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Medacta Shoulder System - Reverse

Reverse Shoulder Prosthesis

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

Short Humeral Diaphysis

The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy.

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.

Medacta Shoulder System - Anatomic

Anatomic Shoulder Prosthesis

The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

Short Humeral Diaphysis

The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Shoulder Systems are modular systems intended to be used for shoulder arthroplasty (anatomical or reverse). System components were previously cleared by the FDA under K170910 (anatomic shoulder prosthesis) and K170452 (reverse shoulder prosthesis).

The Long Humeral Diaphysis implants, subject of this 510(k), are implantable devices used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System components as an alternative to the Standard Humeral Diaphysis components provided with those systems.

The Medacta Shoulder System Long Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the cemented and cementless Humeral Anatomic Metaphysis (K170910) in the anatomic configuration. The long humeral diaphysis, provided in 160 mm and 200 mm length options, may be used when additional distal stability in the humeral canal is needed.

The subject devices are manufactured from titanium alloy (Ti6A17Nb) and are provided sterile in 11 sizes per length option.

This device is a medical implant, not an AI/ML device, therefore, the requested information regarding acceptance criteria and study details related to AI/ML performance is not applicable. The provided text is an FDA 510(k) clearance letter and summary for a physical medical device: the Medacta Shoulder System. This document focuses on demonstrating substantial equivalence to a predicate device through material, design, and performance testing, which are different from the criteria typically found in AI/ML device evaluations.

However, I can provide a summary of the performance data that was provided in support of the substantial equivalence determination for this medical device, as described in the document.

Performance Data Provided:

The 510(k) summary lists the following performance data:

• Sterilization Validation: Per UNI EN ISO 11137-1:2015 and AAMI/ANSI/ISO 11137-2:2013. This ensures the device can be properly sterilized for safe use.
• Fatigue Testing: Per ASTM F1378-17. This evaluates the device's mechanical durability and its ability to withstand repeated stress over time, simulating conditions within the human body.
• Cadaver Studies: These studies typically assess surgical technique, implant fit, and preliminary biomechanical performance within an anatomical context.

Please note that none of the specific AI/ML related questions (sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are relevant to the information presented in this 510(k) summary for the Medacta Shoulder System.

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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 rotator cuff deficient shoulder joint with severe arthropathy failed joint replacement with 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 Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy.

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 Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder ioint, severe arthropathy failed ioint replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application.

The Medacta Anatomic Shoulder Prosthesis - Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid component is intended for cemented application.

The Medacta Shoulder System Short Humeral Diaphysis is an implantable device used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System cleared under K170452 and the Medacta Anatomic Shoulder Prosthesis cleared under K170910, as an alternative to the Standard Humeral Diaphysis - Cementless provided with those systems.

The Medacta Shoulder System Short Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the Humeral Anatomical Metaphysis -Cementless (K170910) in the anatomic configuration. The short humeral diaphysis implant minimizes the violation of the humeral intramedullary canal (IM).

The product is manufactured from titanium alloy (Ti6Al7Nb) and is provided sterile in 11 sizes.

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter and a 510(k) Summary for the "Medacta Shoulder System Short Humeral Diaphysis."

While it mentions that "verification activities, as identified through risk analysis, were conducted on the worst-case implants to written protocols with pre-defined acceptance criteria," it does not provide specific details on these acceptance criteria or the results of those tests for the subject device. It primarily states that the subject device did not represent a new worst-case for mechanical testing and that performance tests were conducted on the predicate devices (K170452 and K170910).

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: The document mentions "pre-defined acceptance criteria" but does not state what they are, nor does it report the performance against these criteria for the subject device.
2. Sample size used for the test set and the data provenance: Not mentioned for the subject device.
3. Number of experts used and their qualifications: Not applicable, as this is a mechanical device clearance, not an AI/diagnostic device.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only): Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on establishing substantial equivalence based on intended use, design, technological characteristics, and that the performance data from predicate devices were reviewed.

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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 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 deficient rotator cuff shoulder joint.

The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo.

The glenoid baseplate is intended for cementless application of screws for primary stability.

The Medacta Shoulder System is a modular system intended to be used for Reverse Shoulder Arthroplastises (RSA). The Medacta Shoulder System is composed of the following components:

• Humeral Diaphysis Cemented
• Humeral Diaphysis - Cementless
• Humeral Reverse Metaphysis
• Humeral Reverse HC Liner (also referred to as PE Liner)
• Glenoid Baseplate
• Glenoidsphere
• Glenoid Polyaxial Locking Screws
• Reverse Metaphysis Screw
• Glenoidsphere Screw

The Humeral Diaphysis and Humeral Reverse Metaphysis are intended to be assembled together by means of a cylindrical driven-fit coupling and tightened by the Reverse Metaphysis Screw. The Humeral Reverse HC Liner is intended to be coupled by means of an embedded clipping mechanism with the Humeral Reverse Metaphysis.

The Glenoid Baseplate is intended to be fixed on the glenoid bone by means of a central press-fit and with the help of Glenoid Polyaxial Locking Screws. The Glenoidsphere is intended to be assembled with the Glenoid Baseplate by means of a taper Morse connection and secured by the Glenoidsphere Screw.

The Glenoidsphere Screw, Reverse Metaphysis Screw, and Glenoid Polyaxial Locking Screws are made of Ti alloy enhanced with Type-II anodization.

This document is a 510(k) summary for the Medacta Shoulder System, a medical device. It does not describe an AI/ML device, nor does it present acceptance criteria or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, or MRMC studies for an AI/ML device from this document.

The document discusses the substantial equivalence of the Medacta Shoulder System to predicate devices based on:

1. Indications for Use: The Medacta Shoulder System is indicated for treatment of humeral fractures and primary or revision total shoulder replacement in patients with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement and a grossly deficient rotator cuff shoulder joint.
2. Technological Characteristics: Similarities in materials (Titanium Alloy, Cobalt Chromium, UHMWPE), design, coating, thread design, device usage, and sterility to predicate devices.
3. Non-Clinical Studies: Mechanical tests (Wear, Fatigue, Static Fatigue, Micromotions Assessment), and Coating Tests following ASTM standards.
4. Biocompatibility: Demonstrated through similarities in materials to predicate devices and adherence to manufacturing standards.
5. Pyrogenicity: Assessed using Bacterial Endotoxin Test (LAL test) and Pyrogen Test according to European Pharmacopoeia and USP chapters.

No clinical studies were conducted for the Medacta Shoulder System to support the 510(k) submission.

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