies at least one, but the exact number isn't quantified.
• Qualifications of Experts: Only "surgeon" is mentioned. Further specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication method for the test set:

• Adjudication Method: Not specified. With only "a surgeon" mentioned, it's unlikely a formal adjudication method like 2+1 or 3+1 was necessary or described for a single user evaluation.

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:

• MRMC Study: No. This device is a navigation system for surgery, not an AI diagnostic tool involving human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• Standalone Performance: The description emphasizes that the system "assists the surgeon" and "the surgeon maintains control." It provides "real-time support and information throughout the surgery." This strongly indicates that it is a human-in-the-loop system, and a standalone algorithm-only performance assessment would not be relevant or described as such.

7. The type of ground truth used:

• Type of Ground Truth: The context suggests that the ground truth for "design validation" was based on whether "the system meets user needs and intended uses" in a "simulated user setting." For a surgical navigation system, this would typically involve assessing the accuracy of anatomical landmarks, cutting guides, and implant positioning relative to surgical plans or anatomical references, often determined by the evaluating surgeon's assessment of surgical outcomes in the simulated environment. No pathology or outcomes data from actual patients are mentioned for this validation.

8. The sample size for the training set:

• Training Set Sample Size: Not specified. The document describes "design verification" and "design validation" but does not detail a separate "training set" for a machine learning model, as this is a computer-aided navigation system based on stereotaxic technology, not a deep learning AI model that requires extensive training data in the typical sense.

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

• Training Set Ground Truth Establishment: Not applicable/not specified, as the system does not appear to be a machine learning model that learns from a "training set" with established ground truth in the conventional sense. The system's functionality is based on established stereotaxic principles and proprietary software logic.

In summary, the provided document describes a computer-aided surgical navigation system and its regulatory clearance process. While it states that performance testing was conducted and all acceptance criteria were met, it lacks the detailed quantitative and qualitative results, study design specifics, sample sizes, and expert qualifications often found for AI/ML-based diagnostic devices. This is likely because the device is a navigation system based on established principles, rather than a machine learning algorithm requiring extensive data-driven validation for diagnostic accuracy.

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